FDA Calendar

REGENXBIO today reported new, positive interim data from two additional patients in the Phase I/II portion of the AFFINITY DUCHENNE® trial of RGX-202, a differentiated investigational gene therapy for Duchenne muscular dystrophy (Duchenne).

Can-Fite BioPharma Ltd announced that a Phase II design is completed and preparatory work is undergoing for the initiation of clinical study in the rare genetic disease Lowe Syndrome.

bioAffinity Technologies, Inc today released a study of a complex clinical case in which CyPath® Lung's real-time assessment of the lung microenvironment identified a hidden recurrence of breast cancer in an 80-year-old high-risk patient.

Conduit Pharmaceuticals Inc today provides an R&D update on the development progress of pipeline assets AZD1656, AZD5658, and AZD5904.

Tenaya Therapeutics, Inc announced that new clinical and disease burden data pertaining to the company's MYBPC3-associated hypertrophic cardiomyopathy (HCM) program will be presented at the upcoming American College of Cardiology's Annual Scientific Session being held March 29-31, 2025 in Chicago, IL.

CERo Therapeutics Holdings, Inc announces an agreement with the University of California Davis for the manufacturing of CER-1236 to be used in the Company's upcoming Phase 1 clinical trial for Acute Myeloid Leukemia (AML).

Acumen Pharmaceuticals announced topline results from its Phase 1 study comparing pharmacokinetics (PK) between subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy volunteers.

Onconetix, Inc. announced that an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain.

Protara Therapeutics, Inc. announced that data from THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS), will be featured during an oral session at the American Society for Parenteral and Enteral Nutrition (ASPEN) 2025 Nutrition Science & Practice Conference, taking place March 22 through March 25, 2025 in Columbus, Ohio.

Orthofix Medical Inc announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the European CE Mark for the TrueLok™ Elevate Transverse Bone Transport (TBT) System.

Acrivon Therapeutics, Inc announced it will be holding a virtual R&D event on March 25, 2025 from 4:00 p.m. to 5:15 p.m. ET.

RenovoRx, Inc. announce a presentation of a new pre-clinical clinical data abstract at the upcoming Society of Surgical Oncology (SSO) 2025 Annual Meeting.

Immunovant, Inc reported topline results from its Phase 3 study of batoclimab in MG and initial results from Period 1 of its Phase 2b study in CIDP.

Precision BioSciences, Inc announced the presentation of preclinical data for its PBGENE-DMD development program for the treatment of Duchenne muscular dystrophy (DMD) during an oral presentation at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference being held March 16-19, 2025 in Dallas, TX.

Servier and Black Diamond Therapeutics, Inc announced a strategic worldwide licensing agreement for BDTX-4933, a potential best-in-class targeted therapy for solid tumors.

Benitec Biopharma Inc. announces continued durable improvements in swallowing function and reductions in total dysphagic symptom burden following administration of the low-dose of BB-301 in the first three Subjects treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD).

Atea Pharmaceuticals, Inc. announced the poster presentation of bemnifosbuvir preclinical data at the 38th International Conference on Antiviral Research (ICAR) 2025 taking place March 17-21, 2025 in Las Vegas, Nevada.

MediWound Ltd. Provides Corporate Update

Merck announced that Health Canada approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA® as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

Biodexa Pharmaceuticals PLC announced that it is making progress in readying the launch of a phase 3 trial for eRapa, its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP)..

Merck announced that new clinical and outcomes research data will be presented at the American College of Cardiology's Annual Scientific Session and Expo (ACC.25) in Chicago from March 29-31.

Liquidia Corporation Provides Corporate Update

Virpax Pharmaceuticals, Inc announced positive results from a beagle dog dose range finding ("DRF") study. .

Olema Pharmaceuticals provided updates

Trevi Therapeutics, provided business updates.

Tonix Pharmaceuticals provided an overview of recent operational highlights.

Innovent Biologics, Inc and HUTCHMED (China) Limited jointly announce that the FRUSICA-2 Phase 2/3 clinical trial evaluating sintilimab in combination with fruquintinib as second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China has met its primary endpoint of progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR).

Biofrontera Inc. announced the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk.

Dogwood Therapeutics, Inc. announces the dosing of the first patient in its Phase 2b clinical trial, referred to as HALT-CINP (Halneuron® Treatment of Chemotherapy-Induced Neuropathic Pain), evaluating Halneuron® for the treatment of neuropathic pain associated with prior chemotherapy treatment ("CINP").

Dr. Reddy's Laboratories Ltd and Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia® (denosumab) and Xgeva® (denosumab).

Can-Fite BioPharma Ltd. announced that it received a single FDA approval for the compassionate use treatment of a U.S. based pancreatic cancer patient with its anti-cancer drug Namodenoson.

Alpha Cognition Inc announced the official commercial launch of ZUNVEYL, a new treatment for mild to moderate Alzheimer's disease.

Aptevo Therapeutics a leader in the development of novel bispecific antibodies for cancer treatment, based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies provided an overview of solid tumor anti-cancer compound APVO603, currently in preclinical development for the treatment of solid tumors.

Hoth Therapeutics, Inc. announced breakthrough preclinical findings demonstrating the efficacy of HT-KIT, a novel targeted therapy for gastrointestinal stromal tumors (GIST). T

SCIENTURE HOLDINGS, announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL.

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sjögren's disease (SjD), having previously been granted Breakthrough Therapy designation (BTD) for the investigational therapy late last year.

Ocugen, Inc. announced that the Data and Safety Monitoring Board (DSMB) for the OCU200 clinical trial recently convened and reviewed safety data following dosing of the first cohort in the dose-escalation portion of the Phase 1 study and approved continuation of dosing in the second cohort.

Cidara Therapeutics, Inc. announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR).

ZyVersa Therapeutics, Inc. highlights newly published animal model data demonstrating that inflammasome inhibition attenuates obesity-associated cardiomyopathy, which has a 5-year survival rate <50%.

Indaptus Therapeutics Tells Benzinga Co. Initiates Phase I Combination Study Of Decoy20 With PD-1 Checkpoint Inhibitor Tislelizumab

Clearmind Medicine announces that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile of its innovative treatment, CMND-100, in Alcohol Use Disorder (AUD) patients.

Stoke Therapeutics, Inc provided business updates.

RedHill Biopharma Ltd announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of helicobacter pylori (H. pylori) infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval..

Compass Pathways plc announced the publication of results from the COMP004 study, an observational 52-week follow-up from the Phase 2 COMP001 and COMP003 trials of COMP360 psilocybin treatment in patients with treatment-resistant depression (TRD).

Genmab A/S announced today updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S®), an investigational folate receptor-alpha (FRα)-targeted, TOPO1 antibody-drug conjugate (ADC) that showed Rina-S 120 mg/m2 every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRα expression levels.

Capricor Therapeutics announced positive long-term data from its ongoing HOPE-2 open label extension ("OLE") clinical trial, demonstrating the potential of the Company's lead asset, deramiocel, to slow disease progression and preserve upper limb function in patients with Duchenne muscular dystrophy ("DMD").

Actinium Pharmaceuticals, Inc. announced that results from the clinical trial evaluating Actimab-A in combination with the chemotherapy CLAG-M in patients with relapsed/refractory acute myeloid leukemia (r/r AML) have been published in the peer-reviewed journal Leukemia.

Neurocrine Biosciences, Inc. presented data from the KINECT®-HD study showcasing significant improvements in chorea across body regions with once-daily INGREZZA® (valbenazine) capsules in adults with Huntington's disease.

vTv Therapeutics Inc. announced that the United States Food and Drug Administration (FDA) has lifted the clinical hold on the cadisegliatin clinical program, which includes the CATT1 Phase 3 trial in type 1 diabetes (T1D).

Savara Inc announced the acceptance of two abstracts for poster presentation at the American Thoracic Society (ATS) International Conference taking place May 16-21, 2025, in San Francisco, CA.

GRI Bio, Inc provided a corporate update.

Allarity Therapeutics, Inc. announced the presentation of new clinical data from its ongoing Phase 2 trial with stenoparib monotherapy in advanced Ovarian Cancer at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer, held March 14-17 in Seattle, Washington.

Xeris Biopharma Holdings, Inc. announced that its supplemental new drug application (sNDA) of Gvoke VialDx™ has received U.S Food and Drug Administration (FDA) approval for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

CEL-SCI Corporation announced it received comments from the U.S. Food and Drug Administration (FDA) on the confirmatory Registration Study's Statistical Analysis Plan (SAP) submitted in December of 2024 for the study of Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer.

MBX Biosciences, Inc. highlighted recent corporate progress.

CervoMed Inc Provides Corporate Updates

atai Life Sciences Recent Corporate Highlights

Mineralys Therapeutics, Inc. announced that data from the Phase 2 Advance-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) will be presented in a late-breaking clinical trials session at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25), which is being held in Chicago on March 29-31, 2025.

Pliant Therapeutics, Inc announced data from the first three of five potential cohorts of its ongoing Phase 1 dose escalation clinical trial evaluating PLN-101095, an integrin αvβ8 and αvβ1 inhibitor, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI) -refractory advanced or metastatic solid tumors.

ProKidney Corp. provided business highlights for the year ended December 31, 2024.

Arcutis Canada, Inc announced that Health Canada has approved PrZORYVE® (roflumilast cream 0.15%), for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older.

Precision BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PBGENE-HBV.

Travere Therapeutics, Inc., announced the Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking priority review for traditional approval of FILSPARI® (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS).

Avidity Biosciences, Inc. announced positive del-zota topline data from the Phase 1/2 EXPLORE44® trial in people living with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44) demonstrating consistent, statistically significant improvements in dystrophin, exon skipping and creatine kinase as well as favorable safety and tolerability across the dose cohorts.

Incyte announced positive topline results from its pivotal Phase 3 STOP-HS clinical trial program evaluating the safety and efficacy of povorcitinib (INCB054707), an oral small-molecule JAK1 inhibitor, in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS).

Harrow today introduced VEVYE® Access for All, a groundbreaking initiative that underscores Harrow's long‑standing commitment to access and affordability.

Nurix Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to bexobrutideg (NX-5948) for the treatment of Waldenström macroglobulinemia (WM).

Perspective, Therapeutics, Inc. announced that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), in patients with histologically confirmed melanoma and positive melanocortin 1 receptor (MC1R) imaging scans.

Monogram Technologies announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance

Greenwich LifeSciences, announced the following update on FLAMINGO-01 open label safety data.

Cidara Therapeutics, Inc. announced the publication of preclinical data assessing CD388, the company's influenza DFC, in the peer-reviewed scientific journal Nature Microbiology.

AstraZeneca announced High-level results from the CALYPSO Phase III trial showed that eneboparatide (AZP-3601), an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with statistical significance in adults with chronic hypoparathyroidism (HypoPT) at 24 weeks, compared to placebo.

Scholar Rock announced that new efficacy and safety data from the Phase 3 pivotal SAPPHIRE trial (NCT05156320) will be presented in multiple clinical presentations at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Dallas, Texas.

Dyne Therapeutics, Inc. announced that Potential for Biologics License Application submission for U.S. accelerated approval in early 2026 -

Dyne Therapeutics, Inc. announced new long-term clinical data from its ongoing Phase 1/2 DELIVER trial of DYNE-251 demonstrating unprecedented and sustained functional improvement at the selected registrational dose of 20 mg/kg Q4W (approximate PMO dose).

Sutro Biopharma, Inc announced expanded data in a late-breaking oral presentation from the dose-optimization portion of the REFRαME-O1 trial with luveltamab tazevibulin (luvelta) in patients with platinum resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer®.

Zentalis® Pharmaceuticals, announced updated clinical data from Part 1b of the ongoing DENALI clinical trial of azenosertib in patients with PROC in an oral presentation at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer.

Palisade Bio, Inc today provided an update on its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).

Korro Bio, Inc announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the investigational medicine KRRO-110 for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

Gain Therapeutics, Inc announced the dosing of the first participant with Parkinson's disease (PD) in its Phase 1b clinical trial of GT-02287, the Company's lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation.

Bristol Myers Squibb announced that the European Commission (EC) has granted approval to Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Eton Pharmaceuticals, Inc announced positive results from its bioequivalence study of ET-600, a proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.

ANI Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).

bioAffinity Technologies, Inc announced the release of physicians' case studies showing the benefit to patients and their doctors of using CyPath® Lung, the Company's noninvasive test for early detection of lung cancer.

ImmunityBio, Inc announced U.S. Urology Partners, one of the nation's largest independent providers of urology and related specialty services, is one of the first providers to participate in ImmunityBio's Expanded Access Program (EAP) for recombinant Bacillus Calmette-Guérin (rBCG) to address the current shortage of TICE® BCG in the U.S.

Allarity Therapeutics, Inc announced that it has reached a final settlement with the U.S. Securities and Exchange Commission (SEC) relating to the previously disclosed investigation regarding the Company's past disclosures concerning its interactions with the U.S. Food and Drug Administration (FDA) regarding its New Drug Application ("NDA") for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.

Femasys Inc announces Conformité Européene (CE) mark certification under European Union Medical Device Regulation (EU MDR) as the first regulatory approval in the world for the FemBloc® delivery system for non-surgical female permanent birth control.

Emergent BioSolutions Inc. is strengthening relationships with partners across sectors and continuing its commitment to ensuring widespread opioid emergency preparedness as opioid overdose death rates continue to decline nationwide for the first time in five years.1 These efforts include working with organizations to expand access to NARCAN® Nasal Spray and educate the public on how to respond to an opioid overdose emergency.

Amgen announced new data from the Phase 3, registrational MINT trial evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) in adults living with generalized myasthenia gravis (gMG).

CERo Therapeutics Holdings, Inc announces it is presenting encouraging preclinical results of lead compound CER-1236 in ovarian cancer during the 2025 SITC Spring Scientific Cellular Therapy for Solid Tumors in San Diego, March 12-14.

Vir Biotechnology, Inc announced the enrollment of the first patient in its Phase 3 ECLIPSE registrational program.

PDS Biotechnology announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug ("IND") application filed in January 2025 to evaluate a combination of Versamune® MUC1 (formerly PDS0103), its novel investigational MUC1-targeted immunotherapy candidate + PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma ("mCRC") in patients who failed previous treatment.

Tempest Therapeutics, announced that the Cancer Prevention Clinical Trials Network received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA) to evaluate TPST-1495, the company's novel dual receptor inhibitor of prostaglandin (PGE2) signaling, in a Phase 2 clinical trial for the treatment of patients with Familial Adenomatous Polyposis (FAP).

TransCode Therapeutics, Inc. announced that the Safety Review Committee (SRC) monitoring its Phase I clinical trial has unanimously approved opening of the fourth cohort of patients based on the SRC's favorable review of Cohort 3 safety data.

MIRA Pharmaceuticals Inc announced the formulation of Ketamir-2 as a topical treatment for localized neuropathic and inflammatory pain.

OS Therapies, Inc announced that it has been awarded a presentation slot at the MIB Agents Factor Osteosarcoma Conference to be held June 26-28, 2025 in Salt Lake City, Utah.

Lucid Diagnostics and subsidiary of PAVmed Inc. announced that Highmark Blue Cross Blue Shield, an independent licensee of the Blue Cross and Blue Shield Association, has issued a positive coverage policy for non-invasive screening of esophageal precancer and cancer in New York state.

Vivani Medical, Inc announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1™ clinical trial.

MeiraGTx Holdings plc announced a broad strategic collaboration with Hologen Limited, a world-leading developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development.

Indaptus Therapeutics, Inc provides a corporate update.

Akebia Therapeutics® recent business highlights.

Cellectar Biosciences, provided a corporate update.

Vigil Neuroscience, provided updates on recent progress.

Cartesian Therapeutics, outlined recent corporate updates.

Unicycive Therapeutics, announced that it will present patient reported outcomes data from its pivotal UNI-OLC-201 clinical study characterizing the potential impact of oxylanthanum carbonate (OLC) on the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

Seres Therapeutics provided business updates.

SCYNEXIS, Inc. Provides Corporate Update

Avidity Biosciences, Inc. announced that the company will be presenting one oral and two poster presentations at the 2025 MDA Clinical & Scientific Conference (MDA) in Dallas, Texas, being held March 16-19, 2025 and will host an investor and analyst webcast event on March 17, 2025.

aTyr Pharma, Inc. announced a publication demonstrating the mechanism of action for its lead therapeutic candidate, efzofitimod, in the journal Science Translational Medicine.

Merck announced the presentation of positive results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100mg/0.25mg)] in adults with HIV-1 infection that is virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF (50mg/200mg/25mg)] in trial MK-8591A-052) or antiretroviral therapy [baseline antiretroviral therapy (bART)] in trial MK-8591A-051.

Palisade Bio, Inc. announced that it has been selected to present data from its lead program PALI-2108 for the treatment of ulcerative colitis at Digestive Disease Week® (DDW) 2025 being held May 3–6, in San Diego, California.

Corvus Pharmaceuticals, Inc announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has initiated a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease.

iECURE, Inc announced that initial data from the Phase 1/2OTC-HOPE clinical trial evaluating in vivo gene editing candidate ECUR-506 in neonatal onset ornithine transcarbamylase (OTC) deficiency will be presented at the 2025 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting taking place March 18-22, 2025 in Los Angeles.

Theratechnologies Inc. today presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV.

Sagimet Biosciences provided recent corporate updates.

KalVista Pharmaceuticals, Inc provided an operational update.

RedHill Biopharma Ltd. announced plans to advance its groundbreaking late-stage program for Crohn's disease (CD) with initiation of an innovative Phase 2 study of RHB-204 in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe CD, utilizing novel endpoints and the new gold standard in imaging techniques, pending Type C discussions on path to FDA approval with guidance from FDA anticipated next quarter.

Geron Corporation announced that the European Commission (EC) has granted marketing authorization for RYTELO® (imetelstat) as a monotherapy for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low or intermediate risk myelodysplastic syndromes (lower-risk MDS or LR-MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (ESAs).

Dianthus Therapeutics, Inc. provided an update on recent business achievements.

Gilead Sciences, Inc. today presented the first data from its ongoing Phase 1 study investigating two novel, once-yearly formulations of lenacapavir, the company's injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention as pre-exposure prophylaxis (PrEP).

Medera Inc announced that patient dosing has been completed in its MUSIC-HFrEF Phase 1/2a clinical trial of the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HErEF).

Actinium Pharmaceuticals, Inc. announced that the first clinical trial under its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for Actimab-A has been initiated.

Longeveron Inc announced the publication in Nature Medicine of results from the CLEAR MIND Phase 2a clinical trial evaluating laromestrocel (Lomecel-B™) as a potential cellular therapy for mild Alzheimer's disease (AD).

Astria Therapeutics, Inc provided a corporate update.

Corbus Pharmaceuticals provided a corporate update

Vaxart, Inc announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs.

Biogen Inc announced the initiation of dosing in the global clinical study, TRANSCEND.

Guardant Health, Inc. announced the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the Shield™ blood test for colorectal cancer (CRC) screening.

atai Life Sciences announced that the first patient has been dosed in the Phase 2 Elumina trial of VLS-01, atai's proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, in people suffering from treatment-resistant depression (TRD).

PolyPid Ltd. announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.

BioXcel Therapeutics, announced that, following the successful raise of $14 million gross proceeds in an equity financing that closed on March 4, 2025, it has approximately $35 million in cash. The strengthened cash position will support continued advancement of the Company's pivotal Phase 3 SERENITY At-Home trial. T

Harrow announced the execution of a five-year strategic supply and development ("SSD") agreement for TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative-free synthetic corticosteroid that is approved by the U.S. Food and Drug Administration (FDA) for visualization during vitrectomy and the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.

Q32 Bio Inc. provided recent corporate updates.

Arvinas, Inc. and Pfizer announced positive topline results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. Inc.

Immunocore Holdings plc today shared initial data from the multiple ascending dose (MAD) portion of its Phase 1/2 STRIVE trial of IMC-M113V, its functional cure candidate for human immunodeficiency virus (HIV).

Caribou Biosciences, Inc reviewed recent pipeline progress.

Lineage Cell Therapeutics, Inc provide a business update.

Kodiak Sciences Inc. announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with diabetic retinopathy ("DR").

NS Pharma, Inc. announced that acceptance has been received by Capricor Therapeutics, Inc from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) filing for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy ("DMD") cardiomyopathy.

LIXTE Biotechnology announced online publication of new pre-clinical data in BioXriv and International Journal of Pharmaceutics demonstrating how the Company's lead clinical compound, LB-100, is converted into its active form, endothall, a protein phosphatase (PP2A) inhibitor that has been found to be effective in cancer treatment in combination with immunotherapy.

Biodexa Pharmaceuticals PLC announced the results of its Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding the protocol for the planned registrational Phase 3 study of eRapa in familial adenomatous polyposis ("FAP").

Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance (NOC) for LAZCLUZE® (lazertinib) in combination with RYBREVANT® (amivantamab) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.1

OKYO Pharma announce the filing of its application for Fast Track designation with the U.S. Food and Drug Administration (FDA) for urcosimod (formerly known as OK-101) for the treatment of neuropathic corneal pain, which is a debilitating condition affecting many tens of thousands worldwide, and is characterized by chronic, severe eye discomfort for which there is no FDA-approved, effective treatment.

Protagonist Therapeutics, Inc. announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC).

Tonix Pharmaceuticals announced it has been awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801 (recombinant horsepox virus, live vaccine).

Aethlon Medical, announced the publication of a pre-clinical study in the peer-reviewed journal Transplant Immunology (https://doi.org/10.1016/j.trim.2025.102215) on February 28, 2025, entitled, " A lectin affinity plasmapheresis device removes extracellular vesicles and microRNAs from renal perfusates following controlled oxygenated rewarming of discarded donor kidneys."

Northstrive Biosciences Inc announced that it has scheduled a pre-Investigational New Drug ("pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") for Wednesday, April 23, 2025.

4D Molecular announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for the treatment of wet age-related macular degeneration (wet AMD).

UroGen Pharma Ltd provided an overview of recent developments.

Immunome, Inc. announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC.

REGENXBIO Inc. announced new interim biomarker data from the Phase I/II portion of the AFFINITY DUCHENNE® trial of RGX-202 for the treatment of Duchenne muscular dystrophy will be presented at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, taking place in Dallas, TX, March 16-19, 2025.

Mineralys Therapeutics, Inc. announced positive topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).

Ionis Pharmaceuticals, Inc. announced that Ionis and AstraZeneca's WAINZUA (eplontersen) has been approved in the European Union (EU) for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, commonly referred to as hATTR-PN or ATTRv-PN.

BioNTech SE provided an update on its corporate progress.

Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo.

MannKind Corporation a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase data from recent studies of inhaled insulin across five presentations at the 18th International Conference on Advanced Technologies and Treatments for Diabetes to be held March 19-22 in Amsterdam.

Trevi Therapeutics, Inc. announced positive topline results from its Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66).

Beam Therapeutics announced initial safety and efficacy data from its Phase 1/2 trial of BEAM-302, establishing clinical proof-of-concept as a potential treatment for alpha-1 antitrypsin deficiency (AATD) and for in vivo base editing. Preliminary results from the first three single-ascending dose cohorts demonstrated that BEAM-302 was well tolerated, with single doses of BEAM-302 leading to durable dose-dependent correction of the disease-causing mutation.

Trevi Therapeutics, announced a conference call and live webcast taking place tomorrow, Monday, March 10th, 2025, at 8:30 a.m. ET, to share topline results from the Phase 2a RIVER trial of Haduvio in patients with refractory chronic cough.

Protagonist Therapeutics announced new icotrokinra (JNJ-2113) data from the comprehensive Phase 3 clinical program and the planned initiation of the first-ever head-to-head study in plaque psoriasis (PsO) seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab.

Q32 Bio Inc. announced additional results from Part A of its SIGNAL-AA Phase 2a clinical trial of bempikibart in patients with alopecia areata (AA) at the 2025 American Academy of Dermatology (AAD) Meeting in Orlando, FL.

Regeneron Pharmaceuticals, Inc today presented positive results from the pivotal ADEPT Phase 2/3 trial evaluating the investigational use of Dupixent® (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP).

Incyte announced results from its pivotal Phase 3 TRuE-PN clinical trial program –TRuE-PN1 and TRuE-PN2 studies – evaluating the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura®), a topical JAK1/2 inhibitor, in adult patients (≥18 years) with prurigo nodularis (PN).

Bristol Myers Squibb announced positive data from the pivotal Phase 3 POETYK PsA-2 trial (IM011-055) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA).

Organon announced results from an analysis of the Phase 3 ADORING 3 open-label, long-term extension study evaluating VTAMA® (tapinarof) cream, 1% once daily in adults and children 2 years of age and older with atopic dermatitis (AD), also known as eczema.

Alumis Inc. announced positive 52-week data from the open-label extension (OLE) of its Phase 2 STRIDE clinical trial evaluating ESK-001 in patients with moderate-to-severe plaque psoriasis.

Amgen announced new results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD).

Mineralys Therapeutics, Inc. announced it will host a conference call and webinar to announce topline results from its Launch-HTN and Advance-HTN pivotal trials on Monday, March 10, 2025, at 8:00 a.m. ET.

Eli Lilly and Company's announced that New results show Eli Lilly and Company's EBGLYSS achieved deep and sustained response for patients with moderate-to-severe atopic dermatitis (eczema) at three years.

PDS Biotechnology announced the initiation of the VERSATILE-003 Phase 3 clinical trial. The trial is now open to patient enrollment.

Oruka Therapeutics, announced new preclinical data on ORKA-002, a novel extended half-life monoclonal antibody targeting IL-17A/F, from its presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

InflaRx N.V announced the presentation of multiple posters describing the utility of vilobelimab in pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS), including clinical efficacy data, safety assessments, and pharmacokinetic (PK) and pharmacodynamic (PD) analyses.

Arcutis Biotherapeutics, Inc. announced new data from two posters shared at the 2025 American Academy of Dermatology Annual Meeting (AAD).

Plus Therapeutics, Inc. announces the publication of results in a peer-reviewed manuscript titled, "Treatment of Recurrent Glioma by Rhenium (186Re) Obisbemeda (186RNL): a Phase 1 clinical trial" in the peer-reviewed medical journal Nature Communications.

TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2025 annual meeting, being held April 5 - 9, 2025, in San Diego, California.

BioXcel Therapeutics, announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial.

I-Mab announced that enrollment has been completed ahead of schedule in the first dose expansion cohort in the Phase 1b givastomig combination study, with continued momentum in the second dose expansion cohort.

AstraZeneca announced Positive high-level results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca's IMFINZI® (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS).

Castle Biosciences, Inc announced that it will share new data on its DecisionDx-Melanoma and DecisionDx-SCC tests for patients with skin cancers at the 2025 AAD Annual Meeting, taking place March 7-11 in Orlando, Florida.

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo®(nivolumab) plus Yervoy®(ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC).

argenx SE announced clinical trial and real-world data for VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) will be presented at the American Academy of Neurology (AAN) Annual Meeting, taking place in San Diego, CA from April 5-9, 2025.

Nuvation Bio Inc provided a business update.

Centessa Pharmaceuticals plc announced that data from the Phase 1 clinical trial of ORX750, an investigational novel highly potent and selective OX2R agonist being progressed for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), will be presented in a poster session at the American Academy of Neurology (AAN) 2025 Annual Meeting being held April 5-9, 2025, in San Diego, CA

Solid Biosciences provided a business update.

CytomX Therapeutics, Inc. provided a business update.

Theriva™ Biologics provided a corporate update.

Oruka Therapeutics, provided a corporate update.

Atea Pharmaceuticals, Inc. provided a business update.

Contineum Therapeutics, Inc affirmed its key clinical development milestones.

Foghorn® Therapeutics Inc provided a business update

NextCure, Inc. provided a business update

aTyr Pharma, Inc announced the outcome of a fourth, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™ study of the Company's lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis.

Adicet Bio, Inc reported operational highlights

Arcturus Therapeutics Holdings Inc provided corporate updates.

Black Diamond Therapeutics, Inc. provided a corporate update.

scPharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for FUROSCIX® to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD).

ALX Oncology Holdings Inc provided a corporate update.

Lexicon Pharmaceuticals, provided an update on key corporate milestones and accomplishments.

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 6 March 2025, approved lazertinib (brand name Lazcluze) for adults with non-small cell lung cancer that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR).

Oragenics, Inc. announced the submission of its Investigator's Brochure (IB) application in preparation for its Phase II clinical trial using ONP-002 in Australia

Chemomab Therapeutics, announced a new scientific presentation that further confirms the potential of nebokitug (CM-101) as a novel treatment for systemic sclerosis (SSc).

Biodexa Pharmaceuticals PLC announced the appointment of Precision for Medicine, LLC ("Precision") as the clinical research organization ("CRO") to conduct the European component of the upcoming registrational Phase 3 study of eRapa in FAP.

CERo Therapeutics Holdings, Inc., announces the execution of an agreement with contract research organization (CRO) CellCarta to manage translational assays for the Company's upcoming Phase 1 clinical trial of CER-1236 for Acute Myeloid Leukemia (AML).

Aditxt, Inc today provided an update on its subsidiary, Adimune, Inc., ("Adimune") and its progress in advancing ADI-100, an investigational product candidate to be studied in patients with Psoriasis, Type I Diabetes (T1D) and Stiff Person Syndrome.

VYNE Therapeutics provided a business update.

Allarity Therapeutics, Inc announced plans for a Phase 2 trial evaluating the combination of stenoparib with temozolomide, a DNA-alkylating chemotherapy agent, for the treatment of recurrent Small Cell Lung Cancer (SCLC).

Gain Therapeutics, Inc announced that Joanne Taylor, Ph.D., Senior Vice President of Research at Gain, will give an oral presentation on the Company's clinical stage lead drug candidate GT-02287 at the AD/PD™ 2025 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders. AD/PD™ 2025 is being held April 1-5, 2025, in Vienna, Austria.

SCIENTURE HOLDINGS, INC. is pleased to announce that its wholly owned subsidiary, Scienture, LLC ("Scienture"), has entered into a definitive agreement with SUMMIT BIOSCIENCES INC. (a wholly owned subsidiary of Kindeva Drug Delivery L.P. ("Kindeva")), for the exclusive U.S. rights to commercially launch REZENOPY® (naloxone HCl) Nasal Spray 10mg, an opioid antagonist that was approved by the FDA on April 19, 2024.

Medicus Pharma Ltd. announce a positively trending interim analysis for SKNJCT-003 Phase 2 clinical study to non-invasively treat basal cell carcinoma of the skin (BCC).

Plus Therapeutics, Inc announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Rhenium (186Re) Obisbemeda for the treatment of leptomeningeal metastases (LM) in patients with lung cancer.

Clearside Biomedical, announced the receipt of the formal meeting minutes from its recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) relating to CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD).

Mind Medicine (MindMed) Inc. provided an update on business highlights.

QIAGEN announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States.

Denali Therapeutics Inc. provided an update that further analyses from Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating eIF2B agonist DNL343 in the treatment of amyotrophic lateral sclerosis (ALS) did not demonstrate a treatment effect on neurofilament light (NfL), a biomarker of neuronal damage, over the 24-week, double-blind period and in a subset of participants that completed an additional 28 weeks in the open-label active treatment extension.

HUTCHMED (China) Limited announces that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma ("IHCC") patients with fibroblast growth factor receptor ("FGFR")2 fusion/rearrangement.

Ascentage Pharma

ARS Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved neffy® 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.).

Journey Medical Corporation announced that full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 ("MVOR-1") and Minocycline Versus Oracea in Rosacea-2 ("MVOR-2"), evaluating Minocycline Hydrochloride Extended Release Capsules, 40 mg ("DFD-29" or "Emrosi") for the treatment of moderate-to-severe papulopustular rosacea in adults were published in the Journal of the American Medical Association - Dermatology ("JAMA Dermatology").

Fate Therapeutics, Inc. today reported business highlights

Hoth Therapeutics Announced Positive Results for HT-001 in Treating EGFR Inhibitor-Associated Papulopustular Eruptions Findings to be Presented at the American Academy of Dermatology 2025 Annual Meeting

Cerus Corporation announced the CE mark approval of its next-generation LED-based illumination device, or the INT200, for the INTERCEPT Blood System for platelets and plasma under the European Union (EU) Medical Device Regulation (MDR).

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, is pleased to announce that Quebec has become the first province to publicly reimburse APRETUDE (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals who are HIV-1 negative.1

Acadia Pharmaceuticals Inc. announced that the journal Medpublished results from the open-label study, DAFFODIL™, evaluating the safety, tolerability and exploratory efficacy of DAYBUE® (trofinetide) in girls ages two to four living with Rett syndrome (n = 15).

Nuvectis Pharma announced that new independent research conducted at the Lerner Research Institute, Cleveland Clinic (at Case Western Reserve University) has demonstrated the superior efficacy of NXP900 when combined with osimertinib (Tagrisso®) in EGFR-mutated non-small cell lung cancer (NSCLC) models.

Inspira Technologies* has reported exceptional clinical study outcomes for its HYLA blood sensor, with 96% accuracy achieved in a key parameter compared to traditional blood analyzers.

Tenax Therapeutics, announced the U.S. Food and Drug Administration (FDA) has completed their review of Tenax Therapeutics' updated Phase 3 development plan for TNX-103 (oral levosimendan), including an Amendment to expand enrolment and increase the power of the ongoing Phase 3 LEVEL study, and the protocol for LEVEL-2, Tenax Therapeutics' second registrational Phase 3 study.

Silexion Therapeutics Corp. announced positive data from orthotopic pancreatic cancer models demonstrating that subcutaneously administered SIL204 effectively reduces both primary tumor growth and metastatic spread.

Neurocrine Biosciences, Inc. announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of investigational compound NBI-1140675 in healthy adult participants.

Opus Genetics, Inc. announced that three abstracts on its investigational gene therapy candidates have been accepted for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting, to take place May 4-8, 2025 in Salt Lake City, UT.

CERo Therapeutics Holdings, Inc announces it will be presenting preclinical results of lead compound CER-1236 in ovarian cancer during the Spring Scientific from the Society for Immunotherapy of Cancer (SITC) in San Diego, March 12-14.

Protara Therapeutic provided a business update

Phio Pharmaceuticals Corp. announced that it has fulfilled the required enrollment for safety in its third dose cohort in its Phase 1b dose escalating clinical study for their lead compound PH-762.

Invivyd, Inc announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA™ (pemivibart) against the currently dominant LP.8.1 variant of SARS-CoV-2.

iTeos Therapeutics provided a business update.

EyePoint Pharmaceuticals, Inc highlighted recent corporate developments.

TScan Therapeutics, provided a business update.

Purple Biotech Ltd. announced that the U.S. Patent and Trademark Office has issued a patent for NT219 used in combination with epidermal growth factor receptor (EGFR) antibodies for treating cancer patients who have acquired resistance to EGFR therapies.

atai Life Sciences announced the completion of patient enrollment in the eight-week, double-blind, core stage of the global Phase 2b clinical trial evaluating BPL-003 (mebufotenin benzoate) in patients with treatment-resistant depression (TRD).

Ocugen, Inc. announced general business update.

BioNTech announced that The U.S. Food and Drug Administration (“FDA”) has informed BioNTech SE (“BioNTech”) that it has placed a clinical hold on BioNTech’s Investigational New Drug application (“IND”) and the related Phase I/IIa clinical trial (NCT06069544) evaluating the safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults.

Cumberland Pharmaceuticals announced 2024 highlights include expanded product labeling, key FDA designations and new study publications

Contineum Therapeutics, Inc announced that Topline data readout planned for early 2026

Contineum Therapeutics, Inc today initiated patient dosing in its exploratory PIPE-791 Phase 1b, randomized, double-blind, placebo-controlled, crossover, chronic pain trial.

Cingulate Inc today released Phase 3 safety data for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Inspira™ Technologies OXY B.H.N. Ltd announced positive results from the clinical study of its AI-powered HYLA™ blood sensor.

Hoth Therapeutics, Inc. announced preclinical findings that highlight the potential of Glial Cell Line-Derived Neurotrophic Factor (GDNF) as a revolutionary treatment for obesity.

Sensus Healthcare, Inc announces the publication of a study titled "Keloid Excision With Primary Closure Combined With Superficial Radiation Therapy (SRT-100)" in the Annals of Plastic Surgery..

Nuvectis Pharma, Inc. announced a new publication from the laboratory of Prof. Ruth Keri, (Cleveland Clinic, Cleveland, OH, USA) demonstrating that the combination of NXP900 and osimertinib (the active ingredient in Tagrisso®) was superior to single agent osimertinib in vivo in a model of Epidermal Growth Factor Receptor(EGFR) mutated non-small cell lung cancer (NSCLC), and led to decreased cell proliferation and increased apoptosis in vitro.

Dermata Therapeutics, Inc. announced that the last patient has completed their last visit in the Company's first pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial of XYNGARI™, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne.

Dermata Therapeutics, Inc announced The Company remains on track to announce topline data by the end of March 2025..

Tiziana Life Sciences, Ltd. announced the submission of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2 clinical trial in ALS.

PepGen Inc. announced its voluntary decision to temporarily pause the Phase 2 CONNECT2-EDO51 study of PGN-EDO51 in patients with Duchenne muscular dystrophy (DMD) until the Company can review results from the 10 mg/kg cohort in the ongoing Phase 2 CONNECT1-EDO51 study.

MIRA Pharmaceuticals, Inc announced that the Israeli Ministry of Health and the Institutional Review Board (IRB) Phase 1 trial for Ketamir-2, the company's novel oral ketamine analog in development for neuropathic pain.

Wellgistics Health, Inc announced that its wholly owned subsidiary, Wellgistics LLC, is collaborating with Protega Pharmaceuticals Inc. ("Protega"). Protega is the innovative specialty pharmaceutical company that launched ROXYBOND™ (oxycodone hydrochloride), the first and only FDA-approved abuse-deterrent immediate-release (IR) opioid pain medication in the U.S.

Quoin Pharmaceuticals Ltd. announced it has filed U.S. and International patent applications for novel topical rapamycin (sirolimus) formulations as potential treatments for a number of rare diseases including microcystic lymphatic malformations, venous malformations and angiofibromas.

REGENXBIO Inc announced the closing of its previously announced strategic partnership with Nippon Shinyaku.

Instil Bio, Inc provided a corporate update.

Capricor Therapeutics announced the U.S. Food and Drug Administration ("FDA") has accepted for review its Biologics License Application ("BLA") seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy ("DMD") cardiomyopathy.

Tonix Pharmaceuticals presented data in an oral presentation at the 7th International Congress on Controversies in Fibromyalgia, held March 3-4, 2025, in Vienna, Austria.

Compugen Ltd provided a corporate update.

CalciMedica Inc. announced that Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica, delivered a plenary presentation at the 30th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) on March 3, 2025 in San Diego, CA.

Y-mAbs Therapeutics, Inc. provided Recent Corporate Developments

The HHS Department Secretary Robert F. Kennedy Jr. wrote an Opinion piece in the FoxNews entitled "Measles outbreak is call to action for all of us". He identifies an important issue that, "…there is no approved antiviral for those who may be infected

Amylyx Pharmaceuticals, Inc announced recent updates

BeiGene, Ltd announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).

ANI Pharmaceuticals announced U.S. Food and Drug Administration (FDA) approval of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel) in a prefilled syringe format.

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia® and XGEVA®.

Corcept Therapeutics Incorporated announced that the U.S. Food and Drug Administration (FDA) filed its New Drug Application (NDA) submission for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism (Cushing's syndrome).

Adverum Biotechnologies, Inc. announced the initiation of the ARTEMIS Phase 3 study.

Pliant Therapeutics, Inc. announced that following a prespecified data review and recommendation by the trial's independent Data Safety Monitoring Board (DSMB), as well as a secondary review and recommendation by an outside expert panel, Pliant has discontinued the BEACON-IPF Phase 2b trial evaluating bexotegrast in patients with idiopathic pulmonary fibrosis (IPF).

Ocugen, Inc. announced that the European Commission has provided a positive opinion from the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) for OCU410 and OCU410ST Advanced Therapy Medicinal Product (ATMP) classification.

Acadia Pharmaceuticals Inc. announced the successful completion of the two originally planned cohorts in their Phase 1 multiple-ascending-dose MAD study (EUCT: 2024-514514-12-00) of ACP-711, formerly SAN711, in healthy volunteers.

Enlivex Therapeutics announced positive interim six-month efficacy data from the Phase I stage of its randomized, multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis.

Celldex Therapeutics, Inc. announced positive preclinical data from CDX-622, a novel bispecific antibody that targets two non-redundant, complementary pathways implicated in inflammation and fibrosis—thymic stromal lymphopoietin (TSLP) and mast cell depletion via stem cell factor (SCF) starvation.

Daiichi Sankyo and AstraZeneca announced Positive topline results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to ramucirumab and paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Zentalis® Pharmaceuticals announced multiple presentations, including an oral presentation with updated clinical data from the ongoing Phase 2 DENALI clinical trial of azenosertib in patients with platinum-resistant ovarian cancer (PROC), at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer, to be held on March 14-17 in Seattle, Washington.,

NKGen Biotech, Inc announced the administration of troculeucel, an expanded autologous NK cell therapy, in a stroke patient under a single compassionate use, Investigational New Drug ("IND") cleared by the U.S. Food and Drug Administration ("FDA").

Esperion Therapeutics announced it has entered into a license and distribution agreement with CSL Seqirus (ASX:CSL) for the exclusive rights to commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Australia and New Zealand.

Acurx Pharmaceuticals, announced the results of a study in a humanized mouse model and its publication in the Journal of Antimicrobial Agents and Chemotherapeutics entitled: "Microbiome impact of ibezapolstat and other Clostridioides difficile infection-relevant antibiotics using humanized mice".

MBX Biosciences, Inc announced the completion of enrollment in its Phase 2 Avail™ trial of MBX 2109 (canvuparatide), the Company's parathyroid hormone (PTH) peptide prodrug.

Chemomab Therapeutics provided a corporate update.

Stereotaxis announced FDA regulatory submission for the first robotically navigated catheter designed to expand usage of Robotic Magnetic Navigation into the broader endovascular field.

Y-mAbs Therapeutics, Inc announced the publication of interim data from a Phase 2 clinical trial evaluating naxitamab with granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with relapsed/refractory high-risk neuroblastoma in the journal Nature Communications..

Biohaven Ltd. highlighted the success of BHV-1300, its potential first-in-class IgG1,2,4 selective degrader, in achieving rapid and deep reductions in total IgG, advancing a novel and transformative MoDE platform molecule for the potential treatment of autoimmune disease.

KalVista Pharmaceuticals, Inc announced the presentation of novel sebetralstat data related to laryngeal hereditary angioedema (HAE) attacks and adolescents with HAE at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress taking place in San Diego, CA from February 28–March 3, 2025.

Mersana Therapeutics, Inc. provided a business update

Opthea Limited announced the publication of sozinibercept Phase 2b data in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina.

Adicet Bio, Inc. announced the acceptance of two abstracts for poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) 2025 Spring Scientific Meeting taking place March 12-14, 2025, in San Diego, C.A.

Traws Pharma, Inc. announced positive topline results from ferrets infected with H5N1 bird flu, an accepted animal model for human influenza, when treated with tivoxavir marboxil as a single dose.

Axsome Therapeutics, Inc announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting a supplemental NDA (sNDA) submission for AXS-05 in Alzheimer's disease agitation..

Lexicon Pharmaceuticals, Inc announced topline results from the PROGRESS Phase 2b study evaluating pilavapadin (LX9211), an oral, non-opioid investigational adaptor-associated kinase 1 (AAK1) inhibitor in adult patients with moderate to severe diabetic peripheral neuropathic pain (DPNP)..

Seres Therapeutics, announced that it has received constructive feedback from a Type B Breakthrough Therapy designation engagement with the U.S. Food and Drug Administration (FDA or the agency) regarding the Company's development strategy for its lead live biotherapeutic, SER-155 in patients undergoing allo-HSCT.

Aura Biosciences, Inc. announced that additional Phase 1 data evaluating bel-sar (AU-011) for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) will be presented at the 40th Annual European Association of Urology (EAU) Congress being held March 21-24, 2025, in Madrid, Spain.

BioXcel Therapeutics announced that the U.S. Food and Drug Administration (FDA) has concluded that the inspection of a single site in its TRANQUILITY II Phase 3 trial is closed under 21 C.F.R.20.64(d)(3) and released the Establishment Inspection Report.

ArriVent BioPharma, Inc. highlighted recent Company progress.

Voyager Therapeutics, announced positive topline data from the Company's single ascending dose (SAD) trial of VY7523, an investigational anti-tau antibody developed to selectively inhibit the spread of pathological tau in Alzheimer's disease (AD).

Pharvaris highlighted safety and efficacy data of deucrictibant, which is currently being evaluated in two pivotal Phase 3 studies, following long-term dosing in the prophylactic and on-demand settings at the American Academy of Allergy, Asthma, & Immunology's Annual Scientific Meeting (AAAAI) and World Allergy Organization (WAO) Joint Congress, which was held from February 28–March 3, 2025, in San Diego, CA.

Protagonist Therapeutics, Inc and Takeda announced positive topline results for the Phase 3 VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV) were randomized to treatment with either rusfertide or placebo, as an add-on to standard of care treatment.

Can-Fite BioPharma Ltd. announced that the European Society of Medicine Journal published an innovative article titled: "The Neuro- Cardio- and Hepato- Protective Effects of Namodenoson are Mediated by Adiponectin".

Apogee Therapeutics, Inc. announced positive interim Phase 1 results from its first-in-human trial of APG990.

GSK plc announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications.

Lexicon Pharmaceuticals, Inc announced the Company will hold a conference call and webcast on Monday, March 3, 2025 at 8:00 a.m. ET to share topline results from the Phase 2b PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating pilavapadin (LX9211), an oral, non-opioid investigational adaptor-associated kinase 1 (AAK1) inhibitor in adult patients with moderate to severe diabetic peripheral neuropathic pain (DPNP).

GSK plc announced full results from the positive ANCHOR-1 and ANCHOR-2 phase III clinical trials assessing the efficacy and safety of depemokimab versus placebo (both with standard of care [SOC]) in adults with CRSwNP.

AstraZeneca and Amgen' announced positive results

Jasper Therapeutics, Inc. is presenting updated clinical data from the Phase 1b/2a BEACON study, as well as data from four preclinical studies evaluating briquilimab, at the AAAAI 2025 Annual Meeting, being held February 28 - March 3, 2025, in San Diego, CA.

Celldex Therapeutics, Inc. announced positive data on measurements of disease control and quality of life from the Company's Phase 2 barzolvolimab studies in patients with chronic urticaria.