Pharmaceutical

Positive VAX-31 Phase 1/2 Adult Data Published in The Lancet Infectious Diseases Highlight Best-in-Class Potential of Vaxcyte’s 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate

03/25/2026

Based on the Strength of Unprecedented Results from the Positive Phase 1/2 Study in Adults Aged 50 and Older, Vaxcyte Advanced VAX-31 High Dose into Comprehensive Phase 3 Adult Program; Topline Data from the OPUS-1 Pivotal Noninferiority Trial Expected in the Fourth Quarter of 2026 At All Doses Studied, VAX-31 Demonstrated Robust Opsonophagocytic Activity and…

Septerna Announces Positive Phase 1 Data for SEP-631, an Oral MRGPRX2 NAM for the Treatment of Mast Cell-Driven Diseases, and Outlines Initial Phase 2 Development Strategy

03/12/2026

SEP-631 Demonstrated Robust, Dose-Dependent Inhibition of Icatibant-Induced Skin Wheal Formation, with Complete Inhibition Observed at Doses as Low as 10 mg Once-Daily  Well-Tolerated Across All Doses Studied with an Adverse Event Profile Comparable to Placebo; Pharmacokinetic Profile Supports Once-Daily Oral Dosing Phase 2 Development Planned to Begin with Chronic Spontaneous Urticaria in the Second Half…

GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-5550 TriKE®, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors Expressing B7-H3

02/24/2026

GTB-5550 Phase 1 dose escalation basket trial expected to initiate mid-2026 Phase 1 protocol allows multiple solid tumor types known to express B7-H3 Unaudited proforma cash balance as of January 31, 2026 of approximately $9 million anticipated to extend cash runway through Q4 2026 Excerpt from the Press Release: SAN FRANCISCO, CALIFORNIA, Feb. 03, 2026…

Corvus Pharmaceuticals Announces Positive Data from Cohort 4 Confirming Results for Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis

01/28/2026

Cohort 4 data demonstrated positive safety and efficacy results, including additional clinical benefit observed following longer 8-week treatment  75% of soquelitinib patients achieved EASI 75, 25% achieved EASI 90 and 33% achieved IGA 0/1 Cohort 1-4 have demonstrated positive safety and efficacy results in patients who have received prior systemic therapy including patients who are…

Epicrispr Reports Early Clinical Activity and Favorable Safety Profile in First-in-Human Epigenetic Editing Study for FSHD

01/23/2026

Company to present at J.P. Morgan Healthcare Conference on Tuesday, Jan 13, 2026 Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Epicrispr, a clinical-stage company pioneering gene-modulating therapies, today reported early clinical data from its ongoing first-in-human, open-label study evaluating EPI-321, an investigational epigenetic therapy for facioscapulohumeral muscular dystrophy (FSHD). Epicrispr holds the first and only…

Foresee Pharmaceuticals announces the Casppian Phase 3 Study Meets Primary Efficacy Endpoint, Demonstrating Robust LH Suppression with 6-Month Dosing Interval of leuprolide mesylate

01/06/2026

The proportion of patients with serum luteinizing hormone (LH) suppression to < 4 mIU/mL at 60 minutes following a GnRHa stimulation test at Week 24 was 94%, and the results were statistically significant (P-value = 0.0005), which exceeded the pre-specified success criterion.  ·   Leuprolide mesylate 42mg injection (FP-001) was well tolerated in patients with Central…

Enveric Biosciences Successfully Completes Key Manufacturing Milestones in Support of Planned IND and Clinical Trials

10/09/2025

Key CMC achievements advance EB-003 on the path to first-in-human trials Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced significant progress in the chemistry, manufacturing, and controls (CMC) development of its lead…

PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation

09/23/2025

Excerpt from the Press Release: PRINCETON, N.J., Sept. 10, 2025 (GLOBE NEWSWIRE) — PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial. The ongoing…

Windtree Announces Istaroxime Phase 2 Interim Analysis in SCAI Stage C Cardiogenic Shock Patients

08/15/2025

Istaroxime was added to currently available inotropes and vasopressors in the study – no new safety signals were identified and physiological improvements were consistent with istaroxime responses in previous trials Cardiogenic shock is a severe presentation of heart failure and SCAI Stage C patients have low blood pressure and signs of organ damage due to…

BioCardia Initiates Patient Enrollment at Emory University School of Medicine for Ongoing CardiAMP HF II Pivotal Study

04/17/2025

CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction and Elevated Markers of Cardiac Stress Dr. Arshed Quyyumi, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director of the Emory Clinical Cardiovascular Research Institute to Serve…