Month: February 2026

Daré Bioscience Announces FDA Clearance of IND for Phase 2 Clinical Study of DARE-HPV, a Potential Treatment for Persistent High-Risk HPV Infection, the Most Common Cause of Cervical Cancer

02/27/2026

DARE-HPV development supported by $10 million ARPA-H contract; program targets major unmet need with no FDA-approved therapies Excerpt from the Press Release: SAN DIEGO, Feb. 23, 2026 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions,…

ORYZON Receives European Medicines Agency Approval to Initiate a Phase II Study of iadademstat in Essential Thrombocythemia

02/26/2026

Excerpt from the Press Release: MADRID and CAMBRIDGE, Mass., Feb. 24, 2026 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today announced that the European Medicines Agency (EMA) has authorized its Clinical Trial Application (CTA) to initiate a Phase II study of…

Evommune Announces Positive Top-line Data from Phase 2a Proof-of-Concept Trial of EVO301 in Moderate-to-Severe Atopic Dermatitis

02/25/2026

– Trial met primary efficacy endpoint at week 12 – EVO301 produced rapid, statistically significant EASI reductions at weeks 4, 8 and 12 versus placebo – 33% placebo-adjusted improvement in EASI at week 12 – 23% of EVO301 patients achieved IGA 0/1 at week 12 Excerpt from the Press Release: PALO ALTO, Calif. & NEW…

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…

Anixa Biosciences Reports Encouraging Patient Survival Observations in Ovarian Cancer CAR-T Trial; Achieves Regulatory Approval Enabling Major Dose Escalation

02/23/2026

Multiple patients substantially exceed expected survival at low dose levels; absence of dose-limiting toxicities supports escalation to doses up to 100x higher Trial expansion reflects growing confidence in intra-peritoneal CAR-T delivery and introduceslymphodepletion to potentially enhance efficacy Anixa to participate in Water Tower Research fireside chat at 11:00am ET on February 10, 2026to discuss trial…

Neomorph Announces First Patient Dosed in Phase 1/2 Trial Evaluating NEO-811 For the Treatment of Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

02/16/2026

Initiation of trial marks first-in-human milestone for Neomorph’s novel molecular glue degrader platform Excerpt from the Press Release: SAN DIEGO, Feb. 03, 2026 (GLOBE NEWSWIRE) — Neomorph, Inc., a biotechnology company pioneering molecular glue degraders to address previously undruggable proteins, today announced the first patient has been dosed in the Phase 1/2 clinical trial (NCT07300241)…

Curium Group, PeptiDream and PDRadiopharma Enroll First Patient to Registrational Clinical Trial of Lu-PSMA-I&T for Prostate Cancer in Japan

02/13/2026

Excerpt from the Press Release: BOSTON, Feb. 04, 2026 (GLOBE NEWSWIRE) — Curium Group today announced that together with PeptiDream Inc. and PDRadiopharma Inc., the first patient has been dosed in the companies’ registrational clinical trial of 177Lu-PSMA-I&T in Japan for patients with PSMA (*1)-positive metastatic castration-resistant prostate cancer (mCRPC). 177Lu-PSMA-I&T is a radiotherapeutic agent…

Pulmovant Announces Completion of Enrollment in the Phase 2 PHocus Study of Mosliciguat in Patients with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

02/12/2026

Excerpt from the Press Release: WALTHAM, Mass., Feb. 06, 2026 (GLOBE NEWSWIRE) — Pulmovant, a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases, and a Roivant (Nasdaq: ROIV) company, today announced that it has completed enrollment in the Phase 2 PHocus clinical trial evaluating mosliciguat for the treatment of pulmonary…

K36 Therapeutics Completes Dosing of First Cohort in Phase 1 Clinical Trial of KTX-2001 in Prostate Cancer, Announces New CMO

02/11/2026

KTX-2001 being evaluated both as a monotherapy and in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) Shinta Cheng, M.D., Ph.D., joins company as Chief Medical Officer Excerpt from the Press Release: CAMBRIDGE, Mass., Feb. 5, 2026 /PRNewswire/ — K36 Therapeutics, Inc. (“K36”), a privately held clinical-stage biotechnology company developing novel targeted therapies for…

Affinia Therapeutics Announces FDA Acceptance of IND Application to Advance AFTX-201 to a Phase 1/2 Trial for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM)

02/10/2026

AFTX-201 uses Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids Company on track to initiate the UPBEAT© clinical trial to investigate safety, pharmacodynamics, and preliminary efficacy of AFTX-201 in BAG3 DCM in the first half of 2026 Excerpt from the Press Release:…