Day: May 14, 2024

Conference Call and Webcast Today at 8:30 a.m. ETAll three first-in-class modifier gene therapy product candidates currently in the clinic with OCU400 Phase 3 in progress OCU400 on track to meet 2026 Biologics License Application (BLA) and Market Authorization Application (MAA) approval targetsMALVERN, Pa., May 14, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today reported first quarter 2024 financial results along with a general business update. “We’ve experienced several important clinical and regulatory milestones since the beginning of 2024 that we believe are leading the way to a new treatment paradigm for patients with blindness diseases,” said Dr. Shankar Musunuri,...

Currently Enrolling Patients in Phase 3 LEVEL Study with 24 Investigative Sites Initiated Secured Global Development and Commercial Rights to Levosimendan for Treatment of PH-HFpEF Expanded Intellectual Property Estate for Levosimendan with Issuance of New U.S. Patent Recently Hosted KOL Event, “LEVEL Setting,” Featuring Four Experts in Heart Failure Discussing the Unmet Medical Need in PH-HFpEF and Potential of Levosimendan to Address Disease Raised Approximately $8 Million of Net Proceeds in Registered Public Offering in February 2024 CHAPEL HILL, N.C., May 14, 2024 (GLOBE NEWSWIRE) — Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced...

Announced positive survival data from ongoing randomized phase 2 clinical trial of CAN-2409 in borderline resectable pancreatic cancer Phase 2 topline overall survival data for CAN-2409 in non-small cell lung cancer (NSCLC), to be presented at ASCO on June 3, 2024 On track for topline disease-free survival data from CAN-2409 phase 3 clinical trial in localized intermediate/high risk prostate cancer, expected in Q4 2024NEEDHAM, Mass., May 14, 2024 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update. “It was a catalyst-rich first quarter for Candel, marked...

Conference Call and Webcast Today at 4:30 p.m. ET Development Program Highlights and Anticipated 2024 MilestonesOvaprene® hormone-free monthly intravaginal contraceptive candidate pivotal Phase 3 contraceptive efficacy study recruiting across the United States Sildenafil Cream, 3.6% topical formulation of sildenafil being developed to treat female sexual arousal disorder successful completion of end-of-Phase 2 meeting with FDA; forthcoming additional FDA feedback; Phase 3 design, development, and collaboration strategy updatesSAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today reported financial results for the quarter ended March 31, 2024 and provided a company update. “The progress across our portfolio in the first quarter, along...

– Gained alignment with U.S. Food and Drug Administration (FDA) on brilaroxazine clinical trials for New Drug Application (NDA) submission in schizophrenia – – Registrational RECOVER-2 trial expected to initiate Q2 2024; topline data expected Q3 2025 – – Topline data from 1-year open-label extension (OLE) trial expected Q4 2024 – CUPERTINO, Calif., May 14, 2024 (GLOBE NEWSWIRE) — Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today reported financial results for the first quarter ended March 31, 2024 and summarized recent business highlights. “This quarter we made strong progress across our late-stage brilaroxazine...

Takeda has completed two Phase 3 trials studying soticlestat as a treatment for Lennox-Gastaut syndrome and Dravet syndrome; topline data are anticipated in Takeda’s H1 2024 fiscal yearA Phase 1, double-blind, multiple-ascending dose trial evaluating OV888 (GV101) is complete; topline safety data are expected in H1 2024Ovid expects to initiate a Phase 2 clinical program studying OV888 (GV101) in cerebral cavernous malformations in H2 2024Cash, cash equivalents and marketable securities were $90.3 million as of March 31, 2024; this capital is expected to support operations into H1 2026NEW YORK, May 14, 2024 (GLOBE NEWSWIRE) — Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to meaningfully improving the lives of people affected by rare epilepsies and brain conditions, today reported business...

WATERTOWN, Mass., May 14, 2024 (GLOBE NEWSWIRE) — Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics (AP3), today reported financial results for the first quarter ended March 31, 2024 and reviewed business highlights. “Within the first few months of 2024, we have demonstrated significant progress across our AP3 platform and our clinical and preclinical pipeline,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “We now have achieved statistically...

U.S. FDA cleared IND for APR-1051, a highly selective and potentially best-in-class oral WEE1 inhibitor; Company plans to initiate Phase 1 ACESOT-1051 clinical trial in June 2024 First-in-class macrocyclic ATR inhibitor, ATRN-119, on track to complete dose escalation in ABOYA-119 clinical trial and potentially generate initial human efficacy data in 2H 2024 Company had four poster presentations at the AACR Annual Meeting, including updates on APR-1051 and ATRN-119 $32.4 million in cash and cash equivalents as of March 31, 2024 DOYLESTOWN, Pa., May 14, 2024 (GLOBE NEWSWIRE) — Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the first quarter ended March 31, 2024, and provided...

Revenue of $19.4 million and Adjusted EBITDA of $3.5 for the quarter BEVERLY, Mass. and TORONTO, May 14, 2024 (GLOBE NEWSWIRE) — Hamilton Thorne Ltd. (TSX: HTL), a leading provider of precision instruments, laboratory equipment, consumables, software, and services to the Assisted Reproductive Technologies (ART), research, and cell biology markets, today reported audited financial results for the quarter ended March 31, 2024. Financial Highlights1st quarter sales increased 16% to $19.4 million; sales for the quarter increased 15% on a constant currency basis, on the high-end of guidance. Adjusted EBITDA increased 24% to $3.5 million or 18% of sales, in line with guidance. Organic sales growth was 9%. Gross profit margin was 52.4% for the quarter, up 182 bps versus the prior year. Net loss was $936 thousand. Confirming guidance...