The independent Data Safety Monitoring Board recommended continuation of patient enrollment as planned No safety or futility signals were reported in the first 50 patients This patient population could represent up to 1 million bipolar depression patients in the US and represents a portion of the indication expansion recommended in recent correspondence with the FDA Trial has been upgraded to a Phase 2b/3 study that may be used for a...Read more
NORCROSS, Ga., March 16, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, today reported the positive outcome of its third data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). NAVIGATE is the first study of its...Read more
Media Release Integrated Phase II/III trial design incorporates feedback from the FDA and EMA and will help inform a BLA and MAA HR+/HER2-neg/low metastatic breast cancer (MBC) patient population has been expanded to include triple-negative breast cancer, which together account for ~78% of breast cancer cases Approval for study start received in US and IRB approval in Spain, with more countries to follow shortly First patient...Read more
RAHWAY, N.J. & KINGSTON, Ontario / Mar 10, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced that the Phase 2/3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival (OS) for the first-line treatment of patients with unresectable...Read more
Registration-enabling Phase 3 segment of RINGSIDE is enrolling patients globally Updated data on AL102 Phase 2 segment of RINGSIDE are planned for presentation at a medical meeting in 2023 REHOVOT, Israel and MONMOUTH JUNCTION, N.J., March 03, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that the Independent Data Monitoring Committee (IDMC) for its Phase 2/3...Read more
NORCROSS, Ga., March 02, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, announced that in late December 2022, it ended the enrollment of new patients into NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The last patient was randomized into NAVIGATE at the...Read more
The randomized, double-blind, placebo-controlled study is evaluating SLS-005 in 160 patients over 24 weeks and Seelos anticipates delivering topline data in the second half of 2023. Seelos will also enroll patients in an Expanded Access Program that will be fully funded by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) under the Accelerating Access for Critical Therapies for ALS Act (ACT for...Read more
LA JOLLA, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that Health Canada has completed its review of the clinical trial application and has granted authorization to commence a grant-funded, multi-center, randomized, clinical trial to evaluate MN-166 (ibudilast)...Read more
COVA study met primary end point with 44% significant reduction in the risk of respiratory failure or early death Filing for Early Access Programs to Sarconeos (BIO101) is being initated while preparing for Marketing Authorisation in Europe and the USA PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / February 2, 2023 / Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage...Read more
NEW YORK, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the total enrollment of 92 patients with...Read more
Direct delivery of clofazimine to the lungs may provide a treatment option for nontuberculous mycobacterial (NTM) lung disease that potentially overcomes systemic toxicity and lessens side effects Paper published on clofazimine inhalation suspension demonstrates promising tolerability and toxicokinetics for treating pulmonary NTM infection DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Jan. 23, 2023 (GLOBE NEWSWIRE) -- MannKind...Read more
Study met both co-primary endpoints with robust immune responses COVAXIN™ was found to be well-tolerated in vaccine-naïve individuals and in individuals previously vaccinated with mRNA vaccines in the United States (U.S.), with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis These data add to the body of evidence that COVAXIN™, an adjuvated whole SARS-CoV-2 virus inactivated...Read more
NORCROSS, Ga., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, announced today that in late December 2022, it ended enrollment of NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). NAVIGATE is the first study of its kind and is a global effort that...Read more
Robust, Statistically Significant and Clinically Meaningful Absolute Improvement in Cognitive Function as Measured by ADAS-Cog and ADCS-ADL Key Secondary Endpoint CDR-SB Also Met, Demonstrating Statistically Significant Results Plan to Meet with Regulatory Authorities to Determine Next Steps NEW YORK, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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