Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for Stargardt diseaseLast subject visit completed in the pivotal Phase 3 DRAGON trial of Tinlarebant in Stargardt diseaseTopline data expected in Q4 2025 SAN DIEGO, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical-stage drug develo

WILMETTE, Ill., Sept. 14, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that new data on the long-term neurological efficacy and safety of its investigational therapy ALXN1840 (tiomolybdate choline) for Wilson disease will be presented at the 150th American Neurological Association (ANA) Annual Meeting on September

Sept. 11, 2025 -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced positive IND-enabling updates from its psoriasis research program demonstrating the potential of human dermal fibroblast (HDF) spheroids as a novel therapeutic approach for chronic-relapse pso

Sept. 11, 2025 -- FOXO Technologies Inc. (OTC: FOXO) (the “Company”), announces that it has signed a stock purchase agreement to acquire Vector Biosource Inc. (“Vector”). Vector is an information, data and biospecimen sourcing provider serving the biotechnology, clinical research and pharmaceutical research industries. Vector generated second quarter 2025 net revenues of approximately $225,000 ($0.9 million on an annual run rate basis) and is expected to grow significantly post-acquisition. Th

NPI-001 shows more than 50% reduction in photoreceptor loss caused by RP associated with USH over two years NPI-001 was well tolerated, with no persistent drug-related adverse events Results were leveraged to design confirmatory trial planned for 2026 Sept. 11, 2025 -- Nacuity Pharmaceuticals, Inc. (Nacuity), a clinical-stage biopharmaceutical company focused on innovative treatment of ocular diseases involving oxidative stress, today announced positive, new results from the SLO-RP Phase 1/2

Tzield approved in China as first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes Approval based on the TN-10 study, demonstrating Tzield’s ability to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older, with stage 2 T1D compared to placebo Additional regulatory reviews are ongoing across different disease stages by regulatory authorities around the world September 10, 2025- The Chinese National Medical Products Admin

The $2.5 Million in NIH STTR Phase 2 Grant allows NanoNewron to start the IND-enabling program for the NN-840 program with an IND submission expected next year This NIH grant award strongly confirms the scientific and clinical promise of the innovative approach of NanoNewron to treat Alzheimer’s Disease This STTR grant strengthens the collaboration between NanoNewron and Rutgers University, the State University of New Jersey, a leading academic institution Sept. 10, 2025 -- NanoNewron (“NanoNe

Sept. 11, 2025 -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who had failed two or more standard-of-care therapy regim

– Proceeds to support clinical trials of Kriya’s five lead pipeline programs, as well as the Company’s R&D and manufacturing engine for new product development – Sept. 10, 2025 -- Kriya Therapeutics, Inc. (“Kriya”), a clinical-stage biopharmaceutical company developing gene therapies to address common chronic diseases of high unmet need, today announced the closing of a $320 million Series D financing. The round was co-led by Patient Square Capital and Premji Invest, with participation from ot

Sept. 10, 2025 -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population. The designation specifically states that "GLSI-100 for the treatment of patients with HLA-A*02 genotype and HER2-positive breast