SPY072 is a potential first- and best-in-class anti-TL1A antibody for rheumatic diseases targeting quarterly or twice-yearly subcutaneous dosing SKYWAY study is evaluating SPY072 in patients with moderate-to-severely active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) Proof-of-concept data for all three indications are expected in 2026 SKYLINE and SKYWAY trials are expected to provide 9 proof-of-concept readouts in 2026-27 Sept. 15, 2025 -- Spyre Th

- Results were published in the Journal of Vascular Surgery - - Publication described treatment of patients with Symvess who had hospital-acquired iatrogenic injuries or complications of vascular surgical procedures - - Patients treated with Symvess were observed to have high levels of patency, 100% limb salvage, and zero cases of conduit infection - Sept. 15, 2025 -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioenginee

Preclinical Data for OPK-8801003 Demonstrate Substantially Longer Biological Half-Life with Peak Plasma Levels Comparable to Gattex®, the Only Approved GLP-2 Therapy Oral GLP-2 Tablet Could Transform Treatment Paradigm for 30,000 Short Bowel Syndrome (SBS) Patients Currently Dependent on Daily Injections of the Peptide Sept. 15, 2025 -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and protein replacement therapies, today announced the presentation of a poster t

Sept. 12, 2025 -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that President and co-CEO Sam Lee, PhD discussed the scientific foundation and clinical progress with the Company’s lead pan-viral protease inhibitor CDI-988 during a podium presentation at the 9th International Calicivirus Conference, held September 7–11, 2025 in Banff, Alberta. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a potential first oral antiviral for the prevent

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 disease Last subject visit completed in the pivotal Phase 3 DRAGON trial of Tinlarebant in Stargardt disease Topline data expected in Q4 2025 Sept. 12, 2025 -- Belite Bio Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical-stage drug development company focused on ad

Sept. 14, 2025 -- 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 14-15, 2025. The poster and oral

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

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

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