Aug. 21, 2025 -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH). Atumelnant is the first and only small molecule ACTH receptor antagonist in clinical development. “Receiving Orphan Drug Designation from the FDA und

Aug. 21, 2025 -- Beacon Therapeutics Holdings Limited (‘Beacon Therapeutics’ or ‘the Company’), a leading clinical-stage biotechnology company with a mission to save and restore the vision of patients with blinding retinal diseases, today announces upcoming presentations on the preliminary 9+-month data from the Phase 2 DAWN trial and 36-month results of the randomized, controlled Phase 2 SKYLINE trial of the Company’s lead program, laru-zova (laruparetigene zovaparvovec), in patients with X-li

Aug. 20, 2025 -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced the U.S. Food and Drug Administration (“FDA”) granted Orphan Drug designation for KER-065 for the treatment of Duchenne muscular dystrophy (“DMD”). “

Aug. 21, 2025 -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in the registrational trial of B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) for patients with BTK inhibitor treated mantle cell lymphoma (MCL) in China. Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor. BCL2 is an important regulatory protein in the apopto

Aug. 20, 2025 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces the completion of patient enrollment of SANOVO, a China Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) as a first-line treatment in certain non-small cell lung cancer (“NSCLC”) patients whose tumors harbor epidermal growth factor receptor (“EGFR”) mutation and MET overexpression. The last patient was enrolled on August 18, 2025. This Phase III trial is a blinded, randomiz

90-day trial measuring change in general fatigue in chronic babesiosis patients Enrollment expected to commence Q4 2025 and to be completed by Q2 2026 Site has clinical expertise in infectious disease trials and access to a robust patient population with tick-borne illness, including chronic babesiosis No FDA-approved treatment exists for chronic babesiosis, a debilitating illness Aug. 19, 2025 -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a

Aug. 19, 2025 -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the Company to initiate its Phase 2 “RENEW” clinical trial of LTI-03, the Company’s lead drug candidate for idiopathic pulmonary fibrosis (IPF). IPF is a serious, p

Aug. 19, 2025 -- COUR Pharma, a clinical-stage biotechnology company developing first-in-class, disease-modifying therapies to treat autoimmune diseases, today announced that the first patient has been dosed in the Phase 1b/2a clinical trial for CNP-103, a tolerogenic nanoparticle therapy in development to address the underlying autoimmunity associated with type 1 diabetes (T1D). “The initiation of this trial is important for patients, as we believe our approach to antigen-specific immune toler

-- Achieved Primary Endpoint with 30mg Dose of RE104 Demonstrating 23.0-Point Reduction from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Score on Day 7, a 5.8-Point Greater Reduction Than Patients Treated with 1.5mg Dose (p=0.0094) -- -- Clinically Meaningful Reductions in MADRS Observed for RE104 30mg on the First Day Following Administration and Maintained Through Day 28 Follow-Up -- -- RE104 Observed to be Generally Well-Tolerated with No Serious Adverse Events; 92.7% of Pat

U.S. FDA has placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on third-party nebulizer used to deliver BX004; no concerns were raised in the clinical hold notification regarding the BX004 drug candidate Enrollment and dosing of patients outside the US is continuing in accordance with protocol Aug. 19, 2025 -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting s