• First Patient Dosing Expected in Q1 2026 • Clinical Trial to Prioritize Biomarker-Selected RBM39-Dependent Cancers Aug. 11, 2025 -- SEED Therapeutics, Inc. (“SEED”), a clinical-stage biotechnology company pioneering rational molecular glue degraders for historically undruggable disease drivers, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ST-01156. The clearance enables initiation of a first-in-human Phase 1 c

Enrollment in the planned second dose expansion cohort completed ahead of expectations Topline results expected in Q1 2026 Positive Phase 1b dose escalation data presented at ESMO GI on July 2nd Aug. 11, 2025 -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that enrollment in the planned Phase 1b dose expansion cohorts evaluating givastomig, a bispecific Clau

Aug. 11, 2025 -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced selection of a novel modified release oral formulation for enobosarm, a selective androgen receptor modulator, for chronic weight loss management, following confirmation of pharmacokinetic endpoints in a clinical study. The single dose, open label pilot study evaluated the plasma co

Aug. 11, 2025 -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, is pleased to announce that the U.S. Food & Drug Administration (FDA) have approved the IND for its Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy (MSA). Multiple System Atrophy is an unme

FibroGen has reached agreement with the FDA on important design elements for a pivotal Phase 3 clinical trial for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden Company intends to file the Phase 3 protocol in the fourth quarter of 2025 Aug. 07, 2025 -- FibroGen, Inc. (NASDAQ: FGEN) today announced positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadusta

CT-155 showed a reduction in experiential negative symptoms as an adjunct to standard of care antipsychotic therapy from baseline to week 16, as measured by CAINS-MAP. CT-155 is an investigational prescription digital therapeutic being evaluated to target negative symptoms of schizophrenia in a registrational randomized clinical trial.1,2 Often underappreciated and less recognized, negative symptoms impact more than half of people living with schizophrenia.3 Boehringer Ingelheim and Click Thera

Aug. 08, 2025 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application (“sNDA”) for toripalimab (trade name: TUOYI®) in combination with disitamab vedotin, an antibody-drug conjugate (“ADC”) developed by RemeGen Co., Ltd. as the treatment of HER2-expressing (HER2 expression is

Aug. 07, 2025 -- SNIPR Biome ApS (“SNIPR”), the company pioneering the development of microbial CRISPR-medicine, today announced the close of a EUR 35 million Series B raise with funding from new investors the Cystic Fibrosis Foundation and the German Federal Agency for Breakthrough Innovation (SPRIN-D) as well as existing investors Lundbeckfonden BioCapital, North-East Family Office and Wellington Partners. This funding will support the development of a CRISPR-Cas therapy specifically target

Gildeuretinol acetate demonstrated less loss in ellipsoid zone (EZ) area compared to historical sibling controls. Early-stage Stargardt disease patients treated with gildeuretinol for two to seven years exhibited relatively stable disease over the course therapy. Gildeuretinol was well tolerated and had a safety profile consistent with prior gildeuretinol studies, with the majority of adverse events being mild or moderate. Aug. 07, 2025 -- Alkeus Pharmaceuticals, Inc. today announced the pres

‘1104 sublingual formulation achieved extensive systemic exposure and demonstrated impact across measures of disease in additional preclinical studies in atopic dermatitis Sublingual formulation and novel upstream mechanism of action for ‘1104, supported in Phase 2 trials with IV formulation, offers differentiated product profile and expanding target patient market in eosinophilic esophagitis (EoE), atopic dermatitis (AD) and other allergic disease patients Sublingual formulation expected to ent