The approval marks the first new treatment option for people living with progressive pulmonary fibrosis (PPF) in more than five years. PPF is a rare lung condition, more life-threatening than many forms of cancer, causing a continuous decline in lung function.1,2,3 PPF is the second approved indication in China for nerandomilast, following recent approvals in the U.S. and China for the treatment of idiopathic pulmonary fibrosis (IPF).4,5 China’s National Medical Products Administration (NMPA) h

Dec. 09, 2025 -- ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced the publication of data from its Phase 1b study of xelafaslatide (formerly ONL1204 Ophthalmic Solution) in Ophthalmology Science, the peer-reviewed journal of the American Academy of Ophthalmology. Xelafaslatide is an investigational, first-in-class small molecule Fas inhibitor designed to protect key retinal

Placebo-adjusted mean weight loss of 11.3% (27.3 lbs) with 120 mg dose in the 36-week Phase 2b ACCESS study with a 10.4% adverse event-related treatment discontinuation Placebo-adjusted mean weight loss up to 15.3% (35.5 lbs) observed with 240 mg dose in the exploratory ACCESS II study at 36 weeks No adverse event-related treatment discontinuations observed when starting at lower 2.5 mg dose in ACCESS Open Label Extension and Body Composition Study Data comprehensively support and inform advance

- NON-MTS & BILATERAL MTLE: First data reported from non-MTS and bilateral MTLE subjects demonstrate robust seizure reduction - LOW DOSE COHORT: 89% median reduction in disabling seizures for unilateral subjects with MTS at the primary efficacy evaluation period of 7-12 months post administration (n=9) - HIGH DOSE COHORT: 78% median reduction in disabling seizures for unilateral subjects with MTS at interim efficacy evaluation period of 4-6 months post administration (n=9) - DURABILITY: Several

December 7, 2025 Trial demonstrated treatment with fixed duration EPKINLY plus rituximab and lenalidomide (EPKINLY+ R2) resulted in statistically significant and clinically meaningful reduction in the risk of disease progression or death and overall response compared to R2 alone EPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific-based therapy for follicular lymphoma in the second-line setting Results of EPCORE FL-1 simultaneously publishe

Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates consistent overall response rate and safety profile comparable to 1500mg QW dose, further derisking pivotal FORTIFI-HN01 study interim analysis Totality of data demonstrates that greater TGF-β inhibition, observed at 1500mg of ficerafusp alfa, drives deeper tumor responses that translate to more durable outcomes for patients Pivotal FORTIFI-HN01 optimal dose declaration expected in first quarter 2026 Company to host conferen

– Initial clinical data expected mid-2026 – Dec. 03, 2025 -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that the patients in the first cohort have been dosed in its Phase 1 trial evaluating STRO-004 in a range of Tissue Factor (TF) expressing solid tumors. STRO-004 is the Company’s TF-targeting exatecan ADC engineered for best-in-class stability, potenc

Dec. 07, 2025 --- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced the publication of Phase 1/2 clinical data with PM359, the Company’s investigational autologous hematopoietic stem cell product for p47phox chronic granulomatous disease (CGD) in the New England Journal of Medicine (NEJM). The data will also be presented in a poster session at the 67th American Society of Hemat

Longer-term analyses reinforce duvelisib’s activity across treatment-experienced PTCL populations, including patients with ≥3 prior lines of therapy, with no new safety signals emerging over time. Findings further strengthen rationale for ongoing global Phase 3 TERZO study in nodal TFH lymphoma. Dec. 07, 2025 -- Secura Bio, Inc. , an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today presented extended follow up analyses examining additional safety d

– Data demonstrate superior efficacy compared to ruxolitinib, an approved type I JAK2 inhibitor, including reductions in mutant allele burden and bone marrow fibrosis, key markers of disease modification – – AJ1-11095 is currently in a Phase 1 clinical trial in patients with myelofibrosis, previously treated with a type I JAK2 inhibitor – Dec. 04, 2025 -- Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasm