Fast Track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis (AD) patient trial KT-621 BROADEN2 Phase 2b AD trial ongoing, with data expected to be reported by mid-2027 and BREADTH Phase 2b trial in asthma on track to initiate in 1Q26 Dec. 11, 2025 -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that the

Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years1-3 Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease1 ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third experience recurrence on or after adjuvant endocrine therapy treatment4-7 Data will be featured

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. 10, 2025 -- Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AJ1-11095 for the treatment of myelofibrosis, a debilitating blood cancer that affects approximately 20,000 patients in the U.S. AJ1-11095 is the first JAK2 inhibitor to enter the clinic that binds the Type II conformation of th

RMAT designation indicates that SENTI-202 has the potential to address unmet medical needs for patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) based on preliminary clinical evidence, and offers benefits of FDA working closely with Senti Bio to provide guidance and advice on generating the data needed to support approval of the product in an efficient manner Second FDA designation for SENTI-202 this year, after Orphan Drug Designation, is supported by clinical data showing de

ERJ Open Research article reports first clinical trial of glasmacinal (EP395) in COPD patients Glasmacinal, a novel macrolide, was well tolerated and reduced neutrophilic inflammation in COPD patients. Glasmacinal had no detectable impact on the lung microbiome supporting the in vitro findings of negligible anti-microbial activity. 8 December 2025 – EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’) is developing glasmacinal, an orally available macrolide with reduced antimicrobial resistance

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

Ragistomig is a 4-1BB X PD-L1 bispecific antibody, designed to treat patients who are relapsed or refractory to checkpoint inhibitors, a multi-billion dollar drug class hampered by widespread resistance The Phase 1 ragistomig study achieved its objective, as the new Q6W extended dosing interval produced strong anti-tumor efficacy in PD-L1-non-responders, with an improved safety profile The interim results, including immunological data on CD8+ cell proliferation and memory T-cell activation, are