Jan. 29, 2026 -- MicuRx Pharmaceuticals, Inc. ("MicuRx"), a clinical-stage biopharmaceutical company focused on developing novel anti-infective therapies for drug-resistant bacterial infections, recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MRX-5, enabling the company to initiate a Phase 2a clinical trial in patients with Mycobacterium abscessus pulmonary disease. M. abscessus pulmonary disease is a serious an

Jan. 29, 2026 -- Innovative Molecules GmbH, a German clinical stage biotech company focused on development of novel agents in the field of herpes-mediated diseases, today announced the successful completion of its Phase 1 clinical development program and the transition into Phase 2 for its oral selective helicase primase HSV inhibitor adibelivir (IM-250). The Phase 1 clinical development program included the following clinical trials: IM-101: Phase 1a single-ascending dose study in healthy volu

Jan. 29, 2026 -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient was dosed in its first-in-human clinical trial evaluating RMC-5127, a RAS(ON) G12V-selective inhibitor. The first-in-human trial, RMC-5127-001 [NCT07349537], is an open-label trial evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of RMC-5127 as both a monotherapy and in combi

MYQORZO, a Cardiac Myosin Inhibitor, Directly Addresses Underlying Hypercontractility Associated with Obstructive HCM Jan. 27, 2026 -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MYQORZO™ (aficamten) is now available for prescription in 5 mg, 10 mg, 15 mg and 20 mg tablets in the U.S. MYQORZO was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional ca

Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous lupus erythematosus (CLE) skin disease activity Litifilimab has the potential to be a first-in-class therapy targeting blood dendritic cell antigen 2 (BDCA2) in CLE, a chronic autoimmune skin disease that has a substantial impact on the daily life of patients, and may result in permanent scarring and disfigurement FDA Breakthrough Therapy Designati

Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint in the pivotal, global Phase 3 DRAGON trial with 36% reduction in lesion growth (p-value=0.0033) 60 adolescent STGD1 subjects enrolled in DRAGON II clinical trial across Japan, the United States, and the United Kingdom Belite Bio plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 1H 2026 Jan. 27, 2026 -- Belite Bio, In

Jan. 28, 2026 -- TETRAPHARM, a Copenhagen-based biopharmaceutical company focused on neuroscience, psychiatry, and metabolic disorders, today announced promising preclinical data for TPC-026, a novel investigational compound being developed for the chronic treatment and long-term management of multiple metabolic disorders, including obesity. The preclinical findings support TPC-026 as a differentiated therapeutic candidate, designed to address underlying disease mechanisms, rather than symptoms

Jan. 27, 2026 -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to CTD402, the company’s investigational allogeneic anti-CD7 CAR-T cell therapy for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL). This designation underscores the significant unmet need for new treatmen

Nine-month findings show mean improvement in Composite Unified Huntington's Disease Rating Scale from baseline of +0.64 points, compared to natural history expected worsening of cUHDRS in symptomatic patients of -0.73 points over nine months, based on propensity score weighting. Skyhawk also announces SKY-0515's Phase 2/3 FALCON-HD trial has expanded worldwide. Skyhawk has now dosed more than 90 patients. Jan. 27, 2026 -- Skyhawk Therapeutics, Inc., a clinical-stage biotechnology company develo

- Cogent will submit the PEAK New Drug Application (NDA) under previously announced RTOR designation; on track to complete NDA submission in April 2026 Jan. 26, 2026 -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bezuclastinib in combination with sunitinib for patients with Gastr