—sNDA Under Review for Full Approval Is Based on Positive Results From Phase 3b ENCORE Study— —Full Approval Could Bring ARIKAYCE to Patients Earlier in Their Disease Course and Would Fulfill Post-Marketing Requirement From FDA— Sept. 21, 2026 -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administr

Sept. 20, 2026 -- Accro Bioscience Inc. (Accro Bio), a clinical-stage biotechnology company pioneering the development of novel therapeutics for immune mediated diseases, today announced the dosing of their first patient in the Phase IIb clinical trial of AC-101, a selective RIPK2 inhibitor, in patients with moderate-to-severe ulcerative colitis (UC). The Phase IIb study is a multicenter, double-blind, placebo-controlled clinical trial designed to evaluate AC-101 in patients with moderate-to-sev

Eli Lilly is sharpening its competitive edge in the crowded oral SERD arena as the FDA has approved a combination of its Inluriyo with its CDK4/6 inhibitor Verzenio. The label expansion builds on Inluriyo’s existing monotherapy indication, approved nearly a year ago to treat ER-positive, HER2-negative breast cancer that carries ESR1 mutations in previously treated patients. Given the longer progression-free survival (PFS), Jake Van Naarden, president of Lilly Oncology and head of corporate busi

mAbxience and Sandoz have entered into a collaboration agreement combining mAbxience's development and manufacturing expertise with Sandoz's global commercial capabilities for a proposed emicizumab biosimilar candidate. Emicizumab biosimilar expands mAbxience's pipeline into haemophilia A and strengthens its presence in rare diseases. The agreement is consistent with mAbxience's strategy of broadening patient access to high-quality biologic medicines through selected partnerships in global marke

Electra Therapeutics has exceeded its initial fundraising plans as it becomes the 26th biotech to debut publicly this year and outlines pivotal development plans for its monoclonal antibody ipsoprubart. Electra Therapeutics is charging toward the public markets, raising an upsized $350 million initial public offering to help push its lead asset through pivotal testing and to potential market approval. The IPO encompasses 23.3 million shares sold at $15 per share, with underwriters given 30 da

September 17, 2026 – The NationalInstitute of Diabetes and Digestive and Kidney Diseases (NIDDK), a division ofthe National Institutes of Health (NIH), has awarded SignaBlok, Inc., a biopharmaceutical company focused on developing novel peptide antagonists of cell receptors, a Phase I Small Business Innovation Research (SBIR) grant to develop a new therapeutic approach for inflammatory bowel disease (IBD). SignaBlok’s approach to IBD therapy targets TREM-1, a cell-surface receptor that has emer

It is intended for scientific, financial and investor media only. If approved, Jyseleca will be indicated for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy. Despite the availability of multiple treatment options, nearly half of people living with axSpA do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks

Lisata Therapeutics Announces Acquisition of Marea Therapeutics and $225 Million Concurrent Private Placement Combined company to focus on developing first-in-class next-generation medicines for cardioendocrine diseases Marea has multiple late-stage clinical product candidates: MAR001/005 for severe hypertriglyceridemia (sHTG) currently in Phase 2b and MAR002 for the treatment of acromegaly which is advancing to a Phase 2 study Concurrent financing of $225 million from leading life sciences inve

Sling Therapeutics has closed a $123-million series C round as it advances linsitinib into Phase III testing for thyroid eye disease (TED), putting the oral small-molecule IGF-1R inhibitor on track to challenge infusion-based therapies including Amgen's Tepezza (teprotumumab-trbw) and Viridian Therapeutics' Lumvoa (veligrotug-vvze). The financing, led by Forbion with participation from TPG Life Sciences Innovations and new investor Sectoral Asset Management, comes as Sling begins dosing patient

Protocol Submitted for IRB Review at a Leading Cancer Research Institution, Advancing the Study Toward Site Initiation Sept. 17, 2026 -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced that, following review and comments from the U.S. Food and Drug Administration (FDA), the Phase 2a protocol evaluating Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) has