—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

Roche and Dualitas Therapeutics, a biotechnology company developing next-generation bispecific antibody therapies for immunology and inflammation (I&I) diseases, have announced a research collaboration and license agreement with to advance novel bispecific antibodies for I&I diseases In what is believed to be one of the largest-scale bispecific discovery endeavours, Dualitas will use its DualScreen Bispecific Discovery Engine to functionally screen over 300,000 novel bispecific combinations to

Rare disease drugmaker Electra Therapeutics on Thursday banked $350 million in an initial public offering, becoming the 21st biotechnology company to price a new stock issuance in 2026. Electra plans to use the proceeds to continue developing an experimental drug for secondary hemophagocytic lymphohistiocytosis or “HLH,” a rare, sometimes life-threatening immune disorder with no approved treatments. That drug, called ipsoprubart, is in a registrational trial. Electra expects to complete enrollme

- FDA approval represents a monumental milestone for patients with MPS IIIA and validates Abeona’s foundational R&D and clinical development efforts - - Ultragenyx successfully brought a life-changing therapy across the finish line for MPS IIIA patients and families - Sept. 18, 2026 -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing genetic medicines for serious diseases with high unmet need, today congratulated Ultragenyx Pharmaceutical Inc., o

Sept. 18, 2026 -- CDT Equity Inc. (Nasdaq: CDT) (“CDT” or the “Company”), today announced that it has entered into a partnership with QIMA Life Sciences, a world leading preclinical dermatology CRO, to explore the potential of several of CDT’s assets in autoimmune skin diseases. CDT plans to leverage QIMA’s unique access to human skin from both healthy donors and patients. The use of patient tissue offers the most clinically relevant data possible, providing rapid translation to clinic and pro

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