GRI Bio Inc.’s oral version of tazarotene is showing phase IIa promise in idiopathic pulmonary fibrosis (IPF). The peek at interim safety with the compound, a RAR-βɣ dual agonist designed to inhibit the activity of human type 1 invariant natural killer T cells, consisted of a preplanned analysis of two-week results in the biomarker study. GRI-0621 at 4.5 mg once daily proved safe and well-tolerated in the first 12 patients. Read More
Despite missing the primary endpoint in a phase III study of solriamfetol in major depressive disorder, Axsome Therapeutics Inc. still sees a path to another phase III study. It’s a path some analysts and investors are concerned about, though its precision-medicine approach got plenty of nods of approval.
As the U.S. Department of Health and Human Services begins implementing its reorganization and reduction-in-force plan by sending out termination notices this week to 10,000 more employees across its agencies, top Democrats in Congress are demanding details about the plan. Read More
Anocca AB has secured the first regulatory authorization in Europe for a CRISPR-Cas gene-edited T-cell receptor T-cell therapy trial, with the phase I/II study now due to start over the next three months at sites in Sweden, Germany, Denmark and the Netherlands. Read More
As it prepares to advance its lead RNA editing candidate, AIR-001, into a phase I/II trial for alpha-1 antitrypsin deficiency, Airna Corp. Inc. closed an oversubscribed $155 million series B financing less than a year after completing its series A round. The company, based in Cambridge, Mass., with research operations in Tübingen, Germany, focuses not only on repairing harmful genetic variants found in rare genetic disorders, but also on introducing beneficial variants that improve health in common conditions. Read More
Merck KGaA is exercising its option for a global license to commercialize Abbisko Therapeutics Co. Ltd.’s pimicotinib for $85 million. As previously reported by BioWorld, Abbisko out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck in a deal worth up to $605.5 million in December 2023. Read More
The biopharma sector is still trying to get its wind and resume its once-powerful investment ways. Medical technology has sidestepped much of biopharma’s issues by being more flexible along the development path, according to BioWorld MedTech Editor Annette Boyle in this edition of the podcast. Boyle described the current financing climate on the newest BioWorld Insider podcast and explained why the sector is performing well year to date.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alnylam, Biocardia, Biomx, Cabaletta, Corcept, Eli Lilly, Fibrogen, Keros, LB, Mineralys, Nanobiotix, Novo Nordisk, Opthea, Palatin, Regulus, Sensei, Transcend, Vaxcyte, Vertex. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ayrmid, Biora, Bluebird, Cyclo, Nervgen, Rafael. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, BMS, Halozyme, Ideaya, Moderna, Novartis, Otsuka. Read More
