Updated results from a phase II test of Viking Therapeutics Inc.'s VK-2809 in people with nonalcoholic fatty liver disease (NAFLD) and elevated LDL-cholesterol found it delivered durable reductions in liver fat even four weeks post-treatment.
Triumvira Immunologics Inc., a U.S.-Canadian immuno-oncology startup, has raised $55 million in series A financing to back a pipeline of four new T-cell therapy candidates for the potential treatment of both liquid and solid tumors. Bayer AG's Leaps unit and Northpond Ventures led the round. China-based Oceanpine Capital and Viva Biotech Holdings also provided funds.
Kinnate Biopharma Inc., a San Diego-based company focused on the discovery and development of small-molecule kinase inhibitors for genomically defined cancers, has raised $98 million in a series C financing.
Moving to build out its central nervous system (CNS) portfolio with an eye to what Acadia Pharmaceuticals Inc. CEO Steve Davis called an "urgent need for new approaches to treat pain without causing addiction," the company is acquiring privately-held Cersci Therapeutics Inc. for $52.5 million, primarily in stock.
A phase III study evaluating a combination of a Novartis AG anti-PD-1 candidate with the well-established BRAF/MEK inhibitor combo in first-line unresectable or metastatic BRAF V600 mutant melanoma missed its primary endpoint of progression-free survival.
Tricida Inc. executives were not surprised when the FDA issued a complete response letter for veverimer to treat chronic metabolic acidosis. Despite an Aug. 22 PDUFA date, the company had received an FDA notification on July 16 that there were deficiencies that would preclude discussion of labeling and postmarketing requirements and commitments.
A third child with X-linked myotubular myopathy (XLMTM) has died after receiving the higher of two doses of an experimental gene therapy for the rare disease under development at Audentes Therapeutics Inc. Preliminary findings indicate that the immediate cause of death was gastrointestinal bleeding, Audentes said. The trial, testing AT-132 (resamirigene bilparvovec), was already on an FDA clinical hold.
Advanced talks between the European Commission and Curevac AG have positioned the company to potentially supply up to 405 million doses of its investigational mRNA-based COVID-19 vaccine to the bloc. News of the progress, following similar EU-level talks with an alliance of Sanofi SA and Glaxosmithkline plc, Johnson & Johnson and Astrazeneca plc, sent Curevac's recently-listed U.S. shares (NASDAQ:CVAC) climbing 16% to $66 on Aug. 20.
An FDA rejection of Galapagos NV's rheumatoid arthritis (RA) drug filgotinib, announced Aug. 18, was "disappointing and unexpected," CEO Onno van de Stolpe said, adding that "there is so much more" to his company's story and pipeline. Gilead Sciences Inc., the Belgian company's partner and a substantial backer of both the drug and the pipeline, said it would "evaluate the points raised" by the CRL, but continued to believe in the drug.
