The FDA has approved Xywav (calcium, magnesium, potassium and sodium oxybates; JZP-258), an oxybate product for treating both cataplexy and excessive daytime sleepiness in narcolepsy patients ages 7 and older, from Jazz Pharmaceuticals plc.
Fulcrum Therapeutics Inc. and Myokardia Inc. agreed to discover, develop and commercialize therapies for treating genetic cardiomyopathies, a deal spun out of two companies with a mutual appreciation of each other’s abilities as well as personal relations and networking, Fulcrum’s CEO told BioWorld.
IPOs from Alx Oncology Holdings Inc. and Pandion Therapeutics Inc. launched July 17 as investors continued to pour money into biopharma’s public sector. Through June, $8.53 billion in biopharma IPOs had been filed so far this year by 35 companies.
Courtesy of a $50 million series A, Adagio Therapeutics Inc. will join a raft of other companies attempting to end the COVID-19 pandemic with antibodies.
With an Aug. 22 PDUFA date set, Tricida Inc. said it received an FDA notification regarding the NDA for veverimer (TRC-101) for treating metabolic acidosis in chronic kidney disease (CKD) patients, noting that it had identified deficiencies precluding discussion of labeling and postmarketing requirements/commitments.
Cytokinetics Inc.’s new deal with RTW Investments gives the company a new presence in Asia and a strong influx of cash that should last at least two or three years.
Nextcure Inc. won’t advance the non-small-cell lung cancer (NSCLC) and ovarian cancer cohorts in the stage two portion of its phase I/II study of NC-318, a monoclonal antibody targeting Siglec-15 (S15), as a monotherapy. The data and decision prompted the company stock to shed more than half its value July 13 and several analysts to adjust their price targets downward.
Privately held Foghorn Therapeutics Inc., of Cambridge, Mass., cut a collaboration deal with Merck & Co. Inc. to discover and develop therapeutics targeting the chromatin regulatory system in oncology that could eventually bring in as much as $450 million.
Two more companies, Novavax Inc. and Regeneron Pharmaceuticals Inc., are on the receiving end of U.S. federal government funding to develop and deliver a COVID-19 vaccine in 2021.
