Lured by what Amgen Inc. CEO Bob Bradway called a "compelling opportunity" to strengthen the Thousand Oaks, Calif.-based company's oncology portfolio and support its international expansion strategy, Amgen on March 4 moved to buy South San Francisco-based Five Prime Therapeutics Inc. for $38 per share, or about $1.9 billion.
Shares of Paris-based Abivax SA (Paris:ABVX) fell 25.4% to €21 (US$25.07) on March 8 after the company said it would halt a phase IIb/III trial of its lead candidate, ABX-464, in high-risk COVID-19 patients for lack of efficacy. The decision was based on a data safety monitoring board analysis that Abivax said revealed a "lower than expected rate (10.1%) of progression to severe disease or death with no difference between ABX-464 and placebo groups," each of which also received standard-of-care therapy.
More than a decade after first approving Actemra (tocilizumab) for the treatment of rheumatoid arthritis, the FDA has added a sixth use to its label: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.
Lured by what Amgen Inc. CEO Bob Bradway called a "compelling opportunity" to strengthen the Thousand Oaks, Calif.-based company's oncology portfolio and support its international expansion strategy, Amgen on March 4 moved to buy South San Francisco-based Five Prime Therapeutics Inc. for $38 per share, or about $1.9 billion.
Berkeley, Calif.-based Caribou Biosciences Inc. has raised $115 million in an oversubscribed series C financing co-led by Farallon Capital Management, PFM Health Sciences and Ridgeback Capital Investments. Proceeds from the round will be used to advance its CRISPR technology platform and pipeline of off-the-shelf genome-edited CAR T and CAR-NK cell cancer therapies, including CB-010, its lead CAR T program, now in a phase I trial for patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
A new once-daily attention deficit hyperactive disorder (ADHD) drug developed by prodrug specialist Kempharm Inc. has won FDA approval under the brand name Azstarys. The medicine combines serdexmethylphenidate, Kempharm's prodrug of the CNS stimulant dexmethylphenidate, with immediate-release d-MPH, the core medicine in the now off-patent product Focalin, a refined formulation of Ritalin.
Molybdenum cofactor deficiency (MoCD) type A, an ultra-rare metabolic disorder causing intractable seizures, brain injury and death, now has a world-first treatment in Nulibry (fosdenopterin), a new I.V. therapy developed by Bridgebio Pharma Inc. subsidiary Origin Biosciences Inc. The agency's priority review, supported by its orphan, breakthrough and rare pediatric disease programs, also yielded a priority review voucher (PRV) for Origin.
A failure of Tricida Inc.'s most recent efforts to overcome FDA objections to an NDA for the company's sole candidate, veverimer, for treating metabolic acidosis, sent company shares (NASDAQ:TCDA) 30.6% lower to $5.11 on Feb. 26. The complex story appears focused now on the agency's desire for additional and more reliable data to support a potential approval. Tricida President and CEO Gerrit Klaerner on Thursday suggested the ongoing renal outcomes study, Valor-CKD, might provide it.
Jaguar Gene Therapy LLC, a startup reuniting former Avexis Inc. executives to develop a portfolio of potential treatments for severe genetic diseases, announced its public debut Feb. 25 with more than $40 million in series A financing from co-creator Deerfield Management.
Cancer immunotherapy developer Xilio Therapeutics Inc. has raised $95 million in series C financing to support its efforts to move a duo of tumor-selective candidates into the clinic. IND applications for both its interleukin-2 agonist, XTX-202, and anti-cytotoxic T-lymphocyte-associated protein 4 antibody, XTX-101, are planned for this year.
