Feb. 17 Quick Takes: Apellis’ Syfovre first to market for geographic atrophy
Plus: Amid partnership talks, Madrigal also ‘open’ to M&A; and updates from Panakès, Aqilion- Merck KGaA, Pfizer, Merck & Co.
FDA’s approval of Syfovre pegcetacoplan makes Apellis Pharmaceuticals Inc. (NASDAQ:APLS) first to market in the geographic atrophy field. The C3 inhibitor is indicated to treat patients with GA secondary to age-related macular degeneration. FDA had extended its review of Syfovre by three months, shortening its lead over a competing program from Iveric bio Inc. (NASDAQ:ISEE); that molecule, C5 inhibitor Zimura avacincaptad pegol, is under priority review with an Aug. 19 PDUFA date. Apellis gained $3.58 to $55.49 on Friday. Shares of Iveric, which announced Zimura’s acceptance for review late Thursday, rose 32% to an intraday high of $26.35 before settling in to close at $21.95, up 10%, following news of Syfovre’s approval.
Shares of Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) got a lift this week after Chairman and CEO Paul Friedman said the company believes ongoing discussions concerning an ex-U.S. deal for resmetirom will “evolve” into M&A talks, and said the company is “open to that parallel track.” Resmetirom, a THRB agonist, has met both primary endpoints in the Phase III MAESTRO-NASH study to treat non-alcoholic steatohepatitis, setting up Madrigal for a regulatory submission. Friedman’s remarks came Tuesday at the SVB Securities Global Biopharma Conference; since Monday’s close at $255.36, Madrigal’s shares have gained 19% to $303.39...