What one analyst characterized as “a little bit of an exotic or at least unusual statistical analysis on the phase II primary endpoint” may have dampened enthusiasm somewhat for Evelo Biosciences Inc.’s results in mild and moderate psoriasis with EDP-1815, but the firm is advancing the compound to registration studies.
Capricor Therapeutics Inc. CEO Linda Marban said the company’s CAP-1002 for Duchenne muscular dystrophy (DMD) should serve as “adjunctive to any of the therapies out there” – a handful are approved – and bring bonus favorable effects on cardiac function that one analyst called “a one-two punch” against the disease.
Imugene Ltd.’s recent win with a patent granted in Japan with its HER-Vaxx immunotherapy, in development for HER2-positive gastric cancer, represented a smallish but significant win in the HER2/neu space, where plenty of other players are busy, with Greenwich Life Sciences Inc. a strong emerging name.
Hexagon Bio Inc.’s latest, $61 million financing to advance work with small molecules mined from microbial genomes will help the firm build its DNA database, add to the team and advance preclinical work, said CEO Maureen Hillenmeyer.
Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.
Sanofi SA’s high-profile phase III blow-up Sept. 9 with the oral BTK inhibitor rilzabrutinib in pemphigus brought fresh attention to the group of rare diseases – which cause blisters on the skin and mucous membranes throughout the body – and to players pushing for a new treatment.
Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. Byooviz is the first ophthalmology biosimilar to win the go-ahead in the U.S., and was approved in the EU on Aug. 18, 2021, followed by the U.K. on Aug. 31, 2021.
Aerie Pharmaceuticals Inc.’s wide-net endpoint approach with the phase IIb study called Comet-1 seemed less than appreciated by the stock market as the firm unveiled top-line data in dry eye disease with AR-15512.
The market’s appetite for immunology candidates in chronic disease – in particular an oral interleukin-17 (IL-17) therapy for psoriasis – was proved by the upsized IPO pulled off by Dice Therapeutics Inc., and Tyra Biosciences Inc. benefited from the ongoing appetite in precision oncology in another, bigger-than-expected debut. Preclinical-stage Pasithea Therapeutics Inc. went public as well, albeit less spectacularly.
Apellis Pharmaceuticals Inc.’s win with one phase III trial and narrow miss with an identical one testing pegcetacoplan in geographic atrophy secondary to age-related macular degeneration caused Wall Street to punish the company while rewarding competitor Iveric Bio Inc.
