Unexpected cataract cases in top-line data from two of three phase III trials for eye diseases is leading Kodiak Sciences Inc. to quit work with tarcocimab tedromer, an antibody biopolymer conjugate also known as KSI-301.
Artificial intelligence (AI) drug discovery specialist Insilico Medicine Inc. is progressing INS018-055, its lead compound to phase II trials for idiopathic pulmonary fibrosis, a chronic lung disease that results in progressive and irreversible decline in lung function.
Vir Biotechnology Inc. said it won’t be discussing further the phase II data from the influenza A prevention study called Peninsula until the company’s second-quarter earnings update Aug. 3, and a closer look at the results has yet to decide the fate of monoclonal antibody VIR-2482, which missed its primary and secondary endpoints.
Argenx SE’s top-line results from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP) sparked buzz about other developers in the space with similar mechanisms of action to Vyvgart Hytrulo, such as Immunovant Inc.
Apellis Pharmaceutical Inc.’s shares nosedived by 37% July 17 after the American Society of Retina Specialists wrote to ophthalmologists warning them of the risk of serious intraocular inflammation events in patients following injection of the company’s geographic atrophy drug, Syfovre (pegcetacoplan).
Strong and complete phase III results for Eli Lilly and Co.’s donanemab for treating early Alzheimer's disease (AD) will no doubt inspire more comparisons with recently approved Leqembi (lecanemab). The newly released data for donanemab show it significantly slowed cognitive and functional decline for those with amyloid-positive early symptomatic AD, which lowered the disease-progression risk.
Camurus AB’s subcutaneous octreotide hydrochloride injection pen, CAM-2029, yielded statistically significant improvements in “multiple endpoints” in a 52-week phase III extension trial in patients with acromegaly, moving it closer to providing a more convenient treatment option for patients with the rare, chronic growth disorder than currently available therapies.
While the 12-month data from Bridgebio Pharma Inc.’s phase III ATTRibute-CM study testing acoramidis in transthyretin amyloid cardiomyopathy were deemed “puzzling” in late 2021, the 30-month results reported July 17 proved far more pleasing to investors. The trial hit all its endpoints and showed promising results on exploratory markers, sending company shares (NASDAQ:BBIO) up 76%, to close at $32.04, up $13.82.
Dose-limiting toxicities in a phase I/II study led Theseus Pharmaceuticals Inc. to quit work with lead compound THE-630, a pan-variant KIT Inhibitor for gastrointestinal stromal tumors (GIST), but the company plans to nominate another such candidate in the same indication during the first half of 2024. Meanwhile, the firm is prioritizing THE-349, a fourth-generation EGFR inhibitor for non-small-cell lung cancer, due for an IND application in the fourth quarter of this year.
Although shares of TG Therapeutics Inc. took a hit on word of positive phase III data in multiple sclerosis (MS) from competitor Genentech, a unit of Roche Holding AG, the results may not end up affecting much the market showdown between the CD20 players.
RSS
