Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor inhibitor, pimicotinib, met both primary and secondary endpoints in the phase III Maneuver global study evaluating pimicotinib for treatment of tenosynovial giant cell tumor.
Rapt Therapeutics Inc. has decided to shut down its zelnecirnon (RPT-193) program in asthma and atopic dermatitis, causing the company’s stock (NASDAQ:RAPT) to sharply decline Nov. 11.
Abbvie Inc.’s much-hyped emraclidine, the centerpiece of its $8.7 billion buyout of Cerevel Therapeutics Inc., failed to hit its endpoints in two phase II trials in schizophrenia, sending company shares (NYSE:ABBV) down more than 12.6%, to close at 174.43, catching industry watchers by surprise and removing a potentially near-term competitor for Bristol Myers Squibb Co.’s recently approved antipsychotic, Cobenfy (xanomeline-trospium).
Radiopharmaceutical biotech and contract development and organization firm Duchembio Co. Ltd. filed a securities report to South Korea’s Financial Services Commission Nov. 11, kickstarting the IPO process to list on the Korea Exchange.
As an array of developers push their Friedreich’s ataxia (FA) drugs along, PTC Therapeutics Inc.’s recent update on its program piqued thirst for the 15-lipoxygenase inhibitor vatiquinone. Warren, N.J.-based PTC said the prespecified endpoint for two different FA long-term extension studies was met, with highly statistically significant evidence of durable treatment benefit on disease progression.
In a pipeline shakeup, Tango Therapeutics Inc. has halted enrollment in a phase I/II study in order to push two other brain cancer drugs into development. TNG-908 had success in treating non-CNS solid tumors such as non-small-cell lung cancer and pancreatic cancer but missed the minimum pharmacokinetic exposure in clinical efficacy for treating glioblastoma.
Atossa Therapeutics Inc. moved a step closer in its efforts to develop a preventative approach to breast cancer, with top-line data from a phase II study showing (Z)-endoxifen significantly reduced mammographic breast density, while demonstrating a good tolerability profile.
Disc Medicine Inc. found itself after an end-of-phase II meeting with the U.S. FDA in what Wainwright analyst Douglas Tsao called a “best-case scenario” regarding the path forward for bitopertin in erythropoietic protoporphyria (EPP).
Shares of Essa Pharma Inc. tanked Nov. 1 after the company said it is terminating all trials of masofaniten, its N-terminal domain androgen receptor inhibitor and sole clinical-stage program, following a disappointing readout from a phase II study in metastatic castration-resistant prostate cancer. The stock (NASDAQ:EPIX) hit a 52-week low, closing at $1.40, down $3.80, or 73%.
The second time around wasn’t lovelier for Lexicon Pharmaceuticals Inc. as it once again made its case before the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista (sotagliflozin) as an adjunct to insulin to improve glycemic control in people with type 1 diabetes and mild to moderate chronic kidney disease.
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