Detailed Viktoria-1 results of Celcuity Inc.’s gedatolisib positions the pan-PI3K/mTORC1/2 inhibitor as a top contender for second-line treatment of HR+/HER2- PIK3CA wild-type advanced breast cancer – a multibillion-dollar indication in need of new treatments.
Neuphoria Therapeutics Inc.’s phase III study of social anxiety disorder has missed its primary and secondary endpoints, prompting the company to stop the program’s development and hold a full strategic review of its operations and portfolio. It’s the second stumble for lead candidate BNC-210, a negative allosteric modulator of alpha7 nicotinic acetylcholine receptor, in the indication.
Despite a recent stock surge, Olema Oncology Inc. shares (NASDAQ:OLMA) slipped 17% on Oct. 20 to close at $7.77 each in the wake of updated and positive phase Ib/II results for palazestrant, the company’s metastatic breast cancer drug.
Much-awaited detailed data from Exelixis Inc.’s phase III Stellar-303 study of zanzalintinib, presented at the European Society for Medical Oncology meeting, showed the third-generation, oral tyrosine kinase inhibitor in combination with Tecentriq (atezolizumab, Roche AG) reduced the risk of death by 20% vs. Stivarga (regorafenib, Bayer AG) in patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer and are expected to pave the way for an NDA filing later this year.
The U.S. FDA named the first nine recipients of the recently unveiled commissioner’s national priority voucher (CNPV) program aimed at addressing unmet public health needs by shortening regulatory review times to as little as one to two months. For one of those firms, Disc Medicine Inc., which submitted an NDA for bitopertin for rare genetic disorder erythropoietic protoporphyria in September, that could mean a potential approval before the end of 2025.
Xortx Therapeutics Inc. has entered into a binding term sheet to acquire a renal anti-fibrotic therapeutic program from Vectus Biosystems Ltd., including a novel new chemical entity, VB4-P5.
Success by nearly all measures with Praxis Precision Medicines Inc.’s essential tremor phase III candidate, ulixacaltamide, drove the company’s stock up significantly and provided solid data for an NDA filing planned for early 2026.
Touting a science-driven, regenerative medicine-based treatment for hair loss “designed for the 21st century,” Pelage Pharmaceuticals Inc. drew a solid group of investors to the table in an oversubscribed $120 million series B round to fund an upcoming phase III program for PP-405, a topical small molecule targeting hair follicle stem cells.
CF Pharmtech Inc. raised HK$607.67 million (US$78.12 million) through the sale of 41.19 million H shares on the Hong Kong Stock Exchange (HKEX) Oct. 8. The proceeds will be used to advance the Suzhou, China-based drug developer’s portfolio of inhalation candidates for respiratory diseases.
In a deal that could top $2 billion, China-based Innocare Pharma Ltd. licensed the exclusive worldwide development and commercialization rights to the BTK inhibitor orelabrutinib to Zenas Biopharma Inc. for multiple sclerosis and other indications aside from oncology.