Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics Inc., Belharra Therapeutics Inc. and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors.
Takeda Pharmaceutical Co. Ltd. has signed an option agreement to in-license Ascentage Pharma Group Inc.’s olverembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI). If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.
Aerovate Therapeutics Inc. is shutting down the ongoing phase III portion of its Impahct study of AV-101, an inhaled version of PDGFR inhibitor imatinib, after reporting top-line data from the phase IIb portion failed to meet primary and secondary endpoints in patients with pulmonary arterial hypertension (PAH). It was a major blow for the single-product company, sending shares (NASDAQ:AVTE) falling 93% to close June 17 at $1.65, down $22.97.
The U.S. Supreme Court unanimously upheld the FDA’s relaxed regulation of the abortion drug mifepristone when it ruled June 13 that the organizations challenging those changes lacked the standing to do so.
Following a phase II/III failure, Stamford, Conn.-based Cara Therapeutics Inc. discontinued its only pipeline program, that of oral difelikefalin for moderate to severe pruritis in adults with notalgia paresthetica, placing the company’s future in question.
Urogen Pharma Ltd. shares (NASDAQ:URGN) closed June 13 at $17.50, up $4.78, or 37%, on word of an 82.3% 12-month duration of response data by Kaplan-Meier estimate from its phase III Envision study with UGN-102. The finding was made in in low-grade, intermediate-risk, non-muscle invasive bladder cancer patients who achieved complete response at three months after the first instillation of the drug for intravesical solution.
Chinese artificial intelligence (AI)-driven drug discovery firm Quantumpharm Inc., also known as Xtalpi, began trading on the Hong Kong stock exchange June 13, listing under a new special technology listing track that lured it away from an IPO in the U.S.
The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler.
After delivering animal data to show that inhibiting the NLRP3 inflammasome induces weight loss in mice, Nodthera Ltd. has now demonstrated this effect translates to humans. In a phase Ib/II study of NT-0796, an orally available, brain-penetrant drug, subjects in both the active and placebo arms all lost weight, due to the calorie-restricted diet they received in the 28-day trial.
Ipsen SA picked up U.S. FDA accelerated approval for its Genfit SA-licensed elafibranor, making it the first new drug in eight years for treating primary biliary cholangitis, though a potential competitor lurks just around the corner.
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