Unblinding, zealous therapists, severity of harms, abuse potential and actual benefit could all be part of the conversation June 4 when the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee meets in person for the first time since the COVID-19 lockdowns to consider the use of a psychedelic drug, guided by psychotherapy, to treat post-traumatic stress disorder, or PTSD.
Japanese industrial conglomerate Asahi Kasei Corp. has made an offer to acquire Swedish rare diseases specialist Calliditas Therapeutics AB for SEK11.8 billion (US$1.1 billion). The offer, at an 83% premium to the closing share price of SEK113.60 on Monday, May 27, is recommended by the three biggest shareholders and the board of Calliditas, which said the company would benefit from “being part of a larger platform.”
As the company began a rolling NDA submission to the U.S. FDA for its drug combo in low-grade serous ovarian cancer, Verastem Oncology Inc. popped the lid off phase I/II data in pancreatic tumors, but Wall Street seemed uncertain about the news. Boston-based Verastem disclosed upbeat outcomes from the Ramp 205 study testing the RAF/MEK clamp avutometinib when paired with focal adhesion kinase inhibitor defactinib in combination with gemcitabine plus nab-paclitaxel as first-line therapy for metastatic pancreatic cancer.
Shanghai- and San Diego-based Degron Therapeutics Inc. secured a potential $1.2 billion deal with Tokyo-headquartered Takeda Pharmaceutical Co. Ltd. May 23 for a multitarget collaboration and exclusive licensing agreement for molecular glue degraders. “It is a breakthrough technology in the small-molecule drug discovery field,” Degron CEO Lily Zou told BioWorld. “People talk about cell and gene therapy, but small molecules are still the mainstream of drug discovery, [with] more reach.”
Grey Wolf Therapeutics Ltd. added $50 million to its series B, bringing the total for the round to $99 million and providing funding to expand the scope of an ongoing phase I/II trial of its lead antigen modulation program.
Hørsholm, Denmark-based Contera Pharma A/S’ lead asset for levodopa-induced dyskinesia in Parkinson’s disease, JM-010, failed to meet its primary endpoint in the late-stage phase IIb Astoria trial. JM-010 is a novel drug formulation and 5-HT receptor modulator that combines existing medications of immediate-release buspirone and extended-release zolmitriptan.
Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME.
Théa Open Innovation, a subsidiary of France’s Laboratoires Théa SAS, returned rights to South Korea’s Curacle Co. Ltd.’s CU-06, an oral diabetic macular edema drug candidate. Curacle posted positive top-line phase IIa data of CU-06 just three months prior.
With positive phase IIa data for ENV-101 in idiopathic pulmonary fibrosis (IPF) in hand, showing some lung damage was reversed, Endeavor Biomedicines Inc. said it’s ready to begin further phase II studies in the indication.
Shaking up corporate and pipeline structure, San Diego-based cancer developer Erasca Inc. in-licensed two assets from China-based biopharmas in all-cash deals, while laying off 18% of its workforce, primarily in drug discovery. The flurry of announcements made on May 16, which included $160 million raised in private placement, showed that Erasca would scrap three existing pipeline assets – ERAS-007, ERAS-801 and ERAS-4 – and reshape development to a RAS-targeting franchise.
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