Today, a brief rundown of news from the Food and Drug Administration and Takeda, as well as updates from Syneron Bio and Stipple Bio that you may have missed.
The Food and Drug Administration is proposing a way to speed experimental drugs into human testing in an effort to match a regulatory framework in China that has shifted early drug development activity away from the U.S. The agency’s budget proposal for the 2027 fiscal year, which begins Oct. 1, said a new “optional, risk-based” expedited Investigational New Drug pathway could be available for experimental drugs with existing preclinical data that can be confirmed without animal tests. That policy would “create an accelerated path” to U.S.-based Phase 1 clinical trials, lower the regulatory burden for drugs with “adequate” preclinical data and cut development costs, according to the document. Congressional action would be necessary to create the new pathway. — Jonathan Gardner
Takeda has terminated a deal with Denali Therapeutics to co-develop a treatment for frontotemporal dementia. Denali said in a Friday statement that the decision was driven by “strategic considerations” and wasn't related to efficacy or safety of the therapy, which is known as DNL593. Denali will now regain rights to the treatment and expects to report results from an ongoing early-stage trial later this year. Takeda first partnered with Denali in 2018, paying the biotech firm $150 million upfront to work on up to three drugs for neurodegenerative diseases. — Ben Fidler
Syneron Bio has raised $150 million in Series B funding from more than a dozen investors including U.K. drugmaker AstraZeneca. The Beijing-based biotech will use the financing to develop macrocyclic peptide drugs — mid-sized medicines with some of the strengths of small molecules and targeting antibodies. The round follows a multibillion-dollar alliance between AstraZeneca and Syneron last March and about $100 million in additional funding the startup announced in December. It'll help propel multiple programs towards clinical testing, Syneron said. — Ben Fidler
Stipple Bio emerged from stealth on Monday with $100 million in Series A funding that will help advance its lead candidate into clinical testing and identify additional drug programs. Stipple is using a type of discovery platform to unearth precision cancer medicines it hopes will have a “high therapeutic index,” or wide range of safe and effective doses. Its top program, known as STP-100, is an antibody-drug conjugate aimed at an unspecified target and expected to enter clinical human studies in early 2027. Stipple’s funding was co-led by a16z Bio+Health, RA Capital Management and Nextech Invest, and should enable the company to operate into 2029. — Delilah Alvarado
