The deals keep rolling in, with Lilly penning a $7 billion pact for gene delivery biotech Kelonia Therapeutics and UCB taking over cell therapy-focused Neurona Therapeutics; President Trump signed a new executive order supporting the development of psychedelic therapies, sparking fanfare and concern alike; and the FDA’s recent Replimune decision has triggered broader debate about the agency’s flexibility.
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After entering the CAR T arena in February, Eli Lilly jumped onto the in vivo bandwagon, penning a deal worth up to $7 billion for Kelonia Therapeutics and its gene therapy delivery tech iGPS. Meanwhile, Belgium-based UCB scooped up Neurona Therapeutics for $650 million upfront and up to $500 million in milestone payments. The deal’s focal point is NRTX-1001, a single-dose cell therapy being evaluated in a Phase 1/2 trial for epilepsy.
On the policy front, President Donald Trump signed a new executive order that analysts believe could help psychedelic therapies become the “key next wave” of mental health therapies. The EO instructs the FDA to grant Commissioner’s National Priority Vouchers (CNPVs) to “appropriate psychedelic drugs” that have secured breakthrough designation, a move that could cut review timelines from 10-12 months to 1-2 months for these therapies.
Elsewhere, the FDA’s rebuff of Replimune’s advanced melanoma drug RP1 continues to make waves, with CEO Sushil Patel slamming the agency for failing to exercise flexibility, while experts have lamented the regulator’s inconsistency. A recent BioSpace poll generated mixed feedback on the question of flexibility vs. regulatory rigor, with 34% of respondents saying the agency is too inflexible, 23% saying the FDA is too flexible, 19% believe there is an appropriate balance and 24% aren’t sure.
On the business side, Kailera managed to break biopharma’s all-time IPO record, raising $625 million last week. The new all-time high prompted BioSpace to take a look back at other historic IPOs in the industry, with mRNA heavyweight Moderna’s 2018 debut falling into second place.
BioSpace also spoke with Denali Therapeutics CEO Ryan Watts about the company’s long-awaited FDA approval for Hunter syndrome drug Avlayah. “It was the greatest professional moment of my life,” Watts said during an event put on by Utah’s biotech community hub, BioHive.
