In its largest acquisition to date, Incyte Inc. snagged rights to phase III-stage VGA-039, a monoclonal antibody the firm said could offer a new standard of care in von Willebrand disease (VWD), in a buyout of Vega Therapeutics Inc. that includes a $1.25 billion up-front payment and up to $750 million tied to the achievement of sales milestones. The announcement was followed shortly by news of another buyout, Johnson & Johnson’s deal to acquire Firefly Bio Inc. for $1 billion in cash, both moves continuing this year’s trend of larger, more strategic M&A transactions.
The U.S. FDA’s year-old Commissioner’s National Priority Voucher (CNPV) pilot program played to mixed reviews at the agency’s June 4 listening session intended to get various stakeholders’ perspective on the ultra-accelerated review process being offered to qualifying drugs.
Agios Pharmaceuticals Inc.’s potential $665 million deal for Oscotec Inc.’s cevidoplenib, a phase III-ready oral SYK inhibitor to treat immune thrombocytopenia, marks a new chapter of development focused on cancer therapy resistance for Oscotec, CEO Yoon Tae-young said.
The U.S. Supreme Court handed Hikma Pharmaceuticals and the entire generic industry a big victory June 4 with its 9-0 opinion ensuring the future of skinny labels and correcting the Federal Circuit’s flawed understanding of infringed inducement.
Achieving high marks in the phase II Amplify-BD trial for bipolar I and II depression, Autobahn Therapeutics Inc.’s elunetirom, a brain-penetrant central nervous system thyroid hormone receptor agonist, or thyromimetic, is moving toward a registrational path and a clinical readout in major depressive disorder.
ADC Therapeutics SA blamed patients’ advanced age on the death imbalance in the phase III Lotis-5 confirmatory trial testing Zynlonta (loncastuximab tesirine-lpyl) in combination with rituximab to treat relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). Whatever the reason, Wall Street wasn’t pleased and shares (NYSE:ADCT) closed June 4 at $1.32, down 57%, or $1.77.
Nearly a year after Health and Human Services Secretary Robert Kennedy announced the U.S. was cutting off funding for Gavi, a global vaccine alliance, Secretary of State Marco Rubio said his department is reengaging with the organization in light of the ongoing Ebola outbreak in central Africa. In testifying before a June 2 Senate Foreign Relations Committee hearing, Rubio said the State Department made the decision to reengage a few weeks earlier with Gavi. He provided no detail of what that engagement looks like.
Mammogen Inc. raised $30 million in equity financing in a series A round to support the clinical advancement and commercialization of its RNA-powered molecular diagnostics platform. The company’s lead product is Gentru-breast, a blood-based assay designed to detect molecular signatures associated with breast cancer from a simple blood draw.
Cytomx Therapeutics Inc. and Regeneron Pharmaceuticals Inc., which inked a bispecifics-focused collaboration worth up to $2 billion in 2022, agreed to broaden their efforts in an expanded deal that provides Cytomx with additional funding up front as it advances its promising colorectal cancer candidate, varsetatug masetecan (Varseta-M), and fills the gap left by the recently terminated agreement with Astellas Pharma Inc.
Once again, Eli Lilly and Co. has signed a billion-dollar deal, this time with Boston-based Ascidian Therapeutics Inc., a company that is barely four years old and one that is focused on treating human diseases by rewriting RNA. “Our technology, we call it RNA exon editing,” said Ascidian Chief Scientific Officer Robert Bell. “It edits RNA, not DNA … but it does so at the kilobase scale.”