Kisunla Approval, Beacon Tx $170M Raise, Arialys CEO Appointment, Maze Tx Spins Out ALS ASO, and 2seventybio/Novo Nordisk Deal

In long-awaited news, Eli Lilly's donanemab (Kisunla) is finally approved by the FDA, making it the third amyloid-targeting therapy to get approved following Aduhelm (now off the market) and Leqembi. Beacon Therapeutics raises $170 million to advance its ophthalmology pipeline and bolsters its Board of Directors with new additions. 2seventybio and Novo Nordisk announce an asset purchase agreement, Maze Therapeutics spins out its ALS ASO into a stealth NewCo and Arialys Therapeutics announces an exciting new C-suite appointment.

Leadership

• Last week, Arialys Therapeutics, Inc. announced the appointment of Peter Flynn as President and Chief Executive Officer . Dr Flynn joins the precision medicine biotech with a wealth of experience across private biotech to established, publicly traded companies. He succeeds Jay Lichter as CEO who has joined the company's Board of Directors as Chair and is also Managing Partner of Avalon BioVentures . Dr Flynn joins the biotech at a time where Arialys advances its lead drug candidate, ART5804, into clinical trials for anti-NMDA receptor encephalitis and autoimmune psychosis next year.

Deals

• Beacon Therapeutics raises $170 million Series B led by Forbion with participation from Syncona Limited , TCGX Capital, and the University of Oxford . The funding will be used to advance the biotech's lead asset, AGTC-501, which is currently in Phase II/III and to develop the broader pipeline. The biotech has also appointed Dr. Dmitrij Hristodorov and Wouter Joustra , General Partners at Forbion, as well as Cariad Chester , Managing Partner of TCGX to its Board of Directors. Dominic Schmidt , General Partner of Advent Life Sciences joins as Board Observer.
• Maze Therapeutics spins out its ALS antisense program into a new stealth company , months after its partnership with Sanofi was blocked by the FTC. The drug is in preclinical development and targets the UNC13A gene.
• 2seventy bio announces an asset purchase agreement with Novo Nordisk . The biotech will receive up to $40 million for the Haemophilia A program and rights to the biotech's in vivo gene editing technology outside of oncology and gene editing for autologous or allogenic cell therapies of immune cells for the treatment of autoimmune disease.

Regulatory

• In long-awaited news, the FDA approves Eli Lilly and Company 's Kisunla? (donanemab-azbt) for the treatment of early symptomatic Alzheimer's Disease. The amyloid plaque targeting therapy is the first and only drug of its type that used a limited-duration treatment regimen based on amyloid plaque removal with almost half of patients completing their course in 12 months. In the TRAILBLAZER study, Kisunla reduced amyloid plaques on average by 84% at 18 months compared to the start of the study.

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