In a global deal worth up to $770.5 million in up-front and milestone payments, Autifony Therapeutics Ltd. signed with Jazz Pharmaceuticals plc for two ion channel-targeting programs aimed at finding and developing new drugs for neurological disorders. Autifony will take selected candidates through preclinical development, while Jazz will cover clinical development, manufacturing, regulatory activities and commercialization. The companies did not break down the deal value between up-front and milestone payments, although the milestones are triggered by development, regulatory and commercial achievements across the two programs. The agreement also includes royalties for Autifony on future net sales of products that reach the market.

Eyebiotech series A nets $130M as phase Ib/IIa rolls on

Eyebiotech Ltd. doubled the size of its series A round to raise $130 million. The firm also disclosed the completion of enrollment into the multiple ascending-dose portion of Amarone, the phase Ib/IIa trial testing the drug called Restoret in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Restoret is an investigational, intravitreally delivered, trispecific antibody that acts as an agonist of the Wnt signaling pathway to resolve residual fluid in the retina, designed to thus improve visual acuity in NVAMD and DME as well as other retinal diseases of permeability.

Acurx surges 250% as BIDI hits lowest point of the year

The BioWorld Infectious Disease Index (BIDI) jumped 13.04% at the end of January and has been mostly on a downturn since, echoing trends that BioWorld analysis noted last year. BIDI ended October down 47.98%, lower than the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which were down 12.31% and 0.28%, respectively.

Bayer pulling Aliqopa from market in latest blow to PI3K inhibitor class

Bayer AG said it will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market after a confirmatory trial required by the U.S. FDA failed to meet the primary endpoint of progression-free survival vs. standard immunochemotherapy in patients with relapsed follicular lymphoma. It marks the latest stumble for PI3K-targeting drugs in the non-Hodgkin’s lymphoma space.

Is 20+ years too long for a confirmatory trial? ODAC to weigh in

If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication. The FDA’s Oncologic Drugs Advisory Committee (ODAC) will have something to say about the reasonableness of that proposed timeline Thursday. It also will be asked to discuss strategies to promote a timely completion of the three-arm confirmatory trial that will test both drugs, as well as how lessons learned from Acrotech’s experience could facilitate the completion of confirmatory studies for future accelerated approvals.

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