→ Bio­gen has picked up a new, pre­clin­i­cal gene ther­a­py pro­gram from Mass­a­chu­setts Eye and Ear for in­her­it­ed reti­nal de­gen­er­a­tion due to mu­ta­tions in the PRPF31 gene, among the most com­mon caus­es for au­to­so­mal dom­i­nant re­tini­tis pig­men­tosa. They’re build­ing on the work of Har­vard’s Er­ic Pierce. “The treat­ment of IRDs with high­ly ef­fec­tive AAV-based gene ther­a­pies is core to Bio­gen’s oph­thal­mol­o­gy strat­e­gy,” said Chris Hen­der­son, the re­search head at Bio­gen. “This agree­ment un­der­scores our com­mit­ment to that strat­e­gy and builds off of our ac­qui­si­tion of Night­star Ther­a­peu­tics in 2019 and our ac­tive clin­i­cal tri­als of gene ther­a­pies for dif­fer­ent ge­net­ic forms of IRD.”

→ Sarep­ta has inked a col­lab­o­ra­tion with Hansa to de­vel­op their ex­per­i­men­tal drug im­li­fi­dase as a pre-treat­ment for their gene ther­a­pies. The drug is in­tend­ed for use in pa­tients who have neu­tral­iz­ing an­ti­bod­ies that would pre­vent gene ther­a­pies for Duchenne mus­cu­lar dy­s­tro­phy and Limb-gir­dle mus­cu­lar dy­s­tro­phy from work­ing. Hansa gets a $10 mil­lion up­front and up to $397.5 mil­lion in mile­stones.

→ It’s been rain­ing mon­ey on Wall Street — at least when it comes to drug de­vel­op­ers. CRISPR Ther­a­peu­tics $CR­SP and Ac­celeron each raised a whop­ping $450 mil­lion this week af­ter pric­ing fol­low-on of­fer­ings. CRISPR priced 6,428,572 com­mon shares at a pub­lic of­fer­ing price of $70.00 per share, while Ac­celeron $XL­RN auc­tioned off 4,864,864 shares of com­mon stock at a price to the pub­lic of $92.50 per share.

→ The transat­lantic biotech play­er Immat­ics has com­plet­ed its flip on­to Nas­daq through the Arya Sci­ences Ac­qui­si­tion Corp. The can­cer drug biotech will trade as $IMTX af­ter it raised $253 mil­lion in the process. The SPAC was set up by Per­cep­tive Ad­vi­sors.

→ Seat­tle-based Ne­oleukin Ther­a­peu­tics, mean­while, raised $76.2 mil­lion $NLTX for its work on pro­tein ther­a­peu­tics.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.