→ For­bion has led a $62.5 mil­lion round for Prile­nia Ther­a­peu­tics to fund two late-stage tri­als in Hunt­ing­ton’s dis­ease and amy­otroph­ic lat­er­al scle­ro­sis. Michael Hay­den, the for­mer Te­va R&D chief who’s been serv­ing as chair­man, will now take over as CEO to over­see the pro­gram for pri­do­pi­dine, which ag­o­nizes the sig­ma-1 re­cep­tor (S1R). Morn­ing­side and Sec­toral As­set Man­age­ment al­so joined, as did Tal­is­man Cap­i­tal Part­ners and Gen­works 2.

→ Aus­tralia’s CSL Behring is team­ing up with Seat­tle Chil­dren’s Re­search In­sti­tute to de­vel­op stem cell gene ther­a­pies for rare pri­ma­ry im­mun­od­e­fi­cien­cy dis­eases, start­ing with Wiskott-Aldrich Syn­drome and X-linked Agam­ma­glob­u­line­mia. They are among 400 pri­ma­ry im­mun­od­e­fi­cien­cy dis­eases, in which the hu­man im­mune sys­tem is dys­func­tion­al. “Ex­pand­ing our gene ther­a­py port­fo­lio in­to an area of im­munol­o­gy well known to CSL ex­em­pli­fies how we are strate­gi­cal­ly grow­ing our ca­pa­bil­i­ties in this strate­gic sci­en­tif­ic plat­form and are col­lab­o­rat­ing with world class in­sti­tu­tions to ac­cess in­no­va­tion with the po­ten­tial to vast­ly im­prove pa­tients’ lives,” not­ed CSL R&D chief Bill Mez­zan­otte.

→ Hy­loris Phar­ma­ceu­ti­cals, a Bel­gian com­pa­ny ded­i­cat­ed to re­for­mu­lat­ing well-known drugs, is look­ing to tap the pub­lic mar­ket by list­ing on Eu­ronext Brus­sels. “The IPO is ex­pect­ed to pro­vide us with the re­sources need­ed to fi­nance the de­vel­op­ment of our ex­ist­ing port­fo­lio of prod­uct can­di­dates, as well as es­tab­lish a com­mer­cial in­fra­struc­ture in the Unit­ed States for our IV Car­dio­vas­cu­lar port­fo­lio (ex­cl. So­talol IV, which is com­mer­cial­ized through a part­ner), where we will fo­cus on ad­dress­ing pre­scribers in a cost-ef­fi­cient man­ner by con­cen­trat­ing on spe­cial­ized care fa­cil­i­ties such as hos­pi­tals,” CEO Sti­jn Van Rompay said in a state­ment.

→ GHO Cap­i­tal has put the $1 bil­lion-plus fund it closed at the end of last year to use, buy­ing X-Chem from an af­fil­i­ate of The Car­lyle Group and Hell­man & Fried­man. The com­pa­ny spe­cial­izes in DNA-En­cod­ed Li­brary (DEL)-based dis­cov­ery ser­vices and has li­censed over 70 re­search pro­grams to bio­phar­ma part­ners over the years. Matt Clark, a co-founder and the cur­rent SVP of chem­istry, will re­place Rick Wag­n­er as CEO.

→ Dublin-based Avec­tas has en­list­ed Scott Si­mon’s lab at UC Davis to char­ac­ter­ize cells en­gi­neered on its plat­form, with the goal of in­form­ing the de­vel­op­ment of next-gen cell ther­a­pies. “A ma­jor fo­cus of our group is to un­der­stand how chem­i­cal and me­chan­i­cal forces act­ing on im­mune cells en­able them to lo­cal­ize at sites of in­flam­ma­tion,” Si­mon said in a state­ment. “The part­ner­ship with Avec­tas will help us eval­u­ate how these same forces play a role to de­liv­er­ing mR­NA and pro­teins to im­mune cells and there­by ex­tend their ther­a­peu­tic ap­pli­ca­tions.”

→ Ire­land’s Shorla Phar­ma has closed its Se­ries A at $8.3 mil­lion to ad­vance a slate of drugs for rare, or­phan and pe­di­atric can­cers. Ser­o­ba Life Sci­ences led the round, which fea­tured oth­er lo­cal in­vestors as well as fam­i­ly of­fices in Cana­da.

→ Chris­t­ian Anger­may­er, founder of the men­tal health and psy­che­delics biotech ATAI, is try­ing to bring the Aus­tralian biotech Bio­nom­ics and its PTSD drug back from the near-dead. Bio­nom­ic’s stock flat­lined to $0.04 af­ter the drug’s fail­ure in a Phase II tri­al, but the com­pa­ny, which has al­so part­nered with Mer­ck on Alzheimer’s, has since re­for­mu­lat­ed the drug, and Anger­may­er is bet­ting it might now work. His firm Ape­iron put down $5 mil­lion and un­der­wrote $15 mil­lion in fund­ing to put the com­pound back in­to tri­als.

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.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

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.