Mass­a­chu­setts-based biotech Ri­bon Ther­a­peu­tics has roped in a big name for some fi­nan­cial back­ing.

Ri­bon an­nounced on Mon­day that Pfiz­er has in­vest­ed $25 mil­lion in­to the biotech. Robert Rick­ert, Pfiz­er’s head of can­cer im­munol­o­gy dis­cov­ery, will be com­ing on­to Ri­bon’s sci­en­tif­ic ad­vi­so­ry board. The start­up will use the funds to sup­port the de­vel­op­ment of its pro­grams for on­col­o­gy and im­munol­o­gy.

Both com­pa­nies al­so reached an agree­ment to have Pfiz­er pro­vide ex­per­tise to sup­port mov­ing for­ward Ri­bon’s pipeline, but the biotech will keep the eco­nom­ic rights and con­trol of the de­vel­op­ment of all pro­grams. Ri­bon’s can­di­dates in­clude a PARP7 in­hibitor that tar­gets sol­id tu­mors and a PARP14 in­hibitor go­ing af­ter in­flam­ma­to­ry dis­eases.

“Pfiz­er’s cap­i­tal sup­port and ex­per­tise will be in­stru­men­tal as we work to ad­vance our lead pro­grams—RBN-2397 in can­cer and RBN-3143 in im­munol­o­gy—to key clin­i­cal mile­stones and en­able fur­ther drug dis­cov­ery and de­vel­op­ment from our pro­pri­etary BEA­CON+ plat­form,” said Ri­bon CEO Prakash Ra­man, in a re­lease.

Ar­genx’s PDU­FA date ex­tend­ed

The FDA has de­cid­ed to ex­tend the re­view for the Bel­gian-based com­pa­ny ar­genx.

Last week, ar­genx an­nounced US reg­u­la­tors had ex­tend­ed the re­view of the BLA for sub­cu­ta­neous ef­gar­tigi­mod for treat­ing adults with the au­toim­mune dis­ease gen­er­al­ized myas­the­nia gravis (gMG). The date has now been pushed back to the sum­mer, specif­i­cal­ly June 20.

The biotech added that the in­for­ma­tion sub­mit­ted for the drug re­view had a “ma­jor amend­ment” and need­ed an ex­ten­sion so it could be looked at. How­ev­er, no ad­di­tion­al da­ta or stud­ies will need to be done for now.

“We are con­fi­dent in the pro­file of SC ef­gar­tigi­mod and the strength of the ADAPT-SC dataset show­ing non­in­fe­ri­or­i­ty of our sub­cu­ta­neous prod­uct to VYV­GART. “We will con­tin­ue to work close­ly with the FDA as it com­pletes its re­view to bring this im­por­tant med­i­cine to peo­ple liv­ing with gMG,” said ar­genx CMO Luc Truyen, in a re­lease.

In No­vem­ber of last year, the com­pa­ny net­ted a pri­or­i­ty re­view vouch­er for $102 mil­lion from blue­bird bio, which planned to short­en the re­view pe­ri­od from 10 months to around six months.

Struc­ture Ther­a­peu­tics sets the terms for its IPO

An­oth­er biotech looks to be toss­ing its hat in­to the IPO ring.

Struc­ture Ther­a­peu­tics, a Cal­i­for­nia-based com­pa­ny, fo­cus­es on GPCRs (al­so the pro­posed tick­er sym­bol) and has can­di­dates tar­get­ing di­a­betes and id­io­path­ic pul­monary fi­bro­sis.

Ac­cord­ing to SEC doc­u­ments, Struc­ture is look­ing to en­ter Nas­daq, of­fer­ing up 8,950,000 shares, and ex­pect­ing the IPO to be priced be­tween $13 to $15.

Struc­ture plans to net around $111.5 mil­lion from the IPO, with around $90 mil­lion be­ing put to­ward the de­vel­op­ment of its GLP-1R pro­gram meant to treat di­a­betes and obe­si­ty.

The funds will be used to fin­ish a Phase Ib and Phase IIa study. Around $13 mil­lion will go to an­oth­er pro­gram, with the re­main­ing cash be­ing used for R&D and oth­er gen­er­al us­es. The IPO is meant to fund the com­pa­ny through 2025.

The share­hold­ers in­clude sev­er­al ven­ture cap­i­tal firms along with CEO Ray­mond Stevens and CFO Jun Yoon hold­ing over 3%, among oth­ers.

Ed­i­tor’s Note: A cor­rec­tion has been made to the spelling of Prakash Ra­man’s name.

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.