An IDH1 in­hibitor on the cusp of an FDA de­ci­sion is chang­ing hands.

Wa­ter­town, MA-based For­ma Ther­a­peu­tics has long made it clear that olu­tasi­denib, its oral in­hibitor of mu­tant isoc­i­trate de­hy­dro­ge­nase 1, is a non-core pro­gram. So per­haps it’s lit­tle sur­prise that as the FDA ac­cepts its NDA, For­ma’s li­cens­ing the drug to Rigel Phar­ma­ceu­ti­cals in a $235 mil­lion deal.

Rigel is on­ly pay­ing $2 mil­lion of that up­front, but For­ma could col­lect an­oth­er $17.5 mil­lion soon if it meets cer­tain reg­u­la­to­ry, ap­proval and first com­mer­cial sales mile­stones. The rest is tied to fu­ture de­vel­op­ment and com­mer­cial work.

The dead­line for FDA ac­tion is now set for Feb. 15, 2023.

Sim­i­lar to Agios’ Tib­so­vo — which is now owned by Servi­er — olu­tasi­denib is de­signed to treat a sub­set of re­lapsed or re­frac­to­ry acute myeloid leukemia: cas­es where pa­tients have a con­firmed IDH1 mu­ta­tion. Reg­is­tra­tional Phase II da­ta sug­gest­ed that on the pri­ma­ry end­point of com­plete re­mis­sion plus a com­plete re­mis­sion with par­tial hema­to­log­i­cal re­cov­ery, the drug spurred a CR+CRh rate of 33%, with ear­ly analy­sis point­ing to a me­di­an du­ra­tion of 13.8 months.

“Giv­en Rigel’s fo­cus on hema­to­log­ic dis­eases and can­cers and the strength of their com­mer­cial in­fra­struc­ture, we be­lieve they are well-po­si­tioned to ex­e­cute on our shared ob­jec­tive of de­liv­er­ing olu­tasi­denib to pa­tients in need,” For­ma CEO Frank Lee said in a state­ment.

For­ma’s main fo­cus re­mains etavopi­vat, the oral PKR ac­ti­va­tor be­ing po­si­tioned for sick­le cell dis­ease and a range of hema­to­log­i­cal dis­or­ders. Oth­er hema­tol­ogy and on­col­o­gy pro­grams are rel­a­tive­ly ear­ly-stage.

For Rigel, the deal adds what ap­pears to be a sure shot on goal as a sur­prise Phase III flop clouds the ex­pan­sion plans for its bleed­ing dis­or­der drug Tavalisse (fos­ta­ma­tinib).

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.