Mar­i­on Gru­ber

Two of the FDA’s most se­nior vac­cine lead­ers are ex­it­ing from their po­si­tions, rais­ing fresh ques­tions about the Biden ad­min­is­tra­tion and the way that it’s side­lined the FDA.

Mar­i­on Gru­ber, di­rec­tor of the FDA’s Of­fice of Vac­cines Re­search & Re­view and 32-year vet­er­an of the agency, will leave at the end of Oc­to­ber, and OVRR deputy di­rec­tor Phil Krause, who’s been at FDA for more than a decade, will leave in No­vem­ber. The news, first re­port­ed by Bio­Cen­tu­ry, is a mas­sive blow to con­fi­dence in the agency’s abil­i­ty to reg­u­late vac­cines.

The bomb­shell an­nounce­ment comes at a par­tic­u­lar­ly cru­cial mo­ment, as boost­ers and chil­dren’s shots are be­ing weighed by the reg­u­la­tor. The de­par­tures al­so come as the ad­min­is­tra­tion has re­cent­ly jumped ahead of the FDA’s re­views of boost­er shots, an­nounc­ing that they might be avail­able by the week of Sept. 20.

A for­mer se­nior FDA leader told End­points that they’re de­part­ing be­cause they’re frus­trat­ed that CDC and their ACIP com­mit­tee are in­volved in de­ci­sions that they think should be up to the FDA. The for­mer FDAer al­so said he’s heard they’re up­set with CBER di­rec­tor Pe­ter Marks for not in­sist­ing that those de­ci­sions should be kept in­side FDA. What fi­nal­ly did it for them was the White House get­ting ahead of FDA on boost­er shots.

FDA’s for­mer act­ing chief sci­en­tist Lu­ciana Bo­rio added on Twit­ter, “FDA is los­ing two gi­ants who helped bring us many safe and ef­fec­tive vac­cines over decades of pub­lic ser­vice.”

“These two are the lead­ers for Bi­o­log­ic (vac­cine) re­view in the US. They have a great team, but these two are the true lead­ers of CBER. A huge glob­al loss if they both leave,” For­mer BAR­DA di­rec­tor Rick Bright wrote, weigh­ing in on the news. “Dr. Gru­ber is much more than the Di­rec­tor. She is a glob­al leader. Vi­sion­ary mas­ter­mind be­hind glob­al clin­i­cal reg­u­la­to­ry sci­ence for flu, Ebo­la, Mers, Zi­ka, Sars-cov-2, many oth­ers.”

Phil Krause

In a let­ter from Marks to staff, he ex­plained:

Janet Wood­cock told End­points that she wish­es Gru­ber and Krause well and thanks them for their sig­nif­i­cant ser­vice.

Since at least April 2015, Ampio Pharmaceuticals has reeled from one Phase III fail after another for its knee osteoarthritis drug, known as Ampion.

The issue has only escalated in recent months with a trifecta of hurdles that are now sending the penny stock biotech $AMPE into a downward spiral, with 10 of 18 employees being laid off Tuesday, according to an SEC filing. Ampio had $28.8 million at the end of March, enough to get into the second half of next year.

In this bearish market, public companies have raced to investors primarily only after showing impressive clinical data or reaching other prominent milestones. And as the IPO window remains shut, the newest company to hop on the bandwagon is Arcutis Biotherapeutics.

The California-based company announced Thursday a public offering of $150 million in shares of its common stock. The news comes days after Arcutis won FDA approval for its phosphodiesterase-4 (PDE4) inhibitor roflumilast, marketed as Zoryve, in plaque psoriasis for children and adults ages 12 and up.

As parent company Roche aims to secure a place in the allogeneic CAR-T therapy race, Genentech is spinning its own deal to jump into fibrosis with a program from Kiniksa.

Genentech shelled out $80 million in upfront cash and another $20 million in near-term payments to license Kiniksa’s vixarelimab, formerly known as KPL-716, and shepherd it into new clinical studies, the companies announced Wednesday. If all the milestones are achieved, Kiniksa could stand to gain another $600 million. Investor reaction to the deal was muted, as Kiniksa shares $KNSA were up about 1% in pre-market trading Wednesday.

Cell therapy biotech MeiraGTx is looking to get some quick cash and is putting up its manufacturing facilities to do it.

On Wednesday the company announced that it had clinched a loan with affiliates of Perceptive Advisors for up to $100 million, with the biotech getting $75 million upon closing.

According to CEO Alexandria Forbes, the biotech secured the capital by putting up its manufacturing facilities for collateral, which will extend the company’s cash runway for the next two years and into Q4 of 2024. The Sam Waksal-founded biotech intends to use the cash primarily to continue development of its pipeline, preclinical programs and technology platforms.