Mi­rati is on the cusp of emerg­ing as the sole chal­lenger against Am­gen in the sud­den­ly hot KRAS in­hibitor mar­ket and thinks it has the man to take it across the fin­ish line. But new lead­er­ship of­ten means shake­ups, and now two Mi­rati ex­ecs are be­ing shown the door.

Mi­rati CMO Joseph Lev­eque and Daniel Fa­ga, the biotech’s chief op­er­at­ing of­fi­cer and prin­ci­pal fi­nan­cial of­fi­cer, have both de­part­ed the com­pa­ny as it en­ters the home­stretch for fil­ing its KRAS drug ada­gra­sib with the FDA, Mi­rati re­vealed in an SEC fil­ing Mon­day.

De­tails on the de­par­tures are slim, with Mi­rati not­ing the de­ci­sions on both po­si­tions were made Oct. 28. In Fa­ga’s place, Mi­rati ac­count­ing lead Vick­ie Reed will step in­to the prin­ci­pal fi­nan­cial of­fi­cer role with­out an in­crease in pay, the biotech said.

David Meek

The shake­up comes a lit­tle over a month af­ter Mi­rati ap­point­ed David Meek, a for­mer CEO at Fer­Gene and Ipsen, to the head role, re­plac­ing found­ing CEO Charles Baum.

Meek, who was most­ly re­cent­ly oust­ed from Fer­Gene af­ter the biotech im­plod­ed in spec­tac­u­lar fash­ion ear­li­er this year, came on board right as Mi­rati races to an ex­pect­ed fil­ing for ada­gra­sib this quar­ter, look­ing to keep the heat on Am­gen and its own KRAS in­hibitor Lumakras. The com­pa­ny rolled out Phase II da­ta for ada­gra­sib in non-small cell lung can­cer in Sep­tem­ber it says will serve as the ba­sis for that fil­ing, as well as win­ning mid-stage colon can­cer da­ta at ES­MO21.

Lev­eque had served as CMO at Mi­rati since May 2020, jump­ing over from Syn­thorx, where he served as CMO for a lit­tle un­der two years. Pri­or to that, Lev­eque jumped around be­tween a spate of biotechs and Big Phar­mas, in­clud­ing EMD Serono, Bris­tol My­ers Squibb, Onyx and Am­gen.

Fa­ga had been with Mi­rati since Jan­u­ary 2020, pre­vi­ous­ly hold­ing the chief busi­ness of­fi­cer role at Spark Ther­a­peu­tics for more than three years. He was pre­vi­ous­ly a man­ag­ing di­rec­tor at Cen­ter­view Part­ners and an as­so­ciate at Mer­rill Lynch.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

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.