UPDATED: 6 weeks in, Mirati CEO shows CMO, COO the door ahead of key FDA filing for KRAS drug

exit
Mirati's leadership shuffle comes about six weeks after the biotech hired a new CEO. (Christian Guiton/iStock)

David Meek sees a new leadership team as the key to success. Six weeks into his tenure as CEO, he's showing Mirati Therapeutics' chief medical and operating officers the exit as the biotech searches for a chief financial officer to aide "commercialization capabilities." 

The moves come as the biotech gets closer to asking the FDA for its first drug approval. That drug, adagrasib, is Mirati's attempt to compete against Amgen in the KRAS race. Amgen got to the finish line first nearly six months ago.

The decision to oust Chief Medical Officer Joseph Leveque, M.D., and Chief Operating Officer Daniel Faga was made Oct. 28, Mirati said in an SEC filing. The San Diego biotech's stock fell nearly 15% to $161.40 apiece as of 12:16 p.m. ET on Monday.

Charles Baum, Ph.D, M.D., will add Leveque's duties to his current roster of responsibilities, which include president, founder and head of research & development, according to a statement issued Monday. 

RELATED: Mirati switches up leadership as KRAS drug speeds toward FDA filing

Leveque's stint at Mirati lasted 18 months. He was hired to lead the biotech's KRAS inhibitor adagrasib to the regulatory finish line. Amgen won that race when the FDA approved Lumakras for non-small cell lung cancer, or NSCLC, in May. The work will now be in Baum's hands.

"[The] departure of the CMO may make some investors more cautious on the upcoming data readouts on the adagrasib combinations," SVB Leerink analysts wrote in a note. 

Mirati plans to ask the FDA to approve adagrasib as a second-line treatment for NSCLC in the fourth quarter of this year. We're in November now, so that means within 60 days.

Mirati will now embark on a search for a CFO as the biotech prepares for commercialization and an expanding portfolio. 

Chief Accounting Officer Vickie Reed will take charge of the principal financial duties that Faga held, Mirati said in the regulatory filing.

RELATED: Mirati, Sanofi join forces in lung cancer with a KRAS-SHP2 combo approach

Mirati teamed up with Sanofi to test adagrasib with the Big Pharma's investigational SHP2 inhibitor SAR442720 in patients who have been given some treatment in KRAS G12C-positive NSCLC. Leveque, the now ex-Mirati CMO, was previously CMO at Synthorx, which Sanofi acquired in 2019. 

The leadership shakeup comes less than two months into Meek's role as CEO. He took the top spot in September as founding leader Baum transitioned to his new role.

Editor's Note: This story was amended at 4:40 p.m. ET on Nov. 4, 2021 to clarify the details of Daniel Faga's tenure.