BTIG upgraded Verastem (NASDAQ:VSTM) to “buy” from “neutral” with a new price target of $8, citing a breakthrough designation from the FDA for its KRAS-focused combination therapy of VS-6766 with defactinib for all patients with recurrent low-grade serious ovarian cancer regardless of KRAS status, after one or more prior lines of therapy.
Shares of Verastem were quoted at $3.65, up 45 cents, at mid-day on May 24.
KRAS is one of a group of genes involved in the epidermal growth factor receptor pathway.
Analyst Robert Hazlett writes that the FDA decision follows data from the
company’s Phase 1/2 FRAME study, which most recently showed an objective response rate (ORR) of 52% (11/21 response evaluable patients), 70% ORR with KRAS mutant tumors (7/10 response evaluable patients), and 44% ORR with KRAS wild-type tumors (4/9 response evaluable patients).
“With this early but meaningful regulatory validation de-risking the program, we upgrade Verastem shares to “buy,” he said.
Mr. Hazlett said Verastem recently initiated a Phase 2 registration-directed trial of VS-6766 with defactinib for recurrent low-grade serious ovarian cancer and an adaptive Phase 2 trial investigating VS-6766 alone and in combination with defactinib in KRAS mutant non-small cell lung cancer (NSCLC) patients.