BUZZ-Verastem jumps as FDA grants priority review for ovarian cancer combo therapy

Shares of cancer drugmaker Verastem VSTM.O rise 45.7% to $5.35 premarket

On Monday, VSTM said the U.S. FDA granted Priority Review to its application for its experimental cancer therapy, avutometinib in combination with defactinib

Drugmaker sought approval for the combo therapy for patients with recurrent low-grade serous ovarian cancer who have a KRAS gene mutation and have received at least one prior systemic therapy

Priority Review designation means FDA's goal is to take action on an application within 6 months, compared to 10 months under standard review

Analysts at BTIG say total addressable market for the condition is over $1.7 bln, based on around 2,800 patients in the first 3 to 5 years

Brokerage also has increased the probability of success for the treatment from 65% to 80%, raising PT from $13 to $20, representing a 5x upside to the stock's Monday close

Brokerage B. Riley Securities notes VSTM is "fundamentally undervalued"

The FDA will give its decision on June 30, 2025 - VSTM

FDA is not currently planning to hold an advisory committee meeting to discuss the application - VSTM

Co said it is preparing for commercial launch in mid-2025

As of last close, stock has fallen ~55% YTD

(Reporting by Kamal Choudhury in Bengaluru)

((Kamal.Choudhury@thomsonreuters.com;))