BUZZ-Verastem jumps as FDA grants priority review for ovarian cancer combo therapy
Verastem's shares surged 45.7% to $5.35 premarket after the FDA granted Priority Review for its ovarian cancer therapy, avutometinib combined with defactinib. This designation aims for a decision within 6 months, with a target date of June 30, 2025. Analysts at BTIG estimate a $1.7 billion market for the treatment, raising its success probability from 65% to 80% and price target from $13 to $20. B. Riley Securities considers Verastem fundamentally undervalued, despite a 55% year-to-date decline in stock value.
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
