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

Verastem

31/12/2024 12:16

** 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;))