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VSTM

Verastem

$3.36

0.1 (3.07%)

07:08
02/07/18
02/07
07:08
02/07/18
07:08

Verastem submits NDA for Develisib to FDA

Verastem announced it has submitted a New Drug Application to the U.S. FDA seeking full approval for its lead product candidate duvelisib, a first-in-class oral dual inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma, for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and accelerated approval for the treatment of relapsed or refractory follicular lymphoma. Duvelisib has received Fast Track Designation from the FDA for patients with CLL or peripheral T-cell lymphoma who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. In addition, duvelisib received orphan drug designation in the United States and the European Union for patients with CLL, SLL and FL. The NDA is supported by clinical data from the randomized Phase 3 DUO study demonstrating significant efficacy, along with a consistent and manageable safety profile, of duvelisib monotherapy in patients with relapsed or refractory CLL/SLL. The DUO study met its primary endpoint with oral duvelisib monotherapy achieving a statistically significant improvement in progression-free survival compared to ofatumumab in patients with relapsed or refractory CLL/ SLL, representing a 48% reduction in the risk of disease progression or death. The NDA is also supported by results from the Phase 2 DYNAMO(TM) study in patients with indolent non-Hodgkin's lymphoma that are double-refractory to both rituximab and chemotherapy or radioimmunotherapy, which also achieved its primary endpoint with an objective response rate of 46%. In the subset of patients enrolled in DYNAMO with double-refractory FL, duvelisib demonstrated an ORR of 41%.

VSTM Verastem
$3.36

0.1 (3.07%)

09/06/17
CANT
09/06/17
UPGRADE
CANT
Overweight
Verastem upgraded to Overweight from Neutral at Cantor
09/06/17
CANT
09/06/17
UPGRADE
Target $17
CANT
Verastem upgraded to Overweight after duvelisib data at Cantor
As previously reported, Cantor Fitzgerald analyst Mara Goldstein upgraded Verastem to Overweight from Neutral after the company reported Phase 3 DUO study data on duvelisib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma that was "squarely positive" and suggests a viable commercial opportunity. The analyst, who predicts that duvelisib can capture a reasonable market share in both high risk and low/medium risk patients with relapsed/refractory CLL, raised her price target on Verastem shares to $17 from $2.
11/30/17
ROTH
11/30/17
INITIATION
Target $12
ROTH
Buy
Verastem initiated with a Buy at Roth Capital
Roth Capital analyst Jotin Marango initiated Verastem with a Buy rating and $12 price target, as he believes full CLL data from the DUO pivotal study at ASH next week should bolster investor confidence in duvelisib ahead of an NDA filing he sees as likely in the first quarter of 2018.
12/11/17
OPCO
12/11/17
NO CHANGE
Target $15
OPCO
Outperform
Verastem price target raised to $15 from $6 at Oppenheimer
Oppenheimer analyst Leah Rush Cann raised her price target for Verastem to $15 from $6 to reflect decreased risk of failure, now that details of the DUO data are released. Based on the balance of efficacy and adverse events reported from the DUO study, the analyst continues to expect that Verastem will launch duvelisib in 2019, and it will be the primary revenue and earnings driver for the company. The analyst reiterates an Outperform rating on the shares.

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