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Verastem Shares Rise 25% as FDA Issues Breakthrough Therapy Designation for Ovarian Cancer Drug

Source: Streetwise Reports

 

May 25, 2021 (Investorideas.com Newswire) Verastem Inc. shares reached a new 52-week high after the company reported its VS-6766 in combination with defactinib was granted breakthrough therapy designation by the FDA for treatment of recurrent low-grade serous ovarian cancer.


Biopharmaceutical company Verastem Inc. (VSTM:NASDAQ), which is focused on developing and commercializing medicines to treat patients with solid tumor cancers, today announced that "the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of its investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy."

The National Ovarian Cancer Coalition's CEO Melissa Aucoin commented, "Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with current therapies...A Breakthrough Therapy designation in this disease is a significant step forward for the women who often, at a relatively young age, start a lengthy battle with this highly recurrent and impactful disease."

Verastem Oncology indicated that it is evaluating the efficacy and safety of VS-6766 in combination with defactinib in its ongoing Phase 1/2 FRAME trial. The firm stated that early positive results from the study demonstrated "a 70% overall response rate (ORR) in patients with KRAS Mutant Tumors, 44% ORR in KRAS Wild-Type Tumors and 52% ORR."

Verastem Oncology's CEO Brian Stuglik remarked, "Breakthrough Therapy designation will facilitate our efforts to verify the robust and durable response and compelling safety profile of VS-6766 with defactinib that we have seen in patients with LGSOC and potentially bring a new therapy to these patients as quickly as possible...The majority of LGSOC is RAS pathway-driven, and we are committed to exploring the potential for VS-6766 as a backbone therapy across RAS pathway-driven solid tumors."

The firm explained that the FDA's Breakthrough Therapy designation facilitates expedited development and approval for medicines targeted to treat serious or life-threatening medical conditions.

The company advised that it is also presently studying VS-6766 in a Phase 2 registration-directed trial. The RAMP 201 study is investigating both the use of VS-6766 on a stand-alone basis and in conjunction with defactinib in treating patients with recurrent LGSOC.

Verastem noted that "LGSOC is a recurrent, chemotherapy-resistant cancer with a high mortality rate." The condition represents 6-8% of all ovarian cancers and affects 80,000 women globally.

Verastem Oncology is a biopharmaceutical company headquartered in Needham, Mass., that is engaged in developing and commercializing medicines that can produce improve outcomes for cancer patients. The firm's pipeline is centered upon novel small molecule drugs that inhibit critical signaling pathways in cancer. The leading candidates in its pipeline are VS-6766, an RAF/MEK inhibitor and defactinib, a focal adhesion kinase (FAK) inhibitor.

Verastem started off the day with a market cap of around $548.4 million with approximately 171.9 million shares outstanding and a short interest of about 3.1%. VSTM shares opened about 3% higher today at $3.28 (+$0.09, +2.82%) over Friday's $3.19 closing price and reached a new 52-week high this morning of $4.08. The stock has traded today between $3.26 and $4.08 per share and is currently trading at $4.00 (+$0.81, +25.24%).

Disclosure:

1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

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3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

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5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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