We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
VSTM Stock Soars 22% in a Month on Ovarian Cancer Combo Drug Approval
Read MoreHide Full Article
Verastem Oncology (VSTM - Free Report) shares rallied 22.2% in a month, primarily driven by the FDA approval of the company’s novel combination regimen of avutometinib plus defactinib in early May for treating KRAS mutant recurrent low-grade serous ovarian cancer (LGSOC), a rare and distinct type of ovarian cancer. The FDA's decision came well in advance of the originally expected date of June 30, 2025.
The approval was granted under the FDA’s accelerated approval pathway and is commercialized in the U.S. market as an oral combination co-pack with the two prescription products, known as “Avmapki Fakzynja Co-Pack.”
Following the FDA approval, Avmapki Fakzynja Co-Pack is the first and only FDA-approved treatment for the LGSOC indication. Per Verastem Oncology, the combo offers a much-needed treatment option for patients and sets a new standard of care for women with recurrent LGSOC with a KRAS mutation.
Full approval of the product for this use depends on the detailed evidence of clinical benefit in the follow-up phase III RAMP 301 confirmatory study, which will evaluate the combination in women with and without a KRAS mutation.
Year to date, Verastem Oncology stock has surged 64.8% against the industry’s 5.8% decline.
Image Source: Zacks Investment Research
Please note that the FDA’s decision was based on the results from VSTM’s phase II RAMP 201 study, which evaluated the combination of Avmapki and Fakzynja in adult patients with measurable KRAS-mutated recurrent LGSOC. Per the data readout, a 44% overall response rate was observed in patients treated with the combo therapy, with an acceptable safety profile. Additionally, the median duration of response ranged from 3.3 to 31.1 months in the KRAS mutant population.
The Avmapki/Fakzynja combo enjoys the FDA’s Breakthrough Therapy designation for the treatment of patients with recurrent LGSOC after one or more prior lines of therapy, including platinum-based chemotherapy, in the United States. Avutometinib alone or in combination with defactinib also enjoys the FDA’s Orphan Drug designation for the same indication.
VSTM Reports Upbeat Data From Pancreatic Cancer Study
Verastem Oncology is also looking to expand the label of its approved avutometinib/defactinib combo therapy beyond LGSOC.
Last week, VSTM reported positive updated safety and efficacy results from the phase I/II RAMP 205 study evaluating avutometinib plus defactinib in combination with chemotherapy (gemcitabine and Nab-paclitaxel) for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients. This has also likely contributed to the stock price rally in the past month.
The RAMP 205 study is evaluating 60 patients in five cohorts (12 per cohort) who are receiving one of five dose regimens of avutometinib/defactinib combo with chemotherapy for frontline metastatic PDAC. As of April 25, 2025, patients in the dose level 1 cohort achieved an overall response rate of 83% (eight confirmed and two unconfirmed who remain on treatment).
Based on this encouraging outcome, Verastem Oncology selected dose level 1 as the recommended phase II dose. Additionally, it was found that the dose level 1 showed the best response, and overall, 92% of patients across all dose levels achieved tumor shrinkage. The safety profile of the avutometinib/defactinib combo was acceptable across all the treatment cohorts and no new safety signals were identified.
Verastem Oncology is currently gearing up to initiate a registrational phase III front-line metastatic PDAC study in 2026.
Apart from these indications, the company is simultaneously evaluating avutometinib and defactinib in combination with a KRAS G12C inhibitor, sotorasib, for treating non-small cell lung cancer in a separate mid-stage study.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 45.3%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 6.6%.
LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.
In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 17.1%.
AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
VSTM Stock Soars 22% in a Month on Ovarian Cancer Combo Drug Approval
Verastem Oncology (VSTM - Free Report) shares rallied 22.2% in a month, primarily driven by the FDA approval of the company’s novel combination regimen of avutometinib plus defactinib in early May for treating KRAS mutant recurrent low-grade serous ovarian cancer (LGSOC), a rare and distinct type of ovarian cancer. The FDA's decision came well in advance of the originally expected date of June 30, 2025.
The approval was granted under the FDA’s accelerated approval pathway and is commercialized in the U.S. market as an oral combination co-pack with the two prescription products, known as “Avmapki Fakzynja Co-Pack.”
Following the FDA approval, Avmapki Fakzynja Co-Pack is the first and only FDA-approved treatment for the LGSOC indication. Per Verastem Oncology, the combo offers a much-needed treatment option for patients and sets a new standard of care for women with recurrent LGSOC with a KRAS mutation.
Full approval of the product for this use depends on the detailed evidence of clinical benefit in the follow-up phase III RAMP 301 confirmatory study, which will evaluate the combination in women with and without a KRAS mutation.
Year to date, Verastem Oncology stock has surged 64.8% against the industry’s 5.8% decline.
Image Source: Zacks Investment Research
Please note that the FDA’s decision was based on the results from VSTM’s phase II RAMP 201 study, which evaluated the combination of Avmapki and Fakzynja in adult patients with measurable KRAS-mutated recurrent LGSOC. Per the data readout, a 44% overall response rate was observed in patients treated with the combo therapy, with an acceptable safety profile. Additionally, the median duration of response ranged from 3.3 to 31.1 months in the KRAS mutant population.
The Avmapki/Fakzynja combo enjoys the FDA’s Breakthrough Therapy designation for the treatment of patients with recurrent LGSOC after one or more prior lines of therapy, including platinum-based chemotherapy, in the United States. Avutometinib alone or in combination with defactinib also enjoys the FDA’s Orphan Drug designation for the same indication.
VSTM Reports Upbeat Data From Pancreatic Cancer Study
Verastem Oncology is also looking to expand the label of its approved avutometinib/defactinib combo therapy beyond LGSOC.
Last week, VSTM reported positive updated safety and efficacy results from the phase I/II RAMP 205 study evaluating avutometinib plus defactinib in combination with chemotherapy (gemcitabine and Nab-paclitaxel) for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients. This has also likely contributed to the stock price rally in the past month.
The RAMP 205 study is evaluating 60 patients in five cohorts (12 per cohort) who are receiving one of five dose regimens of avutometinib/defactinib combo with chemotherapy for frontline metastatic PDAC. As of April 25, 2025, patients in the dose level 1 cohort achieved an overall response rate of 83% (eight confirmed and two unconfirmed who remain on treatment).
Based on this encouraging outcome, Verastem Oncology selected dose level 1 as the recommended phase II dose. Additionally, it was found that the dose level 1 showed the best response, and overall, 92% of patients across all dose levels achieved tumor shrinkage. The safety profile of the avutometinib/defactinib combo was acceptable across all the treatment cohorts and no new safety signals were identified.
Verastem Oncology is currently gearing up to initiate a registrational phase III front-line metastatic PDAC study in 2026.
Apart from these indications, the company is simultaneously evaluating avutometinib and defactinib in combination with a KRAS G12C inhibitor, sotorasib, for treating non-small cell lung cancer in a separate mid-stage study.
Verastem, Inc. Price and Consensus
Verastem, Inc. price-consensus-chart | Verastem, Inc. Quote
VSTM’s Zacks Rank & Stocks to Consider
Verastem Oncology currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Bayer (BAYRY - Free Report) , Lexicon Pharmaceuticals (LXRX - Free Report) and Amarin (AMRN - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 45.3%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 6.6%.
LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.
In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 17.1%.
AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.