Latest news with #VSTM
Yahoo
4 days ago
- Business
- Yahoo
VSTM Stock Soars 22% in a Month on Ovarian Cancer Combo Drug Approval
Verastem Oncology VSTM 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. 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-consensus-chart | Verastem, Inc. Quote Verastem Oncology currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Bayer BAYRY, Lexicon Pharmaceuticals LXRX and Amarin AMRN, 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%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report Lexicon Pharmaceuticals, Inc. (LXRX) : Free Stock Analysis Report Amarin Corporation PLC (AMRN) : Free Stock Analysis Report Verastem, Inc. (VSTM) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
23-05-2025
- Business
- Yahoo
Verastem announces positive Phase 1/2 safety and efficacy results in PDAC
Verastem (VSTM) announced positive updated safety and efficacy results from the RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the front-line for patients with metastatic pancreatic ductal adenocarcinoma, or PDAC. As of April 25, 2025, patients in the dose level 1 cohort, which was selected as the recommended Phase 2 dose, achieved an overall response rate of 83% – 10/12 -. As of April 25, 60 patients had been treated in one of five dose regimens with the combination of avutometinib and defactinib with gemcitabine and Nab-paclitaxel in frontline metastatic PDAC. In the dose level 1 cohort, 12 patients received 2.4 mg of avutometinib twice a week, 200 mg of defactinib twice a day for 3 weeks out of every 4 and 800 mg/m2 of gemcitabine and 125 mg/m2 of Nab-paclitaxel on a schedule of day 1, day 8 and day 15. In dose level 1, 83% of patients achieved partial company has selected dose level 1 as the RP2D, has met the pre-defined criteria to advance beyond the first stage of the expansion study, and is now enrolling up to 29 patients at this dose level. In evaluating all the dose cohorts, dose level 1 demonstrated the highest response rate and across all five dose cohorts, 92% of efficacy evaluable patients showed tumor reduction as best response. No new safety signals have emerged. While anticipating results from the study expansion cohort, the company is now developing plans for a registrational Phase 3 front-line metastatic PDAC trial to begin in 2026. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on VSTM: Disclaimer & DisclosureReport an Issue Verastem's Strategic Focus and FDA Approval Drive Buy Rating Verastem files to sell 3.43M shares of common stock for holders Verastem reports Q1 adjusted EPS (79c), two estimates (77c) Verastem price target raised to $13 from $12 at B. Riley Verastem's Market Potential Boosted by Accelerated Approval of AVMAPKI FAKZYNJA for KRAS Mutant LGSOC
Business Insider
23-05-2025
- Business
- Business Insider
Verastem announces positive Phase 1/2 safety and efficacy results in PDAC
Verastem (VSTM) announced positive updated safety and efficacy results from the RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the front-line for patients with metastatic pancreatic ductal adenocarcinoma, or PDAC. As of April 25, 2025, patients in the dose level 1 cohort, which was selected as the recommended Phase 2 dose, achieved an overall response rate of 83% – 10/12 -. As of April 25, 60 patients had been treated in one of five dose regimens with the combination of avutometinib and defactinib with gemcitabine and Nab-paclitaxel in frontline metastatic PDAC. In the dose level 1 cohort, 12 patients received 2.4 mg of avutometinib twice a week, 200 mg of defactinib twice a day for 3 weeks out of every 4 and 800 mg/m2 of gemcitabine and 125 mg/m2 of Nab-paclitaxel on a schedule of day 1, day 8 and day 15. In dose level 1, 83% of patients achieved partial company has selected dose level 1 as the RP2D, has met the pre-defined criteria to advance beyond the first stage of the expansion study, and is now enrolling up to 29 patients at this dose level. In evaluating all the dose cohorts, dose level 1 demonstrated the highest response rate and across all five dose cohorts, 92% of efficacy evaluable patients showed tumor reduction as best response. No new safety signals have emerged. While anticipating results from the study expansion cohort, the company is now developing plans for a registrational Phase 3 front-line metastatic PDAC trial to begin in 2026.
Yahoo
13-05-2025
- Business
- Yahoo
Verastem: Q1 Earnings Snapshot
NEEDHAM, Mass. (AP) — NEEDHAM, Mass. (AP) — Verastem Inc. (VSTM) on Tuesday reported a loss of $52.1 million in its first quarter. The Needham, Massachusetts-based company said it had a loss of 96 cents per share. The results did not meet Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 72 cents per share. _____ This story was generated by Automated Insights ( using data from Zacks Investment Research. Access a Zacks stock report on VSTM at Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Washington Post
13-05-2025
- Business
- Washington Post
Verastem: Q1 Earnings Snapshot
NEEDHAM, Mass. — NEEDHAM, Mass. — Verastem Inc. (VSTM) on Tuesday reported a loss of $52.1 million in its first quarter. The Needham, Massachusetts-based company said it had a loss of 96 cents per share. The results did not meet Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 72 cents per share.
