Verastem NASDAQ: VSTM reported first-quarter 2026 net product revenue of $18.7 million for AVMAPKI FAKZYNJA CO-PACK, as management said the launch of the therapy for KRAS-mutated recurrent low-grade serous ovarian cancer continued to grow despite seasonal headwinds and some early commercial execution challenges.
On the company’s earnings call, President and CEO Dan Paterson said the quarter brought Verastem’s total net product revenue since the May 2025 launch to nearly $50 million. He said new patient starts remained consistent month to month, the prescriber base continued to expand and reimbursement remained favorable.
“While we’re pleased with the growth we’ve seen, we believe there’s meaningful opportunity to build on the foundation we’ve established,” Paterson said.
Commercial launch review leads to changes
Paterson said Verastem conducted a focused review of launch performance and made targeted changes to its commercial organization and leadership. The company appointed Dan Lyons as chief commercial officer, citing his oncology and rare disease launch experience, including at SpringWorks.
Paterson said first-quarter results were affected by insurance turnover, re-verifications and severe weather, which disrupted patient access and affected both new patient starts and refills. The company also observed that some early patients prescribed the therapy were further along in their disease and treatment journey than expected, and in some cases discontinued treatment earlier than anticipated.
According to Paterson, the company has since seen a rebound in new patients through the end of the first quarter. He said physician conviction remains strong, citing a recent physician survey in which a majority indicated the CO-PACK would be their first choice at a patient’s next recurrence.
Through April, the company had more than 400 unique prescribers to date. Prescriptions continued to be split roughly 60% from gynecologic oncologists and 40% from medical oncologists. Paterson said the active patient pool has grown in recent months, but the company is not yet providing duration of therapy or average refill metrics because those figures are still evolving.
Verastem said about 65% of commercially eligible patients are using its Verastem Cares copay program, while other patients did not require assistance. The average copay for commercially insured patients is less than $30. Initial prescriptions are being filled in about 12 to 14 days, helped by rapid prior authorization approvals, and payer mix remains about half commercial and half Medicare.
Company focuses on earlier use and persistence on therapy
Management outlined three commercial priorities for the remainder of 2026: maintaining demand for new patient starts, encouraging earlier use at first recurrence and helping patients stay on therapy.
Paterson said Verastem is using proxy measures in electronic health records to help identify potential low-grade serous ovarian cancer patients, including mutational status and prior AI or MEK inhibitor use. The company has also added personnel to support demand and patient adoption.
He said some discontinuations appear to reflect use in patients outside the intended approved population or in patients who were significantly sicker than those enrolled in the RAMP 201 study that supported FDA approval. Paterson said this reinforces the importance of using the CO-PACK earlier, when patients are more likely to realize its full benefit.
The company also launched a direct-to-physician and patient campaign called “Reimagine Recurrent LGSOC,” aimed at driving earlier use. Paterson cited recent long-term RAMP 201 data presented at the Society of Gynecologic Oncology showing durable benefit after two years of follow-up and discontinuation rates consistent with the package insert.
VS-7375 program advances into registration-directed trials
President of Development Dr. Michael Kauffman said Verastem has renamed its VS-7375 oral KRAS G12D inhibitor trial program TARGET-D. The ongoing TARGET-D 101 phase I/II trial is evaluating dose escalation, dose expansion and combinations, with the company now testing a 1,200 mg daily dose to define the upper end of the dosing range.
Verastem has also developed three phase II registration-directed trials after FDA requested separate phase II protocols for trials intended to support marketing authorization. These studies include:
- TARGET-D 201, a second-line pancreatic cancer study evaluating VS-7375 at 900 mg daily as monotherapy and in combination with cetuximab.
- TARGET-D 202, an advanced non-small cell lung cancer study evaluating VS-7375 at 900 mg daily in patients who have received one or two prior lines of therapy, including platinum chemotherapy and a PD-1 or PD-L1 blocker.
- TARGET-D 203, a metastatic colorectal cancer study evaluating VS-7375 at 900 mg daily as monotherapy and in combination with EGFR inhibitors, including cetuximab or panitumumab.
Kauffman said the primary endpoint across the three phase II trials is overall response rate by blinded independent central radiological review, with duration of response as a key secondary endpoint supporting potential accelerated approvals. He said the company anticipates first patients in each study around mid-year, “if not sooner.”
Updated pharmacokinetic data show the 900 mg dose delivers serum levels at or above the company’s target level and provides clear separation from the 600 mg dose, Kauffman said. He added that the 900 mg dose has been well tolerated to date in more than 20 U.S. patients, supporting its use in phase II trials.
For the first-half update from TARGET-D 101, Kauffman cautioned that efficacy data will still be limited, while safety and pharmacokinetic data will be more mature. He said the company plans to include patient cases across tumor types and combinations, with a more comprehensive data set expected later in the year.
Expenses and cash runway
Chief Financial Officer Dan Calkins said Verastem recorded $2.8 million in product cost of sales in the first quarter. Research and development expenses were $38.2 million, driven by the global confirmatory phase III RAMP 301 trial for the CO-PACK, the VS-7375 TARGET-D 101 trial in the U.S. and higher clinical supply and drug production costs tied to the expanded VS-7375 program.
Selling, general and administrative expenses were $22.3 million, reflecting commercial activities and operations supporting the CO-PACK launch. Calkins said SG&A expenses are expected to remain roughly consistent on a quarterly basis through 2026.
Verastem reported a non-GAAP adjusted net loss of $42.7 million, or $0.43 per diluted share, compared with a non-GAAP adjusted net loss of $42.9 million, or $0.79 per diluted share, in the first quarter of 2025.
The company ended the quarter with $181.7 million in cash, equivalents and investments. Calkins said Verastem believes its current cash, combined with future AVMAPKI FAKZYNJA CO-PACK revenue, will provide runway into the first half of 2027.
Management reiterated that it expects the low-grade serous ovarian cancer franchise to become self-sustaining in the second half of 2026, with CO-PACK revenue funding commercial operations and avutometinib plus defactinib clinical trials.
Q&A highlights
During the question-and-answer session, Paterson said potential partners for VS-7375 are looking for U.S. data showing the drug can be administered tolerably, combined with other agents and begin to replicate the efficacy seen in China. Kauffman said the U.S. experience has shown better tolerability than reported in China, including no significant liver dysfunction, hematologic issues or cumulative toxicities to date.
Kauffman also said Verastem believes the 900 mg dose is likely the go-forward dose, while the 1,200 mg dose is being evaluated as the highest practical dose with the current 100 mg tablets. He said larger tablets are being developed.
On the commercial side, Paterson said Verastem added two sales positions because two regions were too large, increased coordination with specialty pharmacies and is placing more emphasis on follow-up after initial prescriptions. He said the company expects second-quarter revenue growth over the first quarter to be larger than the growth seen from the fourth quarter to the first quarter.
About Verastem NASDAQ: VSTM
Verastem Oncology, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapies that target cancer stemness and resistance pathways. Established in 2010 and headquartered in Needham, Massachusetts, Verastem Oncology applies a precision-medicine approach to identify key signaling nodes responsible for tumor growth and relapse, with an emphasis on hematologic malignancies and solid tumors. The company’s research platform integrates insights into complex signaling networks to advance novel compounds from early discovery through clinical proof of concept.
The company’s lead marketed product is COPIKTRA (duvelisib), an oral inhibitor of PI3K-delta and PI3K-gamma, which received U.S.
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