koto_feja/E+ via Getty Images Verastem ( NASDAQ: VSTM ) shares fell ~59% in the premarket Friday after the company announced the start of a regulatory submission to win FDA approval for its cancer therapy combo, avutometinib and defactinib. However, the stock recorded sharp gains in the postmarket Thursday in reaction to data from a Phase 1/2 study for the drug combo with chemotherapy in treating pancreatic cancer. Friday's announcement marked the beginning of the rolling submission of a new drug application (NDA) that seeks the FDA's accelerated approval for the drug combo.
With the NDA, Verastem ( VSTM ) seeks approval for avutometinib plus defactinib as a late-line therapy for adults with recurrent KRAS mutant (KRAS mt) low-grade serous ovarian cancer (LGSOC). The rolling review process, which allows a gradual NDA submission before all sections of the application are available, is expected to be complete in H2 2024. "In the second half of this year, we anticipate completing our NDA submission with the mature data from the RAMP 201 trial and discussing with the FDA a path forward for patients with KRAS wild-type disease," CEO Dan Paterson remarked.
On Thursday, postmarket, investors welcomed interim efficacy data for the drug combination as a first-line option for metastatic pancreatic cancer. The readout was based on a May 14 data cut representing 41 patients. However, 12 patients experienced 19 treatment-emergent serious adverse events, including 11 patients who indicated.
