Recursion Pharmaceuticals Inc. (RXRX) saw its shares decline on Tuesday following the announcement of Phase 2 data for its experimental treatment for symptomatic Cerebral Cavernous Malformation (CCM).
The SYCAMORE trial, evaluating REC-994 in CCM patients, successfully met its primary endpoint, demonstrating the drug’s safety and tolerability. However, the company noted that improvements in patient or physician-reported outcomes were not observed at the 12-month mark, leading to the stock’s dip.
Despite the lack of immediate improvement in primary endpoints, secondary efficacy endpoints showed a trend towards reduced lesion volume and hemosiderin ring size in patients receiving the highest dose compared to placebo. This suggests potential for REC-994’s efficacy in the long term, although further investigation is needed.
Recursion plans to present the trial data at an upcoming medical conference and submit it for publication in a peer-reviewed scientific journal. The company also anticipates a meeting with the FDA to discuss plans for an additional clinical study.
“We are encouraged by the recent data from our signal-finding Phase 2 study in CCM, where the trial successfully met its primary safety endpoint and became the first investigational therapy to demonstrate safety alongside some promising trends in exploratory efficacy endpoints,” stated Najat Khan, chief R&D officer and chief commercial officer of Recursion. “These results provide critical insights that will inform our next study design, including exploring study duration, higher doses, and a larger cohort of patients.”
Recursion has gained significant retail interest in recent months, with Nvidia highlighting its investment in the company in a 13-F filing with the SEC earlier this year. According to the filing, Recursion is Nvidia’s second-largest investment after Arm Holdings.
The stock’s decline reflects investors’ immediate reaction to the lack of immediate clinical improvement despite the positive safety data. However, the promising trends in secondary endpoints and the company’s commitment to further clinical studies offer hope for REC-994’s future potential in treating CCM.
