2022 to be Catalyst Rich for Biopharma

The potential stock-moving events for Infinity Pharmaceuticals this year include the launch of two clinical trials and readouts from four studies, noted an H.C. Wainwright & Co. report.

Infinity Pharmaceuticals Inc. (INFI:NASDAQ) will finalize the design of its impending MARIO-4 clinical trial after receiving feedback about MARIO-3 during the end-of-Phase 2 meetings with drug regulators, reported H.C. Wainwright & Co. analyst Michael King.

What is certain about MARIO-4 at this point, however, is its endpoints will be progression-free survival and overall survival. Also, the study will be randomized and double blind.

As for results so far from MARIO-3, also a trial of eganelisib in frontline metastatic triple-negative breast cancer, they have been encouraging, King wrote. Eganelisib’s performance is “largely predictive of a reliable efficacy signal and manageable safety profile for the duration of the study.”

King updated H.C. Wainwright’s model of Infinity to reflect the expected start this year of MARIO-4.

“We have pushed the anticipated first approval of eganelisib to 2027 from 2026,” King wrote. “Our model assumes U.S. launch for second-line metastatic triple-negative breast cancer and second-line urothelial cancer in 2028 and 2029, respectively.”

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Disclosures for H.C. Wainwright & Co. LLC, Infinity Pharmaceuticals Inc., Jan. 6, 2022

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