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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None of the research analysts or the research analyst’s household has a financial interest in the securities of Infinity Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of December 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Infinity Pharmaceuticals, Inc. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Infinity Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Infinity Pharmaceuticals, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Infinity Pharmaceuticals, Inc. as of the date of this research report.
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