Melinta Therapeutics & Cidara Therapeutics Announce Publication Of Pooled Data From Phase 3 Pivotal ReSTORE Trial & Phase 2 STRIVE Trial Of REZZAYO For The Treatment Of Candidemia & Invasive Candidiasis In The Lancet ID
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Melinta Therapeutics and Cidara Therapeutics (NASDAQ:CDTX) announced the publication of pooled data from the ReSTORE Phase 3 and STRIVE Phase 2 trials of REZZAYO in The Lancet ID, demonstrating its efficacy and safety for treating candidemia and invasive candidiasis. REZZAYO, a once-weekly echinocandin, was approved by the FDA on March 22, 2023, for adults with limited treatment options and received a CMS J-Code and NTAP. Melinta acquired U.S. commercial rights from Cidara, who retains rights in Japan and licensed rights elsewhere to Melinta and Mundipharma. The EMA is reviewing the MAA for rezafungin.
December 05, 2023 | 2:08 pm
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POSITIVE IMPACT
Cidara Therapeutics published positive trial results for REZZAYO and retains rights in Japan, with Melinta Therapeutics handling U.S. commercialization. FDA approval and CMS support could drive revenue growth.
The positive trial results and FDA approval of REZZAYO are significant milestones for Cidara Therapeutics, likely to increase investor confidence and drive short-term stock performance. The CMS J-Code and NTAP for REZZAYO further enhance its commercial prospects, potentially leading to increased adoption and sales. As Cidara retains rights in Japan and has licensed commercial rights to Melinta in the U.S. and Mundipharma in other regions, the global commercialization strategy could lead to diversified revenue streams.
CONFIDENCE 80
IMPORTANCE 85
RELEVANCE 90