Zydus Lifesciences Limited has informed the Exchange regarding a press release dated December 15, 2025, titled "Sentynl Therapeutics Announces FDA Acceptance of CUTX-101 NDA Resubmission".
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Zydus Lifesciences informed the exchange about a press release from Sentynl Therapeutics regarding US FDA acceptance of the resubmitted New Drug Application (NDA) for CUTX-101. This marks a regulatory milestone as the FDA has agreed to review the application after the previous submission. CUTX-101 is being developed by Sentynl Therapeutics, which is part of the Zydus group. FDA acceptance of an NDA resubmission means the agency found the submission sufficiently complete to proceed with a substantive review.
This is a positive regulatory development for the company, indicating progress in bringing CUTX-101 closer to potential US market approval, which could expand Zydus's specialty pharmaceutical footprint in the US.