SELLAS Life Sciences Provides Regulatory Update for Nelipepimut-S (NPS) for Triple Negative Breast Cancer (TNBC) Following FDA Feedback
SELLAS Life Sciences Group, Inc. (SLS)
Last sellas life sciences group, inc. earnings: 11/14 04:41 pm
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Source: GlobeNewswire
NEW YORK, Feb. 14, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced feedback from a Type C review with the U.S. Food and Drug Administration (FDA) regarding its clinical development program for nelipepimut-S (NPS) in patients with triple negative breast cancer (TNBC). Based on written feedback from the FDA and on the totality of clinical, safety and translational NPS data presented to date, the Company has finalized the design and plan for a Phase 3 registration-enabling study of NPS in combination with trastuzumab for the treatment of patients with TNBC in the adjuvant setting after standard treatment. If successful, this study may be considered as the basis for a Biologics License Application (BLA) submission to the FDA. “We are indeed pleased with the feedba
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- 3/29/24 - Form D
- 3/28/24 - Form S-3
- 3/28/24 - Form S-3
- SLS's page on the SEC website