Replimune Group

REPL

Market cap $175M

Replimune Group Inc. (NASDAQ: REPL) on Friday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its Biologics License Application.

REPL stock plunges after a second FDA CRL delays RP1 melanoma approval, casting doubt on its regulatory path and near-term growth plans.

Replimune Group (NASDAQ:REPL) shares fell roughly 63% following the company's disclosure that it received a Complete Response Letter (CRL) from the US Food and Drug Administration, effectively blocking the approval of its lead melanoma therapy RP1 in combination with nivolumab. The decision represents a significant setback for the biotechnology company, which had been seeking approval based on data from its IGNYTE clinical program in patients with advanced melanoma who had progressed on prior anti-PD-1 therapy.

Philip Astley-Sparke, executive chairman and co-founder at Replimune, joins ‘Squawk on the Street' to discuss the company's next steps after the FDA denied its melanoma drug.

WOBURN, Mass., April 10, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Company's Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.

The ​U.S. ‌Food and ​Drug ​Administration ⁠on ​Friday declined ​to approve ​Replimune's ​drug for ‌advanced ⁠skin cancer, ​the ​regulator ⁠said.

The mean of analysts' price targets for Replimune Group (REPL) points to a 79.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

WOBURN, Mass., March 02, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members from the Replimune management team will present and host investor meetings at the following two conferences: Leerink Partners 2026 Global Healthcare ConferenceDate: Monday, March 9, 2026Fireside Chat Time: 2:20 pm EDT Jefferies 2026 Biotech on the Beach SummitDate: Tuesday, March 10, 20261x1 Meetings Live webcasts of the fireside chat will be available in the Investors section of Replimune's website at www.replimune.com.

The consensus price target hints at a 65.7% upside potential for Replimune Group (REPL). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

WOBURN, Mass., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2025 and provided a business update.