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Replimune shares plunge 84% after FDA rejects RP1 drug approval over study design issues.

Market News
17 Sep 2026
PRNewsWire
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Bearish
Replimune shares plunge 84% after FDA rejects RP1 drug approval over study design issues.

Replimune Group's stock dropped about 84% between October 2025 and April 2026 after the FDA rejected its RP1 biologics license application due to unresolved study design concerns. Despite company statements suggesting progress toward approval, the FDA's complete response letter in April 2026 revealed that critical issues remained unaddressed, causing a sharp decline in share price. A securities class action lawsuit has been filed alleging the company misled investors about the drug's regulatory status. Investors who bought shares during this period may seek compensation by October 5, 2026.

Replimune Group's stock faced a severe decline of about 84% between October 2025 and April 2026 following regulatory setbacks. For readers following health-sector stocks, here is Pluang's market snapshot as of Sep 17, 2026 21:11 WIB: out of 91 priced US health-sector stocks, 59 rose and 31 fell. Notable movers include Recursion Pharmaceuticals Inc (RXRX) with a price of USD 3.37 and a 1-day change of +5.64%, Illumina, Inc. (ILMN) at USD 241.64 with a 1-day change of +5.55%, and Ginkgo Bioworks Holdings Inc (DNA) at USD 7.44 with a 1-day change of +5.38%.

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