Replimune Group (NASDAQ:REPL) shares are down on Thursday.

The company faces an upcoming FDA review decision on Friday, 10 April.

Replimmune RP1 Filing Faces Regulatory Hurdles

In October 2025, the U.S. Food and Drug Administration (FDA) accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma patients who progress on an anti-PD-1 containing regimen.

In June 2025, the FDA issued a Complete Response Letter for the company's RP1 (vusolimogene oderparepvec).

The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.

Internal FDA Dynamics Impact Review Process

As per a media report in August 2025, the FDA's top cancer drug regulator stepped in during the final stages of a heated review of Replimune's skin cancer treatment — a move that played a key role in the drug being rejected at the last minute, despite support from some within the agency.

Ongoing leadership changes, staff turnover, and internal issues at the FDA influenced the review process and the decision to deny approval.

Replimune found itself caught in the middle of the agency's internal turmoil.

The company said existing cash, cash equivalents, and short-term investments of $269.1 million will provide cash runway late into the first quarter of calendar 2027.

Replimmune Technical Indicators Point To Weak Momentum

At $5.79, the stock is trading 20.7% below its 20-day simple moving average (SMA) and 30.2% below its 100-day SMA, suggesting significant short-term weakness. This positioning indicates that the stock is struggling to gain momentum in the near term.

The relative strength index (RSI) is currently at 35.33, which is neutral but leans toward bearish territory, indicating potential downward pressure.

The moving average convergence divergence (MACD) shows a bearish trend, with the MACD at -0.0632 and the signal line at -0.0458, suggesting that selling pressure may persist.

  • Key Resistance: $6.00 — A level where selling pressure has historically emerged.
  • Key Support: $4.50 — A critical level where buying interest may appear.

Replimune's 12-month performance shows a decline of 19.49%, reflecting a challenging year for the stock.

Currently, it is trading near the middle of its 52-week range, which indicates a lack of strong directional momentum.

Benzinga Edge: Momentum Weak at 17.08

Below is the Benzinga Edge scorecard for Replimune Group, highlighting its strengths and weaknesses compared to the broader market:

  • Momentum: Weak (Score: 17.08) — Stock is underperforming the broader market.

REPL Price Action: Replimune Group shares were down 3.99% at $5.65 at the time of publication on Thursday, according to Benzinga Pro data.

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