NEW YORK, August 2, 2026, 18:10 EDT
- Shares of Replimune finished Friday at $11.20, marking a 107% rise, and ended the week up 15.5%.
- Iovance dropped 13.2%, with the estimated gross market-value move around $763 million.
- FDA advisers voted 10-3 in favor of RP1’s efficacy data. The panel’s recommendation does not carry binding authority.
A positive FDA decision triggered the movement of nearly $763 million between two melanoma stocks on Friday. Replimune Group saw an increase of around $486 million, while Iovance Biotherapeutics NASDAQ:IOVA lost approximately $277 million. These figures are based on the most recent common-share counts reported by the companies.
The division is significant as Amtagvi stands as RP1’s most obvious commercial comparator. Iovance’s therapy is currently the sole other approved option for these patients. Access, however, may be limited due to its surgical and hospital-related needs.
Replimune’s 107% single-day jump exaggerates its overall movement for the week. Shares closed only 15.5% higher compared to levels at the July 24 close. Friday’s gains mostly offset the decline seen after Tuesday’s FDA remarks.
Initial estimates on competitive repricing following Thursday’s panel decision
| Company | Friday close | One-day move | Approximate value change |
|---|---|---|---|
| Replimune Group NASDAQ:REPL | $11.20 | +107.0% | +$486 million |
| Iovance Biotherapeutics NASDAQ:IOVA | $4.07 | -13.2% | -$277 million |
| Total opposite change | — | — | $763 million |
U.S. cash markets did not open on Sunday. On Friday, 33.63 million Replimune shares traded hands, representing approximately 40% of the most recent reported share total and 5.4 times the average volume.
Volatile week for Replimune
| Session | Closing price | Daily move |
|---|---|---|
| July 24 | $9.70 | Reference point |
| July 27 | $8.63 | -11.0% |
| July 28 | $5.35 | -38.0% |
| July 29 | $5.41 | +1.1% |
| July 31 | $11.20 | +107.0% |
| Full week | $11.20 | +15.5% |
(Source: )
The FDA advisory committee determined that IGNYTE’s efficacy data could be assessed and had clinical significance. The agency’s target decision date was Sunday. As of the dateline, neither company statements nor FDA announcements showed a final decision.
Analyst Evan Seigerman cited patient and doctor accounts as providing “a compelling case for RP1.” He called accelerated approval “almost certain.” Chief Executive Sushil Patel stated that Replimune remains committed to collaborating with the FDA. Reuters
The core data disagreement remains unresolved after the vote. Replimune stated an objective response rate of 33.6%. The FDA’s main reanalysis showed 15.7%. Median duration of response dropped to 14.1 months compared to 24.8 months previously.
Three interpretations of the identical IGNYTE group
| Analysis | Evaluable patients | Objective response rate | Median response duration |
|---|---|---|---|
| Applicant analysis | 140 | 33.6% | 24.8 months |
| FDA primary analysis | 140 | 15.7% | 14.1 months |
| FDA sensitivity analysis | 89 | 24.7% | 14.1 months |
FDA reviewers noted that the single-arm trial did not make it possible to determine RP1’s specific impact, as the treatment regimen also involved Bristol Myers Squibb NYSE:BMY’s Opdivo. The reviewers raised concerns about whether the destruction observed in injected lesions was localized rather than reflecting a systemic effect.
Panel physicians highlighted the ongoing need for new options. Hussein Tawbi described RP1 as “a lot safer, a lot easier” compared to Amtagvi. This statement was not based on a randomized head-to-head study. Reuters
Approval would not alleviate funding challenges. Replimune reported $268.9 million in cash and short-term investments as of March 31, after posting a $313.9 million loss for fiscal 2026. Management projects that current resources will cover operations into early 2027, not factoring in any possible revenue.
Replimune’s funding position
| Metric | Reported value |
|---|---|
| Cash and short-term investments | $268.9 million |
| Research costs for fiscal 2026 | $221.2 million |
| Selling and administrative costs for fiscal 2026 | $98.7 million |
| Net loss for fiscal 2026 | $313.9 million |
| Projected operating cash runway | Through first-quarter 2027 |
The focus in the week ahead is on the FDA’s final correspondence and any resulting approved label. Investors are set to review postmarketing requirements and details of the launch. The IGNYTE-3 randomized confirmatory trial has begun recruitment, using overall survival as its primary endpoint.
Risks: The FDA may still delay or deny approval regardless of the panel’s recommendation. Any clearance might include a restricted label or require expensive additional trials. Replimune also faces a short funding runway, which could mean dilution ahead.
Related articles: NASDAQ:IOVA
