BIOTECH MARKET RESEARCH $REPL | Ep. 732

Replimune Group

Replimune (REPL) is approaching a pivotal inflection point with the upcoming PDUFA date for RP1 in combination with Opdivo (nivolumab) for advanced melanoma. This BLA filing marks the company’s first potential approval for its oncolytic immunotherapy platform, and the outcome could significantly reshape investor perception. While RP1 has demonstrated promising response rates and durable activity in earlier studies, the FDA's view on intratumoral delivery, clinical meaningfulness, and contribution of RP1 beyond anti–PD-1 remains uncertain. Sentiment heading into the decision is mixed, with volatility running high (±70%) as traders weigh the binary nature of approval versus potential delays or a CRL. This milestone could either validate Replimune’s platform or reignite concerns about the commercial viability of oncolytic virus therapies.

Every Monday we are out with public biotech research, profiling biotech companies with near term catalysts. This will focus primarily on the major market moving biotech events such as data readouts from the major scientific conferences as well as potential regulatory approvals.

We will not offer specific trading advice (and we do not hold any publicly traded biotech equity), but rather flag emerging events that will likely materially drive stock prices (sometimes +/-100% in either direction).

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HOW TO PLAY BIOTECH APPROVAL/DATA READOUTS ANNOUNCEMENTS

While biotech equities will move on news of announcement, often if there is high conviction in a positive read, a large run up ahead of the news will occur and the actual event turns into a sell the news event. Sometimes, investors wait for the actual event to make a long/short decision. And obviously if the news is disappointing (more often than not) the stock will tank.

This is not financial advice so you will have to make your own call on how to best play these events. Our aim is simply to flag catalysts with high projected volatility.

🚨 ALERT: PDUFA - RP1 + Opdivo (nivolumab) in Melanoma

📅 DATE: July 22nd, 2025

📈 IMPLIED VOLATILITY: +/- 70%

BACKGROUND: