Replimune. Our Analyst Sells. We say Auf Wiedersehen. $2.17 to $10.07.
Shareholders (for now) are enjoying massive $657 million gain, in just three months..
Just to be clear, we are not putting a sell rating on Replimune. One of our analysts (we work with many), told us he just sold all of his Replimune. And as he happens to be the one who told us about it, when it was trading a $2.17, we pay attention.
Here’s our updates on Replimune:
June 8th: We’re Up 360% in Six Weeks. Replimune (REPL). (detailed report)
April 23rd: Biotech 12 Pack Watch List to be Released.
April 22nd: Adding Replimune to Watch List to 2026 Watch List @ $2.17
Institutional Analyst Inc., via the various stock reviews do not itself issue buy or sell recommendations. We are essentially a bird dog – passing on some of the interesting ideas we hear on a daily basis. Similar to the analyst we speak with, they never tell us what to buy or sell, they simply tell us “look what we found.”
We are fast approaching a judgment day (July 30, 2026) where he feels Replimune can stumble back to $2.00 if not approved, or if approved (which he feels it will) could jump to $16 or much higher. So despite his belief that it will get approved, and without getting too complicated as to why they feel it will get approved, he feels the risk-to-reward is now a little bit out of whack.
Note also – there is no truly telling how high Replimune can go the day/week of approval. Investors will no doubt looking at the UniQure (QURE) chart which jumped from $9 to $47 pre-trial and may get overly-excited.
Party Time at UniQure (QURE)! From $8.86 to $47.21, up 432%.
Note also, the action in our second biggest Biotech winner ever, the heavily shorted Immunomedics (IMMU). We added it to the Watch List at $3.00. When an ‘unexpected’ (unexpected by Goldman Sachs) approval came from the FDA it jumped from $16 to $23. While other investors were taking a quick gain, Steve Cohen from SAC Capital bought 10 million shares at near $20. Then a few months later it was acquired by Gilead Sciences, Inc. (GILD) for$88!
If this does get acquired for in excess of $1 billion, it will be our 4th billion dollar acquisition from companies who were on their death bed when we discovered them. Current market cap is $839 million (oh so close..).
- Immunomedics (IMMU) $3 to $87 up 2,800%, a gain of $20.7 billion. Acquired by Gilead Sciences (GILD)
- Dicerna (DRNA) $3.30 to $38.25 up 1,175%, a gain of $2.9 billion. Acquired by Novo Nordisk (NVO).
- Provention Bio (PRVB) $4.60 to $25 up 443%, a gain of $2.8 billion. Acquired by Sanofi (SNY).
And We Have a $26.4 Billion Winning Trifecta!
You can watch a live stream of the meeting (like a hurricane party), with a bag of popcorn and pitcher of Vodka Lemonades, by clicking here on the 30th:
Big picture, we understand that Wall Street is constantly changing and you cannot control every wave that comes. Once you truly accept this, a quiet freedom arises. You’re no longer trapped by the belief that your stock trading must unfold in a certain way in order for it to be meaningful. You’re free to find new ideas, this won’t be your last great idea and let Wall Street do exactly what it does without resistance or regret.
What this means is that we should learn to release our grip on our original price target. We should stop being consumed by the what-ifs, and the imagined futures that haven’t arrived yet. Instead, just bring our attention back to the present, to the process, to the effort you’re putting in to finding a new idea. And yes we have another coming soon. Enjoy the journey, rather than fear its destination. You can tell we’re prepping ourselves in advance for a pop over $20, and that we’re not there for the ride lol. They call getting out to soon ‘selling the winning lotto ticket’..
Biotech investing is not for the faint of heart. It is a high-stakes world where multi-million-dollar companies can double in a day or collapse by morning based on a single piece of government news. Right now, all eyes are locked on Replimune as it approaches a massive make-or-break regulatory moment in a few weeks.
Also when we remove something from the Watch ist, it doesn’t mean we will stop following it. It just means not so enthusiastically.
Subscribe for updates on Replimune
Here is your front-row seat to the drama, the science, and where the stock could head next. It’ll either end in celebration, or end in tears.
The Science: A Trojan Horse for Cancer
At the center of Replimune’s entire story is RP1, an experimental therapy targeting advanced melanoma (a deadly form of skin cancer). Instead of standard chemotherapy, Replimune is pioneering oncolytic immunotherapies.
In plain terms, they take a modified version of the herpes simplex virus—yes, the cold sore virus—and turn it into a targeted weapon. They inject it directly into the tumor. The virus acts like a Trojan Horse: it multiplies inside the cancer cells until they burst, releasing a signal flare that tells the body’s immune system exactly where to attack.
In their main clinical trial (codenamed IGNYTE), they paired this virus with a blockbuster immunotherapy drug (Opdivo). The results were impressive, showing that over 33% of patients saw their tumors shrink significantly, and a remarkably high percentage of those responders stayed alive years later.
Bristol Myers Squibb (BMY) reported that Opdivo alone brought in $10.05 billion in global net sales for the full year of 2025. The way Wall Street thinks, is they assume BMY would execute a corporate acquisition—buying out Replimune entirely to take 100% ownership of the RP1 asset. They would then package and sell RP1 alongside Opdivo as a proprietary, branded combination therapy.
Opdivo is facing an upcoming “patent cliff” later this decade, meaning cheaper generics will eventually try to eat its market share. If BMY owns RP1, they can pitch the RP1 + Opdivo combo as a brand-new, highly effective treatment standard. This allows them to extend their multi-billion-dollar melanoma monopoly and give Opdivo a massive second life.
Off topic it makes us think of a combo of Gedeptin from GeoVax (GOVX) and Keytruda from Merck (MRK), a $31 billion drug, which we believe is coming off patent in 2028. Hmm.
As you can tell from this chart, Replimune was at one point highly impressing a portion of Wall Street, when trading near $50.
Major Drama: Rejections and Resurrections
If the data was good, why the roller coaster? Because the FDA has been a tough critic.
The agency initially handed Replimune a “Complete Response Letter”—biotech speak for a rejection—arguing the trial design wasn’t “adequate and well-controlled” enough. The stock plunged, and the company even warned that a permanent rejection might mean the drug wasn’t viable.
But like any good thriller, there was a twist. Replimune went back to the drawing board, package-dealt new trial data, and resubmitted their application. The FDA surprised the market by accepting it as an urgent review, setting up a fast-tracked showdown this summer.
The Catalyst Calendar
Mark your calendars, because these two dates will dictate everything:
- July 30, 2026 (The Advisory Committee): A panel of independent experts meets publicly to debate the drug’s merits and vote on whether to recommend approval.
- August 2, 2026 (The PDUFA Date): The official deadline for the FDA to give its final “Yes” or “No.”
Where Does the Stock Go From Here?
Because this is a classic binary event, Wall Street analysts are split, but the math points to massive volatility. Wall Street loves the term binary event and so do we. What it really means, since we prefer to speak English is “you’re either going to the moon, or you are going to the emergency room.”
- The Upside Scenario: If the FDA approves RP1 on August 2nd, analysts suggest the commercial market for advanced melanoma could launch the stock significantly higher. Some of the most bullish targets on the Street project a move up toward the $16.00 to $27.00 range over the next year.
- The Downside Scenario: If the committee passes a negative vote or the FDA issues another rejection, the story unravels fast. Given the company’s limited cash runway, a failure would likely send the stock plunging straight down to $2.00, wiping out recent gains.
With our hedge buddy fund taking his chips off the table ahead of this coin-flip moment, the sidelines look like a very comfortable place to watch the fireworks for us..
As of March 31, 2026, cash, cash equivalents and short-term investments were $268.9 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations into the first quarter of calendar 2027.
We don’t know for sure, but we’ll bet they have an ATM in the wings ready for a hopeful approval day, to fund some executive bonuses. They’ll deserve it, if they pull it off. Just saying.
A final interesting thought is we wonder what BMY is thinking? They no doubt have read the Replimune interim reports as close, if not closer than the FDA. When it broke down to $2.00 they could have stepped up and offered $10 or even $5 with an agreement to handle the re-submit. Playing it same may cost them billions.
But with $119 billion in sales ($10 billion from Opivo alone), maybe they’re not in cost saving mode. They’ve come a long way from Excedrin, Bufferin and first commercial electric toothbrush.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the status of the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to the outcome of FDA’s review process, our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
