It Can Be a One Day LOSS of Around $400 Million!
Or.. a One Day GAIN of Around $839 Million!
Tomorrow, When the FDA Votes. Nobody Knows..
That’s a lot of money, when you think about it. Poof, $400 million gone, or Cha Ching $800 million fiesta – in one day..
Let the Festivities Begin.
FDA advisory meeting going on today, where experts from all sides, chime in with their two bits, as to whether the FDA should go thumbs up, or thumbs down (August 2nd). So break out the champagne, or pitcher of Vodka Lemonade, and pull up a chair!
No matter what happens – assuming you’re on the sidelines that is – this is going to be a hell of a lot of fun to watch. Better than a Soccer match for sure.
You can watch the action now, LIVE at the FDA advisory committee MEETING below.
TRADING HALTED
Replimune Group’s melanoma immunotherapy treatment (RP1 combined with nivolumab) is August 2, 2026. The exact hour of the decision is not publicly announced by the FDA, but decisions are typically posted on the official FDA Approvals Database or announced via company press release once finalized. [1, 2, 3]
WATCH FDA ADVISORY MEETING VIDEO
ARCHIVES
July 14th: Inside the Wild Ride of Replimune (REPL) $10.07. We’re Up And Out, With 360% Gain.
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
WHAT THE EXPERTS ARE SAYING
Replimune Wins!
Replimune Loses
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
