[glenn1919]

REPL.............................https://stockcharts.com/sc3/ui/?s=REPL&p=w&b=5&g=0&id=p86431144783

[glenn1919]

REPL.................................p/m

[glenn1919]

REPL..............................https://stockcharts.com/sc3/ui/?s=REPL&p=W&b=5&g=0&id=p86431144783

[glenn1919]

REPL......................https://stockcharts.com/sc3/ui/?s=REPL&p=W&b=5&g=0&id=p86431144783

[Law of Averages]

Shorts may have to cover soon this is going back up.

[jondoeuk]

Read the CRLs. Here is the second CRL https://download.open.fda.gov/crl/CRL_BLA125827_20260410.pdf

[Law of Averages]

REPL looking like it wants to make a run here up 7% already.

[Law of Averages]

I think the market overreacted to what happened i see a nice bounce coming.

[ErnieBilco]

I don't know but reading the news it really sounds to me like they were spiking the punchbowl right at assessment times. IMO very very unethical. The FDA is right to want another trial since the one they did was "altered" by injecting lesions kinda nullifies everything they were trying to show the DRUG does not the regular standard of care.

[keepemcloser]

Can’t understand denial decision as this drug currently IS saving/extending lives and patients are asking for it or to have their trials extended.You would think the insurers would be rallying around our company.Crazy

[iHub News]

Replimune plunges after second FDA setback for melanoma therapy; analysts turn bearish

April 13, 2026 6:28 AM
IH Market News

Shares of Replimune Group (NASDAQ:REPL) tumbled sharply in premarket trading on Monday, falling close to 60% after the U.S. Food and Drug Administration issued a second complete response letter (CRL) for RP1, its oncolytic virus treatment being developed in combination with nivolumab for advanced melanoma.

The stock was down more than 57% by 05:10 ET in premarket activity.

Analysts reacted swiftly to the news. BMO Capital Markets cut its rating to Underperform and slashed its price target to $1 from $11, while JPMorgan downgraded the shares to Underweight from Neutral and removed its $10 target altogether.

The FDA’s decision focused on persistent concerns surrounding the design of Replimune’s IGNYTE trial—issues that had been highlighted well before the company filed its original application.

According to BMO analyst Evan David Seigerman, regulators had already indicated during a March 2021 meeting that a single-arm study “would not enable identification of the contribution of each component of the combination to the overall response rate” and that it “would not recommend that the Sponsor submit a BLA based on the results of a single-arm study.”

“Through the detailed CRL, we are able to more clearly see challenges FDA raised with the RP1 development plan that likely require a subsequent trial to address. Such a path will likely be long and financially challenging for Replimune and shareholders,” Seigerman wrote.

In its latest response, the FDA pointed to difficulties in evaluating systemic treatment effects, noting that more than half of the patients assessed for efficacy did not have non-injected lesions.

The agency also raised concerns over aspects of the trial protocol, including reinjection of lesions just before progression assessments, surgical interventions conducted prior to tumor measurement, and histology analyses that lacked central review—all of which complicated interpretation of the efficacy data.

Additional challenges included patient variability and the absence of a control arm, limiting regulators’ ability to determine how much incremental benefit RP1 provided beyond nivolumab alone.

JPMorgan analyst Anupam Rama said he had previously believed the overall RP1 dataset supported approval, though he acknowledged there had been regulatory risks ahead of the decision.

Seigerman also suggested that earlier resubmission attempts appeared “grounded more on hope than true alignment with FDA.”

“Hope is never a winning strategy, unfortunately,” he added.

Replimune ended 2025 with less than $200 million in net cash, and analysts believe the company may need to implement significant cost reductions. Seigerman noted that strategic alternatives could include returning capital to shareholders or seeking a larger partner to take over development of RP1.

Replimune Group stock price

Original: Replimune plunges after second FDA setback for melanoma therapy; analysts turn bearish

[WID]

Following the CRL and subsequent FDA meeting, it looks like REPL has found a path to approval. Hang onto your shares!

[jondoeuk]

Now this https://www.linkedin.com/pulse/replimune-complete-response-letter-case-study-science-brian-shields-nmhke

[jondoeuk]

For those without an account https://archive.is/VCR4m

[jondoeuk]

Not a good look https://www.linkedin.com/pulse/replimune-makes-trumps-fda-offer-cant-refuse-brian-shields-mdf2e/

[jack7377]

REPL#$$: Hey Bulba and Junebugs, we will most likely be sitting at $2.50 by Fridays close. Insiders Dumping like all get out . New BagHolders on Old News! 7come11 Babe, Hit me! Roll-D-Dice. Who brought at $7.50 ?

[jondoeuk]

Dr. Wong and his colleagues involved in the trial have published an open letter to the FDA detailing their objections to the CRL https://www.linkedin.com/posts/melanomaexpert_melanoma-activity-7357932840908378113-gAKs

[jondoeuk]

So it was Dr. Pazdur https://www.statnews.com/2025/08/04/replimune-skin-cancer-drug-rejection-pazdur-prasad/

[jondoeuk]

From this (behind a wall): ''Replimune is waiting for the FDA to further explain last week’s surprise rejection of its advanced melanoma treatment before engaging in the formal process that pharma companies typically take to resolve the agency’s questions and concerns in a complete response letter.

Replimune’s founder and executive chairman Philip Astley-Sparke told Endpoints News in an interview Friday that the company has asked the FDA to provide more details on what exactly it wants from the therapy to move forward, but has yet to have any dialogue.

“There’s a lot of speculation, but we do not know for certain. And before we interact with the agency in any more formal way, we would actually like to understand from the agency what led to such a drastic pivot,” Astley-Sparke said.

Replimune’s treatment, called RP1, is an HSV-1-based oncolytic immunotherapy that was tested in combination with Bristol Myers Squibb’s PD-1 inhibitor Opdivo for advanced melanoma.

An accelerated approval seemed to be all but certain leading up to the July 22 decision date. The FDA hadn’t requested an advisory committee and the biotech said it was in label negotiations with the agency, and had already completed manufacturing inspections and clinical trial site inspections — the usual final steps ahead of an approval.

When it received a CRL from the FDA instead, Replimune said that the issues that were raised hadn’t been part of its dialogue with the agency leading up to the action. According to the company, the FDA said the CRL was the result of the “heterogeneity” of the patient population in the pivotal trial, and the potential that Opdivo might be driving patients’ responses.

But the idea that size of the effect could be from Opdivo alone “just doesn’t hold water,” Astley-Sparke argued

Replimune added that the FDA also took issue with the design of a confirmatory trial that was necessary to get an accelerated approval, even after aligning on the design of that trial with the agency. Astley-Sparke said it’s unlikely the company will be able to complete the study if the market doesn’t think there’s a shot at approval.

“That study is very much still enrolling, but we would not be able to finance it,” he said.

Astley-Sparke declined to comment further on the confirmatory study since the company isn’t exactly clear on what the agency wants, he said.

After losing almost 80% of its value after the CRL, Replimune’s stock has rebounded in recent days; investors have been encouraged that Vinay Prasad’s exit from CBER might change its fortunes.

Astley-Sparke confirmed the rise is likely the result of investors thinking RP1 will ultimately win an accelerated approval.

There has also been speculation of whether FDA leaders, including Prasad, might have driven the Replimune rejection, overruling scientific staff.

A now-deleted comment from a CBER branch chief on LinkedIn said agency “leadership” did not agree with the clinical review team’s assessment of RP1, and then pushed the CRL. A former senior leader in CBER told Endpoints last week that the Replimune CRL came from Rick Pazdur, director of the FDA’s Oncology Center of Excellence.

Astley-Sparke said he had heard “rumors” of Pazdur’s involvement, but he noted that Pazdur “does not have signature authority over CBER decisions.” The FDA didn’t respond to a request for comment on Friday, and Pazdur didn’t respond to a question sent directly to him.'' https://endpoints.news/replimune-says-its-waiting-for-fda-on-a-path-forward-for-rejected-cancer-treatment/

[Penny Grabber]

Called 7.50 friday 4pm when it was 3.30

Come over to RAYA. Could go as high as a buck.

Currently 8 cents after dilution (now 190M shares).

Before the offerings market cap was 160M.

Currently 16M.

Could see a 10x there 💪

[Doubledown75]

Nice coin man!!!

[Dennis14]

That was my average. Thank you

[makinezmoney]

$REPL: Don't remember seeing that $2.98 buyin post......................

But you're in $TRIP / $TRUFF which is gonna be a MEGA WINNER so I'll give you a bye for now.


GO $TRUFF

[Chrion Capital]

+>>>REPL - Trending on StockTwits... Headed for High of the Day! Dollar Volume about to cross 1 Billion. Could be easily over $10 tomorrow on the momentum alone!!!

CC

[Dennis14]

I was in at 2.98 out at 7.15

[Doubledown75]

Me too I'm out 

[Penny Grabber]

Left PM. Went the GAME for a buck.

Nice run 2.80 to 7 💪

[Trend-Setter]

https://www.ajmc.com/view/from-super-skeptical-beginnings-a-new-immune-modulatory-vaccine-awaits-phase-3-results

[Doubledown75]

I'm my own worst enemy.
Crapshoot
Happens to me all them time.
FDA fired that prasad guy. REPL stuff works but he has a beef with Trump, so I think I understand what is going on.
Goodluck

[makinezmoney]

$REPL: Uhggggghhhhh........ so dumb for getting out at $3

Congrats to all the winners.

SHoulda had more patience.


GO $REPL

[Doubledown75]

Holy moly!!!
Man I'm hitting some good plays

[Penny Grabber]

Under massive accumulation.

Multi day runner here

7.50 target by 4pm Friday.

[Doubledown75]

I raise 

[Penny Grabber]

Still holding from the drop...

Target: $7.50

[Penny Grabber]

Based on recent reports, IQVIA Holdings (IQV) made a non-binding offer to acquire Replimune Group Inc (REPL) for $7.00 per share in cash.
According to Google

[Doubledown75]

Gettin a little love 

[jondoeuk]

Found this https://www.biotechtv.com/post/sushil-patel-july-23-2025

Also https://www.insights.phyusionbio.com/p/from-breakthrough-to-breakdown-the

[Doubledown75]

SSR today 
Should bounce 

[Penny Grabber]

Hedge funds lost 100s on millions in this yesterday. Some are dumping. Some are adding. Still shaking out.

I expect this to be back over $5 in no time.

Adding big today.

[jondoeuk]

Stating "The issues highlighted in the CRL were not raised by the agency during the mid- and late-cycle reviews" is a polite way of saying they had agreement with the FDA, that Prasad just ignored. Mad men running the asylum.

[Penny Grabber]

Great discount. Might as well buy this ticker take the R&D and move on without management.

Got some value here for a bigger pharma with this balance sheet.

[Doubledown75]

I like reptiles 
Let's go!!!

[threewheeler]

2.68 to 3.56 in minutes great trade my day is done already REPL

[makinezmoney]

$REPL: Out here at $3 !!!!!!

DONE

THanksssssssssssss

GO $REPL

[makinezmoney]

$REPL: Added 30k shares here at $2.85

Gonna just scalp out............ don't worry......... don't expect anything major here on this dropoff


GO $REPL

[Penny Grabber]

485M in cash ans short term investments on 3/31.

Last year cash burn was 189M. 47.25M/quarter.

Fast forward to July 2025 assuming same burn, company has roughly 430M as of today.

77M shares.

$5.58/share in cash and short term investments.

Current share price - $2.85/share.

[morokoy]

From Chat GPT -

Replimune’s investigational therapy RP1 (vusolimogene oderparepvec) combined with nivolumab is on track for a definitive FDA decision by July 22, 2025, under a Priority Review designation
ir.replimune.com

Here are the key points affecting its approval chances:

✅ Strong FDA Support & Smooth Pathway
Breakthrough Therapy designation and Priority Review signals prioritize expedited review based on strong efficacy in high-need setting
.
No Advisory Committee planned and no review issues flagged — an encouraging sign that the FDA doesn’t foresee major safety or requirement hurdles

Manufacturing inspections and late-cycle review are complete with all processes on track

📊 Supporting Clinical Data
Phase 2 IGNYTE trial in anti–PD-1 refractory melanoma showed:

33.6% objective response rate (ORR), including 15% complete responses

Confirmed durable responses (median duration ~21.6 months)

Strong 1-, 2-, and 3-year survival rates of 75%, 63%, and 55% respectively

Safety profile was manageable: mostly grade 1/2 events, ~13% grade 3+; no treatment-related deaths

🧠 Analyst and Industry Outlook
Analysts view the lack of Advisory Committee and clean review process as de-risking approval

As of March?31, 2025, Replimune held nearly $484million in cash, supporting their commercial readiness (est. 13,000 eligible U.S. patients annually, ~80% eligible for RP1)

🔎 Approval Likelihood: Bullish But Not Guaranteed
Likely scenario:
FDA approves RP1 + nivolumab by July 22, 2025, given priority status, solid Phase 2 data, no AdComm, and regulatory prep.
Potential risks:
Issues could arise in late-stage confirmatory data or existing manufacturing concerns, but none are evident so far.

📝 In Summary
All current signs point toward a high probability of FDA approval by late July 2025. Breakthrough/priority designations, lack of advisory meeting, favorable clinical results, and no red flags from the FDA are powerful indicators of a smooth approval process.

🎯 Final Take: Replimune is strongly positioned for RP1 approval this summer — watch for the July 22 decision.

[Monksdream]

REPL under $15

[Monksdream]

REPL under $11

[Monksdream]

REPL under $10