#Replimune
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statnews.com
The US is currently a biotech leader, but the inconsistency at the FDA will make it hard to make new medicines.

“I think this is going to kill drug development,” Replimune CEO Sushil Patel told Adam Feuerstein at the #STATSummit.
October 19, 2025 at 10:35 PM
statnews.com
The FDA rejected a viral-based treatment from Replimune Group intended for patients with advanced skin cancer — a decision that again signals a hardened stance on drug approvals from Vinay Prasad.
www.statnews.com/2025/07/22/r...
Replimune skin cancer therapy rejected by FDA, a sign of regulators' hardened stance
The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new agency officials
www.statnews.com
July 22, 2025 at 5:16 PM
statnews.com
News: FDA approves Replimune melanoma drug previously rejected twice www.statnews.com/2026/08/06/r...
FDA approves Replimune melanoma drug previously rejected twice
The FDA approved Replimune’s treatment for advanced melanoma, dealing the company and patient advocates a big win after a tumultuous saga.
www.statnews.com
August 6, 2026 at 8:07 PM
wsj.com
Exclusive: Replimune Group is expected to announce that it has reached an agreement with the FDA on a path to resubmit its experimental melanoma treatment for approval, people familiar with the matter said.
Replimune Gets Third Try at FDA Approval After Makary Departure
Experimental melanoma drug was rejected twice because the Food and Drug Administration questioned its study design.
on.wsj.com
May 29, 2026 at 11:50 AM
joho.bsky.social
Seems that canceled research will be a key legacy of Prasad and Makary.

www.statnews.com/2025/08/21/k...
FDA 'uncertainty' forces Krystal Biotech to shutter cancer drug trial
The FDA's controversial rejection of a skin cancer therapy from Replimune Group has prompted Krystal Biotech to shut down of a clinical trial involving a similar drug.
www.statnews.com
August 21, 2025 at 12:31 PM
reuters.com
US Health Secretary Kennedy distances himself from FDA's Replimune cancer drug rejection reut.rs/3QptiuR
US Health Secretary Kennedy distances himself from FDA's Replimune cancer drug rejection
Health Secretary Robert F. Kennedy Jr. told ​a Senate hearing on Wednesday that he had nothing to do with the U.S. FDA's ‌decision to not approve Replimune's drug for advanced skin cancer, saying it was in the hands of the agency's Commissioner Dr. Marty Makary.
reut.rs
April 22, 2026 at 10:15 PM
wsj.com
Replimune representatives met with White House officials in early May and by the end of month, the Food and Drug Administration was planning to review the melanoma medication again. on.wsj.com/3PT5oIi
How Replimune’s drug got a third chance after the White House intervened
Replimune representatives met with White House officials in early May and by the end of month, the Food and Drug Administration was planning to review the melanoma medication again.
on.wsj.com
May 30, 2026 at 1:57 AM
reuters.com
US FDA panel backs Replimune skin cancer drug study data reut.rs/4hEKWGq
US FDA panel backs Replimune skin cancer drug study data
A panel of outside ​advisers to the US Food ‌and Drug Administration voted to back results from a trial ​studying Replimune's drug for ​a type of skin cancer ⁠in a meeting on ​Thursday.
reut.rs
July 30, 2026 at 9:35 PM
reuters.com
Replimune surges after FDA advisers back skin cancer drug reut.rs/4yKGFHD
Replimune surges after FDA advisers back skin cancer drug
Shares ‌of Replimune more than doubled premarket on Friday after the U.S. Food and Drug Administration's panel of outside advisers voted to back trial results for its drug for a ​type of skin cancer.
reut.rs
July 31, 2026 at 9:50 AM
wsj.com
Replimune representatives met with White House officials in early May and by the end of month, the Food and Drug Administration was planning to review the melanoma medication again. on.wsj.com/4x5GAh5
How Replimune’s Drug Got Third Chance After White House Intervention
Replimune representatives met with White House officials in early May and by the end of month, the Food and Drug Administration was planning to review the melanoma medication again.
on.wsj.com
May 30, 2026 at 1:55 AM
altfda.altgov.info
Good morning ppl! It’s Federal Fuckery Friday… let’s start this shit off with a total bribe paid. www.statnews.com/2026/08/06/r...
FDA approves Replimune melanoma drug previously rejected twice
The FDA approved Replimune’s treatment for advanced melanoma, dealing the company and patient advocates a big win after a tumultuous saga.
www.statnews.com
August 7, 2026 at 1:17 PM
doritreiss.bsky.social
Replimune skin cancer therapy rejected by FDA, a sign of regulators’ hardened stance www.statnews.com/2025/07/22/r... via @statnews.com @matthewherper.bsky.social
Replimune skin cancer therapy rejected by FDA, a sign of regulators' hardened stance
The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new agency officials
www.statnews.com
July 23, 2025 at 12:32 AM
cnbc.com
Replimune to resubmit twice-rejected drug for approval after FDA shakeup
Replimune to resubmit twice-rejected drug for approval after FDA shakeup
Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.
cnb.cx
May 29, 2026 at 12:55 PM
statnews.com
Earlier this year, STAT reported that a top cancer drug regulator was involved in pushing to deny Replimune’s application for a skin cancer drug, against the wishes of the drugs’ scientific reviewers.
Read more: www.statnews.com/2025/08/04/r...
FDA’s top cancer drug regulator played key role in rejection of Replimune therapy, officials say
The FDA's top regulator of cancer drugs played a key role in the rejection of a skin cancer therapy from Replimune Group, STAT has learned.
www.statnews.com
October 19, 2025 at 10:35 PM
mcbridetd.bsky.social
STAT+: FDA’s top cancer drug regulator played key role in rejection of Replimune therapy, officials say www.statnews.com/2025/08/04/r...
FDA’s top cancer drug regulator played key role in rejection of Replimune therapy, officials say
The FDA's top regulator of cancer drugs played a key role in the rejection of a skin cancer therapy from Replimune Group, STAT has learned.
www.statnews.com
August 4, 2025 at 1:15 PM
newsen.bsky.social
Securities Class Action Filed Against Replimune Group, Inc. with Deadline Approaching#Class_Action#FDA ##Replimune_Group
Securities Class Action Filed Against Replimune Group, Inc. with Deadline Approaching
SueWallSt alerts investors of a securities class action against Replimune Group, Inc., following significant stock price declines after an FDA response.
third-news.com
September 24, 2026 at 2:18 PM
newsen.bsky.social
Pomerantz Law Firm Updates Investors Regarding Class Action Against Replimune Group, Key Deadlines Approaching#USA#New_York#Pomerantz_Law#FDA_Response#Replimune_Group
Pomerantz Law Firm Updates Investors Regarding Class Action Against Replimune Group, Key Deadlines Approaching
Investors of Replimune Group, Inc. are alerted by Pomerantz Law Firm about a pending class action lawsuit and crucial deadlines. Details included.
third-news.com
September 24, 2026 at 8:34 PM
drtimos.bsky.social
Signal or noise? > Replimune Announces Favorable Outcome of FDA’s Advisory
Committee Meeting - Oncodaily >> Comment below! #strategy #competitiveintelligence #marketing #biotech #healthcare #pharmaceutical #competitivemarketing #pharma
Replimune Announces Favorable Outcome of FDA’s Advisory Committee Meeting - Oncodaily
Replimune Announces Favorable Outcome of FDA’s Advisory Committee Meeting  Oncodaily
dlvr.it
August 2, 2026 at 10:58 AM
merlintrader.bsky.social
Replimune (#$REPL): TUDRIQEV U.S. Launch Guided by Mid-October, Authorized Shares Doubled

Free Biotech Catalyst Calendar on Merlintrader.

www.merlintrader.com/replimune-gr...
September 23, 2026 at 10:55 PM
wsj.com
Experimental melanoma drug was rejected twice because the Food and Drug Administration questioned its study design. on.wsj.com/4wYfTum
Replimune Gets Third Try at FDA Approval After Makary Departure
Experimental melanoma drug was rejected twice because the Food and Drug Administration questioned its study design.
on.wsj.com
May 29, 2026 at 11:31 AM
thebabaklab.bsky.social
📸 Image generated using Sora by OpenAI.
Article link: www.fda.gov/drugs/resour...
FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in c
On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combi...
www.fda.gov
September 28, 2026 at 5:54 PM
stockquakes.com
#Trading #StockMarket
Stock Premarket - May 29, 2026

See StockQuakes.substack.com

UP
↑ PRFX Prf Technologies LTD 231.4%
↑ OLOX Olenox Industries Inc 110.6%
↑ STG Sunlands Technology Group 98.9%
↑ REPL Replimune Group, Inc 74.6%
↑ CMND Clearmind Medicine Inc 54.7%
↑ IOTR Iothree LTD 38.9%
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StockQuakes.substack.com
May 29, 2026 at 1:06 PM
legal.reuters.com
Shares of Replimune more than doubled premarket on Friday after the U.S. Food and Drug Administration's panel of outside advisers voted to back trial results for its drug for a type of skin cancer.
Replimune surges after FDA advisers back skin cancer drug
Shares ‌of Replimune more than doubled premarket on Friday after the U.S. Food and Drug Administration's panel of outside advisers voted to back trial results for its drug for a ​type of skin cancer.
reut.rs
July 31, 2026 at 9:50 AM
publichealthguy1.bsky.social
all that capital came calling www.wsj.com/politics/pol...
Senior leaders in the White House increasingly concluded Makary was out of step with the president's priorities on vaping and other policy issues, people familiar with the matter said. Pharmaceutical-industry insiders were coming to the White House with complaints, as executives from Massachusetts-based Replimune Group did last week, and some were calling for Makary's removal. Even some of the people he had elevated to senior roles at his agency no longer trusted him, according to people familiar with the dynamics.
May 13, 2026 at 2:50 AM
newsen.bsky.social
Levi & Korsinsky Alerts on Securities Class Action for Replimune Group Stockholders#United_States#New_York#Levi_&_Korsinsky#Securities_Class_Action#Replimune_Group
Levi & Korsinsky Alerts on Securities Class Action for Replimune Group Stockholders
Levi & Korsinsky, LLP has issued a warning to shareholders of Replimune Group, Inc. regarding a newly filed securities class action lawsuit in light of major stock price declines.
third-news.com
September 23, 2026 at 2:47 PM