News

Health Check: Audeara strives to be ‘the next Cochlear’ in affordable hearing collab
Cochlear’s Baha devices – as in bone-anchored hearing aid – cost around $10,000 locally. Strictly speaking, the $4 million ...
InvestorsHub on MSN1d
Replimune Shares Slide as FDA Dispute Over Cancer Drug Approval Comes to Light
Shares of Replimune Group Inc. (NASDAQ:REPL) plunged 36% in premarket trading after a report revealed new details about the ...
Replimune stock plunges after FDA cancer drug rejection details emerge
The rejection occurred amid broader turmoil at the FDA, which has been experiencing leadership changes, staff upheaval, and internal dysfunction. These organizational issues reportedly factored into ...
Replimune down as FDA’s top cancer drug regulator reportedly intervened in drug rejection
Replimune (REPL) stock plummets as report suggests FDA’s top regulator of cancer drugs intervened in rejecting its lead asset ...
STAT1d
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, ...
The Daily Reflector3d
Bragar Eagel & Squire, P.C. Is Reminds Investors of Class Actions Against Neogen, Alto,
Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf ...
Stocktwits on MSN6d
Replimune Stock Catches Retail Fire As Analyst Says FDA Shakeup Removes 'Major Obstacle' For Skin Cancer Drug's Potential Approval
Retail trader buzz around Replimune Group surged Wednesday after Cantor Fitzgerald upgraded the stock to ‘Overweight’ from ...
PharmExec6d
IGNYTE Trial Investigators Press FDA to Reconsider Replimune CRL Amid Promising Melanoma Data, Leadership Shakeup
Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...
BioSpace6d
Exit Stage Right: With Prasad Out, Analysts Hope for More Traditional Replacement
As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more ...
The Bakersfield Californian8d
Replimune (REPL) Faces Securities Class Action Following Stock’s Collapse Amid FDA’s Rejection ...
A securities class action lawsuit, styled Jboor v. Replimune Group, Inc., et al., No. 1:25-cv-12085 (D. Mass.), has been filed and seeks ...
Replimune (REPL) Faces Securities Class Action Following Stock's Collapse Amid FDA's Rejection Of Melanoma Drug - Hagens Berman
The lawsuit comes after Replimune investors witnessed a 77% collapse in the price of their shares on July 22 when the company announced that the Food and Drug Administration (FDA) had rejected its ...