MarketPulse

Complete Response Letter

44 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

Atara Biotherapeutics Hit With Securities Fraud Class Action Over Failed Drug Approval

Pomerantz Law Firm files class action against $ATRA over alleged misstatements regarding tabelecleucel's regulatory prospects, following FDA rejections and severe stock declines.
ATRAsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Disc Medicine Stock Crashes 22% After FDA Rejects Bitopertin; Class Action Looms

FDA rejected Disc Medicine's bitopertin drug application on February 13, 2026, triggering a 22% stock plunge. The Rosen Law Firm investigates potential securities claims for affected shareholders.
IRONstock declineinvestor losses
BenzingaBenzinga··Vandana Singh

AbbVie's TrenibotE Setback Raises Manufacturing Questions Amid $1.4B Plant Investment

AbbVie received FDA rejection for wrinkle drug TrenibotE over manufacturing issues, though safety and efficacy cleared. Company plans response within months.
ABBVFDA rejectionComplete Response Letter
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

Corcept Faces Class Action Over Relacorilant Misstatement; Investor Deadline Looms

Corcept Therapeutics faces class action lawsuit alleging investor deception over failed relacorilant drug trial. Stock plunged 50.4% after FDA rejection.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Disc Medicine Stock Crashes 22% After FDA Rejects Bitopertin Application

Disc Medicine ($IRON) shares fell 22% after FDA rejected its bitopertin drug application, prompting class action investigation into securities claims.
IRONsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Hagens Berman

Corcept Faces Securities Lawsuit as Relacorilant FDA Rejection Wipes $2.5B in Value

Hagens Berman alerts $CORT investors to April 21 lead plaintiff deadline in securities fraud lawsuit over failed relacorilant drug approval and alleged FDA warning concealment.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Hagens Berman

Corcept Investors Face April 21 Deadline in $2.5B Securities Fraud Lawsuit Over Drug Failure

Hagens Berman alerts $CORT investors to April 21 lead plaintiff deadline in securities fraud class action alleging concealment of FDA concerns about relacorilant ahead of rejection.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

Corcept Therapeutics Hit With Class Action Over Misleading FDA Drug Claims

Corcept Therapeutics faces class action lawsuit for allegedly misleading investors about relacorilant's FDA prospects. Stock plummeted 50.4% after FDA rejection; investors from October 2024-December 2025 eligible to sue.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Replimune Group, Inc.

Replimune's Melanoma Drug Rejected by FDA Despite Promising Trial Data

Replimune receives FDA rejection for RP1 immunotherapy despite 34% response rate in trials. Company plans layoffs, blames regulatory process.
REPLFDA rejectionComplete Response Letter
GlobeNewswire Inc.GlobeNewswire Inc.··Hagens Berman

Corcept Stock Crashes 50% After FDA Rejection; Class Action Lawsuit Filed

Hagens Berman launches securities class action against $CORT after FDA rejects lead drug relacorilant, citing insufficient evidence. Stock plummeted 50% on December 31, 2025.
CORTsecurities class actionrelacorilant
GlobeNewswire Inc.GlobeNewswire Inc.··Kirby Mcinerney Llp

Atara Biotherapeutics Faces Securities Fraud Class Action Over Failed Drug Candidate

Class action lawsuit filed against $ATRA over alleged misstatements on tabelecleucel prospects. FDA rejected drug twice; stock crashed 40-57% post-announcements.
ATRAsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

Disc Medicine Stock Plummets After FDA Rejects Bitopertin Application

Disc Medicine stock tumbled 30% after FDA rejected bitopertin drug application, prompting securities fraud investigation by Pomerantz LLP.
IRONsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

Corcept Plunges 50% After FDA Rejects Lead Drug; Securities Lawsuit Filed

Corcept Therapeutics faces securities class action after FDA rejected relacorilant, causing 50% stock collapse. Investors have until April 21 to file claims.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Hagens Berman

Corcept Therapeutics Hit With Securities Lawsuit Over FDA Rejection and Patent Loss

Hagens Berman files class action against $CORT over alleged concealment of FDA warnings. Stock plunged 50% after December rejection, erasing $2.5B in market value.
CORTsecurities class actionFDA rejection
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Disc Medicine Stock Plummets 22% After FDA Rejects Bitopertin Program

Disc Medicine ($IRON) stock fell 22% after FDA rejected bitopertin program, triggering class action lawsuit investigation by Rosen Law Firm.
IRONsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Hagens Berman

Corcept Faces Securities Lawsuit After FDA Rejection, $2.5B Market Wipeout

Hagens Berman sues $CORT over alleged concealment of FDA warnings on relacorilant. Stock crashed 50% following Complete Response Letter, erasing $2.5B in market value.
CORTsecurities class actionFDA rejection
GlobeNewswire Inc.GlobeNewswire Inc.··Portnoy Law Firm

Disc Medicine Stock Plummets 22% as FDA Rejects Lead Drug, Triggering Securities Probe

Disc Medicine faces securities probe after FDA rejects bitopertin drug; stock slides 22% on February 13, 2026.
IRONsecurities fraudstock decline
GlobeNewswire Inc.GlobeNewswire Inc.··Glancy Prongay Wolke & Rotter Llp

CORT Stock Plunges 50% on FDA Rejection; Securities Fraud Lawsuit Filed

Corcept Therapeutics shares crashed 50% after FDA rejected relacorilant application. Class action lawsuit alleges company concealed prior FDA warnings about clinical development concerns.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Claimsfiler

CORT Stock Tanks 50% on Failed FDA Review; Class Action Lawsuit Deadline Looms

Corcept Therapeutics faces class action lawsuit after FDA rejected lead drug relacorilant in December. Stock fell 50.4%; investors with $100K+ losses have until April 2026 to file suit.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

ALDX Stock Crashes 71% After FDA Rejects Reproxalap; Securities Probe Launched

Aldeyra Therapeutics plummets 71% after FDA rejects lead dry eye drug. Securities litigation firm investigating potential investor claims following efficacy concerns.
ALDXinvestor lossessecurities class action