MarketPulse

BLA submission

31 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Kyverna's Miv-cel Shows Durable Benefits in Stiff Person Syndrome Trial

Kyverna's miv-cel shows statistically significant benefits across all endpoints in stiff person syndrome trial, with 81% achieving meaningful walking speed improvement.
KYTXclinical trialautoimmune disease
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

uniQure Stock Crashes 49% After FDA Rejects Gene Therapy Data; Class Action Launched

uniQure faces securities fraud lawsuit after FDA rejection of AMT-130 data triggers 49% stock plunge from $67.69 to $34.29 on November 3, 2025.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

uniQure Stock Plunges 49% After FDA Gene Therapy Setback; Class Action Launched

Pomerantz Law Firm filed class action against $QURE after 49% stock decline following FDA concerns over gene therapy study data adequacy.
SMRQUREAMCsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

Inovio Faces Securities Fraud Class Action Over Misleading FDA Claims

Pomerantz LLP files class action against Inovio Pharmaceuticals for securities fraud over false FDA claims; stock fell 24.45% in December 2025.
INOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Biocryst Pharmaceuticals, Inc.

BioCryst Names Pharma Veteran Menon as Chief R&D Officer Amid Pipeline Expansion

BioCryst appoints experienced pharma executive Sandeep Menon as Chief R&D Officer, bolstering leadership as it advances navenibart toward FDA approval.
BCRXFDA approvalclinical development
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

uniQure Faces Class Action Over FDA Study Delays; Investor Claims Deadline Looms

uniQure faces securities class action over alleged FDA disclosure failures; investors have until April 13, 2026, to join litigation seeking damages.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

uniQure Plummets 49% After FDA Rejection; Securities Fraud Suit Filed

uniQure's stock plummeted 49% after FDA rejected its AMT-130 drug candidate; securities fraud lawsuit filed for alleged failure to disclose approval risks during September-October 2025.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

uniQure Stock Plunges 49% on FDA Gene Therapy Setback; Class Action Lawsuit Filed

$QURE plummeted 49% after FDA feedback on AMT-130 gene therapy. Pomerantz Law Firm filed class action lawsuit; investor deadline April 13, 2026.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Portnoy Law Firm

Gene Therapy Setback Triggers Class Action as uniQure Stock Plummets 49%

uniQure shares collapsed 49% after FDA signaled Phase I/II data insufficient for AMT-130 approval, prompting investors to file class action lawsuit.
QUREclass action lawsuitstock decline
GlobeNewswire Inc.GlobeNewswire Inc.··Moonlake Immunotherapeutics

MoonLake's Sonelokimab Sustains Strong Phase 3 Results in Hidradenitis Suppurativa

MoonLake reports Week 40 Phase 3 data for sonelokimab showing 62% HiSCR75 response rates in hidradenitis suppurativa with no new safety signals.
MLTXPhase 3 clinical trialquality of life
GlobeNewswire Inc.GlobeNewswire Inc.··Claimsfiler

uniQure Stock Crashes 49% After FDA Rejection; Class Action Deadline Looms

uniQure faces securities lawsuit after FDA rejected AMT-130 drug candidate data adequacy. Stock plunged 49% following disclosure. Lead plaintiff deadline April 13, 2026.
QUREsecurities class actionlead plaintiff deadline
The Motley FoolThe Motley Fool··Seena Hassouna

ENAVATE's Zenas Stake Surge Masks Real Story: Obexelimab Pipeline

ENAVATE deepens Zenas BioPharma stake to $142.3M. Key catalyst: obexelimab Phase 2 lupus data and Q2 2026 FDA submission.
ZBIOFDA approvalautoimmune diseases
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

uniQure Hit by Class Action Over FDA Approval Claims and BLA Timeline Delays

Class action lawsuit filed against $UQRR alleging materially false statements about FDA approval and BLA timeline delays. Investors urged to join by April 13, 2026 deadline.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Taysha Gene Therapies Posts $109M Loss, Advances Rett Syndrome Therapy

Taysha Gene Therapies reported $109M 2025 loss while advancing TSHA-102 gene therapy for Rett syndrome with positive safety data and FDA regulatory alignment through 2028.
TSHAFDA approvalclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

Inovio Faces Securities Fraud Class Action Over Manufacturing Claims and FDA Setbacks

Pomerantz Law Firm files class action against $INO for alleged securities fraud involving false manufacturing capability and FDA approval claims for INO-3107.
INOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Claimsfiler

uniQure Stock Crashes 49% on FDA Setback; Class Action Deadline Looms

uniQure faces securities lawsuit after FDA rejected AMT-130 approval pathway. Stock plummeted 49% following disclosure. Lead plaintiff deadline: April 13, 2026.
QUREsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

Inovio Faces Securities Class Action Over Undisclosed Manufacturing Delays, FDA Review Setbacks

Law firm Levi & Korsinsky seeks investors in Inovio Pharmaceuticals securities class action alleging failure to disclose manufacturing delays and FDA's standard review decision.
INOsecurities class actionFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Kessler Topaz Meltzer & Check, Llp

uniQure Stock Crashes 49% as Gene Therapy Lawsuit Alleges FDA Misrepresentations

Class action lawsuit filed against $QURE over alleged misstatements about AMT-130 gene therapy FDA approval status. Stock plunged 49% after FDA reversed position on Phase I/II data adequacy.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Claimsfiler

Gene Therapy Stock $QURE Crashes 49% as FDA Rejects AMT-130 Data; Class Action Looms

$QURE plunged 49% after FDA rejected AMT-130 Phase I/II data for accelerated approval. Securities lawsuit filed; lead plaintiff deadline April 13, 2026.
QUREsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Kessler Topaz Meltzer & Check, Llp

uniQure Stock Crashes 49% as FDA Rejects Huntington's Gene Therapy Pathway

uniQure's $QURE stock crashes 49% after FDA rejects Huntington's gene therapy approval pathway; securities fraud lawsuit filed alleging misleading statements about regulatory expectations.
QUREsecurities fraudclass action lawsuit