MarketPulse

BLA submission

20 articles
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
GlobeNewswire Inc.GlobeNewswire Inc.··Dbv Technologies

DBV Technologies' Peanut Allergy Patch Shows Strong Phase 3 Data Ahead of FDA Submission

DBV Technologies announced strong Phase 3 data for VIASKIN® Peanut patch, with 82.8% of treated children showing improved tolerance. FDA submission planned for H1 2026.
DBVTFDA approvalclinical trial results
GlobeNewswire Inc.GlobeNewswire Inc.··Dbv Technologies

DBV Technologies' Peanut Allergy Patch Shows Strong Phase 3 Data Ahead of FDA Submission

DBV Technologies' peanut allergy patch met Phase 3 goals with 46.6% responder rate versus 14.8% placebo, supporting planned 2026 FDA submission.
DBVTFDA approvalBLA submission
GlobeNewswire Inc.GlobeNewswire Inc.··Claimsfiler

uniQure Class Action: Deadline Set for Lead Plaintiff Claims Over FDA Disclosure

uniQure faces class action lawsuit over failing to disclose FDA rejection of AMT-130 drug candidate, causing 49% stock decline. Lead plaintiff deadline: April 13, 2026.
QUREsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

Legal Action Filed Against uniQure Over FDA Approval Statements

Class action lawsuit filed against uniQure for allegedly making false statements about FDA approval status and BLA submission timelines, misleading investors.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

uniQure Faces Class Action Over FDA Study Claims and BLA Timeline Disclosures

uniQure faces class action lawsuit alleging misleading statements about FDA study status and BLA timeline delays. Investors who purchased shares Sept-Oct 2025 may be eligible to claim.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Kirby Mcinerney Llp

Class Action Lawsuit Alleges uniQure Withheld FDA Study Design Concerns

Class action lawsuit alleges uniQure withheld FDA study design concerns from investors, causing 49% stock decline after disclosure in November 2025.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Class Action Lawsuit Filed Against uniQure Over FDA Approval Disclosures

uniQure faces class action lawsuit alleging misleading FDA approval statements and understated BLA timeline risks. Investors who purchased securities between September-October 2025 may be eligible to participate.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Claimsfiler

uniQure Faces Securities Lawsuit Over FDA Disclosure Gap; Lead Plaintiff Deadline Set

uniQure faces securities lawsuit over failing to disclose that FDA rejected its gene therapy candidate AMT-130, causing stock to plunge 49%. Lead plaintiff deadline set for April 13, 2026.
QUREsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

uniQure Stock Drops 49% Following FDA Rejection of AMT-130 Accelerated Approval

uniQure stock plummeted 49% after FDA rejected accelerated approval for gene therapy AMT-130, triggering a class action lawsuit alleging securities fraud.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Robbins Llp

uniQure Investors Face April Deadline in Securities Class Action Over FDA Disclosure Claims

Securities lawsuit against uniQure alleges misleading FDA disclosure statements about gene therapy candidate AMT-130. Stock fell 49% after November FDA feedback; investors must file claims by April 13, 2026.
QUREclass action lawsuitshareholder fraud
GlobeNewswire Inc.GlobeNewswire Inc.··Faruqi & Faruqi, Llp

QURE Investors Face April Deadline in Securities Class Action Over AMT-130 Claims

uniQure faces securities lawsuit alleging misleading statements about AMT-130's FDA pathway. Stock dropped 49% after FDA reversed stance. Investors have April deadline for lead plaintiff claims.
QUREsecurities class actionmisleading statements