iHub News
3時間前
uniQure Positioned for Gains After FDA Supports Accelerated Approval Path for AMT-130June 17, 2026 8:55 AM
IH Market News uniQure N.V. (NASDAQ:QURE) was halted pending news on Wednesday and appeared set for a strong move higher once trading resumed after announcing positive regulatory feedback from the U.S. Food and Drug Administration regarding its Huntington’s disease treatment candidate, AMT-130. The company said the FDA has agreed that data from its ongoing Phase I/II study could form the primary foundation of a future Biologics License Application (BLA) seeking accelerated approval. FDA Accepts Three-Year Study Data as Basis for Submission According to uniQure, discussions with the regulator during a recent Type B meeting resulted in agreement that three-year follow-up data from the trial would be suitable as the principal dataset supporting a BLA filing. The company plans to submit the application during the third quarter of 2026. Management added that the FDA expressed a willingness to work closely and efficiently with uniQure to finalize details surrounding a post-approval confirmatory study before the BLA is filed. Confirmatory Study Discussions Continue The FDA is seeking further alignment on the design of the confirmatory trial that would support accelerated approval. Among the topics under consideration is the potential use of a concurrent control group receiving standard-of-care treatment rather than employing a sham surgical procedure. uniQure said it remains committed to launching the confirmatory study as quickly as possible and expects to continue discussions with the agency to finalize the protocol ahead of submission. AMT-130 Holds Multiple FDA Designations AMT-130 has already received several important regulatory designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT), Breakthrough Therapy and Fast Track status. The RMAT designation was particularly significant as it represented the first time the FDA granted the designation to a treatment candidate targeting Huntington’s disease. These designations are intended to facilitate the development and review of therapies addressing serious conditions with significant unmet medical needs. Ongoing Studies Continue to Generate Data uniQure is currently running two multicenter, dose-escalation Phase I/II studies evaluating the safety, tolerability and potential efficacy of AMT-130. The U.S. trial enrolled 26 patients with early manifest Huntington’s disease, who were randomized to either treatment or a sham procedure. Participants receiving therapy were administered a single dose of AMT-130 directly into the striatum using MRI-guided stereotactic neurosurgery. Next Regulatory Milestone Approaches The company expects to receive the official meeting minutes from the FDA within 30 days of the Type B meeting. With a planned BLA submission targeted for the third quarter of 2026 and ongoing discussions around the confirmatory study design, investors are likely to focus on the next regulatory updates as AMT-130 advances toward a potential accelerated approval pathway. uniQure stock priceThe post uniQure Positioned for Gains After FDA Supports Accelerated Approval Path for AMT-130 appeared first on US Editors. Original: uniQure Positioned for Gains After FDA Supports Accelerated Approval Path for AMT-130
iHub News
3時間前
ClearPoint Neuro Shares Jump as FDA Progress for UniQure Therapy Highlights Platform ValueJune 17, 2026 8:56 AM
IH Market News ClearPoint Neuro (NASDAQ:CLPT) surged 50% on Wednesday after partner company UniQure announced a significant regulatory milestone for its Huntington’s disease treatment candidate, AMT-130. Investors responded positively to the update, which could accelerate development of a therapy that relies on ClearPoint’s technology platform for delivery. UniQure Receives Positive FDA Feedback UniQure (NASDAQ:QURE) disclosed that the U.S. Food and Drug Administration has agreed that three-year data from its Phase I/II clinical study may serve as the primary basis for a Biologics License Application seeking accelerated approval of AMT-130. The feedback was provided during a recent Type B meeting with the agency. The company plans to submit its BLA during the third quarter of 2026, marking a potentially important step toward commercialization. ClearPoint Technology Used in AMT-130 Administration AMT-130 is delivered using ClearPoint Neuro’s navigation platform together with its SmartFlow cannula system. As a result, progress in the development of the Huntington’s disease therapy is viewed as a positive indicator for the broader adoption and validation of ClearPoint’s neurosurgical technologies. The market reaction reflected growing expectations that successful advancement of AMT-130 could increase visibility for the company’s platform within the gene therapy and neurological disease sectors. Confirmatory Study Discussions Continue According to UniQure, the FDA is working with the company to finalize the design of a confirmatory study that would support the accelerated approval pathway. Among the issues being evaluated is the possibility of using a concurrent control group receiving standard-of-care treatment rather than a sham procedure. The agency indicated that it intends to work as quickly as possible with UniQure to align on the study design before the BLA submission. AMT-130 Holds Multiple Regulatory Designations The treatment candidate has already received several important FDA designations designed to support its development. These include Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation and Fast Track designation. Notably, AMT-130 became the first Huntington’s disease programme to receive RMAT status from the FDA. Next Steps Ahead of Filing UniQure expects to receive the official minutes from the Type B meeting within the next 30 days. The company reiterated its commitment to moving forward with the confirmatory study without delay and intends to continue working with regulators to finalize the required details ahead of the planned BLA submission. The regulatory progress boosted sentiment toward ClearPoint Neuro, whose delivery technology remains an important component of the AMT-130 development programme. ClearPoint Neuro stock price uniQure stock priceThe post ClearPoint Neuro Shares Jump as FDA Progress for UniQure Therapy Highlights Platform Value appeared first on US Editors. Original: ClearPoint Neuro Shares Jump as FDA Progress for UniQure Therapy Highlights Platform Value
US Market News
2月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREApril 12, 2026 11:54 PM
PR Newswire (US)
LOS ANGELES, April 12, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure" or "the Company") (NASDAQ: QURE) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery.CLASS PERIOD: September 24, 2025 to October 31, 2025DEADLINE: April 13, 2026CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate.WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.CONTACT:
David J. Schwartz
DJS Law Group
274 White Plains Road, Suite 1
Eastchester, NY 10709
Phone: 914-206-9742
Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302739988.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
US Market News
2月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREApril 6, 2026 4:03 AM
PR Newswire (US)
LOS ANGELES, April 6, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure" or "the Company") (NASDAQ: QURE) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery.CLASS PERIOD: September 24, 2025 to October 31, 2025DEADLINE: April 13, 2026CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate.WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.CONTACT:
David J. Schwartz
DJS Law Group
274 White Plains Road, Suite 1
Eastchester, NY 10709
Phone: 914-206-9742
Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302734512.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
US Market News
3月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREMarch 30, 2026 4:06 AM
PR Newswire (US)
LOS ANGELES, March 30, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure" or "the Company") (NASDAQ: QURE) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery.CLASS PERIOD: September 24, 2025 to October 31, 2025DEADLINE: April 13, 2026CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate.WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.CONTACT:
David J. Schwartz
DJS Law Group
274 White Plains Road, Suite 1
Eastchester, NY 10709
Phone: 914-206-9742
Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302728378.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
US Market News
3月前
QURE Shareholder Alert: uniQure N.V. Securities Class Action Lawsuit Investors With Losses May Join -- The Gross Law FirmMarch 24, 2026 9:00 AM
PR Newswire (US)
NEW YORK, March 24, 2026 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of uniQure N.V. (NASDAQ: QURE).
Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/uniqure-loss-submission-form/?id=184734&from=4CLASS PERIOD: September 24, 2025 to October 31, 2025ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially false and/or misleading statements and/or failed to disclose that: (1) the design of uniQure's Pivotal Study—including comparison of the Pivotal Study results to the ENROLL-HD external historical data set—was not fully approved by the FDA; (2) defendants downplayed the likelihood that, despite purportedly highly successful results from the Pivotal Study, uniQure would have to delay its Biologics License Application ("BLA") timeline to perform additional studies to supplement its BLA submission; and (3) as a result, defendants' statements about the Company's business, operations, and prospects lacked a reasonable basis.DEADLINE: April 13, 2026 Shareholders should not delay in registering for this class action. Register your information here: https://securitiesclasslaw.com/securities/uniqure-loss-submission-form/?id=184734&from=4NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of QURE during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead plaintiff is April 13, 2026. There is no cost or obligation to you to participate in this case.WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company's stock. Attorney advertising. Prior results do not guarantee similar outcomes.CONTACT:
The Gross Law Firm
15 West 38th Street, 12th floor
New York, NY, 10018
Email: dg @bback
View original content to download multimedia:https://www.prnewswire.com/news-releases/qure-shareholder-alert-uniqure-nv-securities-class-action-lawsuit-investors-with-losses-may-join--the-gross-law-firm-302722736.htmlSOURCE The Gross Law Firm
Original: QURE Shareholder Alert: uniQure N.V. Securities Class Action Lawsuit Investors With Losses May Join -- The Gross Law Firm
US Market News
3月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREMarch 20, 2026 3:23 AM
PR Newswire (US)
LOS ANGELES, March 20, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure" or "the Company") (NASDAQ: QURE) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery.CLASS PERIOD: September 24, 2025 to October 31, 2025DEADLINE: April 13, 2026CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate.WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.CONTACT:David J. SchwartzDJS Law Group274 White Plains Road, Suite 1 Eastchester, NY 10709Phone: 914-206-9742Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302719452.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
iHub News
3月前
uniQure shares jump 36% after news of FDA gene therapy chief’s departureMarch 9, 2026 10:14 AM
IH Market News
Shares of uniQure BV (NASDAQ:QURE) surged 36% on Monday after reports emerged that the head of the U.S. Food and Drug Administration’s vaccines and gene therapies division will step down, triggering several analyst upgrades across the biotechnology sector. Other companies in the space also rallied, with REGENXBIO (NASDAQ:RGNX) rising 13% and Biohaven (NYSE:BHVN) gaining 23%.Vinay Prasad, who currently leads the FDA’s Center for Biologics Evaluation and Research division overseeing vaccines and gene therapies, is expected to leave the agency next month to return to academia. His tenure has been viewed by some industry observers as a period of heightened regulatory scrutiny for gene therapy developers.RBC Capital analyst Luca Issi upgraded uniQure from Sector Perform to Outperform and raised the firm’s price target to $35.00 from $11.00. The company had recently faced regulatory setbacks after the FDA indicated it would not approve its Huntington’s disease therapy based solely on comparisons to natural history data, a development uniQure described as a “key shift” from earlier feedback given before changes in FDA leadership.“We believe that Prasad’s departure is likely to open up a more balanced discussion on risk/reward for HD,” Issi wrote, adding that he now estimates a 50% probability that the therapy could eventually gain approval.Stifel analyst Paul Matteis also reacted positively to the news, calling Prasad’s exit “a big win for biotech, especially for companies in the rare disease space.” Matteis added that several gene therapy and rare disease developers had been under pressure as part of what he described as the “FDA risk off” basket, with Prasad reportedly overriding review teams to recommend negative outcomes in certain cases.An analyst at Truist noted that Prasad’s leadership “marked a sharp departure from the more flexible regulatory approach for rare and serious diseases” seen under his predecessor Peter Marks. According to the analyst, several companies encountered evolving regulatory expectations during development discussions while Prasad was in charge.uniQure is scheduled to hold a Type B meeting with the FDA in the second quarter.uniQure stock price
Original: uniQure shares jump 36% after news of FDA gene therapy chief’s departure
US Market News
3月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREMarch 5, 2026 4:39 AM
PR Newswire (US)
LOS ANGELES, March 5, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure" or "the Company") (NASDAQ: QURE) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery.CLASS PERIOD: September 24, 2025 to October 31, 2025 DEADLINE: April 13, 2026 CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate .WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.CONTACT:
David J. Schwartz
DJS Law Group
274 White Plains Road, Suite 1
Eastchester, NY 10709
Phone: 914-206-9742
Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302704856.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
iHub News
4月前
uniQure shares plunge 45% after FDA setback on Huntington’s gene therapyMarch 2, 2026 8:04 AM
IH Market News
Shares of uniQure N.V. (NASDAQ:QURE) dropped 45% on Monday after the company revealed that the U.S. Food and Drug Administration declined to support its proposed regulatory pathway for the approval of AMT-130, an experimental gene therapy targeting Huntington’s disease.According to final minutes from a Type A meeting held on January 30, the FDA said it could not agree that results from Phase I/II trials — when compared with an external control group — provide sufficient primary evidence of effectiveness to support a marketing application for AMT-130. The agency instead strongly recommended that uniQure conduct a prospective, randomized, double-blind study incorporating a sham surgery control.The company said it plans to continue discussions with the FDA regarding Phase III development requirements and intends to request a Type B meeting in the second quarter of 2026 to further explore potential clinical trial design options.“While we did not reach alignment on a submission pathway based on the Phase I/II data, we believe the totality and durability of our data warrant continued substantive dialogue regarding how the FDA’s stated commitment to regulatory flexibility may be appropriately applied in this setting,” said uniQure Chief Executive Officer Matt Kapusta.The FDA’s stance represents a significant delay to the company’s development timeline, as conducting a new controlled trial would require additional investment and extend the path toward potential commercialization.AMT-130 is being developed as a treatment for Huntington’s disease, a hereditary condition that leads to the gradual degeneration of nerve cells in the brain.uniQure describes itself as a gene therapy developer focused on advancing potentially transformative treatments for patients with serious and unmet medical needs.
Original: uniQure shares plunge 45% after FDA setback on Huntington’s gene therapy
US Market News
4月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREMarch 2, 2026 4:18 AM
PR Newswire (US)
LOS ANGELES, March 2, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure " or "the Company") (NASDAQ: QURE) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery. CLASS PERIOD: September 24, 2025 to October 31, 2025 DEADLINE: April 13, 2026 CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate. WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. CONTACT: David J. SchwartzDJS Law Group274 White Plains Road, Suite 1Eastchester, NY 10709Phone: 914-206-9742Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302700646.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
US Market News
4月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREFebruary 27, 2026 3:11 AM
PR Newswire (US)
LOS ANGELES, Feb. 27, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure " or "the Company") (NASDAQ: QURE ) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery.CLASS PERIOD: September 24, 2025 to October 31, 2025 DEADLINE: April 13, 2026 CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate . WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. CONTACT: David J. SchwartzDJS Law Group274 White Plains Road, Suite 1Eastchester, NY 10709Phone: 914-206-9742Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302699315.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
US Market News
4月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREFebruary 23, 2026 2:14 AM
PR Newswire (US)
LOS ANGELES, Feb. 23, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure " or "the Company") (NASDAQ: QURE ) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery. CLASS PERIOD: September 24, 2025 to October 31, 2025 DEADLINE: April 13, 2026 CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate . WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. CONTACT: David J. SchwartzDJS Law Group274 White Plains Road, Suite 1 Eastchester, NY 10709Phone: 914-206-9742Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302694283.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
US Market News
4月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREFebruary 20, 2026 4:15 AM
PR Newswire (US)
LOS ANGELES, Feb. 20, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure" or "the Company") (NASDAQ: QURE ) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery.CLASS PERIOD: September 24, 2025 to October 31, 2025 DEADLINE: April 13, 2026 CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate.WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. CONTACT: David J. SchwartzDJS Law Group274 White Plains Road, Suite 1Eastchester, NY 10709Phone: 914-206-9742Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302693360.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
US Market News
4月前
The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of April 13, 2026 in uniQure Lawsuit - QUREFebruary 19, 2026 10:00 AM
PR Newswire (US)
NEW YORK, Feb. 19, 2026 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of uniQure N.V. (NASDAQ: QURE).
Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/uniqure-loss-submission-form/?id=183651&from=4CLASS PERIOD: September 24, 2025 to October 31, 2025ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially false and/or misleading statements and/or failed to disclose that: (1) the design of uniQure's Pivotal Study—including comparison of the Pivotal Study results to the ENROLL-HD external historical data set—was not fully approved by the FDA; (2) defendants downplayed the likelihood that, despite purportedly highly successful results from the Pivotal Study, uniQure would have to delay its Biologics License Application ("BLA") timeline to perform additional studies to supplement its BLA submission; and (3) as a result, defendants' statements about the Company's business, operations, and prospects lacked a reasonable basis.DEADLINE: April 13, 2026 Shareholders should not delay in registering for this class action. Register your information here: https://securitiesclasslaw.com/securities/uniqure-loss-submission-form/?id=183651&from=4NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of QURE during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead plaintiff is April 13, 2026. There is no cost or obligation to you to participate in this case.WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company's stock. Attorney advertising. Prior results do not guarantee similar outcomes.CONTACT:
The Gross Law Firm
15 West 38th Street, 12th floor
New York, NY, 10018
Email: dg @bback
View original content to download multimedia:https://www.prnewswire.com/news-releases/the-gross-law-firm-reminds-shareholders-of-a-lead-plaintiff-deadline-of-april-13-2026-in-uniqure-lawsuit--qure-302692452.htmlSOURCE The Gross Law Firm
Original: The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of April 13, 2026 in uniQure Lawsuit - QURE
US Market News
4月前
uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QUREFebruary 13, 2026 1:11 AM
PR Newswire (US)
LOS ANGELES, Feb. 13, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against uniQure N.V. ("uniQure " or "the Company") (NASDAQ: QURE ) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Shareholders who purchased shares of QURE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery. CLASS PERIOD: September 24, 2025 to October 31, 2025 DEADLINE: April 13, 2026 CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. UniQure's Pivotal Study design, including the comparison of the Pivotal Study to the ENROLL-HD data set, did not achieve full FDA approval. The Company understated the chances its BLA application with the FDA would face delays caused by the need for additional studies. Based on these facts, uniQure's public statements were false and materially misleading throughout the class period.If you are a shareholder who suffered a loss, contact us to participate . WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.Join the case to recover your losses.This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. CONTACT: David J. SchwartzDJS Law Group274 White Plains Road, Suite 1 Eastchester, NY 10709Phone: 914-206-9742Email: David@djslawllp.com
View original content:https://www.prnewswire.com/news-releases/uniqure-nv-sued-for-securities-law-violations---contact-the-djs-law-group-to-discuss-your-rights--qure-302687170.htmlSOURCE DJS Law Group LLP
Original: uniQure N.V. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - QURE
MiamiGent
4年前
QURE
$26.36 +3.36 (+14.61%)
As of Nov-23-20224:00:00 PM ET
https://stockcharts.com/h-sc/ui?s=QURE
FDA Approves UniQure's Hemgenix, First Hemophilia B Gene Therapy For Adults
BENZINGA 8:12 AM ET Nov-23-2022
UniQure N.V.'s (NASDAQ:QURE) partner CSL Limited (OTC:CSLLY) has received FDA approval for Hemgenix (etranacogene dezaparvovec-drlb), a one-time gene therapy for hemophilia B.
CSL licensed the exclusive global rights to Hemgenix from uniQure in May 2021.
UniQure has received about $500 million so far from CSL and will also be eligible to get up to an additional $1.5 billion in commercial milestone payments and royalties.
Cowen analyst Joseph Thome said that Hemgenix's price of $3.5 million is higher than the brokerage's estimated $1.9 million, but its consultants have been optimistic about the therapy's uptake, Reuters reported.
Results from the pivotal HOPE-B trial support the FDA approval, the largest gene therapy trial in hemophilia B.
Results from the study demonstrated that Hemgenix allowed patients to produce mean factor IX activity of 39% at six months and 36.7% at 24 months post-infusion.
Seven to 18 months post-infusion, the mean adjusted annualized bleeding rate (ABR) for all bleeds was reduced by 54% compared to the six-month lead-in period on factor IX prophylactic replacement therapy (4.1 to 1.9).
In addition, 94% of patients treated with Hemgenix discontinued prophylaxis and remained free of previous continuous routine prophylaxis therapy.
The FDA has already cleared two gene therapies, Zynteglo and Skysona, from Bluebird bio Inc (NASDAQ: BLUE) in August and September, respectively.