Latest news with #ResponseLetter
Business Wire
a day ago
- Business
- Business Wire
INVESTOR ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Replimune
NEW YORK--(BUSINESS WIRE)-- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Replimune Group, Inc. ('Replimune or the 'Company') (NASDAQ: REPL). Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See On July 22, 2025, before the market opened, Replimune issued a press release entitled 'Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma.' The press release stated that Replimune had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.' The press release stated that the CRL 'indicates that the FDA is unable to approve the application in its present form. The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.' On this news, Replimune common stock plummeted over 73% during intraday trading on July 22, 2025. To learn more about the Replimune investigation, go to or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). Follow us for updates on LinkedIn, on X, or on Facebook. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP ( Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.
Business Wire
4 days ago
- Business
- Business Wire
UNCY Investors Have Opportunity to Join Unicycive Therapeutics, Inc. Fraud Investigation With the Schall Law Firm
LOS ANGELES--(BUSINESS WIRE)-- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Unicycive Therapeutics, Inc. ('Unicycive' or 'the Company') (NASDAQ: UNCY) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Unicycive announced on June 30, 2025, that the FDA 'has issued a CRL [Complete Response Letter] for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis." The Company added that "After submitting the NDA, and as a part of the application review and routine information requests, the FDA notified Unicycive that a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection." Based on this news, shares of Unicycive fell by 29.85% on the same day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at bschall@ The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.
Business Wire
11-07-2025
- Business
- Business Wire
Capricor Therapeutics, Inc. (NASDAQ: CAPR) Securities Fraud Investigation; CAPR Investors Urged to Contact Award-Winning Firm, Gibbs Mura
BUSINESS WIRE)--Shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on Friday, July 11, 2025, after the U.S. Food and Drug Administration rejected the company's Biologics License Application for its lead cell therapy candidate, Deramiocel, claiming that the application 'does not meet the statutory requirement for substantial evidence of effectiveness' and lacks 'certain outstanding items.' Gibbs Mura is investigating a potential Capricor Therapeutics, Inc. (NASDAQ: CAPR) Securities Class Action Lawsuit on behalf of shareholders who lost money in Capricor Therapeutics, Inc. What Should Capricor Therapeutics, Inc. Investors Do? If you invested in Capricor Therapeutics, Inc., visit our Capricor Therapeutics, Inc. Investigation webpage or call us at (888) 410-2925 to get more information about how you may be able to recover your losses. Our investigation concerns whether Capricor Therapeutics, Inc. has violated federal securities laws by providing false or misleading statements to investors. What is the Capricor Therapeutics, Inc. (CAPR) Lawsuit Investigation About? On July 11, 2025, Capricor Therapeutics announced that the FDA rejected the company's Biologics License Application (BLA) for its cell therapy candidate, Deramiocel, citing that the application 'does not meet the statutory requirement for substantial evidence of effectiveness' and lacks 'certain outstanding items.' The FDA's Complete Response Letter specified that the deficiencies were in the BLA's Chemistry, Manufacturing, and Controls section, and emphasized a need for additional clinical data. Following this news, shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on July 11, 2025, causing harm to investors. Previously, on May 5, 2025, Capricor announced that the FDA 'confirmed its intent to hold an advisory committee meeting' following the completion of a mid-cycle review meeting for the company's BLA for Deramiocel. Following the announcement, Capricor's stock fell over 29% on May 6, 2025. Then, on June 20, 2025, STAT reported that the director of the FDA's Center for Biologics Evaluation and Research canceled the advisory committee meeting regarding Deramiocel, due to being 'skeptical of the treatment.' In the wake of the report, Capricor's stock fell over 30% on June 20, 2025. About Gibbs Mura Gibbs Mura represents investors nationwide in securities litigation. The firm has recovered over a billion dollars for its clients against some of the world's largest corporations, and our attorneys have received numerous honors for their work, including 'Best Lawyers in America,' 'Top Plaintiff Lawyers in California,' 'California Lawyer Attorney of the Year,' 'Class Action Practice Group of the Year,' 'Consumer Protection MVP,' and 'Top Women Lawyers in California.' This press release may constitute Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Associated Press
14-02-2025
- Business
- Associated Press
Kaplan Fox Alerts Investors to a Deadline for a Securities Fraud Class Action Lawsuit Against Applied Therapeutics (APLT)
NEWMEDIAWIRE) - Kaplan Fox & Kilsheimer LLP announces that a class action lawsuit has been filed against Applied Therapeutics, Inc. ('Applied Therapeutics' or the 'Company') (NASDAQ: APLT) on behalf of investors that purchased or otherwise acquired Applied Therapeutics securities between January 3, 2024 and December 2, 2024 (the 'Class Period'). If you are an investor in Applied Therapeutics and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing [email protected] or by calling (212) 329-8571. DEADLINE REMINDER: If you are a member of the proposed Class, you may move the court no later than February 18, 2025 to serve as a lead plaintiff for the purported class. If you have losses we encourage you to contact us to learn more about the lead plaintiff process. You need not seek to become a lead plaintiff in order to share in any possible recovery. According to the complaint, on November 27, 2024, the Company disclosed that the U.S. Food and Drug Administration ('FDA') issued a Complete Response Letter ('CRL') for its new drug application for govorestat, AT-007-1002, for treatment of classic galactosemia (the 'NDA'). The Company's press release states that the 'CRL indicate[d] that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application.' Following this news, on November 29, 2024, Applied Therapeutics stock fell $6.54 per share, over 76%, to close at $2.03 per share on heavy trading volume. Then, on December 2, 2024 after the markets closed, the Company disclosed in a Form 8-K filing that following issuance of the CRL, the Company received a 'warning letter' limited to the AT-007-1002 study and that the 'warning letter' identified issues relating to 'electronic data capture' and a 'dosing error in the dose-escalation phase of the study resulting in slightly lower levels than targeted in a limited number of patients, which was remedied prior to achieving maintenance dosing.' According to the complaint, Applied Therapeutics' stock price declined from a closing market price of $1.75 per share on December 2, 2024 to close at $1.29 per share on December 5, 2024. WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey. With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand. Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. Jeffrey P. Campisi 800 Third Avenue, 38th Floor New York, New York 10022 (212) 329-8571 Laurence D. King 1999 Harrison Street, Suite 1560 Oakland, California 94612 (415) 772-4704
Associated Press
12-02-2025
- Business
- Associated Press
Kaplan Fox & Kilsheimer LLP Alerts Investors to a Securities Class Action Against Applied Therapeutics, Inc. (APLT) - Deadline is February 18, 2025
NEWMEDIAWIRE) - Kaplan Fox & Kilsheimer LLP announces that a class action lawsuit has been filed against Applied Therapeutics, Inc. ('Applied Therapeutics' or the 'Company') (NASDAQ: APLT) on behalf of investors that purchased or otherwise acquired Applied Therapeutics securities between January 3, 2024 and December 2, 2024 (the 'Class Period'). If you are an investor in Applied Therapeutics and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing [email protected] or by calling (212) 329-8571. DEADLINE REMINDER: If you are a member of the proposed Class, you may move the court no later than February 18, 2025 to serve as a lead plaintiff for the purported class. If you have losses we encourage you to contact us to learn more about the lead plaintiff process. You need not seek to become a lead plaintiff in order to share in any possible recovery. According to the complaint, on November 27, 2024, the Company disclosed that the U.S. Food and Drug Administration ('FDA') issued a Complete Response Letter ('CRL') for its new drug application for govorestat, AT-007-1002, for treatment of classic galactosemia (the 'NDA'). The Company's press release states that the 'CRL indicate[d] that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application.' Following this news, on November 29, 2024, Applied Therapeutics stock fell $6.54 per share, over 76%, to close at $2.03 per share on heavy trading volume. Then, on December 2, 2024 after the markets closed, the Company disclosed in a Form 8-K filing that following issuance of the CRL, the Company received a 'warning letter' limited to the AT-007-1002 study and that the 'warning letter' identified issues relating to 'electronic data capture' and a 'dosing error in the dose-escalation phase of the study resulting in slightly lower levels than targeted in a limited number of patients, which was remedied prior to achieving maintenance dosing.' According to the complaint, Applied Therapeutics' stock price declined from a closing market price of $1.75 per share on December 2, 2024 to close at $1.29 per share on December 5, 2024. WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey. With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand. Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. Jeffrey P. Campisi 800 Third Avenue, 38th Floor New York, New York 10022 (212) 329-8571 1999 Harrison Street, Suite 1560 Oakland, California 94612 (415) 772-4704
