Latest news with #CompleteResponseLetter
Business Wire
5 days ago
- Business
- Business Wire
Kirby McInerney LLP Reminds Capricor Therapeutics, Inc. (CAPR) Investors of Class Action Filing and Encourages Investors to Contact the Firm
NEW YORK--(BUSINESS WIRE)--The law firm of Kirby McInerney LLP reminds investors who purchased Capricor Therapeutics, Inc. ('Capricor' or the 'Company') (NASDAQ:CAPR) securities to contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@ or fill out the contact form below, to discuss your rights or interests with respect to the securities fraud class action lawsuit against the Company. [ LEARN MORE ABOUT THE CLASS ACTION ] On May 5, 2025, Capricor issued a press release announcing it had completed its mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for its lead cell therapy candidate drug deramiocel. The Company announced that the review committee found no significant deficiencies and that the package was on track for a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025. The FDA confirmed its intent to hold an advisory committee meeting. On this news, the price of Capricor shares declined by approximately 29.13%, from $10.30 per share on May 5, 2025 to $7.30 per share on May 6, 2025. On July 11, 2025, Capricor announced that it received a Complete Response Letter (CRL) from the FDA denying the Company's Biologics License Application (BLA) for deramiocel. The CRL cited Capricor's failure to meet the requirement for evidence of effectiveness and the need for additional clinical data. Further, the CRL referenced outstanding items in the Chemistry, Manufacturing, and Controls section of the application. On this news, the price of Capricor stock declined from $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025. According to the lawsuit, Capricor's statements regarding its ability to obtain a BLA for deramiocel from the FDA were misleading. The Company provided overwhelmingly positive statements to investors while, at the same time, disseminating false and misleading statements and/or concealing material adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel. If you purchased or otherwise acquired Capricor securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@ or fill out the contact form below, to discuss your rights or interests with respect to these matters without any cost to you. [ CONTACT FORM ] Kirby McInerney LLP is a New York-based plaintiffs' law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm's efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP's website. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Business Insider
23-07-2025
- Business
- Business Insider
Why Is Replimune Stock (REPL) Down 75% Today?
Replimune (REPL) stock plummeted on Tuesday after the biotechnology company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The FDA didn't approve the Biologics License Application (BLA) for RP1 in combination with nivolumab as a treatment for advanced melanoma. Advanced melanoma occurs when the cancer spreads beyond the skin, such as to the lymph nodes, distant organs, or bones. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Replimune CEO Sushil Patel said, 'We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data.' Replimune intends to request a Type A meeting with the FDA to seek a timely and accelerated approval of RP1. It expects this meeting to be granted within the next 30 days. Replimune Stock Movement Today Replimune stock was down 76.88% in pre-market trading on Tuesday, following a 1.94% rally yesterday. The company's shares have rallied 1.78% year-to-date and 22.76% over the past 12 months. Today's drop came with heavy trading, as some 10 million shares changed hands, compared to a three-month daily average trading volume of 1.63 million shares. Is Replimune Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Replimune is Strong Buy, based on nine Buy ratings over the past three months. With that comes an average REPL stock price target of $22.43, representing a potential 81.99% upside for the shares.
Business Insider
12-07-2025
- Business
- Business Insider
Capricor Therapeutics Stock (CAPR) Plummets 40% on FDA Rejection
Capricor Therapeutics (CAPR) stock dove on Friday after the biotechnology company revealed a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). This letter covered its Biologics License Application (BLA) for Deramiocel, a cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). That's a severe genetic disorder that causes progressive muscle weakness and degeneration. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. The big news here is that the FDA completed its review of the BLA for Deramiocel and has rejected the therapy in its current form. The FDA said it 'does not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data.' The FDA is willing to restart its review with additional data and has granted Capricor Therapeutics a Type A meeting to discuss further action. Capricor Therapeutics CEO Linda Marbán noted that the CRL from the FDA was a surprise. She claimed that the company followed the FDA's guidance throughout the submission process and that no issues were revealed ahead of the CRL. She said the company will 'submit data from the Phase 3 HOPE-3 clinical trial to provide additional evidence of effectiveness from an adequate and well-controlled study.' Capricor Therapeutics Stock Movement Today CAPR stock was down 38.51% in pre-market trading on Friday, following a slight 0.18% dip yesterday. The shares were also down 17.39% year to date, but remained up 159.09% over the past 12 months. Today's news triggered a stock selloff, with some 4 million shares traded this morning, compared to a three-month daily average of about 2.59 million units. Is Capricor Therapeutics Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Capricor Therapeutics is Strong Buy, based on nine Buy and one Hold rating over the past three months. With that comes an average CAPR stock price target of $30.60, representing a potential 167.42% upside for the shares.
Business Wire
05-05-2025
- Business
- Business Wire
Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Dry Eye Disease Chamber Trial of Reproxalap and Plans NDA Resubmission
LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. For the prespecified primary endpoint of ocular discomfort, a symptom of dry eye disease, reproxalap (n=58) was statistically significantly superior to vehicle (n=58) on ocular discomfort symptom score (0‑100) from 80 to 100 minutes after chamber entry (LS mean difference [95% confidence interval] ‑6.5 [‑10.5, ‑2.5], P=0.002). Aldeyra believes that the dry eye chamber trial results, which included no notable differences in baseline scores across treatment arms, potentially address the U.S. Food and Drug Administration (FDA) feedback in a Complete Response Letter received in April 2025 in response to the prior New Drug Application (NDA). The Complete Response Letter identified concerns with a previously completed dry eye chamber trial that may have affected the interpretation of the results, including a baseline difference across treatment arms. Pending a Type A meeting with the FDA, NDA resubmission is anticipated mid‑2025, and the review period is expected to be six months. A recently completed dry eye disease field trial, which was numerically supportive of reproxalap and consistent with prior field trials, did not reach statistical significance, and is expected to be submitted to the planned NDA resubmission as supportive. 'The dry eye chamber results announced today are representative of a number of clinical trials that highlight the potential rapid clinical effect of reproxalap on reducing ocular discomfort,' stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. 'With no notable baseline differences across treatment arms and highly statistically significant results in favor of reproxalap over vehicle, Aldeyra believes the data potentially address the FDA feedback in the Complete Response Letter received last month and we look forward to meeting with the FDA shortly.' To Aldeyra's knowledge, in patients with dry eye disease, reproxalap is the first investigational drug with pivotal data supportive of acute and chronic activity in reducing symptoms, and the first investigational drug for chronic administration with pivotal data supportive of acute activity in reducing exacerbation of ocular redness. There were no safety signals or treatment-related discontinuations observed in either of the recently completed clinical trials, and reproxalap was observed to be well tolerated. Consistent with prior clinical trials, the most commonly reported adverse event was mild and transient instillation site discomfort. Reproxalap has now been studied in over 2,900 patients. Conference Call & Webcast Information Aldeyra will host a conference call at 8:00 a.m. ET tomorrow, May 6, 2025, to discuss the clinical trial results and the plan for resubmission of the NDA for reproxalap in dry eye disease. The dial-in numbers are (833) 470-1428 for domestic callers and (404) 975-4839 for international callers. The access code is 127477. A live webcast of the conference call will be available on the Investor Relations page of the company's website at After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days. About Reproxalap Reproxalap is an investigational new drug candidate in development for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology. Reproxalap is a first-in-class small-molecule modulator of RASP, which are elevated in ocular and systemic inflammatory diseases. The mechanism of action of reproxalap has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap has been studied in more than 2,900 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials. About Aldeyra Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated and metabolic diseases. Our approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our product candidates include RASP (reactive aldehyde species) modulators ADX-629, ADX‑248, ADX-743, ADX-631, ADX-246, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated and metabolic diseases. Our late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of retinitis pigmentosa. Safe Harbor Statement This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Aldeyra's future expectations, plans, and prospects, including without limitation statements regarding: the goals, opportunity, and potential for reproxalap; the outcome and expected timing of discussions with the FDA; the potential and the timing of a potential NDA resubmission; the outcome and timing of the FDA's acceptance, review, or approval of the potential NDA resubmission for reproxalap and the adequacy of the data included in the initial NDA and resubmitted NDA, and expected to be included in the potential resubmitted NDA; the likelihood and timing of the exercise of the Option; and Aldeyra's expectations regarding the labeling for reproxalap, if approved. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' "could," 'can,' 'would,' 'expect,' 'believe,' 'anticipate,' 'project,' 'on track,' 'scheduled,' 'target,' 'design,' 'estimate,' 'predict,' 'contemplates,' 'likely,' 'potential,' 'continue,' 'ongoing,' 'aim,' 'plan,' or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, funding, and other factors that could delay the initiation, enrollment, or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; delay in or failure to obtain regulatory approval of Aldeyra's product candidates, including as a result of the FDA not accepting Aldeyra's regulatory filings, issuing a complete response letter, or requiring additional clinical trials or data prior to review or approval of such filings or in connection with resubmissions of such filings; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity, or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials focused on the same or different indications; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) and obtain reimbursement for Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and future revenue, the timing of future revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's commercialization, marketing and manufacturing capabilities and strategy; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state, and foreign regulatory requirements; political, economic, legal, social, and health risks, public health measures, and war or other military actions, that may affect Aldeyra's business or the global economy; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2024, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at Additional factors may be described in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, expected to be filed with the SEC in the second quarter of 2025, and Aldeyra's other filings with the SEC. In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
Associated Press
21-04-2025
- Business
- Associated Press
Aldeyra Therapeutics, Inc. (ALDX) Faces Scrutiny After Stock Drops 70% On FDA's Reproxalap Complete Response Letter
SAN FRANCISCO, April 21, 2025 (GLOBE NEWSWIRE) -- On April 3, 2025 investors in Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) saw the price of their shares crash over 70% after the company announced that it received a Complete Response Letter ('CRL') from the FDA for the resubmission of the New Drug Application ('NDA') of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. This stark regulatory rejection, which contradicted Aldeyra's repeated assurances of imminent approval, erased over $200 million from the company's market capitalization, prompting investor rights law firm Hagens Berman to launch an investigation into potential securities law violations. Hagens Berman urges investors who purchased Aldeyra shares and suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge that may assist the firm's investigation to contact its attorneys. Visit: Contact the Firm Now: [email protected] 844-916-0895 Aldeyra Therapeutics, Inc. (ALDX) Investigation: The investigation is focused on the propriety of Aldeyra's statements about the prospects for FDA approval of the NDA of reproxalap. In the past, Aldeyra touted the success of its Phase 3 dry eye clinical chamber trial for the drug and said the 'results are uniquely supportive of the potential acute clinical effect of reproxalap on reducing ocular discomfort[.]' More recently, the company assured investors that 'reproxalap is going to get approved on April 2[.]' Instead, on April 3, 2025, Aldeyra announced that it received the FDA's CRL. Aldeyra revealed that: In response to this news, the market swiftly reacted by sending the price of Aldeyra shares down over 70%, wiping out over $200 million of shareholder value. Reed Kathrein, the Hagens Berman Partner leading the investigation, stated, 'We are investigating whether Aldeyra may have misrepresented the propriety of its reproxalap study and results to investors.' If you invested in Aldeyra and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now » If you'd like more information and answers to frequently asked questions about the Aldeyra investigation, read more» Whistleblowers: Persons with non-public information regarding Aldeyra should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected]. About Hagens Berman Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at Follow the firm for updates and news at @ClassActionLaw. Contact: Reed Kathrein, 844-916-0895
