Latest news with #CapricorTherapeutics
Business Insider
4 days ago
- 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
4 days ago
- 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.
Bloomberg
5 days ago
- Business
- Bloomberg
Capricor Shares Sink After FDA Rejects Drug for Muscle Disease
Capricor Therapeutics Inc. shares plunged more than 60% after US regulators rejected the company's treatment for a deadly muscle disorder. The San Diego-based biotech has been developing a cell therapy for a heart condition associated with Duchenne muscular dystrophy, a genetic disorder mainly affecting boys characterized by muscle loss and weakness.
Reuters
5 days ago
- Health
- Reuters
US FDA declines to approve Capricor's muscle disorder therapy
July 11 (Reuters) - Capricor Therapeutics (CAPR.O), opens new tab said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy. The FDA said it needed more data to prove the therapy is effective. Shares of the San Diego-based company fell 33% premarket. Cardiomyopathy, a condition that affects heart muscles, is the leading cause of death in patients with DMD, a genetic disorder characterized by progressive muscle degeneration and weakness.
Business Insider
25-06-2025
- Business
- Business Insider
Capricor Therapeutics price target lowered to $29 from $40 at JonesResearch
JonesResearch lowered the firm's price target on Capricor Therapeutics (CAPR) to $29 from $40 and keeps a Buy rating on the shares. The company confirmed the FDA will not hold a panel meeting for deramiocel in Duchenne muscular dystrophy, the analyst tells investors in a research note. The firm says that while there are cases where canceled panel meetings led to FDA approval, it is inclined to believe the decision signals a complete response letter or FDA action date extension. Center for Biologics Evaluation and Research director Dr. Vinay Prasad has been a vocal advocate for increased regulatory stringency, even in DMD, contends JonesResearch. If the FDA issues a CRL, approval would be pushed to mid 2026, the firm adds. It reduced the probability of approval to 45% from 65%, driving the target cut. Confident Investing Starts Here:
