BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith continues its investigation on behalf of Mesoblast Limited (“Mesoblast” or the “Company”) (NASDAQ: MESO) investors concerning the Company’s possible violations of federal securities laws.
On October 1, 2020, the Company disclosed that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that Mesoblast “conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.” The CRL also “identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product’s biologic activity.”
On this news, Mesoblast’s stock fell $6.53, or 35%, to close at $12.03 per share on October 2, 2020.
If you purchased Mesoblast securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to email@example.com, or visit our website at www.howardsmithlaw.com.
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