BENSALEM, Pa.–(BUSINESS WIRE)–Law Offices of Howard G. Smith announces an investigation on behalf of Tricida, Inc. (“Tricida” or the “Company”) (NASDAQ: TCDA) investors concerning the Company’s possible violations of federal securities laws.
Tricida’s drug candidate, veverimer, is a polymer designed as a potential treatment for metabolic acidosis in patients with chronic kidney disease (“CKD”). The Company has completed a Phase 3, double-blind, placebo-controlled trial of veverimer in patients with CKD and metabolic acidosis.
On September 4, 2019, Tricida announced that it had submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) under the Accelerated Approval Program for approval of veverimer for the treatment of metabolic acidosis in patients with CKD.
On July 15, 2020, Tricida announced that it had received a notice from the FDA “identif[ying] deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.” The Company stated that “[t]he notification does not specify the deficiencies identified by the FDA.”
On this news, the Company’s stock price fell $10.56, or 40.31%, to close at $15.64 per share on July 16, 2020, thereby injuring investors.
Then, on October 29, 2020, following its End-of-Review Type A meeting with the FDA, Tricida announced that it “now believes the FDA will also require evidence of veverimer’s effect on CKD progression from a near-term interim analysis of the VALOR-CKD trial for approval under the Accelerated Approval Program and that the FDA is unlikely to rely solely on serum bicarbonate data for determination of efficacy.” Tricida also disclosed that it was “significantly reducing its headcount from 152 to 59 people and will discuss its commitments with vendors and contract service providers to potentially provide additional financial flexibility.”
On this news, the Company’s stock price fell $3.90, or 47.16%, to close at $4.37 per share on October 29, 2020, thereby injuring investors.
If you purchased Tricida 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 firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.