TCDA - TCDA STOCK NEWS

Tricida, Inc. (TCDA) has announced the issuance of a new U.S. patent for veverimer, extending its patent protection until 2038. This patent enhances their portfolio to a total of 210 patents in 49 countries. The CEO, Gerrit Klaerner, emphasized the importance of this patent in maximizing the potential of veverimer. The drug aims to treat metabolic acidosis in chronic kidney disease (CKD) patients, a condition affecting around three million in the U.S. Currently, there are no FDA-approved treatments for this condition.

Tricida, Inc. (TCDA) reported its financial results for the fourth quarter and year ended December 31, 2020. The company experienced a net loss of $54.8 million for Q4 and $264.8 million for the year. R&D expenses decreased to $27.3 million in Q4 but increased to $148.4 million for the year. Tricida continues to execute the VALOR-CKD trial, with 1,433 subjects randomized. Despite recent setbacks, including an Appeal Denied Letter from the FDA, Tricida plans to focus on acquiring additional data from the trial before the end of 2022.

Tricida, Inc. (Nasdaq: TCDA) has received an Appeal Denied Letter from the FDA regarding its Formal Dispute Resolution Request about clinical trial data for its drug candidate, veverimer. While the trial met serum bicarbonate endpoints, the FDA concluded that the results do not convincingly predict clinical benefits in slowing chronic kidney disease (CKD) progression. Additional concerns included data reliability due to a single high-enrolling site and patient demographic applicability. Tricida plans to continue the VALOR-CKD trial without changes, eyeing both accelerated and traditional approval pathways.

Tricida, Inc. (TCDA) will report its fourth quarter and year-end 2020 financial results on February 25, 2021, after market close. A conference call will be held at 4:30 PM ET to discuss the results and business progress. The drug candidate veverimer, aimed at treating metabolic acidosis in chronic kidney disease (CKD) patients, highlights the company’s focus on addressing a significant health issue affecting around three million people in the U.S.

Tricida, Inc. (Nasdaq: TCDA) will present at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 11:50 am PT / 2:50 pm ET. CEO Gerrit Klaerner will discuss the company's overview and key initiatives. Investors can access a live webcast on the Tricida website, with an archived version available for 90 days post-presentation. Tricida focuses on developing veverimer (TRC101), an investigational drug for treating metabolic acidosis in chronic kidney disease (CKD) patients, which affects approximately three million individuals in the U.S.

Tricida, Inc. (Nasdaq: TCDA) announced updates on its investigational drug veverimer for chronic kidney disease (CKD). The VALOR-CKD trial protocol was revised, now including early stopping for efficacy after key events. Currently, 1,277 out of 1,600 subjects are randomized, with recruitment expected to close by the end of 2022. A Formal Dispute Resolution Request has been submitted to the FDA regarding veverimer's NDA resubmission. Financially, Tricida holds approximately $376 million in resources and plans to extend veverimer's patent until 2038.

Tricida, Inc. (Nasdaq: TCDA) announced it will provide a business update on its investigational drug veverimer (TRC101), aimed at treating metabolic acidosis in chronic kidney disease (CKD) patients. The update will cover development, regulatory status, and patent protection. A conference call is scheduled for December 8, 2020, at 4:30 PM ET, which will be accessible via webcast and dial-in. Veverimer is designed to address metabolic acidosis, a common complication in CKD affecting approximately three million patients in the U.S.

Tricida, Inc. (Nasdaq: TCDA) reported financial results for Q3 and the nine months ended September 30, 2020, announcing a net loss of $77.7 million for Q3 2020 compared to $44.1 million in Q3 2019. The total loss for the nine months reached $209.9 million. The company reorganized, cutting its workforce from 152 to 59 employees to save approximately $25 million annually. Following FDA discussions, Tricida plans interim analyses for its VALOR-CKD trial, emphasizing the need for evidence on CKD progression for veverimer approval. Cash reserves stood at $375.6 million, supporting operations into mid-2022.

Tricida, Inc. (Nasdaq: TCDA) announced results from its End-of-Review Type A meeting with the FDA regarding its drug veverimer for treating metabolic acidosis in CKD patients. Following a Complete Response Letter on August 21, 2020, the FDA advised that evidence on CKD progression may be required alongside serum bicarbonate data for NDA resubmission. This change delays approval timelines. Tricida is reducing its headcount to cut annual costs by $25 million and has $375 million in cash. The company expects formal FDA meeting minutes within 30 days to determine next steps.