Announcement • Jan 28
Tricida, Inc. Announces Resignation of David Bonita as Director O n January 23, 2023, Dr. David Bonita, a director of the board of directors of Tricida, Inc., notified the Company that he is resigning from the Company’s Board and all of the committees of the Board effective immediately. Dr. Bonita’s decision to resign is not due to or in connection with any disagreement or dispute with the Board or the Company, including as related to the Company’s operations, policies or practices. Announcement • Jan 25
Tricida, Inc.(OTCPK:TCDA.Q) dropped from NASDAQ Composite Index Tricida, Inc. has been removed from NASDAQ Composite Index . Announcement • Jan 19
Tricida Receives Delisting Notice from Nasdaq As previously reported, on January 11, 2023, Tricida, Inc. ("the Company") filed a voluntary petition for relief under Chapter 11 of Title 11 of the United States Code in the United States Bankruptcy Court for the District of Delaware (the Filing"), thereby commencing a Chapter 11 case for the Company (Case No. 23-10024)). On January 13, 2023, the Company received notice from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, after a review of publicly available information related to the Filing and in accordance with Nasdaq Listing Rules 5101, 5110(b) and IM-5101-1, the Staff has determined that the Company's securities will be delisted from Nasdaq. Nasdaq's determination is based on the Filing and associated public interest concerns raised by it; concerns regarding the residual equity interest of the existing listed securities holders; and concerns about the Company's ability to sustain compliance with all requirements for continued listing on Nasdaq (including concerns disclosed in the Company's Current Reports on Form 8-K filed on December 7, 2022 and December 12, 2022). The notice also indicates that the Company may appeal Nasdaq's determination pursuant to procedures set in Nasdaq Listing Rule 5800 Series. The Company will not appeal this determination. Trading of the Company's common stock will be suspended at the opening of business on January 24, 2023 and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company's securities from listing and registration on Nasdaq. As a result, the Securities are expected to begin trading on the over-the-counter market on January 24, 2023. Announcement • Dec 13
Tricida Receives Non-Compliance Notice from Nasdaq On December 8, 2022, Tricida received a notice from The Nasdaq Stock Market (“Nasdaq”) that the Company was not in compliance with Nasdaq’s Listing Rule 5450(b)(2)(C), as the market value of publicly held shares (the “MVPHS”) for the Company’s common stock had been below the minimum MVPHS requirement of $15,000,000 for 30 consecutive business days (the “MVPHS Requirement”). The notice has no immediate effect on the listing or trading of the Company’s common stock, which will continue to be listed and traded on the Nasdaq Global Select Market, subject to the Company’s compliance with the other Nasdaq listing requirements. The notice indicated that the Company would be provided 180 calendar days, or until June 6, 2023, in which to regain compliance with the MVPHS Requirement. To regain compliance with the MVPHS Requirement, the Company’s MVPHS must close at $15,000,000 or more for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the MVPHS Requirement by June 6, 2023, the Company may be eligible to transfer to The Nasdaq Capital Market. To qualify, the Company would be required to meet the continued listing requirements for The Nasdaq Capital Market. If the Company does not regain compliance or transfer to The Nasdaq Capital Market before June 6, 2023, the Company will receive a written notification from Nasdaq that its common stock is subject to delisting. If the Company were to receive such a notification, the Company could appeal Nasdaq’s determination to delist its common stock, but there can be no assurance Nasdaq would grant the Company’s request for continued listing. The Company is continuing to assess its options and intends to actively monitor the closing bid price and the market value of its common stock. There can be no assurance, however, that the Company will regain compliance with 5450(b)(2)(C) or will otherwise be in compliance with other Nasdaq listing criteria. Announcement • Dec 08
Tricida Receives A Notice from Nasdaq Regarding Minimum Bid Price On December 6, 2022, Tricida, Inc. (the “Company”) received a notice from The Nasdaq Stock Market (“Nasdaq”) that the Company was not in compliance with Nasdaq’s Listing Rule 5450(a)(1), as the minimum bid price of the Company’s common stock had been below $1.00 per share for 30 consecutive business days (the “Minimum Bid Price Requirement”). Also on December 6, 2022, the Company received a separate notice from Nasdaq that the Company was not in compliance with Nasdaq’s Listing Rule 5450(b)(2)(A), as the market value of listed securities (the “MVLS”) for the Company’s common stock had been below the minimum MVLS requirement of $50,000,000 for 30 consecutive business days (the “MVLS Requirement”), and that the Company also does not comply with either of the two alternative standards of Listing Rule 5450(b), the equity standard and the total assets and total revenue standard. The notices have no immediate effect on the listing or trading of the Company’s common stock, which will continue to be listed and traded on the Nasdaq Global Select Market, subject to the Company’s compliance with the other Nasdaq listing requirements. Each notice of noncompliance indicated that the Company would be provided 180 calendar days, or until June 5, 2023, in which to regain compliance with the respective listing requirement. To regain compliance with the Minimum Bid Price Requirement, the minimum bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the Minimum Bid Price Requirement by June 5, 2023, the Company may be eligible for an additional 180-calendar day compliance period if it elects to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period. To regain compliance with the MVLS Requirement, the Company’s MVLS must close at $50,000,000 or more for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the MVLS Requirement by June 5, 2023, the Company may be eligible to transfer to The Nasdaq Capital Market. To qualify, the Company would be required to meet the continued listing requirements for The Nasdaq Capital Market. If the Company does not regain compliance or transfer to The Nasdaq Capital Market before June 5, 2023, the Company will receive a written notification from Nasdaq that its common stock is subject to delisting. If the Company were to receive such a notification, the Company could appeal Nasdaq’s determination to delist its common stock, but there can be no assurance Nasdaq would grant the Company’s request for continued listing. The Company is continuing to assess its options and intends to actively monitor the closing bid price and the market value of its common stock. There can be no assurance, however, that the Company will regain compliance with Nasdaq’s Listing criteria. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 5 highly experienced directors. Independent Non-Employee Director Kate Falberg was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Oct 25
Tricida, Inc Reports Topline Results from the VALOR-CKD Phase 3 Trial of Veverimer Tricida, Inc. announced the top-line results from its VALOR-CKD renal outcomes clinical trial, designed to evaluate veverimer's ability to slow CKD progression in patients with metabolic acidosis and chronic kidney disease (CKD). Primary Endpoint Analysis The VALOR-CKD trial did not meet its primary endpoint, which was defined as the time to the first occurrence of any event in the composite endpoint of renal death, end-stage renal disease (ESRD), or a confirmed greater than or equal to 40% reduction in estimated glomerular filtration rate (eGFR), also known as DD40. One hundred forty-nine veverimer- treated patients versus 148 placebo-treated patients experienced a DD40 primary endpoint event, representing a veverimer to placebo hazard ratio of 0.99 [95% CI, 0.78, 1.24; (p=0.898)] over the 26.7 months median duration of treatment. The VALOR-CKD Trial Design The VALOR-CKD trial was an international, randomized, multicenter, double-blind, placebo-controlled trial of patients with CKD and metabolic acidosis. To qualify for enrollment in the study, patients were required to have two eGFR values, taken at least 2 weeks apart, in the range of 20 to 40 mL/min/1.73m(2), that were not more than 20% different from each other and three serum bicarbonate values, each taken at least 2 weeks apart from the others and all three within a 6- week period (the Screening Period), in the range of 12 to 20 mEq/L. The entry criteria for the study also required that patients be on a stable, maximum-tolerated, labeled dose of an angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) for at least 4 weeks prior to and during the Screening Period. Both patients taking oral alkali supplements and those not taking them were eligible for enrollment; however, a patient's use and dose of oral alkali was not to be changed during the study and those taking oral alkali were required to be on a stable dose for at least 2 weeks prior to and during the Screening Period. There were no prohibited drugs. Eligible patients were enrolled into a single-blind active-treatment period of 4 to 8 weeks (Part A) that was followed by a randomized withdrawal into a double-blind, randomized treatment period (Part B). Patients in Part A who experienced a greater than or equal to 4 mEq/L increase from baseline in serum bicarbonate and those whose serum bicarbonate increased into the normal range of greater than or equal to 22 mEq/L at Week 4 were randomized in a 1:1 ratio either to continue treatment with veverimer or to treatment with placebo for the double-blind, Part B, portion of the trial. Patients who did not achieve the required serum bicarbonate response to veverimer after 4 weeks in Part A continued to receive veverimer for an additional 4 weeks. After 8 weeks of veverimer treatment in Part A, those patients who experienced a greater than or equal to 4 mEq/L increase in serum bicarbonate and those whose serum bicarbonate increased into the normal range of greater than or equal to 22 mEq/L were randomized in a 1:1 ratio to either continued treatment with veverimer or to treatment with placebo in Part B. Those patients who did not achieve the desired serum bicarbonate response after 8 weeks in Part A discontinued treatment with veverimer and exited the study. In total, 2,198 patients received single-blind treatment with veverimer in Part A. Of these, 1,480 patients were randomized into Part B. The randomized patient population had a mean baseline eGFR of 29.2 mL/min/1.73m(2) and a mean baseline serum bicarbonate of 17.5 mEq/L. The majority of patients randomized in the trial had one or more co-morbid conditions, such as hypertension, heart failure or diabetes. Approximately 12% of patients in the trial were taking oral alkali at baseline. The table below provides selected demographics and baseline characteristics of veverimer- and placebo-treated patients. Announcement • Oct 21
Tricida, Inc. announced that it expects to receive $125 million in funding Tricida, Inc. announced that it has entered into a loan and security agreement with Hercules Capital, Inc. for a private placement of term loan for proceeds of up to $125,000,000 on October 19, 2022. The company will raise funding in tranches. The first tranche in an aggregate principal amount of $25,000,000 will be available for drawdown until December 31, 2022, the second tranche in the amount of $25,000,000 will be available for drawdown until the earlier of (x) 10 business days following the company’s achievement of the NDA Milestone and (y) September 15, 2023, subject to the company achieving the NDA Milestone, the third tranche in the amount of $50,000,000 will be available for drawdown until the earlier of (x) 10 business days following the company’s achievement of the Approval Milestone and (y) February 15, 2024, subject to the company achieving the Approval Milestone, and the fourth tranche in the amount of $25,000,000 may be available for drawdown through December 15, 2024, subject to the approval of agent’s investment committee. The loans bear interest at a floating per annum interest rate equal to the greater of either (i) 8.75% or (ii) the lesser of (x) 8.75% plus the prime rate as reported in The Wall Street Journal minus 6.25% and (y) 10.25%. At the company’s option, the company may elect to prepay all or a portion of the outstanding loans by paying the entire principal balance and all accrued and unpaid interest thereon plus a prepayment charge equal to the following percentage of the principal amount being prepaid: (i) 2.0% if prepaid during the first 12 months following the effective date of the loan agreement, (ii) 1.5% if prepaid after 12 months but prior to 24 months following the effective date of the loan agreement, (iii) 1% if prepaid after 24 months but prior to 36 months following the effective date of the loan agreement and (iv) zero if prepaid any time after 36 months following the effective date of the loan agreement but prior to the maturity date. The maturity date under the Loan Agreement is November 1, 2025. The maturity date may be extended up to an additional two years. Announcement • Aug 02
Tricida, Inc. to Report Q2, 2022 Results on Aug 08, 2022 Tricida, Inc. announced that they will report Q2, 2022 results After-Market on Aug 08, 2022 Announcement • May 20
Tricida, Inc Announces Administrative Stop of the VALOR-CKD Trial Tricida, Inc. announced that as anticipated it is stopping its VALOR-CKD renal outcomes trial early for administrative reasons pursuant to the existing study protocol to allow for six months of financial runway following the reporting of top-line results, currently anticipated to occur early in the fourth quarter of 2022. As of May 18, 2022, the average treatment duration of the 1480 subjects randomized in the trial was approximately 25 months, and the trial had accrued 237 subjects with positively adjudicated primary endpoint events, defined as renal death, end-stage renal disease (ESRD), or greater than or equal to 40% reduction in estimated glomerular filtration rate (eGFR). The trial will continue to accrue primary endpoint events as clinical trial subjects complete their participation in the study which, for the last subject, is currently projected to occur in the third quarter of 2022. Announcement • May 04
Tricida, Inc. to Report Q1, 2022 Results on May 10, 2022 Tricida, Inc. announced that they will report Q1, 2022 results After-Market on May 10, 2022 Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 5 highly experienced directors. Independent Non-Employee Director Kate Falberg was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Apr 26
Tricida, Inc., Annual General Meeting, Jun 15, 2022 Tricida, Inc., Annual General Meeting, Jun 15, 2022, at 07:30 Pacific Daylight. Agenda: To consider the election of the two Class I directors named in the proxy statement; to consider a non-binding advisory vote to approve the Company's executive compensation; to consider the ratification of the appointment of Ernst & Young LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2022; and to consider the transaction of such other business as may properly come before the meeting, or any adjournment or postponement thereof. Announcement • Mar 04
Tricida, Inc. Provides Update on Timing of Top-Line Data for the VALOR-CKD Trial Based on Conflict in Ukraine Tricida, Inc. announced an update on the anticipated date for top-line data from the VALOR-CKD trial based on the ongoing events in Ukraine. Approximately 15% of the patients randomized in VALOR-CKD are from Ukraine. Given the uncertainty around future participation of Ukrainian subjects in the trial and the potential challenges to collecting and monitoring data from Ukrainian sites, top-line data from the VALOR-CKD trial is now anticipated early in the fourth quarter of 2022, versus Tricida’s previous guidance of the third quarter of 2022. The revised guidance is based on Tricida’s evaluation of the current situation in Ukraine which is dynamic. Its estimates may change as events in Ukraine evolve. Tricida believes it will need this incremental time to deal with anticipated disruptions and/or delays in data collection. Tricida does not expect the utility of the data already collected from Ukrainian subjects to be affected. Based upon the latest review of its forecast, Tricida believes that its financial resources will extend for approximately six months following the anticipated announcement of top-line results from the VALOR-CKD trial. As of March 1, 2022, the VALOR-CKD trial had accrued 197 subjects with positively adjudicated primary endpoint events, defined as renal death, end-stage renal disease (ESRD), or greater than or equal to a 40% decline in estimated glomerular filtration rate (eGFR), with an average treatment duration of approximately 23 months. Announcement • Feb 26
Tricida, Inc. Provides Update on FDA Interactions Tricida, Inc. provided an update on its U.S. Food and Drug Administration (FDA) interactions. Tricida has received an Appeal Denied Letter (ADL), from the Office of New Drugs (OND) of the FDA in response to its Formal Dispute Resolution Request (FDRR) submitted in December 2020. While the FDRR was focused on whether the magnitude and durability of serum bicarbonate change seen in the TRCA-301/TRCA-301E trial is reasonably likely to predict clinical benefit in the treatment of metabolic acidosis in patients with CKD, the OND’s decision additionally addressed other deficiencies identified in the Complete Response Letter (CRL), which Tricida received in August 2020. The additional issues addressed included the reliability of the data from the TRCA-301/TRCA-301E trial due to the disproportionate impact of data from a single high-enrolling clinical site on the trial’s results and the applicability of the trial results to the U.S. patient population given that the majority of the subjects in the study were enrolled in sites outside of the United States or were in regions that the FDA does not consider “U.S.-like,” such as Eastern Europe. In the ADL, the OND acknowledged that the TRCA-301/TRCA-301E trial met its serum bicarbonate endpoints with statistical significance but concluded that the extent of serum bicarbonate increase observed in the TRCA-301/TRCA-301E trial is not reasonably likely to provide a discernible reduction in CKD progression. The OND also concluded that the confirmatory trial, VALOR-CKD, is underpowered to detect the effect size (13%) predicted by the original Tangri model (also known as the Predictive MA Model) based upon the placebo-subtracted mean treatment effect observed in the TRCA-301/TRCA-301E trial. The OND also provided feedback on other concerns that are particularly relevant in an NDA supported by a single registrational trial. The OND noted concerns around the trial results being strongly influenced by a single site, and the majority of sites for the TRCA-301/TRCA-301E trial being in Eastern Europe, where differences in patient management, including concomitant medications and diet, might affect the treatment response to veverimer and raise a concern of the applicability to a U.S. patient population. The FDA did not raise any concerns related to its completed inspection of the highest-enrolling clinical trial site and there was no FDA Form 483 issued. Also, while the OND did not suggest that there was a specific unblinding issue in the TRCA-301/TRCA-301E trial, the OND noted concerns around adequate blinding and that, while the measures in place to protect the study blind in the TRCA-301/TRCA-301E trial were reasonable, they may not have optimally protected the blind. Announcement • Feb 24
Tricida, Inc. Appoints Geoffrey Parker as Chief Operating Officer On February 16, 2021, Tricida, Inc. announced that Geoffrey Parker, Chief Financial Officer and Executive Vice President has been promoted to the newly created role of Chief Operating Officer, Chief Financial Officer and Executive Vice President. Mr. Parker joined the Company in April 2017 as Chief Financial Officer and Senior Vice President and, in February 2020, he was promoted to Chief Financial Officer and Executive Vice President. Is New 90 Day High Low • Feb 20
New 90-day low: €5.35 The company is down 13% from its price of €6.15 on 20 November 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 10.0% over the same period. Announcement • Feb 03
Block & Leviton LLP Sues Tricida, Inc. for Violations of the Federal Securities Laws Block & Leviton LLP announces that a lawsuit for violation of the federal securities laws has been filed against Tricida, Inc. and certain of its executives. On July 15, 2020, Tricida, Inc. stunned the market when it announced that it had received a notification from the U.S. Food and Drug Administration that, as part of the FDA’s review of Tricida’s New Drug Application for its drug candidate, veverimer, “the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. Then on October 29, 2020, Tricida announced an update on its End-of-Review Type A meeting with the FDA concerning the veverimer New Drug Application, stating that Tricida “now believes the FDA will also require evidence of veverimer’s effect on CKD progression from a near-term interim analysis of the” trial for approval under the FDA’s 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, Tricida’s stock price fell another $3.90 per share, or over 47%, to close at just $4.37. A lawsuit has been filed against Tricida and certain of its executives in the U.S. District Court for the Northern District of California. The lawsuit is captioned Pardi v. Tricida, Inc., et al., No. 3:21-cv-00076 (N.D. Cal.). The suit alleges that Tricida misled investors as to the viability of its veverimer NDA and that the NDA was materially deficient when presented. Announcement • Jan 29
Robbins Geller Rudman & Dowd LLP Files Class Action Lawsuit Against Tricida, Inc Robbins Geller Rudman & Dowd LLP announced that a class action lawsuit has been filed in the Northern District of California on behalf of purchasers of Tricida, Inc. securities between September 4, 2019 and October 28, 2020, inclusive. The case is captioned Pardi v. Tricida, Inc.,No. 21-cv-00076, and is assigned to Judge Lucy H. Koh. The Tricidaclass action lawsuit charges Tricida and certain of its executives with violations of the Securities Exchange Act of 1934. The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Tricida securities during the Class Period to seek appointment as lead plaintiff in the Tricidaclass action lawsuit. A lead plaintiff is generally the movant with the financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Tricidaclass action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Tricida class action lawsuit. An investor’s ability to share in any potential future recovery of the Tricida class action lawsuit is not dependent upon serving as lead plaintiff. Lead plaintiff motions for the Tricida class action lawsuit must be filed with the court no later than March 8, 2021. Announcement • Jan 14
Law Offices of Howard G. Smith Announces the Filing of Securities Class Action on Behalf of Tricida, Inc. Investors Law Offices of Howard G. Smith announced that a class action lawsuit has been filed on behalf of investors who purchased Tricida, Inc. securities between September 4, 2019 and October 28, 2020, inclusive. Tricida investors have until March 8, 2021 to file a lead plaintiff motion. 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. Announcement • Jan 08
The Schall Law Firm Announces the Filing of A Class Action Lawsuit Against Tricida, Inc The Schall Law Firm announced the filing of a class action lawsuit against Tricida, Inc. for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Investors who purchased the Company's securities between September 4, 2019 and October 28, 2020, inclusive (the Class Period), are encouraged to contact the firm before March 8, 2021. According to the Complaint, the Company made false and misleading statements to the market. Tricida’s NDA submission for veverimer was materially deficient as submitted to the FDA. The Company’s failure to produce a sufficient NDA for veverimer was likely to result in the FDA not accepting the application. Based on these facts, the Company’s public statements were false and materially misleading throughout the class period. When the market learned the truth about Tricida, investors suffered damages. Recent Insider Transactions • Dec 13
CFO & Executive VP recently bought €84k worth of stock On the 10th of December, Geoffrey Parker bought around 15k shares on-market at roughly €5.60 per share. This was the largest purchase by an insider in the last 3 months. Geoffrey has been a buyer over the last 12 months, purchasing a net total of €1.2m worth in shares. Announcement • Dec 10
Tricida, Inc. Announces Updates on Veverimer Development Program, Regulatory Status and New Patent Extending Protection Through 2038 Tricida, Inc. announced key updates on veverimer’s development program, regulatory status and patent protection. Veverimer Development Update: Tricida has revised the protocol for its VALOR-CKD outcome trial. The VALOR-CKD trial evaluates the effect of treating metabolic acidosis with veverimer on the clinical endpoint of slowing of CKD progression. The trial protocol previously had an adaptive design and included an unblinded interim analysis for sample size re-estimation. The revised protocol has a group sequential design, no interim analysis for sample size adjustment, and unblinded interim analyses for early stopping for efficacy after 150 primary endpoint events (anticipated in the second half of 2021) and 250 primary endpoint events (anticipated in mid-2022) have accrued. A primary endpoint event is defined as renal death, end-stage renal disease (ESRD) or = 40% reduction in estimated glomerular filtration rate (eGFR) (DD40). The interim analyses will be conducted by an independent unblinded Interim Analysis Committee, and the trial will remain blinded unless it is stopped early for efficacy. If this trial is successful, Tricida intends for it to serve as the confirmatory trial for accelerated approval or form the basis for traditional approval of veverimer. As of December 7, 2020, the VALOR-CKD trial has randomized 1,277 of 1,600 subjects with an average treatment duration of approximately one year and has accrued 50 of the 511 required subjects with positively adjudicated primary endpoint events. In response to feedback from the U.S. Food and Drug Administration (FDA) at the End-of-Review Type A Meeting, recruitment has been closed in all regions except for the United States, Canada and Western Europe. Recruitment completion is projected to occur by the end of 2022. Veverimer Regulatory Status Update: A Formal Dispute Resolution Request (FDRR) has been submitted to the FDA to seek clarity on the path forward for resubmitting New Drug Application (NDA) through the Accelerated Approval Program. The FDRR requests that the Office of New Drugs (OND) find that the magnitude of serum bicarbonate change seen in the TRCA-301 and TRCA-301E trials is reasonably likely to predict clinical benefit in the treatment of metabolic acidosis associated with CKD and that it can therefore serve as the basis for accelerated approval. If accepted for consideration, a decision on the FDRR is expected in the first quarter of 2021. The timing and next steps for a resubmission of the NDA for veverimer will be dependent upon the OND’s decision. Veverimer Patent Protection Update: Tricida has recently received notice of allowance for a new Orange Book eligible patent which, upon issuance, will extend veverimer’s patent coverage in the United States to 2038. Tricida also holds six previously issued Orange Book eligible patents that provide patent protection until 2034 and several pending patent applications. Tricida also holds multiple patents in Europe and other key international markets that provide patent protection for veverimer to at least 2034. Announcement • Dec 06
Tricida, Inc. Announces Executive Changes Tricida, Inc. announced restructuring plan, on December 4, 2020 the Company announced that Marc Cobo will depart from his position as Senior Vice President, Finance and Chief Accounting Officer as of the close of business on December 4, 2020. Due to the restructuring, Mr. Cobo will be eligible to receive benefits upon his departure under, and consistent with, previously disclosed Executive Severance Plan. In addition, Mr. Cobo has entered into a Consulting Agreement pursuant to which Mr. Cobo agreed to provide finance and accounting services during a transition period. Under the Agreement, Mr. Cobo will be retained as a consultant for up to nine months following his departure. In consideration for the Agreement, Mr. Cobo will be compensated during the consulting period at the gross rate of $300 per hour for up to 40 hours per week. It is intended that all stock options to purchase common stock of the Company or other equity awards that have been granted to Mr. Cobo by the Company prior to his resignation date shall continue to vest during the consulting period. The Company also announced that Annie Yoshiyama has been promoted to Vice President, Finance and Chief Accounting Officer effective as of December 4, 2020. Announcement • Oct 30
Tricida, Inc. Announces Susannah Cantrell Will Depart from the Position as Executive Vice President and Chief Commercial Officer, Effective from October 30, 2020 On October 29, 2020, Tricida, Inc. announced that Susannah Cantrell. will depart from her position as Executive Vice President and Chief Commercial Officer as of the close of business on October 30, 2020. Is New 90 Day High Low • Oct 29
New 90-day low: €6.90 The company is down 38% from its price of €11.10 on 30 July 2020. The German market is down 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €238 per share. Is New 90 Day High Low • Sep 25
New 90-day low: €7.90 The company is down 67% from its price of €24.00 on 26 June 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €261 per share. Announcement • Sep 21
Tricida, Inc.(NasdaqGS:TCDA) dropped from S&P Pharmaceuticals Select Industry Index Tricida, Inc.(NasdaqGS:TCDA) dropped from S&P Pharmaceuticals Select Industry Index