TCDA Tricida Inc.

9.07
0  0%
Previous Close 9.07
Open
52 Week Low 8.76
52 Week High 44.3
Market Cap $453,944,176
Shares 50,048,972
Float 16,811,428
Enterprise Value $265,396,176
Volume 1,051
Av. Daily Volume 927,172
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Drug Pipeline

Drug Stage Notes
TRC 101
Chronic kidney disease
CRL
CRL
CRL announced August 24, 2020.

Latest News

  1. Tricida, Inc. (NASDAQ:TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for veverimer on August 21, 2020. The NDA was reviewed under the Accelerated Approval Program.

    According to the CRL, the FDA is seeking additional data beyond the TRCA-301 and TRCA-301E trials regarding the magnitude and durability of the treatment effect of veverimer on the surrogate marker of serum bicarbonate and the applicability…

    Tricida, Inc. (NASDAQ:TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for veverimer on August 21, 2020. The NDA was reviewed under the Accelerated Approval Program.

    According to the CRL, the FDA is seeking additional data beyond the TRCA-301 and TRCA-301E trials regarding the magnitude and durability of the treatment effect of veverimer on the surrogate marker of serum bicarbonate and the applicability of the treatment effect to the U.S. population. FDA also expressed concern as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit. There were no safety, clinical pharmacology/biopharmaceutics, CMC or non-clinical issues identified in the CRL.

    The CRL provided multiple options for resolving the identified deficiencies. In order to obtain approval for veverimer the company may or may not have to conduct an additional clinical trial. The FDA indicated it is willing to meet with Tricida to discuss options for obtaining approval, including under the Accelerated Approval Program.

    "We have collaborated with the FDA on the Accelerated Approval Program for veverimer and while we are disappointed to receive this CRL, we are pleased that the FDA has provided helpful, specific comments and indicated their willingness to continue to work with us to pursue approval of veverimer," said Gerrit Klaerner, Ph.D., Tricida's Chief Executive Officer and President. "We remain confident in the fundamentals of, and unmet medical need for, veverimer and we continue to conduct our confirmatory trial, VALOR-CKD."

    Tricida plans to request a Type A meeting with the FDA in the coming weeks. A Type A meeting is usually scheduled within 30 days of the meeting request. Following the Type A meeting, anticipated early in the fourth quarter, Tricida plans to provide an update on next steps and estimated timing of a potential resubmission of the NDA.

    Tricida notes that cash, cash equivalents and investments were $437 million at the end of the second quarter of 2020. Based on the current operating plan, the company believes that it is well positioned financially to fund its operations into early 2022.

    About Tricida

    Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with CKD. Tricida is currently conducting its confirmatory postmarketing trial, VALOR-CKD, of veverimer. The Tricida NDA for veverimer was submitted to the FDA for review through the Accelerated Approval Program in August 2019. A CRL was received from the FDA in August 2020. There are no FDA-approved treatments for chronic metabolic acidosis, a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. It is estimated to pose a health risk to approximately three million patients with CKD in the United States.

    For more information about Tricida, please visit www.Tricida.com.

    Cautionary Note on Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 ("Exchange Act"). Forward-looking statements relate to expectations concerning matters that are not historical facts. Words such as "projects," "believes," "anticipates," "plans," "expects," "intends," "may," "will," "could," "should," "would," and similar words and expressions are intended to identify forward-looking statements. Any statements contained herein which do not describe historical facts, including the Company's expectations with regard to its interactions and communications with the FDA and its plans and expectations as to the pathway to approval of veverimer by the FDA are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, without limitation, whether the Company will be able to address the deficiencies identified by FDA, whether additional trials will be necessary, the availability of the Accelerated Approval Program, the receipt and timing of regulatory approval for veverimer, the Company's ability to market and sell veverimer, if approved, the Company's ability to manufacture veverimer, and risks associated with the Company's business prospects, financial results and business operations. These and other factors that may affect the Company's future business prospects, results and operations are identified and described in more detail in the Company's filings with the Securities and Exchange Commission (the "SEC"), including the Company's most recent Annual Report filed on Form 10-K and the subsequently filed Quarterly Report(s) on Form 10-Q. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this filing. Except as required by applicable law, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results, later events or circumstances or to reflect the occurrence of unanticipated events.

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  2. Webcast Today at 4:30 pm Eastern Time

    Tricida, Inc. (NASDAQ:TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today financial results for the three and six months ended June 30, 2020 and provided an update on key initiatives.

    Recent Events

    • On May 22, 2020, Tricida completed an offering of $200.0 million of its 3.50% Convertible Senior Notes due 2027. Net proceeds from the offering were $193.3 million, after deducting underwriting discounts and commissions and other offering costs.
    • In early July, Tricida deployed its field force…

    Webcast Today at 4:30 pm Eastern Time

    Tricida, Inc. (NASDAQ:TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today financial results for the three and six months ended June 30, 2020 and provided an update on key initiatives.

    Recent Events

    • On May 22, 2020, Tricida completed an offering of $200.0 million of its 3.50% Convertible Senior Notes due 2027. Net proceeds from the offering were $193.3 million, after deducting underwriting discounts and commissions and other offering costs.
    • In early July, Tricida deployed its field force of approximately 40 Specialty Account Managers in key geographic regions to communicate directly with 70% to 80% of the 5,000 highest-prescribing nephrologists in the United States. The Specialty Account Managers have initiated metabolic acidosis disease awareness education, and to date, have conducted nearly 6000 virtual or in-person engagements with nephrologists and their staff, hosted numerous nephrologists' roundtable meetings and arranged peer-to-peer educational events.
    • On July 14, 2020, Tricida received a notification from the U.S. Food and Drug Administration (FDA) stating that, as part of its ongoing review of the company's New Drug Application (NDA), the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The notification does not specify the deficiencies identified by the FDA. The FDA stated that the notification does not reflect a final decision on the information under review. The company plans to work with the FDA to identify and seek to resolve the deficiencies.

    Upcoming Events and Projected Milestones

    • The FDA assigned a Prescription Drug User Fee Act, or PDUFA, goal date of August 22, 2020 for the potential approval to market veverimer in the United States. Tricida anticipates that it will receive further clarification related to the FDA notification of July 14, 2020 on or before the PDUFA goal date of August 22, 2020. While the company has no additional information from the FDA since the July 14, 2020 notification, at this time, the company believes it is unlikely to receive approval to market veverimer in the United States on the PDUFA goal date.
    • Tricida plans to complete enrollment of patients in its VALOR-CKD confirmatory postmarketing trial in first half of 2021. The VALOR-CKD trial is an outcomes trial comparing veverimer versus placebo in time to renal disease progression in patients with metabolic acidosis and chronic kidney disease (CKD).

    "While we won't speculate what the FDA notification may entail, we are preparing for all eventualities to swiftly resolve any potential issues. However, we remain confident in the fundamentals of veverimer and its underlying value proposition," said Gerrit Klaerner, Ph.D., Tricida's Chief Executive Officer and President. "I am reassured by the feedback that we have received from our Specialty Account Managers from their initial interactions with community nephrologists that confirms the unmet need to treat metabolic acidosis."

    Financial Results for the Three and Six Months Ended June 30, 2020

    Research and development expense was $28.8 million and $29.0 million for the three months ended June 30, 2020 and 2019, respectively, and $78.1 million and $60.4 million for the six months ended June 30, 2020 and 2019, respectively. The decrease in research and development expense for the three months ended June 30, 2020 compared to the prior year was primarily due to decreased activities in connection with our veverimer clinical development program related to reduced expenditures in our clinical trials, partially offset by an increase in manufacturing process optimization and increased personnel costs. The increase in research and development expense for the six months ended June 30, 2020 compared to the prior year was primarily due to increased activities in connection with our veverimer clinical development program related to manufacturing process optimization and the manufacturing of drug substance, as well as increased personnel costs.

    General and administrative expense was $28.4 million and $8.9 million for the three months ended June 30, 2020 and 2019, respectively, and $51.9 million and $15.2 million for the six months ended June 30, 2020 and 2019, respectively. The increases in general and administrative expense in the three and six months ended June 30, 2020 compared to the three and six months ended June 30, 2019 were primarily due to increased administrative costs supporting the increased activities in connection with our veverimer clinical development program, including pre-commercialization, Medical Affairs, professional service costs, and increased personnel costs.

    Net loss was $58.2 million (non-GAAP net loss of $48.9 million) and $36.6 million (non-GAAP net loss of $31.5 million) for the three months ended June 30, 2020 and 2019, respectively, and $132.3 million (non-GAAP net loss of $112.8 million) and $74.5 million (non-GAAP net loss of $65.9 million) for the six months ended June 30, 2020 and 2019, respectively. Net loss per basic and diluted share was $1.16 and $0.75 for the three months ended June 30, 2020 and 2019, respectively, and $2.65 and $1.64 for the six months ended June 30, 2020 and 2019, respectively.

    As of June 30, 2020, cash, cash equivalents and investments were $436.9 million.

    Today's Conference Call and Webcast

    Tricida will host a conference call today at 4:30 pm Eastern Time to discuss its financial results and business progress. Please access the Tricida Conference Call as follows:

    Tricida Second Quarter 2020 Conference Call

     

    4:30 pm Eastern Time Today

     

    Webcast:

    IR.Tricida.com

    Dial-in:

    (877) 377-5478

    International:

    (629) 228-0740

    Conference ID:

    8994536

    A replay of the webcast will be available on the Investor Relations page of Tricida's website approximately two hours following the completion of the call and will be available for up to 90 days following the presentation.

    About Tricida

    Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with CKD. Metabolic acidosis is a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. It is estimated to pose a health risk to approximately three million patients with CKD in the United States. Tricida is currently conducting its confirmatory postmarketing trial, VALOR-CKD, of veverimer. The Tricida NDA for veverimer has been accepted for review by the FDA through the Accelerated Approval Program. The FDA has assigned a PDUFA goal date of August 22, 2020.

    For more information about Tricida, please visit www.Tricida.com.

    Cautionary Note on Forward-Looking Statements

    This press release includes forward-looking statements, within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 ("Exchange Act"). Forward-looking statements relate to expectations concerning matters that are not historical facts. Words such as "projects," "believes," "anticipates," "plans," "expects," "intends," "may," "will," "could," "should," "would," and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to all of the statements under the heading "Upcoming Events and Projected Milestones" and other statements, including the potential receipt and timing of the FDA's approval of the NDA, the potential receipt and timing of further clarification related to the FDA notification of July 14, 2020, the potential availability of the Accelerated Approval Program, as well as the approvability of veverimer under that program, the Company's expectations with regard to its interactions and communications with the FDA, plans and expectations as to the PDUFA date, and statements regarding the therapeutic potential of, and potential clinical and commercial development plans for, veverimer. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, that we may not be able to address all of the issues that relate to the deficiencies the FDA may identify with respect to veverimer; that we may not be able to achieve upcoming milestones; the cost, timing and results of clinical trials and other studies; that many drug candidates that have completed Phase 3 trials do not become approved drugs on a timely or cost effective basis, or at all; there can be no assurance that the FDA would approve an NDA through the Accelerated Approval Program, or at all, and even if approval for a drug is obtained, there can be no assurance that it will be adopted in the market or accepted as a benefit to patients and healthcare providers; possible safety and efficacy concerns; and that we completely rely on third-party suppliers and manufacturers for many aspects of our business. These and other factors that may affect our future results of operations are identified and described in more detail in our filings with the Securities and Exchange Commission, including the Company's most recent Annual Report filed on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q.

    You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by applicable law, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results, later events or circumstances or to reflect the occurrence of unanticipated events.

    Tricida, Inc.

     

    Condensed Balance Sheets

    (Unaudited)

    (In thousands)

     

     

    June 30,

    2020

     

    December 31,

    2019

    Assets

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    41,900

     

     

     

    $

    18,574

     

     

    Short-term investments

    345,632

     

     

     

    289,424

     

     

    Prepaid expenses and other current assets

    9,830

     

     

     

    4,744

     

     

    Total current assets

    397,362

     

     

     

    312,742

     

     

    Long-term investments

    49,371

     

     

     

    46,980

     

     

    Property and equipment, net

    1,432

     

     

     

    2,728

     

     

    Operating lease right-of-use assets

    8,734

     

     

     

    9,376

     

     

    Total assets

    $

    456,899

     

     

     

    $

    371,826

     

     

     

     

     

     

    Liabilities and stockholders' equity

     

     

     

    Current liabilities:

     

     

     

    Accounts payable

    $

    5,839

     

     

     

    $

    5,911

     

     

    Current operating lease liabilities

    1,088

     

     

     

    1,072

     

     

    Current Term Loan

    6,784

     

     

     

     

     

    Accrued expenses and other current liabilities

    20,769

     

     

     

    32,780

     

     

    Total current liabilities

    34,480

     

     

     

    39,763

     

     

     

     

     

     

    Non-current Term Loan, net

    67,952

     

     

     

    58,374

     

     

    Convertible Senior Notes, net

    114,645

     

     

     

     

     

    Non-current operating lease liabilities

    8,515

     

     

     

    8,783

     

     

    Other long-term liabilities

    327

     

     

     

    1,023

     

     

    Total liabilities

    225,919

     

     

     

    107,943

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

    Preferred stock

     

     

     

     

     

    Common stock

    50

     

     

     

    50

     

     

    Additional paid-in capital

    731,358

     

     

     

    632,647

     

     

    Accumulated other comprehensive income (loss)

    863

     

     

     

    193

     

     

    Accumulated deficit

    (501,291

    )

     

     

    (369,007

    )

     

    Total stockholders' equity

    230,980

     

     

     

    263,883

     

     

    Total liabilities and stockholders' equity

    $

    456,899

     

     

     

    $

    371,826

     

     

    Tricida, Inc.

     

    Condensed Statements of Operations and Comprehensive Loss

    (Unaudited)

    (In thousands, except share and per share amounts)

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

    $

    28,757

     

     

     

    $

    28,976

     

     

     

    $

    78,138

     

     

     

    $

    60,399

     

     

    General and administrative

    28,418

     

     

     

    8,861

     

     

     

    51,944

     

     

     

    15,213

     

     

    Total operating expenses

    57,175

     

     

     

    37,837

     

     

     

    130,082

     

     

     

    75,612

     

     

    Loss from operations

    (57,175

    )

     

     

    (37,837

    )

     

     

    (130,082

    )

     

     

    (75,612

    )

     

    Other income (expense), net

    2,675

     

     

     

    2,602

     

     

     

    3,488

     

     

     

    3,869

     

     

    Interest expense

    (3,756

    )

     

     

    (1,391

    )

     

     

    (5,776

    )

     

     

    (2,780

    )

     

    Loss before income taxes

    (58,256

    )

     

     

    (36,626

    )

     

     

    (132,370

    )

     

     

    (74,523

    )

     

    Income tax benefit

    86

     

     

     

     

     

     

    86

     

     

     

     

     

    Net loss

    (58,170

    )

     

     

    (36,626

    )

     

     

    (132,284

    )

     

     

    (74,523

    )

     

    Other comprehensive income (loss):

     

     

     

     

     

     

     

    Net unrealized gain (loss) on available-for-sale investments, net of tax

    902

     

     

     

    480

     

     

     

    670

     

     

     

    782

     

     

    Total comprehensive loss

    $

    (57,268

    )

     

     

    $

    (36,146

    )

     

     

    $

    (131,614

    )

     

     

    $

    (73,741

    )

     

    Net loss per share, basic and diluted

    $

    (1.16

    )

     

     

    $

    (0.75

    )

     

     

    $

    (2.65

    )

     

     

    $

    (1.64

    )

     

    Weighted-average number of shares outstanding, basic and diluted

    49,960,072

     

     

     

    48,674,238

     

     

     

    49,900,739

     

     

     

    45,489,861

     

     

    Tricida, Inc.

     

    GAAP to non-GAAP reconciliations

    (Unaudited)

    (In thousands)

    A reconciliation between net loss on a GAAP basis and on a non-GAAP basis is as follows:

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    GAAP net loss, as reported

    $

    (58,170

    )

     

     

    $

    (36,626

    )

     

     

    $

    (132,284

    )

     

     

    $

    (74,523

    )

     

    Adjustments:

     

     

     

     

     

     

     

    Non-cash operating lease costs

    70

     

     

     

    209

     

     

     

    390

     

     

     

    413

     

     

    Stock-based compensation

    9,079

     

     

     

    4,413

     

     

     

    17,453

     

     

     

    7,071

     

     

    Accretion of Term Loan and Convertible Senior Notes

    1,580

     

     

     

    523

     

     

     

    2,331

     

     

     

    1,011

     

     

    Changes in fair value of compound derivative liability

    (1,496

    )

     

     

    (9

    )

     

     

    (650

    )

     

     

    165

     

     

    Total adjustments

    9,233

     

     

     

    5,136

     

     

     

    19,524

     

     

     

    8,660

     

     

    Non-GAAP net loss

    $

    (48,937

    )

     

     

    $

    (31,490

    )

     

     

    $

    (112,760

    )

     

     

    $

    (65,863

    )

     

    Use of Non-GAAP Financial Measures

    We supplement our financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss and diluted earnings per share, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

    "Non-GAAP net loss" is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude (1) non-cash operating lease costs, (2) stock-based compensation, (3) accretion of Term Loan and Convertible Senior Notes and (4) changes in fair value of compound derivative liability, in reconciling of our GAAP to Non-GAAP net loss. Non-GAAP financial measures used by Tricida may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

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  3. Tricida, Inc. (NASDAQ:TCDA) today announced that it will report its second quarter 2020 financial results after the close of market on Wednesday, August 5, 2020. Tricida will host a conference call and webcast at 4:30 pm Eastern Time to discuss its financial results and business progress. The call or webcast may be accessed as follows:

    Tricida Second Quarter 2020 Conference Call

    Wednesday, August 5, 2020

    4:30 pm Eastern Time

    Webcast:

    IR.Tricida.com

    Dial-in:

    (877) 377-5478

    International:

    (629) 228-0740

    Conference ID:

    8994536

    A replay of the webcast will be available on Tricida's website approximately two hours following the completion of the call and will be available for up to 90 days following the presentation…

    Tricida, Inc. (NASDAQ:TCDA) today announced that it will report its second quarter 2020 financial results after the close of market on Wednesday, August 5, 2020. Tricida will host a conference call and webcast at 4:30 pm Eastern Time to discuss its financial results and business progress. The call or webcast may be accessed as follows:

    Tricida Second Quarter 2020 Conference Call

    Wednesday, August 5, 2020

    4:30 pm Eastern Time

    Webcast:

    IR.Tricida.com

    Dial-in:

    (877) 377-5478

    International:

    (629) 228-0740

    Conference ID:

    8994536

    A replay of the webcast will be available on Tricida's website approximately two hours following the completion of the call and will be available for up to 90 days following the presentation.

    About Tricida

    Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with CKD. Metabolic acidosis is a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. It is estimated to pose a health risk to approximately three million patients with CKD in the United States.

    For more information about Tricida, please visit www.Tricida.com.

    View Full Article Hide Full Article
  4. Tricida, Inc. (NASDAQ:TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that on July 14, 2020, the Company received a notification from the U.S. Food and Drug Administration (FDA) stating that, as part of its ongoing review of the Company's New Drug Application (NDA), the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

    The notification does not specify…

    Tricida, Inc. (NASDAQ:TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that on July 14, 2020, the Company received a notification from the U.S. Food and Drug Administration (FDA) stating that, as part of its ongoing review of the Company's New Drug Application (NDA), the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

    The notification does not specify the deficiencies identified by the FDA. The Company plans to work with the FDA to identify and seek to resolve the deficiencies. The Company has no current plans to modify or suspend its ongoing confirmatory postmarketing trial, VALOR-CKD. However, at this time the Company is unable to evaluate whether it will be able to address the FDA's concerns.

    "We are surprised and disappointed by this news," said Gerrit Klaerner, Ph.D., Tricida's Chief Executive Officer and President. "We continue to believe in the potential of veverimer to be disease modifying and our goal is to work with FDA to identify and resolve the issues in order to bring veverimer to patients."

    About Tricida

    Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with CKD. Metabolic acidosis is a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. It is estimated to pose a health risk to approximately three million patients with CKD in the United States. Tricida is currently conducting its confirmatory postmarketing trial, VALOR-CKD, of veverimer. The Tricida NDA for veverimer has been accepted for review by the FDA through the Accelerated Approval Program. The FDA has assigned a PDUFA goal date of August 22, 2020.

    For more information about Tricida, please visit www.Tricida.com.

    Cautionary Note on Forward-Looking Statements

    This current report on Form 8-K contains "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 ("Exchange Act"). Forward-looking statements relate to expectations concerning matters that are not historical facts. Words such as "projects," "believes," "anticipates," "plans," "expects," "intends," "may," "will," "could," "should," "would," and similar words and expressions are intended to identify forward-looking statements. Any statements contained herein which do not describe historical facts, including, statements regarding the potential receipt and timing of the FDA's approval of the NDA, the Company's expectations with regard to its interactions and communications with the FDA, plans, and expectations as to the PDUFA date are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, without limitation, any deficiencies the FDA may identify with respect to veverimer and whether the Company will be able to address the issues that may relate to those deficiencies, the receipt of regulatory approval for veverimer, the Company's ability to market and sell veverimer, if approved, the Company's ability to manufacture veverimer, and risks associated with our business prospects, financial results and business operations. These and other factors that may affect our future business prospects, results and operations are identified and described in more detail in our filings with the Securities and Exchange Commission (the "SEC"), including the Company's most recent Annual Report filed on Form 10-K and our subsequently filed Quarterly Report(s) on Form 10-Q. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this filing. Except as required by applicable law, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results, later events or circumstances or to reflect the occurrence of unanticipated events.

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  5. Tricida, Inc. (NASDAQ:TCDA) announced that, due to public health concerns relating to the coronavirus pandemic (COVID-19) and to protect the health of its employees, directors and stockholders, its 2020 annual meeting of stockholders (the "Annual Meeting") will be held in a virtual-only format.

    The previously announced date and time of the Annual Meeting, Thursday, June 11, 2020 at 7:00 a.m. Pacific Daylight Time, will not change, but stockholders will not be able to attend in person. The virtual meeting will provide stockholders with the ability to vote their shares during the meeting and ask questions online. To gain access to the Annual Meeting, stockholders must go to the meeting website at www.virtualstockholdermeeting.com/TCDA2020

    Tricida, Inc. (NASDAQ:TCDA) announced that, due to public health concerns relating to the coronavirus pandemic (COVID-19) and to protect the health of its employees, directors and stockholders, its 2020 annual meeting of stockholders (the "Annual Meeting") will be held in a virtual-only format.

    The previously announced date and time of the Annual Meeting, Thursday, June 11, 2020 at 7:00 a.m. Pacific Daylight Time, will not change, but stockholders will not be able to attend in person. The virtual meeting will provide stockholders with the ability to vote their shares during the meeting and ask questions online. To gain access to the Annual Meeting, stockholders must go to the meeting website at www.virtualstockholdermeeting.com/TCDA2020.

    As described in the proxy materials for the Annual Meeting previously distributed, stockholders as of the close of business on April 15, 2020, the record date, are entitled to participate in the Annual Meeting. To participate, stockholders will need the 16-digit control number included in the proxy materials delivered to such stockholder.

    A notice regarding the change of location of the Annual Meeting (the "Notice") is being filed with the Securities and Exchange Commission together with this press release. Additional information regarding the Annual Meeting, stockholder participation and voting is provided in the Notice.

    About Tricida

    Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). Metabolic acidosis is a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. It is estimated to pose a health risk to approximately three million patients with CKD in the United States. Tricida is currently conducting its confirmatory postmarketing trial, VALOR-CKD, of veverimer. The Tricida New Drug Application (NDA) for veverimer has been accepted for review by the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 22, 2020.

    For more information about Tricida, please visit www.Tricida.com.

    Cautionary Note on Forward-Looking Statements

    This press release includes forward-looking statements, including for example, statements about the assigned PDUFA goal date of August 22, 2020, and the potential availability of the Accelerated Approval Program. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, that we may not be able to achieve upcoming milestones; the cost, timing and results of clinical trials and other studies; that many drug candidates that have completed Phase 3 trials do not become approved drugs on a timely or cost effective basis or at all; there can be no assurance that the FDA would approve an NDA through the Accelerated Approval Program, or at all, and even if approval for a drug is obtained, there can be no assurance that it will be adopted in the market or accepted as a benefit to patients and healthcare providers; possible safety and efficacy concerns; the impact of COVID-19; and that we completely rely on third-party suppliers and manufacturers for many aspects of our business. These and other factors that may affect our future results of operations are identified and described in more detail in our filings with the Securities and Exchange Commission (SEC), including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect Tricida's current views with respect to future events, and Tricida does not undertake and specifically disclaims any obligation to update any forward-looking statements.

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