`
`THE ROSEN LAW FIRM, P.A.
`Laurence Rosen, Esq.
`One Gateway Center, Suite 2600
`Newark, NJ 07102
`Tel: (973) 313-1887
`Fax: (973) 833-0399
`Email: lrosen@rosenlegal.com
`
`Counsel for Plaintiff
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`CHRISTINA PHAM, Individually and
`on behalf of all others similarly situated,
`
`Case No:
`
`CLASS ACTION COMPLAINT
`FOR VIOLATIONS OF THE
`FEDERAL SECURITIES LAWS
`
`JURY TRIAL DEMANDED
`
`Plaintiff,
`
`v.
`
`REATA PHARMACEUTICALS, INC.,
`J. WARREN HUFF, and MANMEET S.
`SONI,
`
`Defendants.
`
`Plaintiff Christina Pham (“Plaintiff”), individually and on behalf of all other
`
`persons similarly situated, by Plaintiff’s undersigned attorneys, for Plaintiff’s
`
`complaint against Defendants (defined below), alleges the following based upon
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`personal knowledge as to Plaintiff and Plaintiff’s own acts, and information and
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`belief as to all other matters, based upon, inter alia, the investigation conducted
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`by and through her attorneys, which included, among other things, a review of
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`the Defendants’ public documents, conference calls and announcements
`
`made by
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`1
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`Case 2:22-cv-00903 Document 1 Filed 02/18/22 Page 2 of 28 PageID: 2
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`Defendants, public filings, wire and press releases published by and regarding
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`Reata Pharmaceuticals, Inc. (“Reata” or the “Company”), and information readily
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`obtainable on the Internet. Plaintiff believes that substantial evidentiary support
`
`will exist for the allegations set forth herein after a reasonable opportunity for
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`discovery.
`
`NATURE OF THE ACTION
`
`1.
`
`This is a class action on behalf of persons or entities who purchased
`
`or otherwise acquired publicly traded Reata securities between November 9, 2020
`
`and December 8, 2021, inclusive (the “Class Period”). Plaintiff seeks to recover
`
`compensable damages caused by Defendants’ violations of the federal securities
`
`laws under the Securities Exchange Act of 1934 (the “Exchange Act”).
`
`JURISDICTION AND VENUE
`
`2.
`
`The claims asserted herein arise under and pursuant to Sections 10(b)
`
`and 20(a) of the Exchange Act (15 U.S.C. §§ 78j(b) and 78t(a)) and Rule 10b-5
`
`promulgated thereunder by the SEC (17 C.F.R. § 240.10b-5).
`
`3.
`
`This Court has jurisdiction over the subject matter of this action
`
`pursuant to 28 U.S.C. § 1331, and Section 27 of the Exchange Act (15 U.S.C.
`
`§78aa).
`
`4.
`
`Venue is proper in this judicial district pursuant to 28 U.S.C. §
`
`1391(b) and Section 27 of the Exchange Act (15 U.S.C. § 78aa(c)) as the alleged
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`2
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`Case 2:22-cv-00903 Document 1 Filed 02/18/22 Page 3 of 28 PageID: 3
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`misstatements entered and the subsequent damages took place in this judicial
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`district.
`
`5.
`
`In connection with the acts, conduct and other wrongs alleged in this
`
`complaint, Defendants (defined below), directly or indirectly, used the means and
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`instrumentalities of interstate commerce, including but not limited to, the United
`
`States mails, interstate telephone communications and the facilities of the national
`
`securities exchange.
`
`PARTIES
`
`6.
`
`Plaintiff, as set forth in the accompanying certification, incorporated
`
`by reference herein, purchased Reata securities during the Class Period and was
`
`economically damaged thereby.
`
`7.
`
`Defendant Reata is a clinical-stage biopharmaceutical company that
`
`focuses on small-molecule therapeutics. One of its two lead product candidates is
`
`bardoxolone methyl (“bardoxolone”), which is being developed for multiple
`
`indications, including chronic kidney disease (“CKD”) caused by Alport
`
`syndrome (“AS”). Reata is incorporated under the laws of Delaware with its
`
`principal executive offices located in Plano, Texas. Reata’s Class A common
`
`stock trades on the NASDAQ exchange (“NASDAQ”) under the symbol “RETA.”
`
`8.
`
`Defendant J. Warren Huff (“Huff”) was the Company’s Chief
`
`Executive Officer at all relevant times.
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`3
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`Case 2:22-cv-00903 Document 1 Filed 02/18/22 Page 4 of 28 PageID: 4
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`
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`9.
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`Defendant Manmeet S. Soni (“Soni”) was the Company’s Chief
`
`Financial Officer at all relevant times.
`
`10. Defendants Huff and Soni are collectively referred to herein as the
`
`“Individual Defendants.”
`
`11. Each of the Individual Defendants:
`
`(a)
`
`directly participated in the management of the Company;
`
`(b) was directly involved in the day-to-day operations of the
`
`Company at the highest levels;
`
`(c) was privy to confidential proprietary information concerning
`
`the Company and its business and operations;
`
`(d) was directly or indirectly involved in drafting, producing,
`
`reviewing and/or disseminating the false and misleading
`
`statements and information alleged herein;
`
`(e) was directly or indirectly involved in the oversight or
`
`implementation of the Company’s internal controls;
`
`(f) was aware of or recklessly disregarded the fact that the false
`
`and misleading statements were being issued concerning the
`
`Company; and/or
`
`(g)
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`approved or ratified these statements in violation of the federal
`
`securities laws.
`
`4
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`12. Reata is liable for the acts of the Individual Defendants and its
`
`employees under the doctrine of respondeat superior and common law principles
`
`of agency because all of the wrongful acts complained of herein were carried out
`
`within the scope of their employment.
`
`13. The scienter of the Individual Defendants and other employees and
`
`agents of the Company is similarly imputed to Reata under respondeat superior
`
`and agency principles.
`
`14. Defendant Reata and the Individual Defendants are collectively
`
`referred to herein as “Defendants.”
`
`SUBSTANTIVE ALLEGATIONS
`
`Materially False and Misleading
`
`Statements Issued During the Class Period
`
`15. The Class Period begins on November 9, 2020. On that day, Reata
`
`announced the results from Year 2 of the Phase 3 CARDINAL study in a press
`
`release that stated, in relevant part:
`
`the
`(“Reata” or
`(Nasdaq:RETA)
`Inc.
`Reata Pharmaceuticals,
`“Company,” or “we”), a clinical-stage biopharmaceutical company,
`today announced that the Phase 3 CARDINAL study of bardoxolone
`methyl (“bardoxolone”) in patients with chronic kidney disease
`(“CKD”) caused by Alport syndrome met its primary and key
`secondary endpoints at the end of Year 2. At Week 100, in the intent-
`to-treat (“ITT”) population, which included estimated glomerular
`filtration rate (“eGFR”) values for patients who either remained on or
`discontinued study drug, patients treated with bardoxolone had a
`statistically significant improvement compared to placebo in mean
`change from baseline in eGFR of 7.7 mL/min/1.73 m2 (p=0.0005). In
`
`5
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`
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`
`
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`the modified ITT (“mITT”) analysis, which assessed the effect of
`receiving treatment by excluding values after patients discontinued
`treatment, patients treated with bardoxolone had a statistically
`significant improvement compared to placebo in mean change from
`baseline in eGFR at Week 100 of 11.3 mL/min/1.73 m2 (p<0.0001).
`At Week 104 (four weeks after last dose in second year of treatment),
`patients in the ITT population treated with bardoxolone had a
`statistically significant improvement compared to placebo in mean
`change from baseline in eGFR of 4.3 mL/min/1.73 m2 (p=0.023).
`Bardoxolone treatment was generally reported to be well-tolerated. In
`the long-term extension study (“EAGLE”), for the 14 patients who
`completed three years of treatment, bardoxolone treatment resulted in
`a mean increase from baseline in eGFR of 11.0 mL/min/1.73 m2.
`Based on these positive results and following a recently completed
`pre-NDA meeting with the U.S. Food and Drug Administration
`(“FDA”), we plan to proceed with the submission of an NDA for full
`marketing approval in the United States in the first quarter of 2021.
`We also plan to pursue marketing approval outside of the United
`States and work has commenced on preparations to file for marketing
`approval in Europe.
`
`
`* * *
`
`“Chronic kidney disease caused by Alport syndrome is a serious,
`progressive disease with an urgent need for new therapeutic options.
`The two-year CARDINAL study, now complete, represents the first
`time that an investigational medicine has shown a significant
`clinical benefit in this disease, and it marks an important step toward
`making a treatment available for patients with Alport syndrome. We
`look forward
`to submitting our New Drug Application for
`bardoxolone in the first quarter of 2021. On behalf of everyone at
`Reata, I would like to express my sincere appreciation to all of the
`patients, families, and
`investigators who participated
`in
`the
`CARDINAL study,” said Warren Huff, Reata’s President and Chief
`Executive Officer.
`
`
`* * *
`
`
`In rare forms of CKD, the FDA has accepted the off-treatment
`endpoint as the basis for approval. Withdrawal of drug after long-
`
`6
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`term treatment provides evidence whether a drug either protected or
`harmed the kidney during treatment. If off-treatment changes in eGFR
`are higher than placebo, this is evidence that the drug protected the
`kidney during treatment, and, if off-treatment changes in eGFR are
`lower than placebo, this is evidence that the drug harmed the kidney
`during treatment. An off-treatment eGFR benefit relative to placebo
`provides evidence that drug treatment may delay kidney failure.
`
`(Emphasis added.)
`
`16. Also on November 9, 2020, the Company filed its quarterly report on
`
`Form 10-Q for the period ended September 30, 2020, stating, in relevant part:
`
`Bardoxolone for CKD Caused by Alport Syndrome
`
`On November 9, 2020, we announced that the Phase 3 CARDINAL
`study of bardoxolone in patients with CKD caused by Alport
`syndrome met its primary and key secondary endpoints at the end of
`Year 2. At Week 100, in the intent-to-treat (ITT) population, which
`included eGFR values for patients who either remained on or have
`discontinued study drug, patients treated with bardoxolone had a
`statistically significant improvement compared to placebo in mean
`change from baseline in estimated glomerular filtration rate (eGFR) of
`7.7 mL/min/1.73 m2 (p=0.0005). In the modified ITT (mITT)
`analysis, which assessed the effect of receiving treatment by
`excluding values after patients discontinued treatment, patients treated
`with bardoxolone had a statistically significant
`improvement
`compared to placebo in mean change from baseline in eGFR at Week
`100 of 11.3 mL/min/1.73 m2 (p<0.0001). At Week 104 (four weeks
`after last dose in second year of treatment), patients in the ITT
`population treated with bardoxolone had a statistically significant
`improvement compared to placebo in mean change from baseline in
`eGFR of 4.3 mL/min/1.73 m2 (p=0.023). Bardoxolone treatment was
`generally reported to be well-tolerated. Based on these positive
`results and following a recently completed pre-NDA meeting with
`the U.S. Food and Drug Administration (FDA), we plan to proceed
`with the submission of an NDA for full marketing approval in the
`United States in the first quarter of 2021. We also plan to pursue
`
`7
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`
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`marketing approval outside of the United States and work has
`commenced on preparations to file for marketing approval in Europe.
`
`(Emphasis added.)
`
`17. On March 1, 2021, Reata announced that it had submitted its NDA
`
`for bardoxolone as a treatment of CKD caused by AS. The Company’s press
`
`release stated, in relevant part:
`
`the
`(“Reata,”
`(Nasdaq: RETA)
`Inc.
`Reata Pharmaceuticals,
`“Company,” or “we”), a clinical-stage biopharmaceutical company,
`today announced that it has submitted a New Drug Application
`(“NDA”) for bardoxolone methyl (“bardoxolone”) for the treatment of
`chronic kidney disease (“CKD”) caused by Alport syndrome to the
`U.S. Food and Drug Administration (“FDA”).
`
`This NDA submission is based on the efficacy and safety data from
`the CARDINAL Phase 3 clinical trial. The submission includes a
`request for Priority Review, which, if granted, would shorten the
`FDA’s review of the NDA to eight months from the time of
`submission, versus a standard review timeline of 12 months. If
`approved, bardoxolone would become the first therapy specifically
`indicated for the treatment of CKD caused by Alport syndrome.
`
`“This NDA submission marks an important step toward making a
`treatment available for patients with Alport syndrome, a serious,
`progressive disease with an urgent need for new therapeutic options,”
`said Warren Huff, Reata’s President and Chief Executive Officer. “I
`want to thank all those who made this moment possible, especially
`Alport syndrome patients and their families. We look forward to next
`steps on the path to making bardoxolone available as a first-in-class
`therapy for Alport syndrome, pending NDA acceptance, review, and
`drug approval.”
`
`(Emphasis added.)
`
`
`8
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`
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`18. Also on March 1, 2021, Reata filed its annual report on Form 10-K
`
`for the period ended December 31, 2020. Regarding risks impacting regulatory
`
`approval of any of its product candidates, Reata stated, in relevant part:
`
`The clinical and commercial success of bardoxolone and
`omaveloxolone will depend on a number of factors, many of which
`are beyond our control.
`
`success of bardoxolone and
`The clinical and commercial
`omaveloxolone will depend on a number of factors, including the
`following, many of which are beyond our control:
`
`
`• the timely initiation, continuation, and completion of our Phase
`2 and Phase 3 clinical
`trials
`for bardoxolone and
`omaveloxolone, which will depend
`substantially upon
`requirements for such trials imposed by the FDA and other
`regulatory agencies and bodies;
`• our ability to demonstrate the safety and efficacy of our product
`candidates to the satisfaction of the relevant regulatory
`authorities;
`• whether the FDA or other regulatory authorities will accept
`NDAs for approval of our product candidates;
`• whether we are required by the FDA or other regulatory
`authorities to conduct additional clinical trials, and the scope
`and nature of such clinical trials, prior to approval to market our
`products;
`• the timely receipt of necessary marketing approvals from the
`FDA and foreign regulatory authorities, including pricing and
`reimbursement determinations;
`• the ability to successfully commercialize our product candidates
`for marketing and sale, if approved by the FDA or foreign
`regulatory authorities, whether alone or in collaboration with
`others;
`• our ability and the ability of third-party manufacturers to
`manufacture the quantities of our product candidates with
`quality attributes necessary to meet regulatory requirements and
`
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`at a scale and yield sufficient to meet anticipated demand at a
`cost that allows us to achieve profitability;
`• our success in educating health care providers and patients
`about the benefits, risks, administration, and use of our product
`candidates, if approved;
`• acceptance of our product candidates, if approved, as safe and
`effective by patients and the healthcare community;
`• the achievement and maintenance of compliance with all
`regulatory requirements applicable to our product candidates,
`our third-party manufacturers, and our internal operations;
`• the maintenance of an acceptable safety profile of our products,
`if any, following any approval;
`• the availability, perceived advantages, relative cost, relative
`safety, and relative efficacy of alternative and competitive
`treatments;
`• our ability to provide approved product with a convenient and
`patient-friendly capsule configuration;
`• our ability to successfully enforce our intellectual property
`rights for our product candidates and against the products of
`potential competitors; and
`• our ability to avoid or succeed in third-party patent interference
`or patent infringement claims.
`
`
`We cannot assure you that we will ever be able to achieve profitability
`through the sale of, or royalties from, our product candidates. If we or our
`collaborators are not successful
`in obtaining approval for and
`commercializing our product candidates, or are delayed in completing
`those efforts, our business and operations would be adversely affected.
`
`(Emphasis added.)
`
`
`19. On April 26, 2021, Reata announced that the FDA had accepted the
`
`NDA submission and set an action date for February 25, 2022. The Company’s
`
`press release stated, in relevant part:
`
`the
`(“Reata,”
`(Nasdaq: RETA)
`Inc.
`Reata Pharmaceuticals,
`“Company,” or “we”), a clinical-stage biopharmaceutical company,
`
`10
`
`
`
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`
`
`
`
`
`today announced that the U.S. Food and Drug Administration
`(“FDA”) accepted for filing the New Drug Application (“NDA”) for
`bardoxolone methyl (“bardoxolone”) for the treatment of patients with
`chronic kidney disease (“CKD”) caused by Alport syndrome.
`
`This NDA submission is based on the efficacy and safety data from
`the CARDINAL Phase 3 clinical trial. The FDA will review the
`application under a Standard Review timeline. The Prescription Drug
`User Fee Act (“PDUFA”) date, the FDA action date for the
`application, is scheduled for February 25, 2022. The FDA also
`advised the Company that it is currently planning to hold an Advisory
`Committee meeting to discuss the application.
`
`“We are pleased with the FDA’s decision to accept for filing our NDA
`for bardoxolone and look forward to continuing to work with the
`Division during the review process,” said Warren Huff, Reata’s
`President and Chief Executive Officer. “Alport syndrome is one of the
`most rapidly progressive forms of CKD and a truly devastating
`disease to those patients and the families who are affected by it. If
`approved, bardoxolone may be the first therapy to slow the
`progression of kidney disease in patients with this serious and
`debilitating disease.”
`
`(Emphasis added.)
`
`20. On May 6, 2021, Reata announced its first quarter 2021 financial
`
`results and provided an update on its clinical development programs. The press
`
`release stated, among other things:
`
`Recent Company Highlights
`
`Bardoxolone Methyl (“Bardoxolone”)
`Syndrome
`
`In April 2021, we announced that the U.S. Food and Drug
`Administration (“FDA”) accepted for filing Reata’s New Drug
`Application (“NDA”) for bardoxolone for the treatment of patients
`with chronic kidney disease (“CKD”) caused by Alport syndrome.
`
`in Patients with Alport
`
`11
`
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`
`
`
`
`The FDA will review the application under a Standard Review
`timeline. The Prescription Drug User Fee Act (“PDUFA”) date, the
`FDA action date for the application, is scheduled for February 25,
`2022. The FDA also advised us that it is currently planning to hold
`an Advisory Committee meeting to discuss the application. If
`approved, bardoxolone may become the first therapy specifically
`indicated for the treatment of CKD caused by Alport syndrome.
`
`“We made significant progress during the first quarter of 2021 with
`the submission of our NDA for bardoxolone for the treatment of CKD
`caused by Alport syndrome coming less than four months after
`reporting positive results from Year 2 of our Phase 3 CARDINAL
`trial,” said Warren Huff, Reata’s President and Chief Executive
`Officer. “Alport syndrome is a devastating disease that affects 30,000
`to 60,000 patients in the United States. We are pleased with the
`FDA’s recent decision to accept our application for filing and look
`forward to continuing to work with the FDA during its review of our
`application.”
`
`(Emphasis added.)
`
`21. On May 6, 2021, Reata filed its quarterly report on Form 10-Q for the
`
`period ended March 31, 2021, stating, in relevant part:
`
`Bardoxolone in Patients with CKD Caused by Alport Syndrome
`
`On April 26, 2021, we announced that the U.S. Food and Drug
`Administration (FDA) accepted for filing the New Drug Application
`(NDA) for bardoxolone for the treatment of patients with CKD caused
`by Alport syndrome. The FDA will review the application under a
`Standard Review timeline. The Prescription Drug User Fee Act
`(PDUFA) date, the FDA action date for the application, is scheduled
`for February 25, 2022. The FDA also advised us that it is currently
`planning to hold an Advisory Committee meeting to discuss the
`application.
`
`Our NDA submission was based on the results of Year 2 of the Phase
`3 CARDINAL study of bardoxolone in patients with CKD caused by
`Alport syndrome announced in November 2020. The study met its
`
`12
`
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`
`
`
`
`primary and key secondary endpoints following two years of
`treatment (referred to as Year 2). Moreover, we also announced that
`patients who completed one year in the EAGLE long-term extension
`study and were treated with bardoxolone for a total of three years
`(n=14) showed a sustained and significant increase from baseline in
`estimated glomerular filtration rate (eGFR). Together, these data
`suggest that bardoxolone treatment has beneficial long-term effects
`on kidney function in patients with Alport syndrome.
`
`(Emphasis added.)
`
`22. On August 9, 2021, Reata announced its second quarter 2021
`
`financial results and provided an update on its clinical development programs. The
`
`press release stated that, during a mid-cycle communication meeting about the
`
`NDA, the FDA had “identified four significant clinical and statistical review
`
`issues” for Reata to address. Specifically, the Company stated:
`
`in Patients with Alport
`
`Bardoxolone Methyl (“Bardoxolone”)
`Syndrome
`
`The NDA for bardoxolone for the treatment of patients with chronic
`kidney disease (“CKD”) caused by Alport syndrome is currently
`under review by the FDA. The FDA completed a bio-research
`monitoring inspection of Reata. We did not receive any observations.
`We also recently completed a mid-cycle communication meeting with
`the FDA. While we have not yet received formal minutes from the
`FDA, in the preliminary agenda for, and during, the meeting, the FDA
`identified four significant clinical and statistical review issues for us
`to address. The FDA invited us to respond to its identified issues in
`follow-up submissions to the NDA, and we believe each of the
`identified issues is addressable with additional data and analyses. The
`FDA did not designate any safety issues as significant issues, and it
`stated that, based on its current review, it does not believe a Risk
`Evaluation and Mitigation Strategies (“REMS”) program is needed.
`The FDA also advised us that an Advisory Committee meeting is
`tentatively scheduled for December 8, 2021. The Prescription Drug
`
`13
`
`
`
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`
`
`
`
`
`User Fee Act (“PDUFA”) date, the FDA action date for the
`application, is scheduled for February 25, 2022.
`
`23. On August 9, 2021, Reata filed its quarterly report on Form 10-Q for
`
`the period ended June 30, 2021, stating, in relevant part:
`
`Bardoxolone in Patients with CKD Caused by Alport Syndrome
`
`On April 26, 2021, we announced that the U.S. Food and Drug
`Administration (FDA) accepted for filing the NDA for bardoxolone
`for the treatment of patients with CKD caused by Alport syndrome,
`and the NDA is currently under review by the FDA. The FDA
`completed a bio-research monitoring inspection of Reata. We did not
`receive any observations. We also recently completed a mid-cycle
`communication meeting with the FDA. While we have not yet
`received formal minutes from the FDA, in the preliminary agenda
`for, and during, the meeting, the FDA identified four significant
`clinical and statistical review issues. We believe each of these issues
`are addressable with additional data and analyses, and the FDA
`invited us to address its identified issues in follow-up submissions to
`the NDA. We plan to address each of the issues through the
`submission of additional data and analyses to the NDA. See Programs
`in Chronic Kidney Disease – Bardoxolone in Patients with CKD
`Caused by Alport Syndrome below.
`
`The FDA made additional information requests and identified a few
`additional issues that were not deemed significant. The FDA did not
`designate any safety issues as significant issues, and it stated that,
`based on its current review, it does not believe a Risk Evaluation and
`Mitigation Strategies (REMS) program is needed. We were notified
`that we would be receiving comments in writing regarding Chemistry,
`Manufacturing, and Controls (CMC), and we will not be receiving any
`nonclinical comments. The FDA also advised us that an Advisory
`Committee meeting is tentatively scheduled for December 8, 2021.
`The Prescription Drug User Fee Act (PDUFA) date, the FDA action
`date for the application, is scheduled for February 25, 2022.
`
`(Emphasis added.)
`
`
`14
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`
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`24. The above statements identified in ¶¶ 15-23 were materially false
`
`and/or misleading, and failed to disclose material adverse facts about the
`
`Company’s business, operations, and prospects. Specifically, Defendants failed to
`
`disclose to investors that: (1) the FDA had raised concerns regarding the validity
`
`of the clinical study designed to measure the efficacy and safety of bardoxolone
`
`for the treatment of CKD caused by AS; (2) as a result, there was a material risk
`
`that Reata’s NDA would not be approved; and (3) as a result of the foregoing,
`
`Defendants’ positive statements about the Company’s business, operations, and
`
`prospects were materially misleading and/or lacked a reasonable basis.
`
`THE TRUTH EMERGES
`
`25. On December 6, 2021, the FDA released briefing documents in
`
`advance of an Advisory Committee meeting for the Company’s NDA for
`
`bardoxolone, stating that the agency had repeatedly questioned the validity of
`
`Reata’s study design because bardoxolone’s pharmacodynamic effect on kidney
`
`function would make the results difficult to assess the effectiveness of the drug.
`
`Specifically, the briefing document noted that, “[i]n September 2018, FDA
`
`encouraged [Reata] to request an end-of-phase 2 meeting to discuss the
`
`development program and ensure alignment,” but Reata declined. Then, in
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`February 2019, the FDA “emphasized the importance of obtaining FDA
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`concurrence that a study intended to support a marketing application was adequate
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`15
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`and acceptable for this purpose.” The briefing document detailed the concerns the
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`FDA had raised with Reata during the course of the clinical studies and NDA
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`submission:
`
`• Bardoxolone’s pharmacodynamic effect on eGFR and assessing
`for effects on disease progression: At a preIND meeting held in
`October 2016,
`the Division
`indicated
`that because of
`bardoxolone’s pharmacodynamic effect on kidney function, on-
`treatment assessments of kidney function would be difficult to
`interpret as a drug effect on disease progression. As such, a
`post-treatment assessment of creatinine should be used to assess
`bardoxolone’s efficacy in treating the disease. Following
`submission of the IND in 2016, the Agency repeatedly voiced
`concerns about
`the
`time-course
`for
`resolution of
`bardoxolone’s pharmacodynamic effect on creatinine/eGFR
`following discontinuation of treatment and whether the off-
`treatment values collected in CARDINAL Phase 3 were in fact
`capturing an effect on disease progression. The Agency
`ultimately recommended that the Applicant conduct a separate
`study to characterize the time course for resolution of
`bardoxolone’s pharmacodynamic effect or modify CARDINAL
`Phase 3 to obtain the information (i.e., revise the protocol to
`include additional off-treatment eGFR measurements).
`• Accelerated Approval: In January and September 2020, the
`Applicant met with Agency to discuss submission of an NDA
`for bardoxolone under the accelerated approval pathway based
`primarily on the Year 1 data on eGFR from CARDINAL Phase
`3. The Division did not agree with the proposed approach,
`voicing concerns about the interpretability of the eGFR
`findings given the available information on the time course
`for resolution of bardoxolone’s pharmacodynamic effect, as
`well as the amount of missing data in the bardoxolone arm
`and lack of clarity on how patients with missing data were
`handled in key analyses intended to disentangle the drug’s
`pharmacodynamic effect on kidney function from its effect on
`the irreversible loss of kidney function.
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`16
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`• Bardoxolone’s effects on blood pressure and albuminuria: At
`the January and September 2020 meetings with the Applicant,
`the Agency voiced concern about bardoxolone’s effects on
`blood pressure and albuminuria and whether, over the long
`term, these effects could accelerate progression to kidney
`failure.
`• Trial integrity: In November 2020, the Applicant submitted an
`addendum to their SAP dated October 30, 2020, and an
`amended Data Access Plan dated August 28, 2020 for
`CARDINAL Phase 3. In its December 2020 response to the
`submission, the Agency expressed concern about the number of
`individuals with access to patient-level clinical data and
`individual treatment assignments following the interim analysis
`of data from Year 1, as well as the late changes to the study’s
`SAP, and provided specific recommendations on additional
`information and analyses that should be included in the
`Applicant’s marketing application to address the integrity of the
`trial data. [Footnote omitted.]
`
`
`(Emphasis added.)
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`
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`26. Though the FDA agreed that Reata’s Phase 3 study met its endpoints,
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`“the FDA review team d[id] not believe the submitted data demonstrate that
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`bardoxolone is effective in slowing the loss of kidney function in patients with AS
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`and reducing the risk of progression to kidney failure.” Among other things, the
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`FDA noted that a “treatment can have both reversible [pharmacodynamic] effects
`
`on kidney function as well as change the trajectory of the decline in kidney
`
`function . . . , but it can be difficult to tease apart the contribution of each
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`component in trials with short treatment duration and/or when off-treatment
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`17
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`measurements of eGFR are obtained before the pharmacodynamic effect on eGFR
`
`has fully reversed.” It further stated:
`
`The CARDINAL Phase 3 study consisted of two years of longitudinal
`on-treatment eGFR assessments with two 4-week washout periods,
`after Year 1 and Year 2, respectively. The time-course of eGFR
`changes in the bardoxolone and placebo groups is shown in Figure 4
`[omitted]. eGFR increased compared to placebo while on treatment at
`Week 48 and Week 100, as evaluated by the primary efficacy
`endpoint; however, eGFR decreased during each of the 4-week
`washout periods, suggesting that the on-treatment increase in eGFR
`was, at least in part, a result of the reversible PD effect of bardoxolone
`on eGFR. If the duration of the washout was long enough to eliminate
`the reversible PD effect on eGFR, then changes in eGFR compared
`with placebo at the end of the Year-2 washout period could indicate
`bardoxolone’s effect on slowing disease progression. A key issue was
`to determine if the study’s 4-week washout was long enough for the
`reversible PD effect on eGFR to have resolved.
`
`[Reata] has justified the 4-week washout in CARDINAL Phase 3
`based on: various pooled analyses of patients across studies with
`eGFR measurements collected up to 42 days off-treatment; off-
`treatment eGFR measurements for studies in patients with CKD with
`treatment duration ≤8 weeks; the pharmacokinetic (PK) profile of
`bardoxolone; exposure-response modeling; and time to return to
`baseline of other PD markers, such as liver enzymes. The FDA has
`not found these justifications compelling to support the adequacy of
`a 4-week washout in patients with AS, as d