NEW YORK, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Cassava Sciences, Inc. (NASDAQ: SAVA), and Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.
Cassava Sciences, Inc. (NASDAQ: SAVA)
Class Period: August 18, 2022 - October 12, 2023
Lead Plaintiff Deadline: April 2, 2024
Cassava is a clinical-stage biotechnology company. The Company's lead therapeutic drug candidate is PTI-125 (or "simufilam"), a small molecule drug for the proposed treatment of Alzheimer's disease.
In March 2020, Cassava initiated a long-term, open-label study to evaluate the long-term safety and tolerability of simufilam 100 mg twice daily for 12 or more months in patients with Alzheimer's disease and to assess exploratory efficacy endpoints, such as changes in cognition, and biomarkers.
Then, in August 2021, a Citizen Petition requested the United States Food & Drug Administration ("FDA") to halt any phase 3 trials of simufilam due to concerns regarding data manipulation. Specifically, the Citizen Petition referenced "grave concerns about the quality and integrity of the laboratory-based studies surrounding this drug candidate and supporting the claims for its efficacy."
However, in response, Cassava denied the allegations in the Citizen Petition and instead touted the effectiveness of simufilam and the efficacy of the Company's research programs. Indeed, in a press release published shortly after the FDA received the Citizen Petition, Cassava stated that "[t]he Company stands behind its science, its scientists and its scientific collaborators." Thereafter, Cassava continued to maintain its defense of simufilam even as criticisms of simufilam were revealed from additional sources and academic journals such as Neurobiology of Aging and the Journal of Neuroscience issued "expressions of concern" regarding the efficacy of the drug.
On October 12, 2023, the peer-reviewed academic journal Science reported that Professor Hoau-Yan Wang ("Dr. Wang"), a City University of New York researcher associated with the research program for simufilam, had been investigated by university officials for possible data manipulation. Although the investigative committee did not have access to the raw data at issue and thus was unable to confirm that data manipulation had occurred, members made their conclusion based on "long-standing and egregious misconduct in data management and record keeping by Dr. Wang" and "found evidence highly suggestive of deliberate scientific misconduct" by Dr. Wang.
On this news, Cassava's stock price fell $2.68 per share, or 15.28%, to close at $14.86 per share on October 13, 2023.
As a result of Defendants' wrongful acts and omissions, and the precipitous decline in the market value of the Company's securities, Plaintiff and other Class members have suffered significant losses and damages.
The Complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements and failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company failed to maintain adequate and effective data management controls and procedures related to its drug research programs; (ii) as a result, the data published in support of simufilam were susceptible to manipulation to overstate the drug's effectiveness; (iii) accordingly, Cassava had misrepresented the efficacy of its research programs and the clinical and/or commercial prospects of simufilam; (iv) all of the foregoing, once revealed, was likely to subject the Company to significant financial and/or reputational harm; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times.
For more information on the Cassava class action go to: https://bespc.com/cases/SAVA
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX)
Class Period: November 11, 2022 - November 8, 2023
Lead Plaintiff Deadline: April 9, 2024
Amylyx is a commercial-stage biotechnology company that engages in the discovery and development of treatments for Amyotrophic Lateral Sclerosis ("ALS"), also known as Lou Gehrig's disease, and other neurodegenerative diseases. The Company's products include, among others, AMX0035 (commercially referred to as "RELYVRIO" in the U.S.), a dual UPR-Bax apoptosis inhibitor composed of sodium phenylbutyrate and taurursodiol, for the treatment of ALS in adults in the U.S.
Following the U.S. Food and Drug Administration's September 2022 approval of RELYVRIO for the treatment of ALS in adults in the U.S., Defendants consistently touted the drug's commercial prospects and prescription rate.
The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants had overstated RELYVRIO's commercial prospects; (ii) patients were discontinuing treatment with RELYVRIO after six months; (iii) the rate at which new patients were starting treatment with RELYVRIO was decreasing; (iv) accordingly, Defendants had also overstated RELYVRIO's prescription rate; (v) Defendants attempted to hide the foregoing negative trends from investors and the market by blocking analysts from viewing RELYVRIO's prescription data; and (vi) as a result, Defendants' public statements were materially false and misleading at all relevant times.
On November 9, 2023, Amylyx issued a press release announcing its third quarter ("Q3") 2023 financial results, including Q3 GAAP earnings per share of $0.30, missing consensus estimates by $0.12. That same day, on a conference call with investors and analysts to discuss these results, Company management revealed that, despite "a [purported] steady cadence of new prescriptions written in" Q3 for RELYVRIO, Amylyx's "results were impacted by a number of factors" including a "slowdown in net adds" for RELYVRIO in Q3, which "was primarily driven by increased discontinuations for a variety of reasons", with only "60% of people taking RELYVRIO remain[ing] on therapy six months after initiation in the U.S."
Also on November 9, 2023, Investor's Business Daily published an article addressing the Company's disappointing financial results (the "IBD Article"). The IBD Article cited an Evercore ISI analyst, who questioned Amylyx's assertion that the number of new patients starting treatment with RELYVRIO was "steady", noting that his math suggested otherwise and that Amylyx had blocked analysts from viewing RELYVRIO's prescription data in the summer of 2023. The analyst also stated that, "[k]nowing that [Amylyx's] stock had underperformed in 2023 already, management could have communicated the discontinuations dynamic much earlier," and that the "[s]tock move today in a bad biotech tape and fund performance doesn't help investor confidence among folks that have held onto the stock."
Following these disclosures and the publication of the IBD Article, Amylyx's stock price fell $5.74 per share, or 31.89%, to close at $12.26 per share on November 9, 2023.
For more information on the Amylyx class action go to: https://bespc.com/cases/AMLX
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact Information:
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
