NEW YORK, May 29, 2022 (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 Axsome Therapeutics, Inc. (NASDAQ: AXSM), Humbl, Inc. (OTCMKTS: HMBL), Okta, Inc. (NASDAQ: OKTA), and CareDx, Inc. (NASDAQ: CDNA). 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.
Axsome Therapeutics, Inc. (NASDAQ: AXSM)
Class Period: December 30, 2019 – April 22, 2022
Lead Plaintiff Deadline: July 12, 2022
Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system disorders in the United States. The Company is developing, among other product candidates, AXS-07, a novel, oral, rapidly absorbed, multi-mechanistic, and investigational medicine for the acute treatment of migraine.
Axsome consistently touted AXS-07’s regulatory and commercial prospects in anticipation of the Company’s submission a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for AXS-07 for the acute treatment of migraine (the “AXS-07 NDA”) based on the drug’s positive results in two Phase 3 trials. However, unbeknownst to investors, the Company’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (“CMC”) issues.
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) Axsome’s CMC practices were deficient with respect to AXS-07 and its manufacturing process; (ii) as a result, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline; (iii) the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA; (iv) accordingly, the FDA was unlikely to approve the AXS-07 NDA; (v) as a result of all the foregoing, Axsome had overstated AXS-07’s regulatory and commercial prospects; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.
On November 5, 2020, Axsome issued a press release reporting the Company’s third quarter 2020 results. That press release disclosed that the Company “plans to submit the [AXS-07] NDA to the FDA in the first quarter of 2021, versus previous guidance of the fourth quarter of 2020, to allow for inclusion of supplemental manufacturing information to ensure a robust submission package.”
On this news, Axsome’s stock price fell $5.22 per share, or 6.99%, to close at $69.51 per share on November 5, 2020.
Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Exchange Commission that, “[o]n April 22, 2022, Axsome . . . was informed by the [FDA] that [CMC] issues identified during the FDA’s review of the Company’s [NDA] for its AXS-07 product candidate for the acute treatment of migraine are unresolved.” That filing also disclosed that “[b]ased upon the time remaining in the NDA review cycle, the Company expects to receive a Complete Response Letter [(‘CRL’)] with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.”
On this news, Axsome’s stock price fell $8.60 per share, or 21.99%, to close at $30.50 per share on April 25, 2022.
Finally, on May 2, 2022, Axsome announced that it received a CRL from the FDA regarding the AXS-07 NDA for the acute treatment of migraine. According to the Company, “[t]he principal reasons given in the CRL relate to [CMC] considerations” including “the need for additional CMC data pertaining to the drug product and manufacturing process.”
For more information on the Axsome class action go to: https://bespc.com/cases/AXSM
Humbl, Inc. (OTCMKTS: HMBL)
Class Period: November 1, 2020 – May 19, 2022
Lead Plaintiff Deadline: July 19, 2022
Humbl is a mobile financial services company that offers investors various financial products associated with “Web 3” technology and decentralized finance.
The complaint alleges that Defendants violated provisions of the Exchange Act by making false and misleading statements concerning the Company’s growth prospects, technological advancements, international partnerships, and financial benefits for Humbl common stock and digital asset investors, as well as using selectively timed announcements to keep Humbl stock price high so that Company insiders could sell off their holdings into artificially created volume. The complaint also alleges that Defendants violated provisions of the Securities Act by selling its unregistered securities (BLOCK ETX digital assets) to investors.
On April 25, 2022, the price of the Humbl common stock hit a low of $0.11 per share, down from a price high of $6.84 during the Class Period, which it has not been able to recover. Likewise, the price of BLOCK ETX has dropped over 87% from its height during the Class Period and has not recovered.
For more information on the Humbl class action go to: https://bespc.com/cases/HMBL
Okta, Inc. (NASDAQ: OKTA)
Class Period: March 5, 2021 – March 22, 2022
Lead Plaintiff Deadline: July 19, 2022
Okta provides identity solutions for enterprises, small and medium-sized businesses, universities, non-profits, and government agencies in the U.S. and internationally. The Company offers a variety of cybersecurity products and services. Following its completed merger with Auth0, Inc., a Delaware corporation (“Auth0”), on May 3, 2021 (the “Merger”), Okta began providing additional Auth0 products related to cybersecurity and login solutions.
Throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Okta had inadequate cybersecurity controls; (ii) as a result, Okta’s systems were vulnerable to data breaches; (iii) Okta ultimately did experience a data breach caused by a hacking group, which potentially affected hundreds of Okta customers; (iv) Okta initially did not disclose and subsequently downplayed the severity of the data breach; (v) all the foregoing, once revealed, was likely to have a material negative impact on Okta’s business, financial condition, and reputation; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.
On or around March 21, 2022, hackers known as LAPSUS$ posted screenshots on their Telegram1 channel showing what they claimed was Okta’s internal company environment. Thereafter, on March 22, 2022, the Company’s Chief Executive Officer (“CEO”), Defendant Todd McKinnon (“McKinnon”), posted a statement on his Twitter account, disclosing that, “[i]n late January 2022, Okta detected an attempt to compromise the account of a third party customer support engineer working for one of our subprocessors”; that “[t]he matter was investigated and contained by the subprocessor”; that “[w]e believe the screenshots shared online are connected to this January event”; and that, “[b]ased on our investigation to date, there is no evidence of ongoing malicious activity beyond the activity detected in January.”
On this news, Okta’s stock price fell $2.98 per share, or 1.76%, to close at $166.43 per share on March 22, 2022.
Later, on March 22, 2022, during after-market hours, in a statement on Okta’s website, the Company’s Chief Security Officer (“CSO”), Defendant David Bradbury (“Bradbury”), disclosed, inter alia, that “[a]fter a thorough analysis of [the LAPSUS$] claims, we have concluded that a small percentage of customers – approximately 2.5% – have potentially been impacted and whose data may have been viewed or acted upon.”
Following Okta’s updated statement, multiple news outlets reported that hundreds of the Company’s clients were potentially affected by the January 2022 data breach. For example, on March 23, 2022, CNN published an article entitled “Okta concedes hundreds of clients could be affected by breach[,]” noting that, despite the Company’s statement that “a small percentage of customers – approximately 2.5% – have potentially been impacted[,]” the Company “has over 15,000 customers, according to its website.” That same day, Reuters and others published similar reports.
Separately, Okta was downgraded by Raymond James from “strong buy” to “market perform,” noting, among other things, that “[w]hile partners were willing to trust Okta’s track record, the handling of its latest security incident adds to our mounting concerns.”
Following Okta’s after-market update and Raymond James downgrade, the Company’s stock price fell $17.88 per share, or 10.74%, to close at $148.55 per share on March 23, 2022.
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.
For more information on the Okta class action go to: https://bespc.com/cases/OKTA
CareDx, Inc. (NASDAQ: CDNA)
Class Period: February 24, 2021 – May 5, 2022
Lead Plaintiff Deadline: July 22, 2022
CareDx is a diagnostics company that offers diagnostic testing services, products, and digital healthcare software for organ transplant patients and care providers. Testing services for kidney and heart transplant recipients represented at least 85% of CareDx’s total revenues, and the Company’s AlloSure blood test for transplant recipients was the Company’s primary source of revenue. Additionally, the higher reimbursement payment rates for its Medicare-approved tests drove growth of the Company’s average sale price (“ASP”), an important metric for investors. Throughout the Class Period, CareDx reported growing revenue and strong demand in the Company’s testing services segment. Defendants also emphasized to investors the success of the Company’s RemoTraC service – a remote, home-based, blood-drawing service that the Company launched in response to the COVID-19 pandemic.
The Class Action alleges that, during the Class Period, Defendants misled investors and/or failed to disclose that: (1) Defendants had engaged in a variety of improper and illegal schemes to inflate testing services revenue and demand, including pushing a surveillance protocol through inaccurate marketing materials, offering extravagant inducements or kickbacks to physicians and other providers, and improperly bundling expensive testing services with other blood tests as part of the RemoTraC service; (2) these practices, and others, subjected CareDx to an undisclosed risk of regulatory scrutiny; (3) these practices rendered the Company’s testing services revenue reported throughout the Class Period artificially inflated; and (4) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.
The truth began to emerge on October 28, 2021, when CareDx filed its quarterly report for the third quarter of 2021 on Form 10-Q with the SEC. Under the heading “United States Department of Justice and United States Securities and Exchange Commission Investigation,” the Company revealed for the first time that CareDx was the subject of at least three government investigations related to its “accounting and public reporting practices.” In response to this news, CareDx’s stock price fell 27%, from a closing price of $70.34 per share on October 28, 2021, to a closing price of $51.00 per share on October 29, 2021.
Investors learned more about the nature of the government investigations when, on April 15, 2022, CareDx’s former Head of Community Nephrology, Dr. Michael Olymbios, filed a complaint in California Superior Court that provided extensive detail about: (1) Defendants’ misconduct, including the use of RemoTraC to improperly bundle the Company’s most expensive testing services, including AlloSure, with other blood tests, that led to the government investigations; (2) Defendants’ knowledge of the misconduct throughout the Class Period; and (3) their attempts to conceal the misconduct. In response to this filing, CareDx’s stock price fell an additional 8% the next trading day, from a closing price of $35.41 per share on April 14, 2022, to a closing price of $32.55 per share on April 18, 2022.
Finally, after the markets closed on May 5, 2022, CareDx issued a press release announcing financial results for the first quarter of 2022, reporting a near 5% decline in the ASP of the Company’s testing services. In response to this news, CareDx’s stock price fell 18.5%, from a closing price of $31.66 per share on May 5, 2022, to a closing price of $25.87 per share on May 6, 2022.
For more information on the CareDx class action go to: https://bespc.com/cases/CDNA
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.
Melissa Fortunato, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
