NEW YORK, Aug. 21, 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 Outset Medical, Inc. (NASDAQ: OM), Missfresh Limited (NASDAQ: MF), Molecular Partners AG (NASDAQ: MOLN), and TG Therapeutics, Inc. (NASDAQ: TGTX). 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.
Outset Medical, Inc. (NASDAQ: OM)
Class Period: September 15, 2020 – June 13, 2022
Lead Plaintiff Deadline: September 6, 2022
Outset Medical is a medical technology company focused on kidney dialysis, the primary treatment for acute and chronic kidney failure. The Company’s flagship product is the Tablo Hemodialysis System (“Tablo”), a dialysis machine that purifies tap water and then artificially purifies and removes toxins from the blood of patients suffering from kidney failure.
The truth began to emerge on May 5, 2022, when the Company announced disappointing results for the first quarter of 2022, which analysts attributed, inter alia, to the untested nature of Tablo in the home setting. In response to this disclosure, and as the market digested this news, the price of Outset Medical common stock declined more than 40% over the three trading days that followed, from a closing price of $39.94 per share on Wednesday, May 4, 2022, to a closing price of $23.06 per share on Monday, May 9, 2022.
Then, after the markets closed on June 13, 2022, Outset Medical announced that the FDA had forced the Company to hold all shipments of Tablo for use in the home until Tablo received proper regulatory clearance. During an “FDA Review Call” held that day with analysts, the Defendants acknowledged the “ship hold” had already been in place for weeks before investors were provided this material information, and that as a result of the shipment hold, the Company was “suspending our prior full-year and long-term guidance.” On this news, the price of Outset Medical stock fell an additional 33%, from a closing price of $20.41 per share on June 13, 2022, to a closing price of $13.46 per share on June 14, 2022.
Throughout the Class Period, Outset Medical touted that Tablo can “serve as a dialysis clinic on wheels” that had been “cleared by the [U.S.] Food and Drug Administration [(the “FDA”)] for use in the hospital, clinic or home setting” under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the “FDCA”). Devices used by non-professionals outside of a clinical setting and that can present serious health consequences like Tablo are subject to heightened scrutiny by the FDA, including post-market surveillance studies pursuant to the FDCA. While performing further regulatory studies during the Class Period, the Company assured investors that it was conducting the studies “in accordance with the FDA approved protocol,” which required an appropriate demonstration of “real-world” human testing given that the device would be used at home by non-professionals.
The Class Action alleges that, during the Class Period, Defendants misled investors and/or failed to disclose that (1) Defendants had “continuously made improvements and updates to Tablo over time since its original clearance” that required an additional 510(k) application; (2) as a result, the Company could not conduct a human factors study on a cleared device in accordance with FDA protocols; (3) the Company’s inability to conduct the human factors study subjected the Company to the likelihood of the FDA imposing a “shipment hold” and marketing suspension, leaving the Company unable to sell Tablo for home use; 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.
For more information on the Outset Medical class action go to: https://bespc.com/cases/OM
Missfresh Limited (NASDAQ: MF)
Class Period: Pursuant to the Company’s June 25, 2021 IPO
Lead Plaintiff Deadline: September 12, 2021
Missfresh purports to be an innovator and leader in China’s neighborhood retail industry which invented the Distributed Mini Warehouse (DMW) model to operate an integrated online-and-offline on-demand retail business focusing on offering fresh produce and fast-moving consumer goods (FMCGs).
On or about June 8, 2021, Missfresh filed with the SEC a Registration Statement on Form F-1, which in combination with a subsequent amendment on Form F-1/A and filed pursuant to Rule 424(b)(4), would be used for the IPO.
On June 23, 2021, Missfresh filed with the SEC its final prospectus for the IPO on Form 424B4 (the “Prospectus”), which forms part of the Registration Statement. In the IPO, Missfresh sold approximately 21 million American Depositary Shares (“ADSs”) at $13.00 per ADS.
On April 29, 2022, after trading hours, Missfresh filed with the SEC a Notification of Late Filing on Form 12b-25 which announced, among other things, that the independent Audit Committee of the Company’s board of directors, with the assistance of professional advisors, “[wa]s in the process of conducting an internal review of certain matters, including those relating to transactions between the Company and certain third-party enterprises.” On this news, Missfresh ADSs fell 13% to close at $0.448 per ADS on May 2, 2021.
Then, on May 24, 2022, Missfresh disclosed that the Company was unable to file its 2021 Annual Report by the extended deadline, "primarily because the Company is unable to complete the audit of the financial statements of the Company for the fiscal year ended December 31, 2021". On this news, Missfresh's ADSs fell $0.018 per share, or 9.7%, over the following two trading days, to close at $0.167 per ADS on May 26, 2022.
Finally, on July 1, 2022, Missfresh issued a press release entitled "Missfresh Announces the Substantial Completion of the Audit Committee-Led Independent Internal Review" which disclosed, among other things, that the Company's review "identified certain transactions . . . that exhibit characteristics of questionable transactions, such as undisclosed relationships between suppliers and customers, different customers or suppliers sharing the same contact information, and/or lack of supporting logistics information" and that consequently, "certain revenue associated with those reporting periods in 2021 may have been inaccurately recorded in the Company's financial statements."
Since the IPO, the price of Missfresh's ADSs has fallen over 97%, closing at $0.3075 per ADS on July 6, 2022.
The class action alleges that Defendants’ statements in the Registration Statement were materially false and misleading when made because: (1) Missfresh provided false financial figures in its Registration Statement; (2) Missfresh would need to amend its financial figures; (3) Missfresh, among other things, had lesser net revenues for the quarter ended March 31, 2021; and (4) as a result, Defendants’ public statements were materially false and misleading at all relevant times and negligently prepared.
For more information on the Missfresh class action go to: https://bespc.com/cases/MF
Molecular Partners AG (NASDAQ: MOLN)
Class Period: June 16, 2021 – April 26, 2022 or pursuant to the Company’s June 16, 2021 IPO
Lead Plaintiff Deadline: September 12, 2022
Molecular Partners operates as a clinical-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of therapeutic proteins. Leading up to and following the IPO, the Company repeatedly touted the clinical and commercial prospects of certain of its product candidates under development in collaboration with other companies.
Among other product candidates, Molecular Partners is developing ensovibep as a treatment for COVID-19 in collaboration with Novartis AG (“Novartis”). One of the Company’s most important development strategies for ensovibep includes securing Emergency Use Authorization (“EUA”) for ensovibep from the U.S. Food and Drug Administration (“FDA”).
In addition, Molecular Partners is developing MP0310 (AMG 506) for the treatment of certain types of cancer in collaboration with Amgen Inc. (“Amgen”). The Company granted Amgen, among other licenses, the right to progress MP0310’s development program into later stage development, including into combination trials, following Phase 1 data.
On April 22, 2021, Molecular Partners filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (“SEC”) in connection with the IPO, which, after several amendments, was declared effective by the SEC on June 15, 2021 (the “Registration Statement”).
On June 16, 2021, Molecular Partners filed a prospectus on Form 424B4 with the SEC in connection with the IPO, which incorporated and formed part of the Registration Statement (collectively, the “Offering Documents”).
Pursuant to the Offering Documents, Molecular Partners conducted the IPO, issuing 3 million of its ADSs to the public at the IPO price $21.25 per ADS, for proceeds to the Company of over $59 million, after underwriting discounts and commissions, and before expenses.
On November 16, 2021, Molecular Partners disclosed that “a planned futility analysis of ensovibep in [an] ongoing [Phase 3] clinical study . . . has not met the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting.”
On this news, Molecular Partners’ ADS price fell $4.64 per ADS, or 31.37%, to close at $10.15 per ADS on November 16, 2021.
On April 26, 2022, months after applying for EUA from the FDA for ensovibep, Novartis’ Chief Executive Officer, Vas Narasimhan, disclosed that “given the latest feedback . . . in our discussions with the [FDA], we would expect the agency to require a Phase 3 study before granting an EUA approval or a general approval” for ensovibep, and that “we need to make a kind of sober evaluation as to is it a doable study in light of the waning rates of COVID around the world[.]”
On this news, Molecular Partners’ ADS price fell $2.68 per ADS, or 16.17%, to close at $13.89 per ADS on April 26, 2022.
Then, also on April 26, 2022, during after-market hours, Molecular Partners “announced that Amgen . . . has informed the Company of their decision to return global rights of MP0310 to Molecular Partners following a strategic pipeline review.”
On this news, Molecular Partners’ ADS price fell $5.19 per ADS, or 37.37%, to close at $8.70 per ADS on April 27, 2022—a total decline of $7.87 per ADS, or 47.5%, over two consecutive trading days, and 59.06% below the $21.25 per ADS IPO price.
As of the time the complaint was filed, the price of Molecular Partners’ ADSs continued to trade below the $21.25 per ADS IPO price, damaging investors.
The complaint alleges that the Offering Documents were negligently prepared and, as a result, contained untrue statements of material fact or omitted to state other facts necessary to make the statements made not misleading and were not prepared in accordance with the rules and regulations governing their preparation. Additionally, the complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, the Offering Documents and Defendants made false and/or misleading statements and/or failed to disclose that: (i) ensovibep was less effective at treating COVID-19 than Defendants had led investors to believe; (ii) accordingly, the FDA was reasonably likely to require an additional Phase 3 study of ensovibep before granting the drug EUA; (iii) waning global rates of COVID-19 significantly reduced the Company’s chances of securing EUA for ensovibep; (iv) as a product candidate, MP0310 was less attractive to Amgen than Defendants had led investors to believe; (v) accordingly, there was a significant likelihood that Amgen would return global rights of MP0310 to Molecular Partners; (vi) as a result of all the foregoing, the clinical and commercial prospects of ensovibep and MP0310 were overstated; and (vii) as a result, the Offering Documents and Defendants’ public statements throughout the Class Period were materially false and/or misleading and failed to state information required to be stated therein.
For more information on the Molecular Partners class action go to: https://bespc.com/cases/MOLN
TG Therapeutics, Inc. (NASDAQ: TGTX)
Class Period: January 15, 2020 – May 31, 2022
Lead Plaintiff Deadline: September 16, 2022
TG Therapeutics, a commercial stage biopharmaceutical company, focuses on the acquisition, development, and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. The Company’s therapeutic product candidates include Ublituximab, an investigational glycoengineered monoclonal antibody for the treatment of B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia (“CLL”), and relapsing forms of multiple sclerosis; and Umbralisib, or UKONIQ, an oral inhibitor of PI3K-delta and CK1-epsilon for the treatment of CLL, marginal zone lymphoma, and follicular lymphoma.
In January 2020, TG Therapeutics initiated a rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”), requesting accelerated approval of Umbralisib as a treatment for patients with previously treated marginal zone lymphoma (“MZL”) and follicular lymphoma (“FL”) (the “Umbralisib MZL/FL NDA”).
In December 2020, TG Therapeutics initiated a rolling submission of a Biologics License Application (“BLA”) to the FDA for Ublituximab in combination with Umbralisib (together, “U2”), as a treatment for patients with CLL (the “U2 BLA”).
In May 2021, TG Therapeutics submitted a supplemental New Drug Application (“sNDA”) for Umbralisib to add an indication for CLL and small lymphocytic lymphoma (“SLL”) in combination with Ublituximab (the “U2 sNDA”).
In September 2021, TG Therapeutics submitted a BLA to the FDA for Ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (“RMS”) (the “Ublituximab RMS BLA”).
On November 30, 2021, TG Therapeutics issued a press release “announc[ing] the U.S. Food and Drug Administration (FDA) has notified the Company that it plans to host a meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).” TG Therapeutics advised that “[t]he FDA has notified the Company that potential questions and discussion topics for the ODAC include: the benefit-risk of the U2 combination in the treatment of CLL or SLL, and the benefit-risk of UKONIQ in relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL). In addition, as part of the benefit-risk analysis, the overall safety profile of the U2 regimen, including adverse events (serious and Grade 3-4), discontinuations due to adverse events, and dose modifications, is expected to be reviewed”, stating that “[t]he FDA’s concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.”
On this news, TG ’Therapeutics’ stock price fell $8.16 per share, or 34.93%, to close at $15.20 per share on November 30, 2021.
Then, on April 15, 2022, TG Therapeutics issued a press release “announc[ing] that the Company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).” The press release stated that “[t]he decision to withdraw was based on recently updated overall survival (OS) data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in OS.”
On this news, TG Therapeutics’ stock price fell $1.93 per share, or 21.81%, to close at $6.92 per share on April 18, 2022.
Then, on May 31, 2022, TG Therapeutics issued a press release announcing that the FDA extended the Prescription Drug User Fee Act date for Ublituximab to December 28, 2022 “to allow time to review a submission provided by the Company in response to an FDA information request, which the FDA deemed a major amendment.”
On this news, TG Therapeutics’ stock price fell $0.75 per share, or 14.51%, to close at $4.42 per share on May 31, 2022.
Finally, on June 1, 2022, the FDA announced that, due to safety concerns, it had withdrawn its approval for Umbralisib for the treatment of MZL and FL. Specifically, the FDA provided that “[u]pdated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving [UKONIQ]. As a result, we determined the risks of treatment with [UKONIQ] outweigh its benefits.”
On this news, TG ’Therapeutics’ stock price fell $0.51 per share, or 11.53%, to close at $3.91 per share on June 1, 2022.
The complaint alleges that 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) clinical trials revealed significant concerns related to the benefit-risk ratio and overall survival data of Ublituximab and Umbralisib; (ii) accordingly, it was unlikely that the Company would be able to obtain FDA approval of the Umbralisib MZL/FL NDA, the U2 BLA, the U2 sNDA, or the Ublituximab RMS BLA in their current forms; (iii) as a result, the Company had significantly overstated Ublituximab and Umbralisib’s clinical and/or commercial prospects; and (iv) therefore, the Company’s public statements were materially false and misleading at all relevant times.
For more information on the TG Therapeutics class action go to: https://bespc.com/cases/TGTX
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.
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investigations@bespc.com
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