NEW YORK, June 25, 2023 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Zai Lab Limited (Zai Lab Limited), Hayward Holdings, Inc. (NYSE: HAYW), Ascendis Pharma A/S (NASDAQ: ASND), and Alvotech SA (NASDAQ: ALVO). Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices. Additional information about each case can be found at the link provided.
Zai Lab Limited (Zai Lab Limited)
On March 9, 2022, the U.S. Securities and Exchange Commission ("SEC") published a notification identifying Zai Lab, among other companies, as in potential violation of the Holding Foreign Companies Accountable Act, which allows the SEC to delist companies and ban a company's shares from being traded if the company fails to allow U.S. regulators to review their company audits for three straight years. Zai Lab and the other companies named in the SEC notification have until March 29, 2022 to challenge the charges against them.
On this news, Zai Lab's stock price fell $6.74 per share, or 18%, to close at $30.02 per share on March 10, 2022.
On June 6, 2023, Zai Lab reported phase 3 trials for an oncology therapy it is developing with NovoCure. It said that its tumor treating fields (TTFields) therapy, which uses skin patches to deliver electric fields to areas of the body, when used with standard therapies, met its primary endpoint of three-month improvement in median overall survival time in metastatic non-small cell lung cancer (NSCLC) patients. However the study was unreliable because many of the study participants didn't use an initial checkpoint inhibitor, which is seen as the leading way to treat NSCLC, thereby allowing for the possibility that the study was highly skewed by comparing TTFields to a lesser therapy.
On this news, Zai Lab's stock fell $4.88 per share, or 14.55%, on unusually high trading volume, to close at $28.66 per share on June 7, 2023.
For more information on the Zai Lab investigation go to: https://bespc.com/cases/ZLAB
Hayward Holdings, Inc. (NYSE: HAYW)
On July 28, 2022, Hayward Holdings revealed that it was expecting its channel partners to reduce its inventory on hand by approximately 4 to 6 weeks in the second half of 2022. Hayward Holdings further disclosed that it was reducing its 2022 guidance to reflect this inventory reduction.
On this news, the price of Hayward Holdings common stock fell by approximately 18%.
For more information on the Hayward Holdings investigation go to: https://bespc.com/cases/HAYW
Ascendis Pharma A/S (NASDAQ: ASND)
On April 3, 2023, Ascendis issued a press release "announc[ing] that the U.S. Food & Drug Administration (FDA) has notified the Company that, as part of their ongoing review, the FDA has identified deficiencies in the Company's New Drug Application (NDA) for TransCon PTH (palopegteriparatide) in hypoparathyroidism that at this time precludes them from holding further discussions about labeling and post-marketing requirements/commitments. The deficiencies were not disclosed in the letter."
On this news, Ascendis's American depositary receipt ("ADR") price fell $34.39 per ADR, or 32.07%, to close at $72.83 per ADR on April 3, 2023.
For more information on the Ascendis investigation go to: https://bespc.com/cases/ASND
Alvotech SA (NASDAQ: ALVO)
On April 13, 2023, Alvotech issued a press release "announc[ing]…that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech's Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA's reinspection of the company's Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved."
On this news, Alvotech's stock price fell sharply during intraday trading on April 14, 2023.
For more information on the Alvotech investigation go to: https://bespc.com/cases/ALVO
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.