March 03, 2021 - An investor in shares of Athenex, Inc. (NASDAQ: ATNX) filed a lawsuit in the U.S. District Court for the Western District of New York over alleged violations of Federal Securities Laws by Athenex, Inc. in connection with certain allegedly false and misleading statements made between August 7, 2019 and February 26, 2021.
Buffalo, NY based Athenex, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of various therapies for the treatment of cancer and related conditions in North America and Asia.
In June 2017, Athenex, Inc. completed its initial public offering (“IPO”), issuing 6 million shares of common stock priced at $11.00 per share.
On May 7, 2020, Athenex reported its financial and operating results for the first quarter of 2020. Among other results, the Company reported earnings per share that missed consensus estimates by $0.07.
On September 1, 2020, the Company announced that the U.S. Food and Drug Administration ( FDA ) accepted Athenex’s New Drug Application ( NDA ) for oral paclitaxel and encequidar in metastatic breast cancer with priority review.
On March 1, 2021, Athenex, Inc reported its fourth quarter and full year 2020 financial results. Athenex, Inc. reported that its annual Total Revenue rose from $101.22 million in 2019 to $144.39 million in 2020, and that its Net Loss increased from $123.74 million in 2019 to $146.17 million in 2020.
On the same day, Athenex, Inc disclosed receipt of a Complete Response Letter ( CRL ) from the FDA stating that the NDA would not be approved in its current form. According to the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequalae on the Oral Paclitaxel arm compared to the IV paclitaxel arm.
The Company stated that the FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent centra review (BICR) [because] the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR. As a result, the FDA had recommended that Athenex conduct additional clinical trials and employ certain risk mitigation strategies to improve toxicity.
Shares of Athenex, Inc. (NASDAQ: ATNX) declined to as low as $3.93 per share on March 5, 2021.
According to the complaint the plaintiff alleges on behalf of purchasers of Athenex, Inc. (NASDAQ: ATNX) common shares between August 7, 2019 and February 26, 2021, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between August 7, 2019 and February 26, 2021, the Defendants failed to disclose to investors that the data included in the Oral Paclitaxel plus Encequidar NDA presented a safety risk to patients in terms of an increase in neutropenia-related sequalae, that the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by BICR, that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR, that the Company’s Phase 3 study that was used to file the NDA was inadequate and not well-conducted in a patient population with metastatic breast cancer representative of the U.S. population, such that the FDA would recommended a new such clinical trial, that as a result, it was foreseeable that the FDA would not approve the Company’s NDA in its current form, and that as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.