Lawsuit Overview
April 13, 2021 - A second amended complaint was filed.
February 16, 2021 - An amended complaint was filed.
September 16, 2020 - An investor in shares of Odonate Therapeutics, Inc. (NASDAQ: ODT) filed a lawsuit in the U.S. District Court for the Southern District of California over alleged violations of Federal Securities Laws by Odonate Therapeutics, Inc. in connection with certain allegedly false and misleading statements made between December 7, 2017, and August 21, 2020.
San Diego, CA based Odonate Therapeutics, Inc., a pharmaceutical company, develops therapeutics for the treatment of cancer. Odonate Therapeutics, Inc is focused on developing tesetaxel, an orally administered chemotherapy agent. Tesetaxel is in Phase 3 clinical study for patients with locally advanced or metastatic breast cancer ( MBC ), called the CONTESSA trial, which is evaluating tesetaxel in combination with capecitabine in patients with MBC.
On December 6, 2017, Odonate Therapeutics, Inc. announced the pricing of its initial public offering (“IPO”) of 6,250,000 shares of common stock at a public offering price of $24.00 per share for aggregate gross proceeds of approximately $150 million.
On February 14, 2018, Odonate Therapeutics, Inc announced its financial results for the three and twelve months ended December 31, 2017. Odonate Therapeutics, Inc. reported that its Net Loss increased from $3.08 million in 2017 to $32.74 million in 2018 Shares of Odonate Therapeutics, Inc. (NASDAQ: ODT) reached as high as $31.25 per share in March 5, 2018.
On August 24, 2020, during pre-market hours, Odonate Therapeutics, Inc announced top-line results from the CONTESSA trial. Although the study met its primary endpoint, tesetaxel plus capecitabine was associated with Grade 3 or higher neutropenia (low levels of white blood cells), which occurred in 71.2% of patients with the combination treatment versus 8.3% for capecitabine alone. Various other Grade 3 or higher treatment-emergent adverse events ( AEs ) were also associated with tesetaxel plus capecitabine versus capecitabine alone.
Further, discontinuation rates were 4.2% from neutropenia and 3.6% from neuropathy, and the overall discontinuation rate was 23.1% in the treatment group compared to 11.9% in the capecitabine alone group. Shares of Odonate Therapeutics, Inc. (NASDAQ: ODT) declined from $41.75 per share on August 10, 2020 to as low as $13.82 per share on September 4, 2020.
According to the complaint the plaintiff alleges on behalf of purchasers of Odonate Therapeutics, Inc. (NASDAQ: ODT) common shares between December 7, 2017, and August 21, 2020, that the defendants violated Federal Securities Laws.
More specifically, the plaintiff claims that between December 7, 2017, and August 21, 2020, the Defendants made false and/or misleading statements and/or failed to disclose that tesetaxel was not as safe or well-tolerated as the Company had led investors to believe, that consequently, tesetaxel's commercial viability as a cancer treatment was overstated, and that as a result, the Company's public statements were materially false and misleading at all relevant times.