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Athenex, Inc. (NASDAQ: ATNX) announced that the FDA has approved its Investigational New Drug (IND) application for TCRT-ESO-A2, an autologous T cell receptor therapy targeting NY-ESO-1 positive solid tumors in specific patients. This approval marks a significant milestone, being the 10th IND granted to Athenex. Developed through a joint venture with Xiangxue Life Sciences, TCRT-ESO-A2 shares technology with TAEST16001, which is undergoing trials in China. Preliminary positive results have emerged from pilot studies of TAEST16001, enhancing Athenex's oncology pipeline.
Athenex, Inc. (Nasdaq: ATNX) announced a public offering of 10 million shares of common stock at $11.00 per share, expected to generate $110 million. The underwriters have a 30-day option to purchase an additional 1.5 million shares. The offering is set to close on September 14, 2020. Proceeds will be used to enhance commercial infrastructure, advance development of product candidates, and fund general corporate purposes. The offering is registered under Form S-3 with the SEC.
Athenex, Inc. (Nasdaq: ATNX) has announced an intention to offer 10,000,000 shares of common stock in a public offering, subject to market conditions. Additionally, underwriters may purchase up to 1,500,000 more shares. This offering is registered under Form S-3 with the SEC. Joint book-running managers include SVB Leerink, RBC Capital Markets, and Evercore ISI. A preliminary prospectus supplement will be filed with the SEC. Athenex aims to advance its efforts in developing cancer therapies.
Athenex, Inc. (ATNX) has launched new study arms in the I-SPY 2 TRIAL to evaluate the combination of oral paclitaxel plus encequidar and GSK's dostarlimab for neoadjuvant chemotherapy in breast cancer patients. The primary goal is to improve pathologic complete response (pCR) rates compared to standard therapies. If successful, this could lead to a subsequent Phase 3 trial. Athenex's oral therapy may offer greater patient convenience and tolerability. The NDA for this treatment was accepted by the FDA for Priority Review, marking a significant step for Athenex in cancer treatment innovation.
Athenex, Inc. (Nasdaq: ATNX) has appointed Dr. Robert J. Spiegel to its Board of Directors, enhancing its leadership with his extensive drug development experience. Dr. Spiegel has a strong history in biotechnology, including overseeing over 30 successful New Drug Applications during his tenure at Schering-Plough. He expressed enthusiasm about Athenex's innovative Orascovery platform, which aims to improve cancer treatments. Concurrently, John Koh has resigned from the board to allow for broader industry expertise, with Athenex acknowledging his contributions since April 2019.
Athenex, Inc. (Nasdaq: ATNX) announced it will release its second quarter 2020 financial results on August 6, 2020, before market opening. The company will host a conference call and live audio webcast at 8:00 AM ET to discuss its financial performance and provide updates on business developments. Athenex is focused on cancer treatment drug development and has a clinical pipeline based on innovative technologies, aiming to improve the lives of cancer patients globally.
Athenex, Inc. (Nasdaq: ATNX) has promoted Teresa Bair to Executive Officer and General Counsel, effective June 23, 2020. With over 23 years of legal experience, she transitions from Senior Vice President, Legal Affairs, and Administration. Bair will oversee global legal matters and lead U.S. administration and government relations. CEO Dr. Johnson Lau praised her valuable counsel and institutional knowledge. Athenex, established in 2003, focuses on developing innovative cancer treatments and has a diverse clinical pipeline.
Athenex, Inc. (NASDAQ: ATNX) has secured a $225 million loan agreement with Oaktree Capital Management to support its cancer treatment initiatives. The funds will aid in the commercial launch of Oral Paclitaxel, refinance existing debt, and support R&D efforts. The initial $100 million will be used to repay previous debt, while the remaining $125 million will be accessible upon meeting specific milestones. This loan matures in June 2026, enhancing Athenex's financial flexibility to advance its clinical pipeline and commercialization efforts.
Athenex, Inc. (NASDAQ: ATNX) has launched the Facing MBC Together campaign to address isolation among individuals living with metastatic breast cancer (MBC). Unveiled at the LBBC 2020 Virtual Conference, the initiative provides digital resources aimed at emotional and practical support for MBC patients. A survey revealed that nearly one-third of MBC patients feel significant loneliness. The campaign includes tools for creating support groups and sharing updates, aiming to counteract the increased isolation experienced during the COVID-19 pandemic.
Athenex, Inc. (NASDAQ: ATNX) reported its Q1 2020 financial results, revealing product sales of $18.5 million, down 26% from $25.2 million in Q1 2019. Key developments include the submission of regulatory filings for tirbanibulin ointment and Oral Paclitaxel, with the PDUFA date for tirbanibulin set for December 30, 2020. The net loss for the quarter was $19.4 million or ($0.24) per diluted share, an improvement from a loss of $35.2 million in the prior year. Athenex projects mid-single-digit sales growth for 2020, considering recent operational challenges and market conditions.
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