ATNX - ATNX STOCK NEWS

Athenex, a global biopharmaceutical company focused on cancer treatments, announced that CEO Johnson Lau and Senior Director Daniel Lang will present at the Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit on September 22, 2021, at 10:45 a.m. ET. Investors can access a live audio webcast of the presentation on Athenex's website, with a replay available for 90 days. Athenex specializes in innovative therapies and has a diverse clinical pipeline driven by multiple technologies, aiming to improve the lives of cancer patients.

Athenex, Inc. (NASDAQ: ATNX) provided its second quarter 2021 update, revealing a 47% drop in product sales to $21.4 million, primarily due to decreased demand for COVID-19 related drugs. The company held a Type A meeting with the FDA regarding the oral paclitaxel NDA for metastatic breast cancer. Athenex is also advancing its KUR-501 CAR-NKT therapy and acquired Kuur Therapeutics. Despite a net loss of $34.3 million, they have a cash reserve of $146.7 million. The company plans to present a new clinical study design to the FDA in Q4 2021.

Athenex has expanded its global reach by entering into licensing agreements for tirbanibulin with Seqirus and AVIR Pharma in Australia, New Zealand, and Canada. These agreements allow Seqirus to exclusively commercialize tirbanibulin in Australia and New Zealand, while AVIR will do so in Canada. This initiative is part of Athenex's strategy to enhance its market presence and increase access to its product, Klisyri, which treats actinic keratosis. The agreements include milestone and royalty payments ranging from 15% to 30% of annual sales.

Athenex, Inc. (Nasdaq: ATNX) announced a corporate and financial update scheduled for August 5, 2021, prior to market opening. The update will include insights into the company's second-quarter performance and future outlook. Management will host a conference call at 8:00 AM Eastern Time, with participation details provided. Athenex focuses on developing therapies for cancer and related conditions, leveraging its three platforms and diverse clinical pipeline derived from innovative technologies.

Athenex (NASDAQ: ATNX) announced that its partner, Almirall, received approval from the European Commission to market Klisyri (tirbanibulin) for treating actinic keratosis on the face or scalp in adults. Klisyri, launched in the U.S. in February 2021, is a first-in-class microtubule inhibitor with a short treatment protocol and a good safety profile. Two pivotal Phase III studies showed significant efficacy, achieving 100% lesion clearance in up to 54% of patients. Athenex is eligible for up to $45 million in milestone payments and tiered royalties starting at 15% on net sales.

Athenex, Inc. (NASDAQ: ATNX) announced a Type A meeting with the FDA in Q2 2021 to address issues raised in a February Complete Response Letter regarding oral paclitaxel and encequidar for metastatic breast cancer. The FDA showed support for the continued development of these therapies and agreed that a well-conducted trial could resolve the deficiencies noted in the CRL. Athenex plans to formulate a clinical study design to present to the FDA in Q4 2021. The company is also working on the same drugs for cutaneous angiosarcoma and received Orphan Drug Designation for both the FDA and the European Commission.

Athenex, Inc. (NASDAQ: ATNX) presented significant findings at ASCO2021, showcasing the efficacy of its oral cancer therapies. Data from a phase I study indicated that oral docetaxel achieved pharmacokinetic exposure comparable to IV docetaxel, with an average bioavailability of 15.9%. Additionally, an update from the phase III oral paclitaxel study revealed a notable overall response rate of 35.8% compared to 23.4% for IV paclitaxel, indicating superior effectiveness across tumor subtypes. These results may influence future treatment strategies in oncology.

Athenex, Inc. (NASDAQ: ATNX) announced a positive opinion from the European Medicines Agency's CHMP for its partner Almirall regarding Klisyri® (tirbanibulin) for treating actinic keratosis (AK) of the face or scalp. This first-in-class microtubule inhibitor has shown substantial efficacy and safety in Phase III trials. Athenex stands to gain up to $45 million in milestone payments and tiered royalties starting at 15%. The FDA approved Klisyri® in the U.S. in December 2020, positioning it as a key player in a market where AK affects roughly 18% of the European population.

Athenex, Inc. (NASDAQ: ATNX) announced new clinical data from the GINAKIT2 phase 1 study of KUR-501, a cell therapy candidate targeting GD2 in neuroblastoma. Presented at the ASGCT Annual Meeting, outcomes include one complete response (CR) and one partial response (PR) among 11 patients. Notably, four patients maintained stable disease. The therapy was well tolerated with no significant toxicities observed. The AUC normalized to disease burden indicated a correlation with treatment response. The ongoing study aims to explore additional dose levels and patient treatments.