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Athenex, Inc. (NASDAQ: ATNX) announced plans to request a Type A meeting with the FDA regarding its oral paclitaxel treatment for metastatic breast cancer by the end of May 2021. Following a Complete Response Letter received on February 26, 2021, the company is gathering additional data to address FDA concerns. Athenex also acquired Kuur Therapeutics for $70 million to enhance its cell therapy capabilities. Q1 2021 revenue rose to $20.4 million, up 10% year-over-year, but the company reported a net loss of $25.1 million. Management will host a conference call on May 6, 2021, to discuss the results.
Athenex has acquired Kuur Therapeutics for a total consideration of up to $185 million, including $70 million upfront in common stock and $115 million in potential milestones. This acquisition enhances Athenex's cell therapy development capabilities, leveraging Kuur's innovative allogeneic CAR-NKT technology to target both hematological and solid cancers. The combined platform aims to address limitations in existing therapies and provides potential synergies with Athenex’s TCR program. The acquisition is expected to accelerate development of advanced cancer treatment options.
Athenex, Inc. (NASDAQ: ATNX) will present its first quarter 2021 corporate and financial update on May 6, 2021, prior to market opening. The management team will conduct a conference call at 8:00 am ET, with participation details including the domestic and international dial-in numbers provided. Athenex, dedicated to developing innovative cancer treatments, operates on three platforms and has an extensive clinical pipeline based on several technologies. For further details, visit Athenex's website.
Athenex, Inc. (NASDAQ: ATNX) announced receipt of a Complete Response Letter (CRL) from the FDA regarding its NDA for oral paclitaxel plus encequidar aimed at treating metastatic breast cancer. The CRL raised safety concerns and recommended further clinical trials. Despite this setback, Athenex reported a 54% year-over-year increase in product sales for Q4 2020, totaling $21.8 million. The company expects sales in 2021 to align with 2020 levels, excluding proprietary products. Athenex plans to discuss its next steps in a conference call today at 8:00 a.m. ET.
Athenex, Inc. (NASDAQ: ATNX) announced a complete response letter (CRL) from the FDA regarding its New Drug Application for oral paclitaxel plus encequidar aimed at treating metastatic breast cancer. The FDA cited concerns about increased safety risks, particularly neutropenia, and uncertainties around the objective response rate. The Agency has urged Athenex to conduct a new clinical trial with optimized dosing and to address toxicity risks before potential approval. Athenex plans to meet with the FDA to discuss the next steps.
Athenex, a biopharmaceutical company focused on cancer treatments, announced it will provide a corporate and financial update for Q4 and the full year 2020 on March 1, 2021, before the market opens. A conference call will follow at 8:00 am ET, accessible via phone or audio webcast. Founded in 2003, Athenex operates three platforms aimed at drug development and commercialization. The company's clinical pipeline includes treatments based on various innovative technologies, aiming to improve patient outcomes in oncology.
Athenex announces the expansion of its partnership with PharmaEssentia to include Japan and South Korea for the development and commercialization of tirbanibulin. This follows the recent U.S. launch of Klisyri® (tirbanibulin) for actinic keratosis, approved by the FDA in December 2020. Under the new agreement, Athenex will receive an upfront payment, milestone payments, and tiered royalties on sales in the new territories. The collaboration aims to bring innovative treatment options to patients across Asia, further enhancing Athenex’s global presence.
Almirall, a biopharmaceutical company, has launched Klisyri (tirbanibulin) in the U.S. for treating actinic keratosis (AK) on the face and scalp. Approved by the FDA in December 2020, Klisyri is notable for its short treatment duration of five days. Clinical trials reveal Klisyri achieved a significant 100% clearance in 44% to 54% of patients, outperforming the vehicle control (5% to 13%). With over 40 million diagnoses of AK annually in the U.S., this therapy addresses critical healthcare needs. The partnership with Athenex may drive global peak sales past €250 million.
The New England Journal of Medicine has published Phase III trial results for Klisyri®, a topical treatment for actinic keratosis (AK), developed by Athenex. Klisyri® shows a significant efficacy with 49% clearance of AK lesions compared to 9% with vehicle ointment at day 57. The trials, involving 702 patients, confirmed a favorable safety profile, with no serious adverse effects reported. Athenex's marketing partner, Almirall, is set to launch Klisyri® in the U.S. in February 2021. Approval from the FDA was granted in December 2020.
Almirall, a biopharmaceutical company, announced the publication of Phase III trial results for Klisyri (tirbanibulin) ointment in the New England Journal of Medicine. The studies involved 702 patients and demonstrated significant efficacy with a 44% and 54% complete clearance rate for Klisyri compared to 5% and 13% for the vehicle control. The treatment showed a favorable safety profile with local skin reactions mostly mild to moderate. This novel treatment offers a short 5-day application regimen for actinic keratosis, marking an important advancement in dermatological care.
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