FDA accepted and granted priority review of NDA for Oral Paclitaxel in metastatic breast cancer
PDUFA dates for tirbanibulin ointment and Oral Paclitaxel set for December 30, 2020 and February 28, 2021, respectively
Four abstracts featuring Oral Paclitaxel accepted for presentation at San Antonio Breast Cancer Virtual Symposium
Product sales in Q3 2020 were $24.8 million, up 29% y/y -- raising full year 2020 guidance to low 20% growth
#ATNX announced its financial results and business highlights for the third quarter ended September 30, 2020.
Third Quarter 2020 and Recent Business Highlights:
Oral Paclitaxel for Breast Cancer
The U.S. Food and Drug Administration (FDA) accepted an NDA for Oral Paclitaxel for the treatment of metastatic breast cancer and has granted the application Priority Review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of February 28, 2021.
Launched two new study arms of the I-SPY 2 TRIAL, sponsored by Quantum Leap Healthcare Collaborative, to evaluate Oral Paclitaxel in combination with GSK’s dostarlimab in Stage 2/3 HER2+ and HER2- breast cancer patients.
Tirbanibulin Ointment for Actinic Keratosis
Under the PDUFA, the FDA has set a target action date for tirbanibulin ointment as December 30, 2020.
TCRT-ESO-A2, a TCR-T cell therapy, for NY-ESO-1 positive solid tumors
FDA has allowed the investigational new drug (IND) application for TCRT-ESO-A2, an autologous T-cell receptor (TCR)-T cell therapy. TCRT-ESO-A2 is being developed by Axis Therapeutics Limited, a joint venture between Athenex and Xiangxue Life Sciences Limited.
Product sales growth in the third quarter was primarily driven by sales of specialty pharmaceutical products used to treat patients hospitalized with COVID-19.
Athenex Pharmaceutical Division (APD) currently markets a total of 30 products with 54 SKUs.
Athenex Pharma Solutions (APS) currently markets 6 products with 18 SKUs.
Corporate Financing Highlights:
Completed an underwritten follow-on public offering of a total of 11.5 million shares generating net proceeds of $118.7 million.
Entered into a $50 million revenue interest financing agreement with Sagard Healthcare Royalty Partners, LP. (“Sagard”).
See press release HERE.
See our ATNX AmpCards HERE.