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MONTREAL, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a pan-American (ex-US) specialty pharmaceutical company, announced filing of the Supplement to a New Drug Submission (SNDS) of NERLYNX for HER2-Positive Metastatic Breast Cancer in Canada.
NERLYNX was originally approved by Health Canada in July 2019 for the extended adjuvant treatment of women with early stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.1
The SNDS is supported by the results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine versus Tykerb® (lapatinib) plus capecitabine in HER2-positive metastatic breast cancer patients previously treated with ≥ 2 HER2-directed regimens.
“We’re excited to submit a new indication of NERLYNX to Health Canada, enabling us to offer a new targeted treatment option for Canadian women and physicians,” said Samira Sakhia, President and Chief Operating Officer at Knight Therapeutics.
Knight and Puma Biotechnology, Inc. (NASDAQ:PBYI) signed a licensing agreement in January 2019 granting Knight the exclusive right to commercialize NERLYNX® (neratinib) in Canada. Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX® in Canada.
