Cascadian Therapeutics Inc (USA) (NASDAQ:CASC) announced the appointment of Marc L. Lesnick, Ph.D., as Senior Vice President, Regulatory Affairs and Quality where he will lead the development of global regulatory strategy and quality processes, including advancing the Company’s lead development program, tucatinib, through planned global regulatory processes to potential registration. Dr. Lesnick will be a member of the Company’s executive committee and will report to Scott Myers, President and Chief Executive Officer of Cascadian Therapeutics.
“Marc brings a wealth of product development and regulatory affairs knowledge and expertise, with multiple successful marketing applications in the United States and Europe,” said Scott D. Myers, President and CEO of Cascadian Therapeutics. “His skills and deep experience, particularly outside the United States, will help Cascadian advance tucatinib for the treatment of patients with HER2-positive metastatic breast cancer through late-stage development and U.S. and international regulatory submissions.”
Dr. Lesnick was most recently Senior Vice President, U.S. Regulatory Affairs, Global Development Projects at Shionogi, Inc., the U.S. subsidiary of Shionogi & Co., Ltd., where he led regulatory strategy for an early stage dual-tyrosine kinase inhibitor program for HER2-positive breast cancer, led the filing of a New Drug Application (NDA) for Symproic (naldemedine) and oversaw approval and launch of Osphena (ospemifene) in the field of women’s health. In this role, Dr. Lesnick had oversight of regulatory strategy, regulatory operations, drug safety and medical writing. In his prior role at Optimer Pharmaceuticals, he led the approval of Dificlir (fidaxomicin) in the EU and Dificid (fidaxomicin) in the US. Dr. Lesnick held similar positions at Verus Pharmaceuticals and PAREXEL International. Dr. Lesnick received his Ph.D. from the University of Oregon, and continued his post-doctoral studies at the University of California, San Diego, School of Medicine. (Original Source)
Shares of Cascadian Therapeutics are currently falling 4.91% to $4.45, or down $0.23 in pre-market trading Wednesday. CASC has a 1-year high of $10.98 and a 1-year low of $4.24. The stock’s 50-day moving average is $4.09 and its 200-day moving average is $1.88.
On the ratings front, Cascadian Therapeutics has been the subject of a number of recent research reports. In a report issued on December 7, Cowen analyst Boris Peaker reiterated a Buy rating on CASC. Separately, on November 7, Jefferies Co.’s Gena Wang reiterated a Buy rating on the stock and has a price target of $3.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and Gena Wang have a yearly average return of 3.3% and a loss of -15.6% respectively. Peaker has a success rate of 37% and is ranked #1156 out of 4351 analysts, while Wang has a success rate of 25% and is ranked #4236.
Cascadian Therapeutics, Inc. is a clinical-stage biopharmaceutical company, engages in the development of therapeutic products for the treatment of cancer. Its lead product candidate ONT-380, is an orally active and selective small-molecule HER2 inhibitor. It also develops preclinical product candidates in oncology using Chk1 kinase inhibitor and protocell technology.