|Day's Range||1.8000 - 1.8000|
The following is a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs Feb. 13.) Anavex Life Sciences Corp (NASDAQ: AVXL ) ...
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company, today announced an update on its U.S. Food and Drug Administration (FDA) submission for the CellFX System. Previously, the Company submitted a 510(k) to FDA seeking clearance to commercialize its CellFX System. On February 13, 2020, the Company received a Not Substantially Equivalent (NSE) letter from FDA indicating that, based on the data provided, the Company has not demonstrated that the CellFX System is substantially equivalent to the predicate device. The Company will continue to work with FDA in pursuit of a clearance via a new 510(k) submission and is prepared to provide additional clinical data as required.
Pulse Biosciences to Present Data on Nano-Pulse Stimulation Technology for Nodular Basal Cell Carcinoma at IMCAS World Congress 2020
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Pulse Biosciences, Inc. (PLSE) (“Pulse Biosciences” or the “Company”), a novel bioelectric medicine company bringing to market its proprietary CellFX™ System, announced today that the Compensation Committee of the Company’s Board of Directors granted non-qualified stock options covering an aggregate of 17,750 shares of Pulse Biosciences common stock to three recently hired non-executive employees under the Pulse Biosciences 2017 Inducement Equity Incentive Plan on June 17, 2019. The 2017 Inducement Equity Incentive Plan is used exclusively to grant equity awards to individuals who were not previously an employee or non-employee director of Pulse Biosciences as an inducement material to such individual’s entering into employment with Pulse Biosciences in accordance with Nasdaq Marketplace Rule 5635(c)(4).
Pulse Biosciences, Inc. (NASDAQ:PLSE) shareholders might understandably be very concerned that the share price has...