DBV Technologies S.A.: DBV Technologies Announces Results of its 2021 Ordinary and Extraordinary General Meeting and the Appointment of Dr. Adora Ndu, Pharm.D., J.D., and Dr. Ravi Madduri Rao, M.D., Ph.D., as Members of its Board of Directors
DBV Technologies Announces Results of its 2021 Ordinary and Extraordinary General Meeting and
Madduri
mbers of its Board of Directors
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today held its Ordinary and Extraordinary General Meeting. DBV Technologies General Meeting was chaired by Michel de Rosen, Chairman of DBV Technologies Board of Directors, in a closed virtual session without the physical presence of shareholders or any other person authorized to attend, at DBV Technologies registered office.
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Interim Report Q1, 2021
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Filing of New Drug Application submission to the FDA Following the positive top line readout of our pivotal Phase 3 trial NefIgArd, which met both the primary and key secondary endpoints with results being statistically significant and clinically relevant we commenced the regulatory filing process which ultimately resulted in the timely filing of the submission to the FDA in Q1 as planned. In April, we received the response from the Food and Drug Administration (FDA) who accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. During Q1, we also submitted a request for accelerated assessment to the EMA, which was granted on April 23rd. These grants reflect the perceived unmet medical need in IgAN by regulators and, in my view, also the strength and overall quality of our dossier.
monday.com Announces Filing of Registration Statement for Proposed Initial Public Offering
Tuesday, May 18, 2021 11:15AM IST (5:45AM GMT)
Tel Aviv, Israel & New York, United States:
monday.com Ltd. (“monday.com”), a work operating system (Work OS) where organizations of any size can create the tools and processes they need to manage every aspect of their work, announced today it has filed a registration statement on Form F-1 with the Securities and Exchange Commission (the “SEC”) relating to the proposed initial public offering of its ordinary shares. The number of shares to be offered and the price range for the proposed offering have not yet been determined. monday.com intends to list its ordinary shares on the Nasdaq Global Select Market under the ticker symbol “MNDY.”