Shares of Dynavax Technologies Corporation (NASDAQ:DVAX) ended Friday session in red amid volatile trading. The shares closed down -0.30 points or -2.80% at $10.40 with 714,420.00 shares getting traded. Post opening the session at $10.65, the shares hit an intraday low of $10.25 and an intraday high of $10.75 and the price vacillated in this range throughout the day. The company has a market cap of $400.37 million and the numbers of outstanding shares have been calculated to be 38.50 million shares.
Dynavax Technologies Corporation (DVAX) announced that the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)].
During recent conversations between Dynavax and the FDA, the Agency communicated decisions to enable compliance with the current Prescription Drug User Fee Act (PDUFA) date of December 15, 2016. The Agency informed Dynavax that the VRBPAC meeting was cancelled and remaining questions will be addressed between Dynavax and the review team via the normal process. The FDA informed Dynavax that it plans to provide information requests related to remaining questions in the upcoming weeks. Dynavax is prepared to address these questions expeditiously in order to enable the FDA to complete its review as soon as possible.
Shares of Ocular Therapeutix Inc (NASDAQ:OCUL) ended Friday session in green amid volatile trading. The shares closed up +0.04 points or 0.58% at $6.88 with 610,688.00 shares getting traded. Post opening the session at $6.80, the shares hit an intraday low of $6.69 and an intraday high of $7.19 and the price vacillated in this range throughout the day. The company has a market cap of $170.77 million and the numbers of outstanding shares have been calculated to be 24.82 million shares.
Ocular Therapeutix Inc (OCUL) announced the appointment of Andy Hurley to the newly created position of chief commercial officer, effective immediately. In this role, Mr. Hurley will be responsible for leading Ocular’s commercial organization, focusing on effective execution of potential future product launches, brand development, and ongoing commercialization strategies.
“Andy brings extensive commercial strategy and product launch expertise as well as a proven ability to develop and lead commercialization efforts globally,” said Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman of Ocular Therapeutix. “Andy’s experience will be extremely valuable as we continue to prepare for the potential launch of our lead product candidate, DEXTENZA™, where our objective is to maximize product uptake and revenue from the outset. If approved by the FDA, we believe DEXTENZA would be the first extended release steroid containing no preservatives available to ophthalmologists that would provide the complete course of therapy with a single placement.”
Mr. Hurley has over two decades of sales, marketing, market access and commercial operations experience across the pharmaceutical industry. Most recently, Mr. Hurley served as Vice President, Sales and Marketing at Dyax Corporation prior to its acquisition by Shire in January 2016. In this role, Mr. Hurley led the strategic and tactical launch planning for the launch of DX-2930, a product candidate under development for the treatment of hereditary angioedema, or HAE. Prior to Dyax, Mr. Hurley held several senior positions within Sunovion Pharmaceuticals, including Vice President of Marketing and Vice President of Commercial Operations. At Sunovion, he was responsible for leading all marketing activities for its asthma franchise, including overall strategic planning, life cycle strategy, advertising campaigns, and market research. He also led commercial operations functions including sales training, relationship marketing and sales operations. Earlier in his career, Mr. Hurley held commercial operations and sales roles at NitroMed and Forest Pharmaceuticals. Mr. Hurley has also held various consulting roles, providing commercial strategy development and tactical support to the biotech industry.