Brace yourself. Novavax, Inc. (NASDAQ:NVAX) is on the move today. The vaccine maker’s stock price has spiked dramatically, after reporting positive top-line results from a Phase I/II trial of NanoFlu, an adjuvanted seasonal influenza nanoparticle vaccine candidate for elderly adults aged 60 years or older. The trial’s primary endpoints were met in indicating that NanoFlu is safe and stimulates a robust immune response against multiple strains of the influenza virus that is superior to a high-dose version of the market-leading egg-based vaccine, FluZone HD, which is currently recommended for use in elderly adults.
Analysts seem to be divided on the stock as 3 recommend buying shares of Novavax, while 3 remain on the sidelines. The average 12-month price target between these 6 analysts is $4.30, marking a 86% potential upside from current levels.
Pain Therapeutics, Inc. (NASDAQ:PTIE) shares rose as much as 22% today. The reason? The FDA has determined that a New Drug Application (NDA) for REMOXY ER, the Company’s lead drug candidate, is sufficiently complete to permit a substantive review.
The FDA has set an action date of August 7, 2018 under the Prescription Drug User Fee Act (PDUFA). The Company believes the FDA will hold an open advisory committee meeting to discuss REMOXY ER, although a date has not yet been determined.
“The acceptance of the REMOXY NDA marks another important milestone for Pain Therapeutics,” said Remi Barbier, Chairman, President and Chief Executive Officer of Pain Therapeutics. “We are grateful to everyone who has contributed to the development of REMOXY ER over the years. We now look forward to working closely with the FDA during the regulatory review process.”