Paratek Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Review Omadacycline New Drug Applications

- August 8th, 2018

Paratek Pharmaceuticals (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that NASDAQ has halted trading of the company’s common stock. As quoted in the press release: The U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee is meeting today to review Paratek’s omadacycline, … Continued

Paratek Pharmaceuticals (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that NASDAQ has halted trading of the company’s common stock.

As quoted in the press release:

The U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee is meeting today to review Paratek’s omadacycline, an investigational once-daily oral and intravenous broad spectrum antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

The Advisory Committee meeting is scheduled from 8:30 a.m. to 1 p.m. ET.  The briefing materials can be found on the FDA website. The Prescription Drug User Fee Act (PDUFA) date for completion of the review of the company’s New Drug Application for omadacycline is in early October 2018.

Advisory committees provide independent advice and recommendations to the Food and Drug Administration (FDA) on scientific and technical matters related to the development and evaluation of products regulated by the Agency.

Click here to read the full press release.

Are You Aware of the FDA's Plans for 2018?

Find out what's going on in our new report
 

Get the latest Biotech Investing stock information

Get the latest information about companies associated with Biotech Investing Delivered directly to your inbox.

Biotech Investing

Select All
Select None

By selecting company or companies above, you are giving consent to receive email from those companies. And remember you can unsubscribe at any time

Leave a Reply

Your email address will not be published. Required fields are marked *