Get the Latest Investment Ideas Delivered Straight to Your Inbox.

News Update

TICKERS: DRRX

Biopharma Receives PDUFA Goal Date for Nonopioid Pain Drug
News Update

Source:

The FDA deemed the firm's submission for analgesic approval complete.

DURECT Corp. (DRRX:NASDAQ) announced in a news release that the company's full response to the U.S. Food and Drug Administration's (FDA's) POSIMIR query has been accepted by the agency as a complete class 2 resubmission. The FDA set a PDUFA goal date of Dec. 27, 2019.

"We are pleased that the FDA considers our POSIMIR submission to be complete," DURECT President and CEO James E. Brown said in the release.

In the submission, DURECT addresses the issues raised concerning POSIMIR in the FDA's complete response letter and requests approval of the analgesic drug. "New nonopioid pain products are much needed in the postoperative pain setting, and we believe that POSIMIR could be an important contributor," Brown added.

[NLINSERT]

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: DURECT Corp. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.




Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe