DURECT Announces Submission to FDA of a Full Response to the POSIMIR® Complete Response Letter
DURECT Corporation (DRRX)
Last durect corporation earnings: 3/3 04:05 pm
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US:NASDAQ Investor Relations:
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Source: PR Newswire
CUPERTINO, Calif., June 27, 2019 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced it has submitted a full response to the Complete Response Letter (CRL) it previously received from U.S. Food and Drug Administration (FDA) related to POSIMIR® (bupivacaine extended-release solution). The submission is intended to address the issues raised in the CRL and seeks FDA approval of POSIMIR based on what the Company and its advisors believe is adequate evidence of both safety and efficacy.DURECT commissioned the advisory services of Dr. Lee S. Simon to first evaluate the adequacy of the existing POSIMIR package to address the issues raised in FDA correspondence, including the CRL, and then to lead the Company's efforts to submit its response to the CRL. Dr. Simon is a physician and research scientist who served as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products from 2001 to 2003, and is now a Principal at SDG, LLC, an FDA advisory fi
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News
- DURECT Corporation (NASDAQ:DRRX) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- DURECT Co. (NASDAQ: DRRX) had its "outperform" rating re-affirmed by analysts at Oppenheimer Holdings Inc.. They now have a $5.00 price target on the stock.MarketBeat
- DURECT Co. (NASDAQ: DRRX) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- DURECT Co. (NASDAQ: DRRX) had its "neutral" rating re-affirmed by analysts at HC Wainwright.MarketBeat
- Durect (DRRX) Reports Q4 Loss, Misses Revenue Estimates [Yahoo! Finance]Yahoo! Finance
DRRX
Earnings
- 3/27/24 - Beat
DRRX
Sec Filings
- 3/28/24 - Form 424B5
- 3/28/24 - Form 10-K
- 3/27/24 - Form 8-K
- DRRX's page on the SEC website