22:43 , Sep 13, 2018 |  BC Week In Review  |  Clinical News

Advisory committee meeting Oct. 12 to discuss NDA for Acelrx's Dsuvia

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet Oct. 12 to discuss an NDA from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) for Dsuvia sufentanil sublingual tablet (ARX-04) to manage moderate to severe acute pain severe...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate of...
18:31 , May 25, 2018 |  BC Week In Review  |  Clinical News

FDA reviewing AcelRx's pain candidate

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) said FDA accepted for review an NDA for Dsuvia sufentanil sublingual tablet (ARX-04) to treat moderate to severe acute pain in medically supervised settings. Its PDUFA date is Nov. 3. The company...
20:17 , May 24, 2018 |  BC Extra  |  Company News

FDA reviewing AcelRx's pain candidate

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) said FDA accepted for review an NDA for Dsuvia sufentanil sublingual tablet (ARX-04) to treat moderate to severe acute pain in medically supervised settings. Its PDUFA date is Nov. 3. The company...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
23:25 , Jan 9, 2018 |  BioCentury  |  Finance

Stars in China

A major clinical flop and a spate of weak earnings reports by U.S. large cap biotechs reverberated throughout the sector in the fourth quarter, breaking a three-quarter-long streak of outperformance. Across all market cap bands,...
19:52 , Oct 13, 2017 |  BC Week In Review  |  Clinical News

AcelRx's Dsuvia gets CRL

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) said FDA issued a complete response letter for its NDA for Dsuvia sufentanil sublingual tablet to treat moderate-to-severe acute pain in medically supervised settings. The CRL is the second the company...
22:34 , Oct 12, 2017 |  BC Extra  |  Company News

AcelRx's Dsuvia gets CRL

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) sank $3.20 (60%) to $2.15 after FDA issued a complete response letter for its NDA for Dsuvia sufentanil sublingual tablet (ARX-04) to treat moderate-to-severe acute pain in medically supervised settings. The...
23:10 , Oct 6, 2017 |  BioCentury  |  Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...
21:43 , Aug 11, 2017 |  BC Extra  |  Company News

Management tracks: Orchard, Maverick, Pieris

Gene therapy company Orchard Therapeutics Ltd. (London, U.K.) named Mark Rothera president and CEO. He was chief commercial officer at PTC Therapeutics Inc. (NASDAQ:PTCT). T cell therapy company Maverick Therapeutics Inc. (Brisbane, Calif.) named James Scibetta...