12:00 AM
Oct 07, 2013
 |  BioCentury  |  Finance

Regulatory milestones

Regulatory, clinical and other milestones
Regulatory milestones

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) gained $0.37 to $10.96 last week after submitting an NDA to FDA for Zalviso sufentanil sublingual microtablet system to manage moderate to severe acute pain in a hospital setting. The company submitted the application under section 505(b)(2) of the Food, Drug and Cosmetic Act.

Anacor Pharmaceuticals Inc. (NASDAQ:ANAC) jumped $2 (20%) to $12.17 last week after FDA accepted an NDA for tavaborole to treat onychomycosis. The PDUFA date is July 29.

Discovery Laboratories Inc. (NASDAQ:DSCO) gained $0.73 (37%) to $2.70 on Friday after confirming it plans to launch Surfaxin lucinactant this quarter. The news came after FDA agreed to the company's updated product specifications for the humanized lung surfactant.

The agency approved Surfaxin in March to prevent respiratory distress syndrome (RDS) in premature infants, and Discovery had planned the launch in 2Q13. However, in April the company said FDA requested clarification on the manufacturing process.

Discovery Labs was up $0.71 (36%) on the week.

H. Lundbeck A/S (CSE:LUN) was off DKK0.50 to DKK119.50 last week after FDA approved an NDA from partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) for Brintellix vortioxetine to treat major depressive disorder (MDD). The companies plan to launch Brintellix in the U.S. by year end. The product is under review in Europe.

Omeros Corp. (NASDAQ:OMER) gained $1.51 (16%) to $11.19 on Wednesday after FDA and EMA accepted for review applications for OMS302 to maintain intraoperative mydriasis, prevent intraoperative miosis and reduce postoperative ocular pain in patients undergoing intraocular lens replacement surgery. The company submitted the NDA in July; a standard 10-month review would place the PDUFA date in May 2014. A specific date...

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