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Early FDA Approval Speculation Sends AcelRX Pharma Shares Soaring

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Early FDA Approval Speculation Sends AcelRX Pharma Shares Soaring

AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) shares have been on a tear and are trading near a two-year high after speculation started doing the rounds that its pain treatment candidate DSUVIA is poised to get early approval.

About 3.25 million shares exchanged hands, roughly 2.5 times the average volume.

At time of writing, shares of AcelRx were soaring 19.57 percent to $5.50.

Renowned biotech investor James DeYonker tweeted, "$ACRX On their home page, News link is now disabled.updating for early PDUFA approval?(admittedly speculative) http://ir.acelrx.com/phoenix.zhtml?c=241441&p=irol-news&nyo=0 …"

See also: Attention Biotech Investors, Here's Your PDUFA Primer For October

The new drug application for DSUVIA, formerly called as ARX-04, was accepted for review by the FDA under section 505(b)(2) on Feb. 27, 2017.

The provision helps to avoid duplication of studies already performed on a previously approved drug, essentially giving the FDA express permission to rely on data not developed by the NDA applicant.

The treatment candidate is a non-invasive investigational product candidate consisting of 30 mcg sufentanil tablets, delivered sublingually by a healthcare professional using a disposable, pre-filled, single-dose applicator.

Sufentanil is already approved for treating pain. DSUVIA uses this active pharmaceutical ingredient to create an acute pain relief product for scenarios such as a battlefield, an ambulance or a post-op room, according to Seeking Alpha.

DSUVIA was indicated for treating moderate-to-severe acute pain in a medically supervised setting.

The PDUFA action date is set for Oct. 12, 2017.

In June, the company said the FDA notified that an advisory committee meeting is not planned for the NDA, with the Street surmising that the Adcom meeting was skipped due to the NDA being considered under section 505(b)(2).

Related Link: Born On The Battlefield: AcelRx Awaits FDA Ruling On Device That Delivers Potent Opioid To Wounded Soldiers

 

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