AcelRx Pharmaceuticals, Inc. (ACRX - Free Report) plunged nearly 60% after it announced that the FDA has issued a complete response letter (“CRL”) to its new drug application (“NDA”) for Dsuvia. The company is looking to get Dsuvia tablets approved for treating moderate-to-severe acute pain following a trauma or injury or surgical procedures.
The NDA included safety data from two phase III studies, which evaluated 30 mcg Dsuvia tablet administered through the company’s non-invasive single-dose applicator ("SDA").
Shares of AcelRx have fallen 17.4% so far this year, underperforming the industry’s gain of 0.5% in the period.
The FDA rejected the NDA in its current form providing recommendations especially regarding safety data and drug administration. The FDA has requested for additional safety data on at least 50 more patients dosed at maximum amount proposed for labelling. The regulatory authority has also recommended changes to labelling to ensure proper administration of the tablet.
AcelRx believes that the data requested in the CRL are manageable. The company is planning to request a meeting with the FDA for discussing the issues before confirming resubmission of the NDA.
A marketing authorization application for the pipeline candidate is under review in the EU.
With no approved products, the company’s growth is completely dependent on its success of opioid analgesics pipeline candidates, which include Dsuvia and Zalviso. Zalviso had also received a CRL in 2014. AcelRx completed a study in August required for resubmission of its NDA, which is anticipated this year.
As evident from the Zalviso CRL, the drug approval process has been delayed by three years. The delays certainly affect the company’s prospects and any other setback will pull shares down further.
Zacks Rank & Stocks to Consider
AcelRx carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Ligand Pharmaceuticals Incorporated (LGND - Free Report) , Aduro BioTech, Inc. (ADRO - Free Report) and Adaptimmune Therapeutics PLC (ADAP - Free Report) . While Ligand and Aduro sport a Zacks Rank #1 (Strong Buy), Adaptimmune carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have remained stable for 2017 and increased from $3.68 to $3.70 for 2018 over the last 30 days. The company delivered positive earnings surprise in two of the trailing four quarters, with an average beat of 6.19%. Share price of the company has increased 41.1% year to date.
Aduro’s loss estimates have narrowed from $1.36 to $1.29 per share for 2017. Estimates have been stable for 2018 over last 60 days. The company came up with positive earnings surprise in two of the trailing four quarters, with an average beat of 2.53%.
Adaptimmune’s loss estimates have narrowed from $1.07 to 95 cents for 2017 and from $1.00 to 90 cents for 2018 over the last 60 days. The company pulled off positive earnings surprise in two of the trailing four quarters, with an average beat of 2.56%. The share price of the company has increased 91.6% year to date.
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