Advertisement
UK markets close in 3 hours 19 minutes

  • FTSE 100

    8,096.40
    +56.02 (+0.70%)
     

  • FTSE 250

    19,728.64
    +9.27 (+0.05%)
     

  • AIM

    755.42
    +0.73 (+0.10%)
     

  • GBP/EUR

    1.1671
    +0.0027 (+0.23%)
     

  • GBP/USD

    1.2511
    +0.0049 (+0.39%)
     

  • Bitcoin GBP

    51,038.46
    -2,290.22 (-4.29%)
     

  • CMC Crypto 200

    1,358.50
    -24.08 (-1.74%)
     

  • S&P 500

    5,071.63
    +1.08 (+0.02%)
     

  • DOW

    38,460.92
    -42.77 (-0.11%)
     

  • CRUDE OIL

    82.99
    +0.18 (+0.22%)
     

  • GOLD FUTURES

    2,340.70
    +2.30 (+0.10%)
     

  • NIKKEI 225

    37,628.48
    -831.60 (-2.16%)
     

  • HANG SENG

    17,284.54
    +83.27 (+0.48%)
     

  • DAX

    17,994.15
    -94.55 (-0.52%)
     

  • CAC 40

    8,029.41
    -62.45 (-0.77%)
     
Stocks:

Trending tickers

Microsoft, Alphabet, Anglo American, IBM, Astrazeneca, Unilever and Sainsbury's

AcelRx's Opioid Painkiller Dsuvia Gets CRL, Shares Plunge

Zacks Equity Research
Updated

AcelRx Pharmaceuticals, Inc. ACRX 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.

ADVERTISEMENT

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.

AcelRx Pharmaceuticals, Inc. Price and Consensus

 

AcelRx Pharmaceuticals, Inc. Price and Consensus | AcelRx Pharmaceuticals, Inc. Quote

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, Aduro BioTech, Inc. ADRO and Adaptimmune Therapeutics PLC ADAP. 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.

4 Stocks to Watch after the Massive Equifax Hack

Cybersecurity stocks spiked on recent news of a data breach affecting 143 million Americans. But which stocks are the best buy candidates right now? And what does the future hold for the cybersecurity industry?

Equifax is just the most recent victim. Computer hacking and identity theft are more common than ever. Zacks has just released Cybersecurity! An Investor’s Guide to inform Zacks.com readers about this $170 billion/year space. More importantly, it highlights 4 cybersecurity picks with strong profit potential.

Get the new Investing Guide now>>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Ligand Pharmaceuticals Incorporated (LGND) : Free Stock Analysis Report
 
Adaptimmune Therapeutics PLC (ADAP) : Free Stock Analysis Report
 
Aduro Biotech, Inc. (ADRO) : Free Stock Analysis Report
 
AcelRx Pharmaceuticals, Inc. (ACRX) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research