SeekingAlpha  Sep 12  Comment 
By Jason Orestes: It's rare a biotech receives a CRL (Complete Response Letter, a polite way of the FDA rejecting your drug) and becomes more compelling. But after an over 40% haircut post-announcement, that's exactly what has occurred for AcelRx...
SeekingAlpha  Aug 12  Comment 
AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Q2 2014 Earnings Conference Call August 11, 2014 4:30 PM ET Executives Tim Morris – CFO Richard King – President, CEO and Acting Chief Commercial Officer Pam Palmer – Chief Medical...
StreetInsider.com  Jul 28  Comment 
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) 40.4% LOWER; AcelRx Pharma announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso™ (sufentanil...
TheStreet.com  Jul 28  Comment 
NEW YORK (TheStreet) -- AcelRx Pharmaceuticals  plummeted Monday after the FDA rejected the company's painkiller dispensing device Zalviso. AcelRx announced the news late Friday that the FDA did not grant approval to the device. The FDA has...
Benzinga  Jul 28  Comment 
Shares of AcelRx Pharmaceuticals (NASDAQ: ACRX) are selling off sharply monday morning after a blow from the FDA to Zalviso. AcelRx made the announcement at an unusual time: 9:59 p.m. ET Friday. The FDA is looking for more information on...
Benzinga  Jul 28  Comment 
Analysts at Sterne Agee downgraded DSW (NYSE: DSW) from Neutral to Underperform. The target price for DSW is set to $23. DSW's shares closed at $27.16 on Friday. BMO Capital downgraded Pfizer (NYSE: PFE) from Outperform to Market Perform. The...
FierceBiotech  Jul 28  Comment 
Shares of AcelRx took a painful 30% plunge on Monday morning as investors got a chance to respond to the biotech's announcement late Friday night that the FDA had rejected its application for Zalviso, its sufentanil sublingual microtablet...
Benzinga  Jul 28  Comment 
Analysts at Canaccord Genuity downgraded AcelRx Pharmaceuticals (NASDAQ: ACRX) from Buy to Hold. The target price for AcelRx Pharmaceuticals has been lowered from $16.00 to $8.00. AcelRx Pharmaceuticals shares have dropped 7.83% over the past...
StreetInsider.com  Jul 28  Comment 
Visit StreetInsider.com at http://www.streetinsider.com/Corporate+News/AcelRx+%28ACRX%29+Receives+CRL+from+FDA+Requesting+Additional+Information+on+Zalviso/9692829.html for the full story.
SeekingAlpha  Jul 28  Comment 
By Night Owl Investor: What is Zalviso exactly? Zalviso is a drug-device combination being developed by AcelRx (NASDAQ:ACRX). This medication is a sublingual narcotic analgesia for post-operative patients. The drug itself is called Sufentanil...


AcelRx (NASDAQ:ACRX) is a pharmaceutical company which develops and sells treatments for acute and breakthrough pain. In particular, the product would help with post-operative pain. AcelRx has completed Phase 2 and is preparing to conduct two Phase 3 clinical trials for its lead product.[1]

Acute and breakthrough pain associated with the post-operation period is often treated with intravenous (IV) opioid injections. These tend to have negative side effects due to the usage of morphine. In addition, there can be delivery and programming errors from the complex infusion pumps used to provide the patients with the opioid. AcelRx's lead candidate involves a patient administered dosage sublingual, or below the tongue. AcelRx also uses Sufentanil rather than morphine.[2]

The company's initial public offering of stock on the NASDAQ occurred on February 10, 2011. The company offered 8M shares each for $5. The company originally planned to sell 5.8M shares within the range of $12-$14. This would have made the deal worth $75.4M, but the drop in price brought the total deal to $40M even after the rise in shares sold. The lead underwriter of the deal was Piper Jaffray Companies (PJC). Canaccord Capital (BER:C6U), Cowen Group (COWN), and JMP Group (JMP) acted as comanagers.[3]

Because AcelRx does not have a commercially viable yet, the company is still in the pre-revenue stage. As a result, the company has incurred high Research & Development expenses without making money. For the first 9 months of 2010, AcelRx's net loss was $10.8M, 58% of which was from research and development expenses. [4]


  1. ACRX S-1/A 2011 PROSPECTUS SUMMARY "Overview" pg1
  2. ACRX S-1/A 2011 PROSPECTUS SUMMARY "Sufentanil NanoTabs" pg1-2
  3. Renaissance Capital - IPO Home "AcelRx prices IPO at $5, below the original $12-$14 range" 11 Feb 2011
  4. ACRX S-1/A 2011 PROSPECTUS SUMMARY "Summary Financial Data" pg10
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