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AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) had a big day on Friday. For longs in the stock, it was a winding road that brought them to this point. After much drama and big plot swings, the company announced on Friday the approval of DSUVIA by the U.S. Food and Drug Administration (FDA). DSUVIA is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

As we covered, the story here is ultimately rooted in an initial misunderstanding of an FDA ad-com briefing put out on October 10 ahead of the committee vote scheduled for October 12.

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) has been developing DSUVIA as a pain solution alternative to opioids, and came into that week with a big binary day on tap. Trading in the stock was heavy and strong arguments and positioning were in play from both sides.

The misunderstanding noted above appeared in a Seeking Alpha article. As history will now relate with a megaphone, the article that popularized the misunderstanding has turned out to be one of the more conspicuously unsuccessful pieces of analysis (or a very successful piece of disinformation?) that comes to mind in recent years in the biotech space.

The article pointed out a statement deep in the briefing that said the committee didn’t like one aspect of the analysis, but it left out the part that said they liked everything else.

The stock was crushed in the premarket and then soared higher during the session. The trapped-in shorts and trapped-out wanna-be longs scrambled all day to catch up to the tape. Two days later, the AdCom vote went well: the company announced that the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10-3 in favor of recommending the approval of DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings for adult patients.

With Friday’s announcement, the whole story comes to a tidy conclusion, and the drug will now be moving full speed ahead into the market.

“The FDA approval of DSUVIA is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings,” said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer, AcelRx.

“As an anesthesiologist, I’ve seen the challenges that IV opioids pose to patients and providers, such as logistical delays in initiating IV lines, difficulty in accessing veins, and medication errors with injectable opioids. AcelRx was founded to develop a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage their patients’ acute pain.”

The DSUVIA commercial launch is expected in the first quarter of 2019.

 

From the Top

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) is a specialty pharmaceutical company that focuses on the development and commercialization of therapies for the treatment of acute pain. Its lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.

DSUVIA (sufentanil sublingual tablet, 30 microgram), known as DZUVEO outside the United States, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings, in adult patients and was designed to eliminate dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) administered by health care professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia.

The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018.

The company also develops ZALVISO, a pre-programmed and patient-controlled analgesia system that allows hospital patients with moderate-to-severe acute pain to self-dose with sufentanil sublingual tablets to manage their pain.

The company was formerly known as SuRx Pharmaceuticals, Inc. and changed its name to AcelRx Pharmaceuticals, Inc. in August 2006. AcelRx Pharmaceuticals, Inc. was founded in 2005 and is headquartered in Redwood City, California.

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) pulled in sales of $818K in its last reported quarterly financials, representing top line growth of -69.2%. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($50.1M against $13.2M).