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AcelRx Pharmaceuticals Inc.


AcelRX Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. Its lead product, Zalviso (sufentanil sublingual microtablet system), is designed to address IV patient-controlled analgesia problems. AcelRx has announced positive results from each of the three phase 3 clinical trials for Zalviso and has submitted an NDA to the FDA seeking its approval. The company has three additional product candidates in clinical development: ARX-02 for the treatment of cancer breakthrough pain; ARX-03 for providing mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office; and ARX-04, a noninvasive, fast-onset sublingual product for the treatment of moderate to severe acute pain.

The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

The Life Sciences Report Interview with Chen Lin (2/20/14) "AcelRx Pharmaceuticals Inc. produces a product to replace morphine after operations. . .a revolutionary painkiller, Zalviso (sufentanil sublingual microtablet system), which can be put under your tongue. Patients can self-control the amount released to reduce pain. The drug is set for approval in July of this year. . .the painkiller is a controlled substance. It is released in increments by a secure, self-controlled device. It is only for use after an operation and only by prescription. AcelRx has a related product, ARX-04 (sufentanil acute pain nanotab), that is in development for the Army to use on the battlefield. That is further back in the pipeline—in phase 2—but it looks to be a very positive product. . .I hold a strong position in AcelRx. . .it is still a very good buy, with lots of upside, because the FDA approval is probably worth $30–40/share." More >

Randall Stanicky, RBC Capital Markets (2/12/14) "We leave our meetings with AcelRx Pharmaceuticals Inc.'s management, continuing to feel like there is likely to be significant upside to the stock, but the key question is when. . .the July 27 Prescription Drug User Fee Act (PDUFA) date is still the key event and less than six months away. . .we do see upcoming updates that can help drive momentum with the stock likely to lift as we get closer to the PDUFA."

Mario Corso, Mizuho Securities (1/16/14) "We continue to expect U.S. Food and Drug Administration (FDA) approval of AcelRx Pharmaceuticals Inc.'s Zalviso at/near the July Prescription Drug User Fee Act (PDUFA) date with revenue potential of +$500M. . .if it is approved at the July PDUFA, it could be shipped by year end. A 3-month delay for chemistry, manufacturing and controls/logistical reasons is possible but a 2015 full launch either way."

Mario Corso, Mizuho Securities (1/6/14) "AcelRx Pharmaceuticals Inc. fits our top pick profile in the <$1B arena. It is a rare, undervalued, new drug application-stage company targeting a $1B market (acute hospital pain) with ample cash for 12–18 months; the next catalyst is the Zalviso Prescription Drug User Fee Act date on July 27."

The Life Sciences Report Interview with Chen Lin (6/27/13) "AcelRx Pharmaceuticals Inc. did extremely well this year. It is designing a new therapy that replaces intravenous (IV) morphine after surgery. We all have been with or seen people who recently have had surgery. Patients usually have needles stuck in their arms to inject morphine. It takes usually two nurses to double check and make sure that the right amount of morphine is being injected with a standard IV. But still, one in every nine IVs has an error. That has created a lot of potential liability for hospitals and is also bad for the patients. In addition, as a patient, placing an IV is a very uncomfortable process, and it can be hard to move around with an IV.

AcelRx has developed a revolutionary delivery product—basically a tiny tablet you put under your tongue. The tablet, part of AcelRx's nanotab technology, is preprogrammed. This takes away potential liability and work for the hospital. The phase 3 test results were fantastic. The company will apply for approval very soon. We've already seen very strong insider buying. The stock tripled this year, so it's been a winner for me. . .it's a potential billion-dollar per year market. The company's market cap right now is about $323M. I see the company as a huge success if it gets FDA approval for its technology. There is much more upside." More >

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