AcelRX Pharmaceuticals (ACRX) has had an impressive year behind it culminating with the completion of three phase 3 trials for its NanoTab™ platform's ARX-01. The therapy is a sublingual caplet containing sufentanil, an opioid analgesic currently marketed for IV and epidural anesthesia. An effective analgesic, sufentanil is typically administered intravenously for the control of many types of pain. However, its effectiveness wanes after an initial spike of the active ingredient in the patient's blood plasma. ARX-01's goal is to address the issue by administering a constant amount of the active ingredient by absorption through the skin of the sublingual (under the tongue) caplet.
The first of the company's phase 3 topline data sets, for its NanoTab™ system, was announced on November 15th with positive results. Data indicated the therapy was "statistically superior to IV PCA morphine for the PGA (patient global assessment) endpoint (p=0.009)." The trial was evaluating ARX-01 versus IV-administered PCA morphine to control post operative pain. Data was impressive and likely indicative of the results probable for the remaining two trials whose data is scheduled to be released in Q1, 2013. Shares soared on the news, with a new 52-week high of $5.25 reached.
Share price has gradually trended down since the news, with acceleration in decline due to an announcement by the company on Wednesday, December 5th that the company had registered an offering for 10 million shares. The price on the offering was not given, and shareholders began panicking. The company's stock sold off from the closing trade on the Tuesday of $3.94 to the opening trades on the 5th of $3.65. The share price continued to trend down with a closing price on Thursday of $3.31. The market has not been as friendly recently with offerings, partly due to the huge discount of Supernus Pharmaceuticals' (SUPN) 6 million share offering. Trading in the $12-$14 range for much of the month since its October 22nd FDA approval for its epilepsy drug, Oxtellar XR™, Supernus' offering was priced at $8.00 per share, a near 20% discount on the previous day's close and a 33% discount on the $12 range it was trading at just a couple of days before.
In what could catalyze AcelRX's share price today, the company announced after the markets had closed yesterday evening that it was pricing its offering at $3.31, at that day's closing price. Not priced at the discount that many likely expected, the news may catalyze the company's share price to the upside not only on Friday but also well into Q1, 2013. With the remaining two phase 3 trials set to present in Q1, investor interest will likely return in anticipation of the data. Investors interested in the company should preview the phase 2 data with the measured reduction in pain intensity relative to the IV PCA morphine of p