AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)
Shares of AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) fell 5.13% in after-hours trading on Thursday as investors reacted to the company’s Q3 financial results. A wider than expected net loss for the three and nine months ended September 30, 2017, appears to have spooked investors and fueled a sell-off of the stock.
DSUVIA NDA Woes
Investor confidence on the stock has hit an all-time low in the wake of the U.S. Food and Drug Administration issuing a Complete Response Letter to the company’s new drug, Dsuvia. The stock plunged to a new 52-week low of $1.95 after the regulator rejected a New Drug Application (NDA) for the drug, pending submission of additional safety data.
AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) has shed more than 60% in market value over the past one month as investors remain skeptical about Dsuvia prospects following the FDA verdict. Disappointing Q3 financial results could accelerate the stock’s sell-off given that the company has no approved products in the market. Its growth is mostly pegged on the success of its opioid analgesics pipeline which under development.
The specialty Pharmaceutical Company has submitted an application for a Type A meeting with the FDA. The meeting is to be used to shed more light on all the requirements that the company must meet as it eyes DSUVIA NDA resubmission.
AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) has already filed a marketing authorization application in Europe.
“DSUVIA remains our core asset as we believe the recommendations in the CRL are manageable. In addition, we successfully completed the ZALVISO Phase 3 study requested by the FDA, and remain focused on providing physicians and patients with non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings,” said CEO, Vince Angotti.
AcelRx Q3 Financial Results
For the three months ended September 30, 2017, AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) generated a net loss of (-$13) million or (-$0.28) a share, compared to a net loss of (-$11.4) million generated last year. Net loss from operations totaled (-$8.9) million compared to (-$8) million during the third quarter of last year. Net Loss for the first nine months of the year increased to (-$41.4) million from (-$33.5) million as of last year.
Revenue in the quarter totaled $1.5 million made up of $1.2 million related to a collaboration with Grunenthal. Revenue for the nine months ended September 30, 2017, totaled $7.2 million. R&D and G&A expenses for the third quarter totaled $8.3 million and $28.4 million for the nine months ended September 30, 2017.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.