AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)’s Posts Unexpected Net Loss

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.

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Implodes After FDA Rejection

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) shares fell 59.8% after the U.S. Food and Drug Administration declined to approve its opioid painkiller Dsuvia. The agency raised a number of issues that the company needs to address pending any future consideration.

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

FDA Recommendation

One of the recommendations requires AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) to collect additional data on at least 50 patients, assessing the safety of DSUVIA at the maximum amount described in the labeling. The company will also have to ensure proper administration of the tablet with the single dose applicator.

The regulator is also demanding changes to the “Directions for Use” instructions that come with the drug, to address issues of tablets that may need to be disposed of.

The FDA decision rattled investors as most of them were expecting the painkiller to achieve regulatory approval. Analysts were optimistic about the drug gaining regulatory approval on its limited abuse potential. The stock consequently suffered its biggest one-day sell-off since it went public in 2011.

AcelRX Defense

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) has sought to quash investor concern and prevent a further slide in the stock price by insisting that the recommendations by the FDA are manageable. In a statement, the company says it will request a meeting with the FDA to discuss topics in the Complete Response Letter.

“We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA. We remain focused on the NDA resubmission and our mission to provide physicians and patients with precise and efficient non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings,” said CEO Vincent J. Angotti.

The Chef Executive Officer says they have a sufficient cash runway of $67.9 million to complete the Dsuvia marketing application resubmission. The company also plans to make a marketing submission application for its other drug, Zalviso.

Opioid Epidemic

The FDA decision comes at a time when the United States is grappling with a major opioid epidemic. The agency has become cautious in recent years in issuing new approvals on heavy-duty painkillers after more than 33,000 deaths were reported in 2015.

Last month the regulator rejected another opioid painkiller from Intellipharmaceutics as it requested additional data to prove the drug’s ability to prevent abuse.

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.

Don’t miss out! Stay informed on $ACRX and receive breaking news on other hot stocks by signing up for our free newsletter!

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.

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX)

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) Stock Price Drops

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) Stock Price

Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) tumbled 12.82% in Tuesday’s trading session after the company reported second quarter financial results that did not meet Wall St. expectations. A net loss of (-$0.29) cents per share was lower than expectations of a loss of (-$0.28) cents per shares. ACRX stock price dropped even as the company reported a successful ZALVISO Phase 3 trial.

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX)
Two month daily candlebar graph for $ACRX Stock Price

ZALVISO Topline Results

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) is a specialty pharmaceutical company focused on the development of therapies for the treatment of moderate to severe acute pain. DSUVIA is the company’s lead product having been accepted for filing by the U.S. Food and Drug Administration (FDA) for the treatment of acute pain. Zalviso is the company’s lead candidate drug indicated for the management of acute pain.

Zalviso is marketed in Europe as part of a licensing agreement with Grunenthal. During the quarter, the drug generated top line results in Phase 3 study targeting 320 hospitalized, postoperative patients. Trial results indicate that 2.2 % of the patients experienced ZALVISO device error which is below 5% limit specified in study objectives.

“We expect to receive a decision from the FDA on our marketing application for DSUVIA in the fourth quarter and are on track to resubmit the NDA for ZALVISO to the FDA that same quarter. We also continue to manage our expenses and cash in line with our plan leading into these major company milestones,” said Vincent J Angotti.

Widening Net Loss

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) generated a net loss of (-$13.1) million in Q2 compared to a net loss of (-$11.1) million reported last year. Net loss from operations increased to (-$9.9) million from (-$8.3) million as of Q2 2016.

Net loss for the six months ending June 30, 2016, soared to ($28.6) million compared to (-$22.1) million as of the same period last year. AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) attributes the higher than expected net loss to decreased Department of Defense contract revenue for Zalviso, coupled by increased cost of goods.

Revenue from ZALVISO sales increased to $2.2 million from $1.3 million as of Q2 2016. Revenue for the first six months of the year totaled $5.2 million compared to $3.1 million for the six months ended June 30, 2016.

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) cash and cash equivalent as of June 30, 2017, stood at $62.1 million compared to $80.3 million as of December 31, 2016.

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.

Don’t miss out! Stay informed on $ACRX and receive breaking news on other hot stocks by signing up for our free newsletter!

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.

Flex Pharma Inc (NASDAQ:FLKS)

FDA Grants Fast Track for Flex Pharma Inc (NASDAQ:FLKS) ALS Drug

Flex Pharma Inc (NASDAQ:FLKS)

Flex Pharma Inc (NASDAQ:FLKS) gained over 11%, ending the day at $4.33, after the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track (FT) designation for the development of FLX-787, Flex Pharma’s co-activator of TRPA1 and TRPV1, to treat severe muscle cramps in patients with amyotrophic lateral sclerosis (ALS).

Flex Pharma Inc (NASDAQ:FLKS)
1Month Daily Candle Graph for $FLKS

Importantly, reports indicate that there are currently no drugs approved to treat ALS in the U.S. The Fast Track designation is used to accelerate the clinical development and review of drugs to treat serious diseases that have an unmet medical need. The Fast Track designation also allows for more frequent communication with the FDA’s Neurology Division throughout the drug development and review process, with the goal of getting important new drugs to patients more rapidly.

William McVicar, Ph.D., Flex Pharma’s interim President and CEO, stated “With Phase 2 clinical trials in both ALS and CMT expected to initiate this quarter in the US, FLX-787 will be amongst the most advanced, novel compounds in the clinic for these degenerative neurological diseases. The R&D team is focused on the execution of these new Phase 2 IND studies, as well as completion of the ongoing exploratory Phase 2 spasticity study in MS in Australia. These studies are expected to yield several important data readouts in 2018.”

FLKS shares are well below their 52-week high of $12.68 but almost 50% above their 52-week low of $3.01. During the past year shares of Flex Pharma Inc (NASDAQ:FLKS) have fallen over 63%, and are down 18% YTD. Last year they posted their forst sales – totaling $1 million. However, the company has posted increasing losses from the beginning. In 2014 the per share loss was (-$0.45), that was followed by a loss of (-$2.08) in 2015 and a (-$2.43) loss in 2016. Of the five investment analysts that follow Flex Pharma Inc (NASDAQ:FLKS), four rate the shares as a “Strong Buy” and one rates the shares a “Hold”.

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.

Don’t miss out! Stay informed on $FLKS and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

Analyst Review Pushes AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Higher

Daily Candle Bar Graph $ACRX July 18

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) impressive run continued in Monday’s trading session. Analysts at Jefferies initiating coverage of the stock with a share price target of $7 a share has apparently helped strengthen bullish sentiments on the stock. The stock was up by 31.25% to end the day at $3.15 a share.

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)
Daily Candle Bar Graph $ACRX July 18

Clinical Pipeline

Taking into considerations Friday’s and Monday’s rallies, the stock is now up over 21% YTD. The specialty pharmaceutical company specializes in the development and commercialization of therapies for the treatment of acute pain. The company’s lead product is DSUVIA – currently in a Phase III clinical trial as a novel treatment for moderate to severe acute pain.

Zalviso is the company’s other candidate drug for the management of moderate to severe acute pain for patients in a hospital setting. AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) has already completed a Phase 3 clinical trial enrollment and topline results are expected before the end of the year.

During the first quarter, AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) completed a multi-center, double blind placebo trial of DSUVIA. Compared to placebo, the drug successfully reduced pain in patients over the study’s 12-hour period. The drug was also well tolerated in patients with nausea and headache side effects being reported.

Jeffries Sentiments

Early last month the U.S. Food and Drug Administration (FDA) canceled a review of the DSUVIA because of the product’s profile. Analysts at Jefferies believe the drug will be approved in October in a move that observers believe should help push the stock higher.

According to analysts, FDA approval should set the ground running on a potential European approval in the first quarter of next year. The equity firm believes the drug has a 75% and 80% chance of gaining regulatory approval in the U.S. and Europe respectively

“ACRX is under-valued due to potent oral opioid Dsuvia’s promise in medically supervised acute pain markets (~92M patients) and we see high likelihood of U.S./EU approvals in Q4’17/H1’18. Risk/reward is favorable into H1’18 with floor of ~$1.25 (no approvals) vs. $12/share (upside scenario),” Jefferies analysts in a statement.

Separately, AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) reported a net loss of (-$15.6) million in the first quarter compared to a net loss of (-$11) million reported last year. Net loss from operations also soared to highs of (-$12.1) million compared to (-$8.5) million reported last year. Revenue under the collaboration agreement with Grunenthal totaled $3 million compared to $1.8 million as of last year.

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.

Don’t miss out! Stay informed on $ACRX and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.