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.

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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.

Insys Therapeutics Inc. (NASDAQ:INSY) Sued

Insys Therapeutics Inc. (NASDAQ:INSY) Sued

Insys Therapeutics Inc. (NASDAQ:INSY) sentiments on Wall Street turned from bad to worse, after the embattled specialty pharmaceutical company responded to claims it fraudulently marketed a powerful painkiller. Shares of the company fell 9.35% to end Tuesday’s trading session at three-year lows.

Insys Therapeutics Inc. (NASDAQ:INSY)

Insys Therapeutics ‘’Fraudulent’ Practices

Investor confidence on the stock continues to hit lower lows after the New Jersey Attorney General accused the company of engaging in a conduct that is ‘nothing short of evil”.

A sell-off wave has pushed the stock to this year’s lows as it continues to trade in a strong downtrend. Insys Therapeutics Inc. (NASDAQ:INSY) is down by more than 10% for the year in an industry that is experiencing strong share growth.

Insys Therapeutics Inc. (NASDAQ:INSY) finds itself in hot water for allegedly directing its sales force to have doctors prescribe its drug, Subsys, for any chronic pain. A point of concern is that the drug was approved only for cancer patients who could not benefit from other opioids.

The lawsuit by New Jersey Attorney General, Christopher Porrino, also alleges that the company paid kickbacks, including sham speaker fees, to medical practitioners as it sought to push for more Subsys prescriptions.

The attorney general’s lawsuit insists that Insys Therapeutics Inc. (NASDAQ:INSY) put hundreds of lives in jeopardy with the illegal practices. One fatality has been reported of a woman who was prescribed Subsys for the treatment of fibromyalgia.

Insys Therapeutics Defense

Insys has quashed the allegations reiterating that Subsys prescription represented about 0.02% of the opioid prescriptions in the U.S. last year. The company says it is working with relevant authorities to resolve issues related to inappropriate action taken by its staff.

“The company is under new management and has replaced 90 percent of the original sales force and commercial organization. While understandable, it’s disingenuous to repeatedly demonize a company that has made a firm and sincere commitment and is taking all the necessary steps to conduct business according to high ethical standards,” Insys Therapeutics in a statement.

Insys Therapeutics Inc. (NASDAQ:INSY) employs about 400 people including scientists, researchers, and physicians who it says are dedicated to coming up with treatment options for various unmet patient needs. However, the company remains under intense scrutiny at a time when opioid abuse is a major public health issue. According to the U.S. Centers for Disease Control and Prevention, there were 33,000 deaths associated with opioid abuse in 2015.

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 $INSY 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.

BioDelivery Sciences Int’l (Nasdaq: BDSI) Gains on CEO Comments

BioDelivery Sciences International Inc. – Nasdaq: BDSI

Yesterday BioDelivery Sciences International President and CEO Mark Sirgo gave shareholders good news. Today shares (BDSI) are responding by gaining over 7% in early trading on the Nasdaq. Sirgo stated to a conference that he forecasts increasing profitability due to the reacquisition of licensing rights to Belbuca, a pain management drug. Sirgo stated “On Jan. 6, we inherited a product on very favorable financial terms that ended the year with a $30 million gross sales run rate”

BioDelivery Sciences International is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine. BDSI utilizes proprietary BioErodible MucoAdhesive and other drug delivery technologies to develop and commercialize new applications of proven therapies aimed at addressing important unmet medical needs. BDSI’s marketed products and those in development address serious and debilitating conditions such as breakthrough cancer pain, chronic pain, painful diabetic neuropathy and opioid dependence.

BDSI has increased year-on-year sales for the past three years and in 2015 BDSI reported a figure of $48.2 million. EPS for BDSI also has been improving though still negative. In 2013 EPS for BDSI was a loss of $1.51 but improved to a smaller loss of $0.72 in 2015. Seven firms follow BioDelivery Sciences. Six rate BDSI shares as a “Strong Buy” and one rates the shares as a “Hold”. Their consensus price target for BDSI is $4.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

Ticker Symbol PLUG
Last Price a/o 8:43 AM EST  $                      2.05
Average Volume                    606,540
Market Cap (mlns)  $                  102.79
Sales (mlns) $43.80
Shares Outstanding (mlns) 54.1
Share Float (mlns) 51.34
Shortable Yes
Optionable Yes
Inside Ownership 1.10%
Short Float 8.65%
Short Interest Ratio 7.32
Quarterly Return -17.39%
YTD Return 8.57%
Year Return -52.14%

Pacira Pharmaceuticals Inc. (Nasdaq: PCRX) Signs Agreement with Depuy Synthes

Pacira Pharmaceuticals, Inc. – Nasdaq: PCRX 

Shares of Pacira Pharmaceuticals, Inc. are up over 5% on news that the company announced an exclusive agreement in the U.S. between DePuy Synthes Sales, Inc. and Pacira Pharmaceuticals Inc. to co-promote Exparel, a long-lasting, non-opioid, local analgesic administered at the orthopaedic surgical site. Pacira Pharmaceuticals trades on the Nasdaq under ticker symbol PCRX.

The agreement allows DePuy Synthes to promote Exparel across its joint reconstruction, spine, sports medicine, and trauma businesses to help with postsurgical patient pain. This will further enhance the company’s portfolio and reach in the operating room while also helping hospital customers better achieve their Triple Aim goals of improving clinical outcomes, reducing costs, and enhancing patient satisfaction. 

In 2015 PCRX enjoyed its first positive EPS ($0.05) in the past five years. Sales have been steadily improving for Pacira. In 2011 reported sales were $15.7 million and in 2015 that figure rose to $249 million.  

Twelve firms follow Pacira Pharmaceuticals. Seven rate PCRS shares as a “Strong Buy” while five rate them as a “Hold”. The consensus price target for PCRX is $44.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

Ticker Symbol PCRX
Last Price a/o 8:44 AM EST  $                    41.00
Average Volume 1.08 million
Market Cap $1.49 Billion
Sales $272.8 million
Shares Outstanding 38.19 million
Share Float 37.23 million
Shortable Yes
Optionable Yes
Inside Ownership 0.20%
Short Float 11.20%
Short Interest Ratio 3.88
Quarterly Return 15.92%
YTD Return 20.59%
Year Return -40.37%

Depomed Inc. (Nasdaq: DEPO) Buyout Imminent?

Depomed Inc. – Nasdaq: DEPO

A New York Post article is sending shares of Depomed Inc. higher in pre-market trading. Depomed Inc. trades on the Nasdaq under ticker DEPO. The article claims that famed Wall St buy-out firm KKR is interested in purchasing Depomed. Previous reports had put any buyout offer would be around $25 a share. At 9:00 AM EST trading for DEPO was under $20.

Newark, CA-based Depomed had previously rejected attempts to purchase the company before finally putting itself out for sale to the market. The moves to reject potential suitors brought scorn for Depomed’s board from shareholders who threatened to remove several board members.

Depomed Inc. specializes in the production of painkillers. Cambria is a drug that addresses migraine headaches but Nucynta, an opiod that carries addiction risks, is their largest source of revenue – $72 million in the last quarter. In addition to its ability to develop and commercialize new drugs, Depomed also has successfully developed and licensed its unique drug-delivery technology, Acuform®. This patented oral-delivery technology allows for the targeted, extended release of pharmaceutical compounds into the upper gastrointestinal tract.

Eight firms follow Depomed Inc. Shares of DEPO have been rated by five analysts as a “Strong Buy”; two as a “Hold”; and one rates it a “Sell”. Revenues and EPS both suffered in 2015 from their 2014 highs.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

Ticker Symbol DEPO
Last Price a/o 9:00 AM EST $19.87
Average Volume 1.68 million
Market Cap 1.11 Billion
Sales $443.2 million
Shares Outstanding 61.42 million
Share Float 60.98 million
Shortable Yes
Optionable Yes
Inside Ownership 0.40%
Short Float 20.61%
Short Interest Ratio 7.46
Quarterly Return -27.83%
YTD Return -0.61%
Year Return -0.61%

Egalet Corporation (Nasdaq: EGLT) Up on Positive News

Egalet Corporation – Nasdaq: EGLT

Shares of Egalet Corporation, based in Wayne, PA, are up today on heavy volume in response to positive news as reported by the company. Egalet Corporation announced positive top-line results from a Category 3 intranasal human abuse potential study of Egalet-002, an abuse-deterrent, extended-release oxycodone product candidate which uses Egalet’s Guardian™ Technology. Egalet-002 is in late-stage development for the management of severe pain that requires around-the-clock, long-term opioid treatment and for which other treatment options are inadequate.

From Egalet Corporation’s press release:

“Given that intranasal abuse is the most common form of non-oral oxycodone abuse, these results, having hit the primary endpoint of reduced maximum drug liking, are promising,” said Bob Radie, president and chief executive officer. “We will look to submit the full data for presentation at a medical meeting in 2017.”

Shares of EGLT closed at $7.01 yesterday but at 2:33 EST shares were trading at $8.12 on heavy volume. Shares of EGLT traded below $4.00 in mid-2015 and above $19.00 in early 2015. Corporate sales rocketed in 2015 – $22.8 million from just $600k in 2011. However, EPS have suffered. In 2015 there was an EPS loss of $2.94, preceded in 2014 by an EPS loss of $2.97. EGLT is traded on the Nasdaq. It is also note-worthy that EGLT has a large short-sale float: 31.7%.

Always perform your own due diligence before making any decisions regarding the buy or sale of any stock. All information or data is provided without any guarantee of its accuracy.

Ticker Symbol EGLT
Last Price a/o 2:44 EST  $                     8.28
Average Volume 556,730
Market Cap $167.12 million
Sales $30.2 million
Shares Outstanding 22.84 million
Share Float 21.99 million
Shortable Yes
Optionable No
Inside Ownership 1.80%
Short Float 31.70%
Short Interest Ratio 12.52
Quarterly Return -1.68%
YTD Return -36.39%
Year Return -34.73%