Theralink Technologies (OTC:THER) Stock, Quote.Headers.trade-ideas

Theralink Technologies Inc is a proteomics-based, precision medicine and molecular profiling company that specializes in patented Reverse Phase Protein Array (RPPA) and protein biomarker assay services that target multiple areas of oncology. The company provides precision oncology data through its Theralink Reverse Phase Protein Array (RPPA) assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. The firm is currently generating revenue with its multiple biopharma contracts and by testing breast cancer patients with its patented Theralink assay.

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UPDATE: Bloom Burton Downgrades Theratechnologies to Sell, Lowers PT

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<a href="https://www.globenewswire.com/Tracker?data=mLIEsJVkrlil_WnUKFlxDysBv0SWBEm5dUbjfnkK09CDB12OWRCgVvU2YkpP8zfQszrFg6yh6o2JRYyhOXk9Tf-xnShtKSXlYtOK1DlFo_I=">Theralink Technologies</a>, Inc. (OTC:<a href="https://www.benzinga.com/stock/THER#OTC">THER</a>) ("Theralink"), a precision oncology company with its exclusive commercial RPPA (reverse phase protein array) technology that can help predict which FDA-approved drug is effective in each cancer, today with its merger partner, IMAC Holdings, INC (NASDAQ:<a href="https://www.benzinga.com/stock/BACK#NASDAQ">BACK</a>), announce that the companies have responded to the SEC's first round of comments on the jointly filed form S-4. A Form S-4 is a registration statement that the Securities and Exchange Commission requires all reporting companies to file in order to publicly offer new securities pursuant to a merger or acquisition. The Companies previously filed the S-4 on September 29th and received comments from the SEC in late October. &nbsp;
Theralink's Chief Executive Officer, Faith Zaslavsky previously stated "The filing of the Form S-4 is a major milestone, as it signifies Theralink and IMAC have reached a definitive agreement and that the transaction is moving forward. The result of the Merger will be a well-positioned proteomics pure play squarely focused on the next generation of cancer care and protein analysis, an opportunity that all stakeholders in our companies are highly excited about. I am unaware of any other proteomics company with a robust patent estate, certified and accredited laboratory, and reimbursement agreements in place with major payors like Medicare that parallels what our new combined company possesses along with the leadership to execute and build value."
The companies expect to hear back from the Securities and Exchange Commission within the next 10 business days.

BACK

Theralink And IMAC Holdings Announce Receipt And Response To The Securities And Exchange Commission Comments On The Previously Filed Form S4; Co's Expect To Hear Back From The Securities And Exchange Commission Within The Next 10 Business Days

Theralink Signs Definitive Merger Agreement To Be Acquired By IMAC Holdings; No Terms Disclosed

Theratechnologies (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a Supplemental New Drug Application (sNDA), filed by its commercial partner, EMD Serono, Inc., providing for the revision of the EGRIFTA(TM) (tesamorelin for injection) prescribing information, to include storage conditions for the 2 mg vial up to 12 weeks at or below 25 degrees C after dispensing to the patient. Previously, EGRIFTA(TM) could only be stored between 2 degrees C and 8 degrees C (36 degrees F and 46 degrees F) until the expiration date."Bringing incremental improvements to EGRIFTA(TM)'s presentation and formulation continues to be a top priority for Theratechnologies. Being able to store EGRIFTA(TM) at temperatures reaching 25 degrees C provides storage flexibility for patients who don't always have access to a refrigerator. Other potential improvements are part of our product lifecycle management strategy aimed at improving the product," stated Luc Tanguay, President and CEO of Theratechnologies. In September 2012, EGRIFTA(TM) became available as a single-vial presentation. About Theratechnologies Theratechnologies (TSX:TH) (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) is a specialty pharmaceutical company that discovers and develops innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
 <a href="http://www.benzinga.com/pressreleases/13/01/m3258750/theratechnologies-inc-fda-approves-alternative-storage-conditions-for-e">See full press release</a>

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Theratechnologies Announces FDA Approves SNDA for Alternative Storage Conditions for EGRIFTA

TAT Technologies Ltd (NASDAQ: <a class="ticker" href="/stock/tatt#NASDAQ">TATT</a>) shares lost 0.82% to create a new 52-week low of $3.63. TAT Technologies' trailing-twelve-month ROE is -7.95%

Questcor Pharmaceuticals (NASDAQ: <a class="ticker" href="/stock/qcor#NASDAQ">QCOR</a>) shares fell 3.72% to touch a new 52-week low of $17.56. Questcor Pharmaceuticals shares have dropped 33.65% over the past 52 weeks, while the S&amp;P 500 index has gained 23.52% in the same period.

Amtech Systems (NASDAQ: <a class="ticker" href="/stock/asys#NASDAQ">ASYS</a>) shares dropped 1.98% to create a new 52-week low of $3.46. Amtech Systems' PEG ratio is -0.12.

Theratechnologies (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) shares declined 5.66% to create a new 52-week low of $0.500. Theratechnologies' profit margin is -107.15%.

Eighteen stocks got new bullish or bearish analyst ratings today, and stocks showed reflection immediately after market open. Below we give three analyst ratings and respective stocks ranked by moves in price compared to today's open. These are moves that follow respective analyst ratings (down for new bearish ratings and up for new bullish ratings).

Morgan Stanley on Research In Motion

Morgan Stanley reduced its rating on Research In Motion (NASDAQ: <a class="ticker" href="/stock/rimm#NASDAQ">RIMM</a>) from Equal-weight to Underweight, and reduced its price target on shares to $7. The stock opened at $9.92 and reached a low of $9.03 at 11:20, for an 8.97 percent move. Benzinga Professional reported this development at 5:59 AM. A preview with analyst comments is available <a href="http://www.benzinga.com/analyst-ratings/analyst-color/12/06/2694111/update-morgan-stanley-downgrades-research-in-motion-to-u">here</a>. 

Bloom Burton on Theratechnologies

Bloom Burton cut its rating on Theratechnologies (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) from Hold to Sell and lowered its price target from $2.50 to $0.75. Shares opened at $0.74 and reached a low of $0.65 at 10:13 AM, for a 12.16 percent move. Benzinga Professional reported on this at 7:42 AM. Read a preview of this report with analyst comments <a href="http://www.benzinga.com/analyst-ratings/analyst-color/12/06/2693826/update-bloom-burton-downgrades-theratechnologies-to-sell">here</a>.

Canaccord Genuity on Synageva BioPharma

Canaccord Genuity initiated coverage on Synageva BioPharma (NASDAQ: <a class="ticker" href="/stock/geva#NASDAQ">GEVA</a>) with a Buy rating and a $90 price target. Trading on the stock opened at $38.66 a share. By 11:20 AM, price reached a high of $41.27, up 6.75 percent. Benzinga Professional reported on this initiation at 7 AM. A preview of the analyst report, with comments, is <a href="http://www.benzinga.com/analyst-ratings/analyst-color/12/06/2693407/update-canaccord-genuity-initiates-synageva-biopharma-at">here</a>. 

The Rest of the Ratings

Six of the 18 new bearish (Sell or similar) and bullish (Buy or similar) ratings commanded the price movement for mere minutes before shares moved in the opposite direction. That said, collective moves in the direction of analyst ratings reached 2.33 percent before above stocks deviated. At the time of writing, the collective price move is still a favorable 0.87 percent in the direction of the analyst ratings (up for new Buy ratings and down for new Sell ratings). 

Trading the Ratings

Had traders taken a maximum $5,000 position on each new rating - bought on new Buy ratings and sold on new Sell ratings - and exited near highs of the day on each of those positions, gross profits would have equaled over $2,250. On the other hand, if those positions were still active, the profit would be just over $795. Commission costs would have been $180. Funds needed to trade all positions would have been just under $90 thousand. 

Follow me at <a href="https://twitter.com/#!/ilirshkurti">@ilirshkurti</a>

In a research comment published earlier today, Bloom Burton &amp; Co. Inc. downgraded its rating for Theratechnologies Inc. (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) from Hold to Sell, and lowered its price target from $2.50 to $0.75.

Bloom Burton went on to say “While the stock has already reacted to this negative news, we now see no reason to hold THER stock. THER has a cash balance of $28.5 million (Feb 28, 2012) or $0.47/share, which is steadily declining. We forecast peak sales of Egrifta of $80-100 million with a 12-13% royalty. If we add in expected manufacturing sales, we estimate total Egrifta royalty + revenues to THER of about $25 million in F2013 ($0.40/share). In addition, as a result of this latest news, we could see further cost cutting measures at THER. We believe there are no meaningful milestones to drive value in the stock in the near term.”

Theratechnologies Inc. closed on Friday at $0.73.

Bloom Burton & Co. Downgrades Theratechnologies from Hold  to Sell, Lowers PT to $0.75

Theratechnologies (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) is trading significantly lower on the session following its regulatory update on Tesamorelin this morning. The company announced that it received a notice of non-compliance from the Therapeutic Products Directorate of Health Canada regarding the NDS of Tesamorelin. 

Theratechnologies also announced its commercial partners in the EU and Brazil have withdrawn their marketing authorization applications. The Company said it is currently assessing the impact of these recent developments on its strategic objectives. 

The shares of Theratechnologies are currently trading at $0.79, a loss of $1.07 or 57.53%.

Theratechnologies Down 57% on Tesamorelin Non-Compliance Notice 

Theratechnologies (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) fell 59.95% to $0.7450 at 12:05 am. Theratechnologies provided important regulatory updates on Tesamorelin.

Arena Pharmaceuticals (NASDAQ: <a class="ticker" href="/stock/arna#NASDAQ">ARNA</a>) shares dipped 19.02% to $9.46. Arena Pharmaceuticals shares have jumped 791.60% over the past 52 weeks, while the S&amp;P 500 index has gained 4.50% in the same period.

American Learning (NASDAQ: <a class="ticker" href="/stock/alrn#NASDAQ">ALRN</a>) dropped 15.25% to $0.8899. American Learning's trailing-twelve-month operating margin is -20.87%.

Ryder System (NYSE: <a class="ticker" href="/stock/r#NYSE">R</a>) shares lost 12.70% to $35.58. Ryder cut its fiscal second-quarter and full-year earnings estimates.

ALRN

ARNA

Mid-Day Market Losers

Theratechnologies Inc. (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) announced today that they have entered into a supply, distribution and licensing agreement with Actelion Pharmaceuticals Canada Inc. providing Actelion with the exclusive commercialization rights to tesamorelin in Canada. 

Under the terms of the agreement, Actelion will be responsible for all ongoing regulatory and future commercialization activities in connection with tesamorelin in Canada. Theratechnologies will be responsible for the manufacture and supply of tesamorelin to Actelion, who will purchase tesamorelin at a predetermined transfer price.

Theratechnologies Announces a Supply, Distribution and Licensing Agreement With Actelion Pharmaceuticals Canada

Pre-Market Outlook

General

PREVIEW:Theratechnolgies to Resume Trading at 9am

Theratechnolgies Halted; Pending News

Theratechnologies Inc. (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) today announced that an affiliate of Sanofi, its commercial partner, has submitted a marketing authorization application for tesamorelin in Mexico with the Federal Commission for the Protection against Sanitary Risk (COFEPRIS).

Tesamorelin is proposed for the reduction of excess visceral fat in HIV-infected adult patients suffering from lipodystrophy with lipohypertrophy of the visceral adipose tissue. Theratechnologies estimates that there are approximately 18,000 HIV-infected patients in treatment suffering from excess abdominal fat in Mexico. Currently, there are no approved treatments available for this condition in Latin America.

"With submissions under review in North and South America, Europe and the Middle East, we are pleased that an application has been filed for tesamorelin by our partner Sanofi in Mexico as well," said Mr. John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies. "The geographic scope of our regulatory filings to date, with the support of our commercial partners, demonstrates our drive to help address a currently unmet medical need and our commitment to maximizing the commercial potential of tesamorelin," concluded Mr. Huss.

Theratechnologies Announces Application for Registration of Tesamorelin in Mexico 

Theratechnologies (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) announced today that it has initiated the patient screening process of its phase 2 clinical trial investigating tesamorelin for the treatment of muscle wasting in patients suffering from chronic obstructive pulmonary disease. This follows the investigator meeting, which took place in Montreal, Quebec, Canada, on August 27, 2011. The objective of the study is to evaluate the effects of two doses of a new formulation of tesamorelin on lean body mass, patient functionality and quality of life.

"I am pleased that we have launched our COPD clinical program as planned and on schedule, in our pursuit of a second indication for our lead compound tesamorelin," said Mr. John-Michel T. Huss, President and Chief Executive Officer. "There are millions of patients worldwide suffering from COPD-associated muscle wasting and if successful, we will be able to address a currently unmet medical need," concluded Mr. Huss.
Based on available market and industry data, the Company estimates that in 2010 there were approximately 3.1 million COPD patients in Global Initiative for Chronic Obstructive Lung Disease Stage II or III only, suffering from a muscle wasting condition with a body mass index under 25, when including the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

The COPD clinical program is a multi-center, double-blind, randomized, placebo-controlled phase 2 clinical trial. It is now open for the screening and enrollment of eligible patients and it will be conducted in up to 25 centers in the United States and Canada. The study will examine the safety and efficacy of a daily administration of either a 2 mg or 3 mg dose of a new formulation of tesamorelin for a period of 26 weeks. The primary endpoint is an increase in LBM as measured by dual-emission X-ray absorptiometry. The study will also assess the effect of tesamorelin on patient functionality and quality of life. This will include a six-minute walking distance test, quadriceps muscle strength and a St. George's Respiratory Questionnaire. The Company expects to enroll approximately 200 patients in the study and its results are expected before the end of 2012.
Tesamorelin is a stabilized analogue of the growth hormone-releasing factor that induces growth hormone production in a specific and physiological manner. The anabolic properties of tesamorelin have led Theratechnologies to pursue its development in muscle wasting in patients with COPD as a second indication for the compound. A previously completed phase 2 trial in stable ambulatory COPD patients demonstrated a statistically significant increase in LBM.

"Muscle-wasting in patients with COPD represents an important medical concern. If we can demonstrate that tesamorelin can reverse muscle loss, it could go a long way toward improving functionality of these patients in their daily activities and more generally, their quality of life," stated Dr. Richard Casaburi, Professor of Medicine at the UCLA School of Medicine and Medical Director of the Rehabilitation Clinical Trials Center of the Los Angeles Biomedical Research Institute. Dr. Casaburi is the Lead Investigator for the COPD clinical program.

Events

Theratechnologies Launches Phase 2 Clinical Trial to Investigate Tesamorelin for the Treatment of COPD-Associated Muscle Wasting

Theratechnologies (NASDAQ: <a class="ticker" href="/stock/ther#NASDAQ">THER</a>) today announced that the results of the independent Somatotrophics, Memory, and Aging Research Trial (SMART) were presented during the 2011 Alzheimer's Association International Conference on Alzheimer's Disease Conference being held July 16-21, in Paris, France. 

This single-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial was led by Dr. Michael V. Vitiello of the University of Washington in Seattle to evaluate the effect of tesamorelin on cognitive function in healthy older adults and older adults with mild cognitive impairment (<a class="ticker" href="/stock/mci#">MCI</a>), also known as pre-Alzheimer's syndrome. Theratechnologies supplied the tesamorelin for the purposes of this clinical trial. Currently, tesamorelin is not indicated for treatments related to MCI. 

A total of 152 older adults, half of whom were cognitively normal and half of whom were diagnosed with amnestic MCI, received either tesamorelin or a placebo. Tesamorelin improved executive function (response inhibition, set-shifting, and working memory) in both cognitively normal healthy older adults and in adults with MCI. Tesamorelin also improved delayed verbal recall in adults with MCI.

Theratechnologies: Results of Independent Study on the Effect of Tesamorelin on Cognitive Function Presented at Conference in France 

Theratechnologies Expects 2011 US EGRIFTA Sales $25-30M; Cuts 25% of Workforce

Theratechnologies (NASDAQ: THER) today announced that an affiliate of its commercial partner, Sanofi, has filed an application for registration with the Israeli Ministry of Health for tesamorelin. 

Tesamorelin is an analogue of the growth hormone-releasing factor proposed for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy. Currently, there are no approved treatments for lipodystrophy in HIV-infected patients available in Israel. 

"This marks the first regulatory filing in the Middle East for Theratechnologies' tesamorelin compound, and we are pleased to expand our product's footprint with our partner Sanofi," said John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies. "Sanofi has a global presence and extensive commercialization expertise. We look forward to working with them throughout this regulatory process and in other countries where Sanofi has exclusive commercialization rights for tesamorelin," concluded Mr. Huss. 

Theratechnologies signed a distribution and licensing agreement with an affiliate of Sanofi on December 6, 2010, granting Sanofi exclusive commercialization rights for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East.

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