NewLink Genetics Corporation (NASDAQ:NLNK) Has a Big Day

NewLink Genetics Corporation (NASDAQ:NLNK)

NewLink Genetics Corporation (NASDAQ:NLNK) gained 17.5% today on over five times the average daily volume. NewLink Genetics announced that it will be presenting at the 2017 American Association of Cancer Research annual meeting. Experts claim that when a firm agrees to participate in such an event, there is a high likelihood that they will be presenting positive news on one of their drug or treatment candidates.

NewLink Genetics (NASDAQ:NLNK) is a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of cancer patients. NewLink Genetics’ product candidates are designed to harness multiple components of the immune system to combat cancer.

Tuesday, February 28, 2017, NewLink Genetics Corp. (NASDAQ:NLNK) reported Q4 and full year earnings. NewLinks lost $13.5 million in its fourth quarter. The Ames, IA-based company said it had a loss of $0.46/share. The results exceeded Wall Street expectations. The average of analysts estimates of four analysts was reported to be a loss of $0.66/share. NewLink Genetics posted revenue of $12.7 million in the period – beating analyst estimates of $4.3 million. NewLink posted a yearly loss of $85.2 million, or $2.94 per share. Revenue was reported as $35.8 million.

NewLink Genetics Corp. (NASDAQ:NLNK) shares have risen 38.2% this week and 92% YTD. NLNK shares started the year around $10 and have risen in value each month for the past three months but are still over 4% from their 52-week highs. Of the six firms that follow NewLink Genetics Corp. (NASDAQ:NLNK), four rate the shares as a “Strong Buy” and two rate NLNK shares as a “Hold”.

3/2/2017
Ticker Symbol NLNK
Last Price a/o 5:08 PM EST  $                    19.73
Average Volume                    281,750
Market Cap (mlns)  $                  578.88
Sales (mlns) $30.70
Shares Outstanding (mlns) 29.34
Share Float (mlns) 21.62
Shortable Yes
Optionable Yes
Inside Ownership 1.50%
Short Float 10.61%
Short Interest Ratio 8.14
Quarterly Return 72.16%
YTD Return 91.93%
Year Return -0.85%

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. 

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.

Pacific Ethanol, Inc. (NASD:PEIX) Beats Estimates but Market Sells

Pacific Ethanol, Inc. (NASD:PEIX)

Pacific Ethanol, Inc. (NASD:PEIX) gapped up on the open and gained 12% before pulling back into negative territory. Yesterday PEIX shares closed at $8.35 and this morning reached $9.35 based on a Q4 and 2016 full-year earnings report that beat analyst expectations. Trading has been around three times the average daily volume.

For Q4 2016, Pacific Ethanol, Inc. (NASD:PEIX) reported net income of $13.1 million – a YoY gain of 17%. Q4 2016 operating income was $18.8 million versus $0.5 million for the same period last year. Net income available to common stockholders was $12.6 million, or $0.30/share, compared to a net loss of $1.1 million, or $0.03/share in Q4 2015.

For the year 2016, net sales were $1,624.8 million, compared to $1,191.2 million in 2015. Gross profit was $51.8 million, compared to $7.4 million in 2015. Net income available to common stockholders was $0.1 million, or $0.00/share, compared to a 2015 net loss of $20.1 million, or $0.60/share.

Pacific Ethanol is a producer and marketer of low-carbon renewable fuels in the Western United States. Pacific Ethanol, Inc. (NASD:PEIX) owns eight ethanol production facilities, four in the Western states of California, Oregon, and Idaho, and four in the Midwestern states of Illinois and Nebraska. The plants have a combined production capacity of 515 million gallons per year, produce over 1 million tons per year of ethanol co-products such as wet and dry distiller grains, wet and dry corn gluten feed, condensed distillers solubles, corn gluten meal, corn germ, corn oil, distillers yeast, and CO2.

Ethanol could be considered an integral part of the country’s transportation fuel market, currently representing nearly 10% of the overall gasoline supply in the United States. Ethanol has many advantages as a component of our transportation fuels. It is made from domestically produced renewable resources and reduces air pollution and carbon dioxide. With its high octane rating, ethanol is claimed to add value to gasoline blends. Ethanol also helps consumers by increasing domestic fuel supplies and refining capacity.

Pacific Ethanol, Inc. (NASD:PEIX) sales have increased from $900 million in 2011 to $1.19 billion in 2015. EPS has been erratic. In 2011 PEIX shareholders experienced a positive EPS of $0.80 – and also in 2014 when the company posted a profit of $0.93 EPS. However there were EPS losses in 2012 (-$2.81), 2013 (-$0.17), and in 2015 (-$0.60). PEIX is currently trading down over 3% below yesterday’s close.

3/2/2017
Ticker Symbol PEIX
Last Price a/o 2:27 PM EST  $                      8.10
Average Volume                    568,000
Market Cap (mlns)  $                  358.13
Sales (mlns) $1,560.00
Shares Outstanding (mlns) 42.89
Share Float (mlns) 34.89
Shortable Yes
Optionable Yes
Inside Ownership 0.20%
Short Float 2.87%
Short Interest Ratio 1.77
Quarterly Return -1.18%
YTD Return -12.11%
Year Return 105.16%

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. 

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.

W&T Offshore Inc. (NYSE:WTI) Could be on the Launch Pad

W&T Offshore Inc. (NYSE:WTI)

W&T Offshore Inc. (NYSE:WTI) is up for the mast month after the independent oil and gas drilling company posted 4th quarter and 2016 results. WTI shares closed at $2.62 on Wednesday but have reached $3.08 in inter-day trading – a gain of over 17%. Volumes have already doubled yesterday’s total.

W&T Offshore Inc. (NYSE:WTI) total annual production was down 1.7 million barrels of oil equivalent (“MMBoe”) in Q4 2016 – down 9.9% from Q4 2015. The lower production was due to natural production declines, well performance, pipeline outages along with field and platform maintenance.  This under-performance was partially offset by new oil production from the development of certain deepwater fields. For the quarter, revenues were $115.2 million, 72% of which was from oil and NGLs, and were up $11.1 million compared to Q4 2015.

Houston, TX-based W&T Offshore, Inc. (NYSE:WTI) is an independent oil and natural gas producer. The company acquires, explores, and develops oil and natural gas fields in the Gulf of Mexico. W&T holds working interests in approximately 54 offshore fields in federal and state waters. W&T has reserves of 76.4 million barrels of oil equivalent.

For the year, W&T Offshore, Inc. (NYSE:WTI) was downgraded by three firms in 2016. WTI performance lags behind oil exploration and drilling ETFs such as $XOP and $IEO. $WTI is up 12%, while XOP is up 44%, and $IEO has gained 30%. It should be noted that the constituents in these ETFs are larger and have access to more favorable financing in an industry that relies heavily on its ability to manage cashflows against volatile pricing.

3/2/2017
Ticker Symbol WTI
Last Price a/o 1:15 PM EST  $                      3.01
Average Volume                2,320,000
Market Cap (mlns)  $                  367.51
Sales (mlns) $388.80
Shares Outstanding (mlns) 140.27
Share Float (mlns) 91.79
Shortable Yes
Optionable Yes
Inside Ownership 32.90%
Short Float 10.17%
Short Interest Ratio 4.02
Quarterly Return 63.75%
YTD Return -5.42%
Year Return 20.74%

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. 

About the author: James Marion is a University of Houston student studying Business with a concentration in Finance.

Why Karyopharm Therapeutics Inc. (NASDAQ:KPTI) Popped

Karyopharm Therapeutics Inc. (NASDAQ:KPTI)

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) has announced it will be presenting at the 2017 American Association for Cancer Research annual meeting. KPTI shares were up over 32%, to a high of $14.63, on the news. Volumes are heavy – over ten times the pro-rata daily average. Traders are expecting that the presentation will reveal positive news concerning Karyopharm’s drug candidates selinexor (KPT-330), KPT-8602, and KPT-9274.

Selinexor is being evaluated in multiple later stage clinical trials in patients with relapsed and/or refractory hematological and solid tumor malignancies. To date, selinexor has been administered to more than 1,900 patients across company-sponsored and investigator-sponsored clinical trials. Karyopharm Therapeutics Inc. (NASDAQ:KPTI) will initiate a pivotal randomized Phase 3 study, known as the BOSTON (Bortezomib, Selinexor and dexamethasone) study in early 2017 which will evaluate selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (SVd) compared to bortezomib and low-dose dexamethasone (Vd) in patients with multiple myeloma who have had one to three prior lines of therapy.

In preclinical models, KPT-8602 has a broad therapeutic window with minimal penetration of the blood brain barrier and, therefore, has the potential to serve as a second generation SINE™ compound for cancer indications. The first-in-humans clinical trial for KPT-8602 is a Phase 1/2 study in patients with relapsed/refractory multiple myeloma. The first patient in the Phase 1 dose escalation portion of the study was dosed in January 2016.

KPT-9274 is a first-in-class orally bioavailable small molecule that is a non-competitive dual modulator of PAK4 and NAMPT. Co-inhibition of these targets leads to synergistic anti-tumor effects through energy depletion, inhibition of DNA repair, cell cycle arrest, inhibition of proliferation, and ultimately apoptosis. The first patient was dosed with KPT-9274 in June 2016.

Of the eight firms that follow Karyopharm Therapeutics Inc. (NASDAQ:KPTI), six rate KPTI shares as a “Strong Buy”, one rates the shares as a “Buy” and one rates the shares as an “Underperform”. The MA-based biotech firm has reported negative EPS every year since 2011 and in 2015 reported an EPS loss of $3.32. Sales increased 50% in 2015 to $300,000 but were down from 2012 when the company posted $600,000 in sales.

3/2/2017
Ticker Symbol KPTI
Last Price a/o 11:02 AM EST  $                    13.38
Average Volume                    184,750
Market Cap (mlns)  $                  462.60
Sales (mlns) $0.10
Shares Outstanding (mlns) 41.94
Share Float (mlns) 29.67
Shortable Yes
Optionable Yes
Inside Ownership 0.10%
Short Float 4.97%
Short Interest Ratio 7.98
Quarterly Return 18.73%
YTD Return 17.34%
Year Return 73.16%

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.

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Phase 2 Data Boosts Shares of Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)

Shares of Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) have hit $6.35 (up over 70%) in pre-market trading on heavy volumes. The Canadian-based company released top-line results from its Phase 2b AURA-LV (AURA) study in lupus nephritis with the firm’s product candidate voclosporin.

Lupus nephritis is a type of kidney disease. The Lupus Foundation of America estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus. Lupus is much more common in women than in men and most often strikes during the child-bearing years. Nine out of ten people who have lupus are women and is found more frequently in people of African or Asian background. African Americans and Asian Americans are about 2 to 3 times more likely to develop lupus than Caucasians.

At 48 weeks, the trial met the complete and partial remission endpoints, demonstrating statistically significantly greater complete and partial endpoints in patients in both low dose and high dose cohorts versus the control group. No unexpected safety signals were observed and there were no additional deaths in the voclosporin treated patients; however, there were three deaths and one malignancy reported in the control arm after completion of the study treatment period. Three deaths occurred during the trail but, according to reports, all were in the placebo group of the trial.

Dr. Brad Rovin, FASN, Director of Nephrology and Vice Chairman of Research for the Department of Internal Medicine at the Ohio State University Wexner Medical Center stated in a press release “The AURA trial’s long-term results convincingly demonstrate that the addition of voclosporin to standard of care treatment is superior to standard of care alone. These data are not only statistically significant, but clinically important. Twice as many patients given 23.7mg voclosporin twice daily achieved a complete renal response compared to those treated with placebo.”

Prior to today’s market activity, Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) had impressive performance. AUPHG shares were up 77.5% for the year, 76.7% YTD, and 15.94% for the month. Should AUPH hold these price levels, it will close the day with new 52-week closing highs. Five firms follow Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH). Four rate AUPH shares as a “Strong Buy” and one rates the shares as a “Hold”.

3/2/2017
Ticker Symbol AUPH
Last Price a/o 9:00 AM EST  $                      6.18
Average Volume                1,750,000
Market Cap (mlns)  $                  143.93
Sales (mlns) $0.20
Shares Outstanding (mlns) 38.79
Share Float (mlns) 22.43
Shortable Yes
Optionable Yes
Inside Ownership 0.00%
Short Float 11.73%
Short Interest Ratio 1.5
Quarterly Return 23.67%
YTD Return 76.67%
Year Return 77.51%

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. 

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.

Harmonic Inc. (NASDAQ:HLIT) Fighting the Shorts

Harmonic Inc. (NASDAQ:HLIT)

Harmonic Inc. (NASDAQ:HLIT) are trading near resistance levels and the short sellers are out. HLIT has a short float of 13.64% and a short ratio of 13.64. The short float is the numbers of shares held short divided by the number of shares in the float. The short interest ratio is defined as the short float divided by the average daily volume. It is also known as “days to cover”. Often used as a sentiment indicator, a value over five is often considered a bearish signal.

In September and October of 2016, HLIT shares briefly traded just over $6.00 before retreating below $4. Prior to that, in 2015 HLIT tried to hold above $6 from August through October before retreating back below $3. Currently HLIT is 3.75% below its 52-week high and has gained 17% in the past month, and is up 18% YTD.

On Tuesday, Harmonic Inc. (NASDAQ:HLIT) released their quarterly earnings and beat estimates. EPS was forecast at $0.06 and HLIT came in at $0.08. Revenues were posted at $113.1 million, besting analyst estimates by $5. Despite the good-looking figures, Q1 guidance was not as bright. The company is forecasting revenues between $87 and $95 million which is under the expected figure of $96.9 million.

Recent news includes an announcement today that that MLB Network has upgraded its existing Harmonic playout platform with a new software-based Spectrum™ X advanced media server system. Free PR such as this may allow shares of Harmonic Inc. (NASDAQ:HLIT) to breech the $6 resistance level and force some shorts to cover. But at the end of the day, it is about earnings and future growth. There is some strong sentiment that the company will not be a rising star, but if the market keep hitting new highs and Harmonic Inc. (NASDAQ:HLIT) keeps reporting financial news that is in-line or better than expectations, there could be a stampede of short covering.

3/1/2017
Ticker Symbol HLIT
Last Price a/o 4:43 PM EST  $                      5.90
Average Volume                    532,100
Market Cap (mlns)  $                  423.09
Sales (mlns) $379.40
Shares Outstanding (mlns) 78.35
Share Float (mlns) 76.16
Shortable Yes
Optionable Yes
Inside Ownership 2.70%
Short Float 13.64%
Short Interest Ratio 19.52
Quarterly Return 14.89%
YTD Return 8.00%
Year Return 61.19%

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.

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Maxwell Technologies, Inc. (NASDAQ:MXWL) Barely Moves Despite Earnings Announcement and Restructuring Plans

Maxwell Technologies, Inc. (NASDAQ:MXWL)

Maxwell Technologies, Inc. (NASDAQ:MXWL) reported, after the close of the market’s regular session, operational and financial results for the three months ended December 31, 2016. Results were generally in line with analyst expectations and MXWL shares barely moved in the after-market – down 1.57% to $5.00. Also announced with Q4 earnings were corporate actions which will likely have a large influence on future earnings.

Total revenues for Q4 2016 were $26.4 million, compared with $25.5 million for Q3 2016 and $49.8 million for the same quarter of the prior year. Net loss for Q4 2016 was $12.2 million, compared with a net loss of $6.9 million for Q3 2016 and a net loss of $2.2 million for the prior year quarter.

San Diego, CA-based Maxwell Technologies, Inc. (NASDAQ:MXWL) develops, manufactures, and markets energy storage and power delivery products globally. The company also provides radiation-hardened microelectronic products consisting of single board computers and components comprising high-density memory and data conversion modules for satellites and spacecraft applications.

Also announced today was the news that Maxwell Technologies, Inc. (NASDAQ:MXWL) will purchase the operating entities of Nesscap Energy, Inc., a developer and manufacturer of ultracapacitor products for use in transportation, renewable energy, industrial and consumer markets, for an aggregate purchase price of $23.175 million, payable in common shares that are subject to a 10% collar adjustment at close. Maxwell expects to benefit from synergies between the two companies that will accelerate revenue and earnings growth, increase the pace of innovation, and create a broader and more advanced product portfolio.

Maxwell Technologies, Inc. (NASDAQ:MXWL) also announced a global restructuring plan which includes a reduction-in-force as well as a consolidation of their manufacturing and supply chains. The company is, however, expanding in one area – the Chinese bus market. Maxwell expanded their agreement with CRRC Qingdao Sifang Rolling Stock Research Institute Co. Ltd. which localizes the manufacturing of ultracapacitor-based modules for use in the China-based bus market.  

2/28/2017
Ticker Symbol MXWL
Last Price a/o 7:53 PM EST  $                      5.00
Average Volume                    166,310
Market Cap (mlns)  $                  161.04
Sales (mlns) $144.70
Shares Outstanding (mlns) 31.7
Share Float (mlns) 31.14
Shortable Yes
Optionable Yes
Inside Ownership 0.70%
Short Float 6.13%
Short Interest Ratio 11.49
Quarterly Return -2.50%
YTD Return -0.78%
Year Return -11.34%

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.

 About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

 

Microbot Medical Inc. (NASDAQ:MBOT) Rises with Large Volumes and No News

Microbot Medical Inc. (NASDAQ:MBOT)

Microbot Medical Inc. (NASDAQ:MBOT) shares have been up on huge volumes. MBOT closed Monday at $5.80 and took off this morning when it opened at $5.76 then hit $6.97 in less than an hour. Volumes are very heavy. MBOT shares average about 435,000 shares traded daily but this morning already 1.2 million shares have traded hands in the first hour of trading. No news has been released that might account for this much activity.

Microbot Medical Inc. (NASDAQ:MBOT) specializes in transformational micro-robotic medical technologies leveraging the natural and artificial lumens within the human body. Microbot Medical Inc. (NASDAQ:MBOT) current platforms, ViRob and TipCAT, are comprised of two highly advanced micro-robotic technologies, from which the Company is currently developing its first two product candidates: the Self Cleaning Shunt, or SCS, for the treatment of hydrocephalus and Normal Pressure Hydrocephalus, or NPH; and a self-propelling, semi-disposable endoscope that is being developed initially for use in colonoscopy procedures.

Shares of Microbot Medical Inc. (NASDAQ:MBOT) are down over 85% for the year but up over 12% for the month. Trader chat rooms are wondering what the fuel is that is pushing shares higher on such large volumes. An internet search on mainstream financial news websites revealed no news being released on the company today.

Microbot Medical Inc. (NASDAQ:MBOT) had its worst year for sales in 2015 – it reported a figure of just $100,000. EPS losses draw the most attention though. In 2011, MBOT lost $162.36 EPS. That figure was narrower in 2015 when Microbot reported an EPS loss of $41.05. In the meantime, the number of outstanbding shares has increased every year since 2011 when it had 130,000 shares outstanding. In 2015 that number had grown to 890,000. The sole firm that covers Microbot Medical Inc. (NASDAQ:MBOT) rates the shares a “Hold”.

2/28/2017
Ticker Symbol MBOT
Last Price a/o 10:18 AM EST  $                      6.76
Average Volume                    435,350
Market Cap (mlns)  $                  165.42
Sales (mlns) $0.10
Shares Outstanding (mlns) 28.52
Share Float (mlns) 5.6
Shortable Yes
Optionable No
Inside Ownership 4.50%
Short Float 6.59%
Short Interest Ratio 0.85
Quarterly Return -46.74%
YTD Return -4.92%
Year Return -85.49%

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.

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Castle Brands Inc. (NYSE:ROX) Stuns with Walmart Inc. (NYSE:WMT) Deal

Castle Brands Inc. (NYSE:ROX)

Castle Brands Inc. (NYSE:ROX) shares have been up over 91% on news that the company has reached an agreement to supply Goslings Stormy Ginger Beer and Goslings Stormy Diet Ginger Beer to all U.S. Walmart stores. Consumers can expect to find Goslings Stormy Ginger Beer in Walmart stores in March 2017. Walmart Inc. (NYSE:WMT) is one of the world’s most valuable companies in the world by market value, and is the largest grocery retailer in the U.S. In 2016, 62.3% of Walmart’s $478.6 billion sales came from its U.S. operations.

 Pre-market trading is seeing ROX at $1.39 – it closed at $0.73 yesterday. Castle Brands Inc. (NYSE:ROX) all-time high is just over $2 and its average daily volume is around 125,000 shares. However over 1 million shares have traded hands before the regular session opens.

On February 10, 2017 Castle Brands Inc.’s (NYSE:ROX) earnings broke even in FY Q3 2017, in line with street estimates. The company had posted a loss of a penny in the same quarter last year. Q3 revenues of $18.31 million missed estimates of $20.74 million by 11.7%. However, revenues reflected a 6.4% YoY increase.

The New York, NY-based company has had increasing sales every year since 2012 when the company reported $35.5 million in sales. EPS has been marginally negative for the past five years and in each of the last two years shareholders of Castle Brands Inc.’s (NYSE:ROX) experienced an EPS loss of $0.02. 

 

2/28/2017
Ticker Symbol ROX
Last Price a/o 9:18 AM EST  $                      1.34
Average Volume                    124,250
Market Cap (mlns)  $                  113.39
Sales (mlns) $74.70
Shares Outstanding (mlns) 155.35
Share Float (mlns) 85.57
Shortable Yes
Optionable No
Inside Ownership 1.80%
Short Float 1.31%
Short Interest Ratio 9.03
Quarterly Return -3.95%
YTD Return -3.96%
Year Return -16.08%

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.

 About the author: James Marion is a University of Houston student studying Business with a concentration in Finance.

 

aTyr Pharma, Inc. (NASDAQ:LIFE) Lead Product Candidate Gets FDA News

aTyr Pharma, Inc. (NASDAQ:LIFE)

aTyr Pharma, Inc. (NASDAQ:LIFE) announced today that the Food & Drug Administration (FDA) has granted Orphan Drug Designation to Atyr’s product candidate Resolaris – a drug developed to treat limb girdle muscular dystrophy. Shares of LIFE are up 10% in pre-market and trading at $3.80.

In October 2016, aTyr announced that Resolaris was granted Fast Track designation by the FDA for the treatment of facioscapulohumeral muscular dystrophy (FSHD), making it the first known therapeutic candidate for the treatment of FSHD to receive the designation In mid-January of 2016, aTyr announced that Resolaris was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy 2B (LGMD2B), making it the first known therapeutic candidate for the treatment of LGMD2B to receive the designation. In addition, the FDA removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials. Clearly, aTyr Pharma, Inc. (NASDAQ:LIFE) fortunes are heavily tied to the performance of Resolaris.

The FDA’s Orphan Drug Designation program is intended to advance the development of products which demonstrate promise in diagnosing or treating rare conditions that affect fewer than 200,000 people in the U.S. Sponsors developing orphan-designated products are eligible for incentives under the program, including seven years of market exclusivity following FDA approval, waiver or partial payment of application fees, and certain tax credits.

Limb girdle muscular dystrophy (LGMD) refers to a group of rare genetic myopathies, of which there are more than 20 different subtypes, none with approved therapies. LGMD affects an estimated 16,000 patients in the U.S., approximately 3,000 of whom have LGMD2B. LGMD2B is a recessive genetic disease caused by a toxic loss of function in the dysferlin gene. Patients experience progressive debilitating muscle weakness and atrophy as well as immune cell invasion in the skeletal muscle. Resolaris is being developed by aTyr Pharma, Inc. (NASDAQ:LIFE) as a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component.

aTyr Pharma, Inc. (NASDAQ:LIFE) likely welcomes the good news. In December 2016 JP Morgan downgraded the shares from “Overweight” to “Neutral. aTyre has no reported sales and has lost EPS every year – LIFE shares had an EPS loss of $2.03 in 2015. All three firms that follow ATyr Pharma rate the shares as a “Hold”.

2/28/2017
Ticker Symbol LIFE
Last Price a/o 8:30 AM EST  $                      3.45
Average Volume                    212,200
Market Cap (mlns)  $                    83.00
Sales (mlns) $0.00
Shares Outstanding (mlns) 24.06
Share Float (mlns) 23.15
Shortable Yes
Optionable No
Inside Ownership 1.60%
Short Float 3.21%
Short Interest Ratio 3.51
Quarterly Return 4.55%
YTD Return 60.47%
Year Return -24.67%

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.

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.