Actinium Pharmaceuticals (NYSE: ATNM) Jumps Over 30% on Massive Volumes

Actinium Pharmaceuticals Inc. – NYSE: ATNM

Actinium Pharmaceuticals gained over 30% in today’s trading on exceptionally heavy volumes. ATNM, traded on the NYSE, has an average daily volume of 275k, but today over 5.5 million shares traded hands.

New York, NY-based Actinium Pharmaceuticals is a biotech company that develops innovative targeted payload immunotherapies for the treatment of advanced cancers. The Company’s radioimmunotherapy product candidates are based on the combination of the cancer targeting precision of monoclonal antibodies (mAb) that seek out specific types of cells combined with the cytotoxic killing power of radioisotopes that unleash their energy once they have reached their target.

Actinium’s lead product is Iomab-B and is in its crucial Phase 3 clinical trial. Iomab-B is a myeloablative therapy, designed to destroy a patient’s bone marrow so that a patient can receive bone marrow from a donor via a transplant. Also in Actiniumn’s pipeline is its Alpha Particle Immunotherapy (APIT) platform. Being 100 times more powerful than beta particles, alpha therapy is effective in cancers that are not sensitive to beta irradiation such as victims of Acute Myeloid Leukemia (AML). AML treatment utilizing APIT has demonstrated extremely high cancer cell kill levels.

On January 27 – 28, 2017, in Dallas, TX, Chief Medical Officer, Dr. Mark Berger will present at the 3rd Annual Think Tank on Integrating New Molecular Targets in Acute Leukemias and Myeloproliferative Neoplasms. Dava Oncology is sponsoring the event as part of their Oncology Meeting Innovations program. Dr. Berger’s talk will focus on Actinium’s Iomab-B.

ATNM shares took a 20% dive in September when the company announced a public offering of an additional 8 million shares at $1.25 a piece plus offering the underwriters a 30-day option on an additional 15% of the sold stock. The price gapped down to below $1.40 and broke the $1 barrier in late October. Shares rebounded slightly and traded around the $1 handle until today when the stock took off and closed at $1.36 – just two cents short of the daily high.

Actinium Pharmaceuticals has yet to post any sales but institutions own over 10% of its shares – a fact which comforts some investors. ATNM had its largest earnings loss in 2012 when the company announced a loss of $7.58 per share. Earnings have never been positive; the last three years have seen per share losses under $1 with 2015 posting a loss of $0.55. Two firms follow Actinium Pharmaceuticals and both rate ATNM shares as a “Strong Buy”.

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.

2/3/2017
Ticker Symbol ATNM
Last Price a/o 3:59 PM EST  $                      1.36
Average Volume                    274,270
Market Cap (mlns)  $                    57.42
Sales (mlns)
Shares Outstanding (mlns) 55.75
Share Float (mlns) 51.06
Shortable Yes
Optionable Yes
Inside Ownership 8.50%
Short Float 2.31%
Short Interest Ratio 4.3
Quarterly Return 4.99%
YTD Return 17.17%
Year Return -50.00%

Stemline Therapeutics (Nasdaq: STML) May Face Lawsuit

Stemline Therapeutics Inc. – Nasdaq: STML

Stemline Therapeutics began trading on the Nasdaq on January 19, 2017 under the ticker STML. At least one law firm is rumored to be investigating whether Stemline violated Federal Securities Laws. The rumored law firm’s investigation may be related to reports that the company allegedly failed to disclose that they had knowledge, on January 18, 2017, of a patient’s death who was participating in a clinical of their cancer drug.

New York, NY-based Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel oncology therapeutics. They have three drugs in development – SL-401, SL-801, and SL-701. The U.S. Food and Drug Administration granted SL-401 Breakthrough Therapy Designation based on data from this ongoing trial, which is demonstrating high overall response rates. A Phase 1 trial is open and enrolling patients with advanced solid tumors, and a Phase 1 trial in hematologic malignancies is planned for SL-801. SL-701 is an immunotherapy designed to activate the immune system to attack tumors. A Phase 2 trial with SL-701 is currently ongoing in adult patients with second-line glioblastoma multiforme.

Stemline Therapeutucs sales have increased every year since 2013. In 2015 they reported $700k in sales. STML shares have never experienced positive EPS and for the past three years STML shares have lost between $2.15 and $2.35. STML shares are rated as a “Strong Buy” from all five analysts that cover the stock. Their consensus price target for STML is $28.50.

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.

2/2/2017
Ticker Symbol STML
Last Price a/o 12:29 PM EST  $                      6.02
Average Volume                    227,330
Market Cap (mlns)  $                  230.59
Sales (mlns) $0.90
Shares Outstanding (mlns) 23.65
Share Float (mlns) 21.29
Shortable Yes
Optionable Yes
Inside Ownership 1.70%
Short Float 6.31%
Short Interest Ratio 5.91
Quarterly Return -14.47%
YTD Return -8.88%
Year Return 110.13%

Regulus Therapeutics, Inc. (Nasdaq: RGLS) Receives FDA Notice – Shares drop 20%

Regulus Therapeutics, Inc. – Nasdaq: RGLS

Regulus Therapeutics shares, traded on the Nasdaq under ticker RGLS, plunged 20% in after-hours trading Friday on news that the biotechnology firm had received a communication from the FDA hat the clinical development program for RG-101 remains on clinical hold.

RGLS ended Friday’s regular session at $2.25 but after the news was released, RGLS shares dropped to $1.65 before settling at $1.80 on moderate volumes. In June of 2016, shares gapped down from $5.01 to $2.54 on the news of the clinical hold.

La Jolla, CA-based Regulus Therapeutics was formed in September 2007 by Alnylam Pharmaceuticals (Nasdaq: ALNY) and Isis Pharmaceuticals, now Ionis Pharmaceuticals (Nasdaq: IONS). The company develops medicines targeting microRNAs. More than 800 microRNAs have been identified in the human genome, and over two-thirds of all human genes are believed to be regulated by microRNAs. A single microRNA can regulate entire networks of genes. As such, these molecules are considered master regulators of the human genome. Targeting microRNAs with anti-miRs, chemically modified, single-stranded oligonucleotides, offers an approach to treating disease by modulating entire biological pathways and may become a new and major class of drugs with broad therapeutic application.

Seven firms follow Regulus Therapeutics. Four rate RGLS as a “Strong Buy”, one rates the shares as a “Buy” and two rate RGLS as a “Hold”. The consensus price target for RGLA is $9.

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.

Pulmatrix Inc. (Nasdaq: PULM) Continues Rise Amid Massive Volumes

Pulmatrix, Inc. – Nasdaq: PULM

At the beginning of the year, Pulmatrix Inc. was trading in the $0.50 handle. However, the last several days have seen a massive increase in volume and a rise in price to an inter-day high of over $2.50 – a gain of 62%+ just this week. PULM, traded on the Nasdaq, had an average daily volume of over 650,000 shares but today volumes are over 16 million.

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for lung diseases, including opportunities in major pulmonary diseases through collaborations.

The most recent news came on January 17, 2017. Pulmatrix announced its drug candidate for treating fungal infections in the lungs of CF patients, PUR1900, has been designated as a “Qualified Infectious Disease Product” (QIDP) by the U.S. Food & Drug Administration.

Pulmatrix and PULM shares are not covered or rated by any firms. PULM ended yesterday at $1.64 and is currently trading above $2.40.

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.

1/26/2017
Ticker Symbol PULM
Last Price a/o 12:58 PM EST  $                      2.45
Average Volume 657,800
Market Cap $24.36 million
Sales $1.00 million
Shares Outstanding 14.85 million
Share Float 13.19 million
Shortable Yes
Optionable No
Inside Ownership 26.44%
Short Float 0.15%
Short Interest Ratio 0.03
Quarterly Return 17.14%
YTD Return 177.97%
Year Return -43.45%

Avinger Inc. (Nasdaq: AVGR) Presents Positive Clinical Data – Shares Rocket

Avinger, Inc. – Nasdaq: AVGR 

Shares of Avinger Inc rose 9.5% in Wednesday’s regular session then rocketed in the after-hours session to end the day at $3.05. Heavy volumes marked both sessions. AVGR, traded on the Nasdaq, closed Tuesday at $2.10. The price was responding to Avinger’s release of positive results stemming from a two-year study of the firm’s proprietary Lumivascular technology.  

The study was designed to evaluate the safety and effectiveness of Avinger’s Pantheris™ system which allows physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. Data from the study, which demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints, supported U.S. Food and Drug Administration (FDA) 510(k) clearance of the system in 2016. 

Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems for the treatment of patients with peripheral artery disease (PAD). PAD is characterized by a build-up of plaque in the arteries that supply blood to the legs and feet. The company’s mission is to dramatically improve the treatment of vascular disease through the introduction of products based on its Lumivascular platform, the only intravascular image-guided system of therapeutic catheters available in this market. 

AVGR had been trading near $25 a little more than a year ago, and EPS has never been positive – 2015 reported a loss of $4.38. Sales have been steadier and were $10.7 million for that same year. Still, AVGR enjoys a “Strong Buy” rating from the two analysts that cover it. They give AVGR a price target of $10. 

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.

1/25/2017
Ticker Symbol AVGR
Last Price a/o 7:59 PM EST  $                      3.05
Average Volume 270,500
Market Cap $56.97 million
Sales $17.4 million
Shares Outstanding 24.77 million
Share Float 20.91 million
Shortable Yes
Optionable Yes
Inside Ownership 0.80%
Short Float 7.18%
Short Interest Ratio 5.55
Quarterly Return -46.51%
YTD Return -37.84%
Year Return -85.85%

Biolase Inc. (Nasdaq: BIOL) Launches FDA Approved Laser

Biolase,Inc. – Nasdaq: BIOL 

Shares of BIOLASE, Inc. are up over 15% on heavy volumes. The company announced today its Epic Pro™ laser system, a new, innovative dental diode laser system that offers higher laser power than most diode lasers in dentistry, has received 510(k) clearance for commercial distribution from the U.S. Food and Drug Administration (FDA). The Epic Pro laser system, which received marketing authorization in select international markets late last year, can now be sold in the U.S. 

Irvine, CA-based Biolase trades on the Nasdaq under ticker symbol BIOL. Biolase, Inc. is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. The company also markets, sells, and distributes dental imaging equipment, including CAD/CAM scanners. Biolase’s products are focused on better enabling clinicians to repair and restore patient’s dental conditions while reducing pain, fear, and anxiety. 

BIOL shares have never experienced positive EPS. In 2014 BIOL shares hit a low with a loss of $0.45 and in 2015 improved to a loss of $0.35. Sales have been relatively consistent. In 2011 reported sales were $48.9 million and in 2015 sales were $48.5 million. No firms or analysts currently rate BIOL shares.  

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.

1/20/2017
Ticker Symbol BIOL
Last Price a/o 4:00 PM EST  $                      1.47
Average Volume 87,900
Market Cap $102 million
Sales $52.6 million
Shares Outstanding 69.39 million
Share Float 49.47 million
Shortable Yes
Optionable No
Inside Ownership 0.60%
Short Float 4.96%
Short Interest Ratio 27.93
Quarterly Return 14.84%
YTD Return 5.00%
Year Return 81.48%

aTyr Pharma (Nasdaq: LIFE) Gets Product Fast-Tracked at FDA

aTyr Pharma, Inc. – Nasdaq: LIFE 

San Diego, CA-based aTyr Pharma, Inc. shares (Nasdaq: LIFE) were up over 30% in today’s trading on news that that its product candidate 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. 

aTyr Pharma. is a biotherapeutics company that develops Physiocrine-based therapeutics for patients suffering from severe and rare diseases. John Mendlein, PhD, CEO of aTyr Pharma commented on the news – “This Fast Track designation, which is granted to drug candidates addressing serious conditions and that demonstrate the potential to address unmet medical needs, represents another step forward for our first product candidate based on the Physiocrine pathway. Combined with our Phase1b/2 data in LGMD2B, adult facioscapulohumeral muscular dystrophy (FSHD) and early onset FSHD patients, we believe we are building a clinical and regulatory foundation for future development of Resolaris to treat patients across multiple rare genetic myopathies with an immune component.” 

aTyr Pharma has no reported sales and LIFE shares have had negative EPS since 2012. In 2015 aTyr Pharma reported an EPS loss of $2.03. Three firms follow aTyr Pharma and all rate LIFE shares as a “Hold” with a consensus price target of $6. 

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.

1/18/2017
Ticker Symbol LIFE
Last Price a/o 4:00 PM EST  $                      3.25
Average Volume 170,000
Market Cap $77 million
Sales
Shares Outstanding 23.72 million
Share Float 23.15 million
Shortable Yes
Optionable No
Inside Ownership 1.60%
Short Float 23.15%
Short Interest Ratio 4.08
Quarterly Return 20.37%
YTD Return 51.16%
Year Return -45.92%

Pulmatrix, Inc. (Nasdaq: PULM) Rockets on FDA Designation

Pulmatrix, Inc. – Nasdaq: PULM

The U.S, Food and Drug Administration designated Pulmatrix’s PUR1900 a Qualified Infectious Disease Product (QIDP) for the treatment of respiratory infections in cystic fibrosis patients. The news sent Pumatrix shares, traded on the Nasdaq under ticker PULM, up over 100% in early trading. The FDA QIPD status confers an accelerated review and a five-year market exclusivity.

Pulmatrix Inc. develops inhaled therapies to address serious pulmonary disease using their clinically validated, proprietary iSPERSE technology. iSPERSE is a, dry powder technology developed, patented and validated by Pulmatrix scientists and engineers to improve how drugs are directed into the lungs. iSPERSE products are designed to maximize local drug concentrations and reduce systemic side effects, in order to make possible a new generation of inhaled therapies to improve patient outcomes.

Pulmatrix, Inc., nor PULM shares, are followed or rated by any firms or analysts. PULM EPS has been negative since 2011 with Pulmatrix reporting no sales.

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.

 

Tracon Pharmaceuticals Inc. (Nasdaq: TCON) Reaches FDA Agreement

Tracon Pharmaceuticals Inc. – Nasdaq: TCON

Shares of San Diego, CA-based Tracon Pharmaceuticals Inc. are trading at their daily highs on heavy volumes. TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases.

Traded on the Nasdaq under ticker symbol TCON, the shares gapped up from their previous close of $4.90 on news that the biotechnology firm reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach for the Company’s Phase 3 study evaluating TRC105 for the treatment of patients with advanced angiosarcoma. The SPA process is one in which a sponsor asks the FDA to evaluate the proposed design and size of Phase 3 clinical trials that are intended to form the primary basis for determining a drug product’s efficacy. An SPA agreement indicates concurrence with the adequacy and acceptability of specific critical elements of protocol design, endpoints and analysis.

Three firms cover Tracon Pharmaceuticals Inc. and all three assign TCON shares a “Strong Buy” with a consensus price target of $12. In 2015 Tracon reported their strongest sales figures yet – $7.9 million but had a EPS loss of $2.20. TCON shares have never experienced positive EPS.

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.

1/3/17
Ticker Symbol TCON
Last Price a/o 11:30 AM EST $5.75
Average Volume 47,000
Market Cap $69.78 million
Sales $4.2 million
Shares Outstanding 14.24 million
Share Float 13.51 million
Shortable Yes
Optionable No
Inside Ownership 37.69%
Short Float 0.70%
Short Interest Ratio 2.01
Quarterly Return -26.54%
YTD Return -46.97%
Year Return -46.97%

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%