NEW YORK (TheStreet) — Capnia (CAPN) stock is up 14.07% to $1.54 on heavy trading volume on Wednesday after the company announced a five-year distribution agreement for one of its products in China.

The deal with Shanghai CiiC Science and Technology Development Co. will allow the company to sell Capnia’s “CoSense” products in China. The terms of the deal were not disclosed.

Sales of CoSense, which measures carbon monoxide in people’s breath, will begin by the end of 2016, Capnia said in a statement.

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“This agreement with Shanghai CiiC allows us to pursue a rapid path to the China market, potentially one of the largest opportunities in the world for CoSense with 16 million births every year,” Capnia CEO Anish Bhatnagar said in a statement. “This long-term partnership will provide synergies with respect to marketing authorization, sales, marketing and distribution, which will add significant value for CoSense.”

Based in Redwood City, CA, Capnia develops medical diagnostics and therapeutics.

So far today, 1.34 million shares of Capnia have traded, versus the company’s 30-day average of about 41,000 shares.

 

 

Source: The street

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Flex Pharma (NASDAQ: FLKS) announced its proprietary treatment prevented muscle cramps in an initial study of athletes participating in high intensity sports.

“We believe this is the first time any consumer beverage has shown a statistically significant reduction of naturally occurring muscle cramps in athletes,” said Marina Hahn, Flex Pharma’s President of Consumer. “As we prepare to launch our product in the first half of 2016, it is critical to test our product in real-life athletic scenarios.”

The study evaluated Flex Pharma’s proprietary treatment in a total of 23 healthy athletes who frequently suffer from muscle cramps while engaging in high intensity sports. Participants included men and women that train 3-4 times a week. Participants administered the treatment 15-30 minutes prior to exercise. The study was intended to evaluate the efficacy of the proprietary treatment in preventing muscle cramps as measured by the incidence of cramps during training sessions. The study showed statistically significant results (p<0.01 by Poisson regression), demonstrating that Flex Pharma’s treatment reduced muscle cramps during a two week workout period by more than 50% when compared to the prior two week baseline observation period. The study also demonstrated a trend towards a reduction in cramp duration.

In another arm of the study, 21 healthy athletes administered the proprietary product as an acute treatment, administered at the onset of a muscle cramp. These data showed positive trends with approximately two-thirds of athletes claiming relief within five minutes when the proprietary treatment was taken at the onset of a muscle cramp.

“This is the first study to demonstrate that our proprietary treatment prevents cramps occurring in a natural setting and adds to the growing body of data that TRP activators may be an effective new treatment in individuals suffering from cramps and spasms,” noted Dr. Tom Wessel, Flex Pharma Chief Medical Officer. “Based upon the consistent outcomes in this initial study, we are now planning larger, placebo-controlled studies in athletes to further support these results.”

The Company expects to present these study results at a future medical meeting. These exercise-associated muscle cramp results follow three randomized, blinded clinical studies, previously reported, where treatment was shown to prevent cramps in electrically induced human cramps.

Flex Pharma’s proprietary treatment is based on research showing that cramps are caused by excessive firing of alpha-motor neurons in the spinal cord. These nerve cells connect to muscle cells through axons and control muscle contraction. The treatment effect occurs quickly by topical neurostimulation of transient receptor potential (TRP) ion channels on sensory fibers in the mucous membranes of the mouth, throat, esophagus and stomach, with minimal concentrations reaching the bloodstream and, consequently, fewer potential systemic side effects.

 

Source: Street Insider

Gamco Investors INC. ET AL raised its stake in Federal-Mogul Holdings Corp (NASDAQ:FDML) by 0.1% during the fourth quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission. The firm owned 7,824,091 shares of the company’s stock after buying an additional 6,548 shares during the period. Gamco Investors INC. ET AL owned approximately 4.63% of Federal-Mogul Holdings Corp worth $53,595,000 as of its most recent filing with the SEC.

Separately, Strs Ohio increased its position in shares of Federal-Mogul Holdings Corp by 25.8% in the fourth quarter. Strs Ohio now owns 1,584,800 shares of the company’s stock valued at $10,855,000 after buying an additional 325,000 shares during the last quarter.

Shares of Federal-Mogul Holdings Corp (NASDAQ:FDML) opened at 9.09 on Wednesday. The stock’s market capitalization is $1.54 billion. Federal-Mogul Holdings Corp has a 12 month low of $3.81 and a 12 month high of $14.00. The company’s 50 day moving average price is $5.72 and its 200 day moving average price is $6.94.
Federal-Mogul Holdings Corp (NASDAQ:FDML) last released its quarterly earnings results on Monday, February 29th. The company reported $0.22 earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of $0.12 by $0.10. The firm had revenue of $1.80 billion for the quarter, compared to analysts’ expectations of $1.81 billion. During the same quarter in the prior year, the business earned $0.07 EPS. The company’s quarterly revenue was up .2% compared to the same quarter last year. Equities analysts anticipate that Federal-Mogul Holdings Corp will post $1.05 earnings per share for the current fiscal year.

Several brokerages recently commented on FDML. Zacks Investment Research upgraded Federal-Mogul Holdings Corp from a “hold” rating to a “buy” rating and set a $8.75 price target for the company in a research report on Wednesday, March 2nd. FBR & Co. reiterated a “market perform” rating on shares of Federal-Mogul Holdings Corp in a research report on Wednesday, January 20th. Finally, BB&T Corp. reiterated a “hold” rating on shares of Federal-Mogul Holdings Corp in a research report on Tuesday, February 2nd.

Federal-Mogul Holdings Corp, formerly Federal-Mogul Corporation, is a global supplier of technology and innovation in vehicle and industrial products for fuel economy, emissions reduction and safety systems. The Company serves original equipment manufacturers (NASDAQ:FDML) and servicers (OES) (collectively OE) of automotive, light, medium and heavy-duty commercial vehicles, off-road, agricultural, marine, rail, aerospace, power generation and industrial equipment, as well as the worldwide aftermarket.

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BioBlast Pharma Ltd. (Nasdaq: ORPN) announced positive results from its HOPEMD Phase 2 six-month open-label clinical study in patients with oculopharyngeal muscular dystrophy (OPMD), a rare progressive muscle-wasting disease characterized by swallowing difficulties (dysphagia), leading to the risk of aspiration of food into the lungs, weight loss, and generalized progressive muscle weakness. These results will be presented today by Prof. Zohar Argov M.D., Senior Medical Advisor to BioBlast, during the plenary session at Myology 2016, a leading muscle conference in Lyon, France, and, in April, 2016, during two general sessions at the American Academy of Neurology in Vancouver, Canada. See information in this release regarding these scientific symposia.

The primary objective of the HOPEMD Phase 2 open-label study was to assess the safety and tolerability of trehalose 90mg/mL IV solution. Although not powered for efficacy, secondary endpoints were included to explore if trehalose 90mg/mL IV solution could improve or prevent worsening of OPMD disease markers. The study enrolled 25 patients with clinical dysphagia and muscle weakness at two centers in Canada and Israel. All patients have now completed 24 weeks of weekly treatment with trehalose 90mg/mL IV solution and these are the data presented today.

Trehalose 90mg/mL IV solution was observed to be safe and well-tolerated with no drug-related serious adverse events. Improvements versus baseline were observed in multiple secondary efficacy endpoints related to dysphagia and muscle strength and function as further discussed below.

“The final study results are consistent with the interim data previously reported and continue to look promising,” stated Bernard Brais, MD, M.Phil., PhD, FRCP(C), Professor, Departments of Neurology and Neurosurgery and Human Genetics, Faculty of Medicine, McGill University, Co-director Rare Neurological Diseases Group at the Montreal Neurological Institute, and Principal Investigator in the study. “With no pharmacotherapy available to treat OPMD, trehalose 90mg/mL IV solution may be a step forward in caring for these patients. We look forward to confirming these results in the planned Phase 2b double blind placebo controlled study.”

HOPEMD Phase 2 Open-Label Clinical Study – Results

Safety and Tolerability – Trehalose 90mg/mL IV solution was observed to be safe and well tolerated with no drug-related serious adverse events reported. There were no significant changes in lab safety data including chemistry, hematology, and ECG tests. There was one death due to aspiration pneumonia that was not considered drug-related but instead, related to the underlying disease. No patients chose to discontinue the study for reasons related to safety or side effects.

Dysphagia Tests (swallowing difficulties) – The dysphagia endpoints were the timed cold water drinking test (80mL) for all sites, the nectar (80mL) and honey (80mL) timed drinking tests at the Canadian site and the Penetration Aspiration Score as measured by video fluoroscopy (VFS-PAS), a radiographic technique to determine the severity of swallowing difficulties and risk of aspiration. A patient reported swallowing quality of life questionnaire (SWAL-QOL) specifically developed for patients suffering from swallowing problems was employed to assess the degree to which patients felt that their swallowing capability improved with treatment.

There was a mean reduction in time to complete the cold water drinking test of 31.8% versus baseline (n=23). In the nectar and honey timed drinking tests, time to complete was reduced by 43.8% and 46.6% respectively (n=11). Out of the 11 patients in Canada whose scores were evaluated in the per protocol analysis of the VFS-PAS, six patients improved (54.5%), two patients showed stabilization (18.2%), and three patients deteriorated (27.2%). As previously reported, due to deviations from protocol and deficient radiological procedures, the VFS-PAS tests from the Israel cohort were excluded from the final analysis. With respect to the SWAL-QOL questionnaire, there was a 12.7% (n=24) improvement versus baseline with the mean total symptom severity score increasing from 43.2 to 48.7.

Muscle Strength Tests – As measured quantitatively by a digital hand-held dynamometer, there was a mean increase in lower body muscle strength compared to baseline in knee extension of 15.0% (n=22) and foot dorsiflexion of 22.4% (n=22). Hip flexion did not materially change (1.3% deterioration, n=21). For the upper extremity strength tests, arm (bicep) flexion increased on average 17.9% (n=22), and shoulder abduction by 11.4% (n=22).

Muscle Function Tests – The 30 second arm-lift test showed a 16.0% increase in the number of completed tasks (n=20) at 24 weeks of treatment versus baseline while the 30 second sit-to-stand test showed a 16.6% increase (n=21). The standard 4-stair climbing test did not materially change (1.5% deterioration, n=21).

“We are encouraged by the safety profile observed and the early efficacy signals noted in this relatively small study of OPMD patients. With this knowledge, we can proceed to develop our double blind placebo controlled study to confirm these results and progress our clinical program to registration,” stated Warren Wasiewski M.D., Chief Medical Officer of BioBlast.

“These positive safety and efficacy signals give us confidence to continue the development of trehalose 90mg/mL IV solution in OPMD,” said Colin Foster, President and Chief Executive Officer of BioBlast. “We look forward to the possibility of significantly helping patients afflicted with this disease.”

HOPEMD Phase 2 Open-Label Clinical Study – Design

The HOPEMD study was designed as an initial proof-of-concept open-label clinical study in 74 patients for 24 weeks, following which it was intended that all patients would be randomized into a treatment arm or non-treatment control group, and followed for an additional 12 months in a separate continuation study. The study was conducted at two centers – Montreal Neurological Institute at McGill University in Montreal, Canada, and Hadassah-Hebrew University Medical Center in Jerusalem, Israel. The primary objective was to assess the safety and tolerability of trehalose 90mg/mL IV solution in patients suffering from OPMD. Although not powered for efficacy, secondary endpoints were included to explore if trehalose 90mg/mL IV solution could improve or prevent worsening of OPMD disease markers, notably those related to dysphagia (difficulty in swallowing) and upper and lower muscle weakness. As previously reported, based on the interim efficacy signals seen in the first 25 patients enrolled in Canada (11 patients) and Israel (14 patients), recruitment was terminated in mid-2015. Now that all patients have received at least 24 weeks of treatment, BioBlast intends to discontinue the ongoing continuation study and offer patients access to the drug in an expanded access program.

Scientific Symposia Information

Final results of the HOPEMD Phase 2 open-label study will be presented at two upcoming scientific neurology conferences:

1. 5th International Congress of Myology 2016, March 14-18, 2016 in Lyon, FrancePlenary Session – Pharmacotherapy, March 16, 2016 ~ 2:30pm-4:00pmPresenter: Prof. Zohar Argov M.D. (Jerusalem, Israel)Title: Intravenous Trehalose for Treatment of Dysphagia and Muscle Function in Oculopharyngeal Muscular Dystrophy (OPMD): Final Results of 24 Week Open-Label Phase 2 Trial
2. American Academy of Neurology 2016 Annual Meeting, April 15-21 in Vancouver, CanadaPresentations:
• Integrated Neuroscience Session – Advances in Acquired and Genetic Muscle Diseases, April 17, 2016 ~ 5:00pm
• Experimental Therapies in Neuromuscular Diseases, April 19, 2016 ~ 7:15am
Presenter: Prof. Zohar Argov M.D. (Jerusalem, Israel)Title: Intravenous Trehalose for Treatment of Dysphagia and Muscle Function in Oculopharyngeal Muscular Dystrophy (OPMD): Final Results of 24 Week Open-Label Phase 2 Trial
About Trehalose 90mg/mL IV Solution

Trehalose 90mg/mL IV solution is a chemical chaperone that protects against pathological processes in cells. It has been shown to reduce pathological aggregation of proteins within cells in several diseases associated with abnormal cellular-protein aggregation as well as acting as an autophagy enhancer. Trehalose 90mg/mL IV solution has been documented as demonstrating significant promise in preclinical animal models of OPMD and other PolyA/PolyQ diseases.

In OPMD, trehalose 90mg/mL IV solution is being developed to prevent the aggregation of the pathological protein (PABPN1) in muscle cells, the hallmark of the disease, by stabilizing the protein, reducing the formation of protein aggregations, and promoting their clearance from cells through autophagy, thus preventing muscle cell death.

About Oculopharyngeal Muscular Dystrophy (OPMD)

OPMD is an inherited myopathy characterized by dysphagia (difficulty in swallowing), eyelid drooping (ptosis), the loss of muscle strength, and weakness in multiple muscles of the body. Symptoms generally appear in mid-life and get worse over time. As the dysphagia becomes more severe, patients become malnourished, lose significant weight, and may suffer from repeated incidents of aspiration pneumonia. Aspiration pneumonia and severe emaciation may result in death. The disease is caused by a genetic mutation responsible for the creation of a mutant protein (PABPN1) with an expanded polyalanine domain that aggregates within patient muscle cells. There is currently no approved pharmacologic treatment for OPMD.

About BioBlast Pharma Ltd.

BioBlast Pharma is a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases. The Company has a portfolio of product candidates with the potential to address unmet medical needs for incurable diseases. The BioBlast platforms are based on a deep understanding of disease-causing biological processes, and potentially offer solutions for several diseases that share the same biological pathology. BioBlast was founded in 2012 and is traded on the NASDAQ under the symbol “ORPN”. For more information, please visit the Company’s website, www.bioblast-pharma.com, the content of which is not incorporated herein by reference.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, the Company is using forward looking statements when it discusses, confirming results of its HOPEMD clinical study in a future clinical study, if such study is commenced and concluded at all, and the design thereof, future efforts and plans to develop trehalose 90mg/mL IV solution, potential uses of its product candidates for various indications, building a diverse portfolio of product candidates with the potential to address unmet medical needs for incurable diseases, or that BioBlast’s platforms potentially offer solutions for several diseases that share the same biological pathology. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions or those historic results referred to in this press release would not be interpreted differently in light of additional research and clinical and preclinical trial results. Because such statements deal with future events and are based on BioBlast Pharma Ltd.’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of BioBlast Pharma could differ materially from those described in or implied by the statements in this press release, including those discussed under the heading “Risk Factors” in BioBlast Pharma’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 31, 2015, and in any subsequent filings with the SEC. Except as otherwise required by law, BioBlast Pharma disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

 

Sorce: Street Insider

 

Zacks Investment Research upgraded shares of Mitel Networks Corp (NASDAQ:MITL) from a hold rating to a buy rating in a research note published on Thursday morning, Market Beat.com reports. They currently have $8.00 target price on the stock.
According to Zacks, “Mitel Networks is a provider of integrated communications solutions focused on the SME market. Its portfolio of IP-based communications solutions consists of IP telephony platforms, unified communications and collaboration applications and managed and network services. By integrating voice, video and data communications with business applications, Mitel enables businesses to improve their performance. Mitel involves in the market evolution to unified communications and collaboration, enabling customers to move beyond basic fixed telephony and disparate communications tools toward integrated multi-media communications and collaboration between users, wherever they may be located. Mitel’s U.S. headquarters are in Phoenix, Arizona. Global headquarters are in Ottawa, Canada, with offices, partners, and resellers worldwide. “
Several institutional investors recently modified their holdings of MITL. Sei Investments Co. raised its position in shares of Mitel Networks Corp by 6.9% in the fourth quarter. Sei Investments Co. now owns 328,305 shares of the company’s stock worth $2,525,000 after buying an additional 21,170 shares in the last quarter. First Interstate Bank raised its position in shares of Mitel Networks Corp by 183.4% in the fourth quarter. First Interstate Bank now owns 32,845 shares of the company’s stock worth $253,000 after buying an additional 21,255 shares in the last quarter. The Manufacturers Life Insurance Company raised its position in shares of Mitel Networks Corp by 2.9% in the fourth quarter. The Manufacturers Life Insurance Company now owns 1,423,623 shares of the company’s stock worth $10,948,000 after buying an additional 40,484 shares in the last quarter. Paradigm Capital Management Inc. NY raised its position in shares of Mitel Networks Corp by 6.5% in the fourth quarter. Paradigm Capital Management Inc. NY now owns 2,033,000 shares of the company’s stock worth $15,633,000 after buying an additional 123,700 shares in the last quarter. Finally, Swiss National Bank bought a new position in shares of Mitel Networks Corp during the fourth quarter worth $1,029,000.
Separately, CIBC reissued a sector outperform rating and issued a $12.50 price objective (down from $13.50) on shares of Mitel Networks Corp in a research note on Thursday, December 3rd.
Mitel Networks Corp (NASDAQ:MITL) opened at 6.85 on Thursday. Mitel Networks Corp has a 52-week low of $5.91 and a 52-week high of $10.81. The firm has a 50 day moving average of $7.02 and a 200-day moving average of $7.46. The stock’s market cap is $824.12 million.
Mitel Networks Corp (NASDAQ:MITL) last announced its quarterly earnings data on Thursday, February 25th. The company reported $0.29 earnings per share (EPS) for the quarter, topping the Zacks’ consensus estimate of $0.28 by $0.01. During the same period last year, the company earned $0.36 earnings per share. The firm earned $335.70 million during the quarter, compared to analysts’ expectations of $332.43 million. The business’s revenue for the quarter was down .3% on a year-over-year basis. Equities analysts anticipate that Mitel Networks Corp will post $0.75 earnings per share for the current fiscal year.
Mitel Networks Corporation (NASDAQ:MITL) is a global provider of business communications and collaboration software, services and solutions. The Company operates in two segments: Premise and Cloud. The Premise segment sells and supports products and services for premise-based customers.

 

 

Source: Zolmax