CTRV Grabs Headlines, Watch Out For EXAS Today, ONCE Gets A Spark

(RTTNews) - Alkermes plc (ALKS) has received FDA approval for ARISTADA (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.

ARISTADA is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection, according to the company.

ARISTADA is expected to be launched immediately.

ALKS closed Monday's trading at $59.77, down 1.17%. In after hours, the stock was up 6.24% at $63.50.

Shares of ContraVir Pharmaceuticals Inc. (CTRV) rose as much as 197% on Monday after the company revealed that its drug candidate CMX157 is 60-fold more active than Gilead's (GILD) Viread against the hepatitis B virus based on in vitro studies.

CMX157 has completed a phase I clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability and drug distribution profile, and is a phase 2-ready compound.

The company's most advanced compound is FV-100, which is in phase III testing, to prevent the debilitating shingles-associated pain known as post-herpetic neuralgia.

Formed in May 2013 by Synergy Pharmaceuticals Inc. (SGYP), ContraVir was spun off as an independent public company in January 2014. ContraVir began trading on the OTC Bulletin Board in February of 2014 under ticker CTRV. The stock was uplisted on The NASDAQ Capital Market on February 27, 2015.

CTRV touched a new high of $6.28 on Monday before closing the day's trading at $4.72, up 123.70%.

DBV Technologies' (DBVT) follow-up study of its lead product candidate Viaskin Peanut patch, dubbed OLFUS, supports its long-term safety and efficacy for the treatment of peanut allergy.

The company reported positive results from a study known as VIPES - a phase IIb clinical trial of Viaskin Peanut in peanut allergic patients in September 2014. The VIPES trial achieved statistical significance in desensitizing a higher proportion of patients after 12 months of treatment with Viaskin Peanut.

The company plans to begin a phase III clinical trial, 'PEPITES', with Viaskin Peanut 250 microg in children (ages 4-11) in the fourth quarter of 2015.

DBVT closed Monday's trading at $38.56, up 4.81%.

Exact Sciences' (EXAS) FDA-approved non-invasive, stool DNA-based colon cancer screening test has been included as an alternative screening test, along with CT colonography in the draft guidelines of the U.S. Preventive Services Task Force.

The draft guidelines now recommend an "A" rating for colorectal cancer screening starting at age 50 and continuing until age 75. Screening for individuals age 75 through 85 is graded a "C." This approach represents a change from the 2008 recommendations, which assigned specific grades for different tests, including an "I" rating for stool-based DNA, noted the company.

A final recommendation is expected to be announced in 2016.

Listed below are the various ratings of the USPTF recommendations. There are 5 ratings of recommendations namely A, B, C, D, or I.

A - The USPSTF recommends the service. There is high certainty that the net benefit is substantial.

B - The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.

C- The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small.

D - The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.

I - The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

Impax Laboratories Inc. (IPXL) has received FDA approval for its generic version of oral diabetes medicine DIABETA (Glyburide) tablets of strengths 1.25 mg, 2.5 mg, and 5 mg.

According to IMS Health (NSP), the U.S. brand and generic sales of glyburide tablets 1.25 mg, 2.5 mg, and 5 mg products were approximately $14 million for the 12 months ending in August 2015, noted the company.

IPXL closed Monday's trading at $38.59, up 1.02%.

The FDA has expanded the approval of NovoCure's (NVCR) Optune in combination with oral chemotherapy drug Temozolomide for the treatment of adult patients with newly diagnosed glioblastoma, or GBM.

Optune is a portable, non-invasive device that delivers low-intensity, intermediate frequency, alternating electric fields - referred to as Tumor Treating Fields (TTFields) - that inhibit cancer cell replication and cause cancer cell death.

Optune was initially approved by the FDA in 2011 to treat patients with GBM that recurred or progressed after chemotherapy.

Additionally, the company announced that its newly designed second generation Optune system has received CE mark. Novocure has initiated roll-out in Germany this month and intends a broader European roll-out by the end of the year.

The newly designed Optune system, which incorporates state of the art digital technology and is more than 50% lighter and 50% smaller than the first generation system, is not yet available in the United States. Novocure intends to file a premarket approval supplement application with the FDA.

NovoCure went public as recently as October 2, 2015, priced at $22 per share. The stock closed Monday's trading at $18.69, up 2.24%.

Otonomy Inc. (OTIC) is all set to commence a phase I dose escalation clinical safety trial of tinnitus product candidate OTO-311 in normal healthy volunteers.

Tinnitus is the medical term for hearing noise when there is no outside source of the sound.

OTIC closed Monday's trading at $20.15, up 7.41%.

Protalex Inc. (PRTX.OB) is all set to begin a phase Ib study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia in France before year end.

Immune Thrombocytopenia, or ITP, is an autoimmune-mediated condition characterized by bruising and increased bleeding as a result of immune-mediated accelerated destruction of platelets and impaired production of platelets.

A U.S. phase I/II clinical trial of PRTX-100 in adult ITP patients is also underway.

The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has also issued a positive opinion recommending PRTX-100 for designation as an orphan medicinal product for the treatment of ITP.

PRTX.OB closed Monday's trading at $4.80, down 12.73%.

Spark Therapeutics (ONCE) surged as much as 50% in intraday trading on Monday, following positive top-line results from a phase III pivotal trial of its lead gene therapy product candidate, SPK-RPE65, for the treatment of RPE65-mediated inherited retinal dystrophies.

SPK-RPE65 demonstrated restoration of functional vision and improvement in light sensitivity in subjects previously progressing toward complete blindness, according to the trial results.

There were no serious adverse events related to SPK-RPE65 or deleterious immune responses observed in the trial.

Based on the encouraging results, Spark intends to file a Biologics License Application for SPK-RPE65 with the FDA in 2016.

ONCE closed Monday's trading at $53.02, up 20.69%.