ADMP Proves A Point, PETX Regains Drug Rights, CBAY Dips, NKTR On Watch

(RTTNews) - Adamis Pharmaceuticals Corp.'s (ADMP) phase I pharmacokinetic study comparing its APC-1000 to Teva Respiratory LLC's Qvar has demonstrated that the extent of absorption of APC-1000 to be equivalent to Qvar.

APC-1000 is ahydrofluoroalkane branded generic inhaled oral steroid for the treatment of asthma and COPD under phase III development.

The company said that its APC-1000 will be as safe and efficacious as Qvar, and expects this to be confirmed in an upcoming phase III study initiated this year in which APC-1000 and Qvar will be compared for non-inferiority.

ADMP closed Tuesday's trading at $6.41, down 1.38%.

Aratana Therapeutics Inc. (PETX) has regained manufacturing and commercial rights for AT-004 in the US and Canada from Novartis Animal Health US, Inc., an affiliate of Elanco Animal Health.

AT-004 received a full product license from the U.S. Department of Agriculture (USDA) on January 2, 2015 as an aid in the treatment of canine B-cell lymphoma.

Aratana will pay Elanco an upfront fee of $2.5 million and will pay an additional $0.5 million on first commercial sale of the product.

PETX closed Tuesday's trading 6.51% higher at $18.17.

BioTime Inc. (BTX) announced that the first patient was successfully treated in its pivotal clinical trial in Europe assessing the efficacy of Renevia for the treatment of HIV-associated lipoatrophy. This marks the beginning of enrollment for this pivotal trial and follows the previous successful safety trial of Renevia, the completion of which was announced last year.

HIV-associated lipoatrophy is a disorder characterized by abnormal loss of body fat from under the skin that occurs in almost half of the approximately three million people on anti-retroviral therapy in the U.S. and Europe.

BTX closed Tuesday's trading at $4.05, up 0.75%.

Cynosure Inc. (CYNO) has received FDA clearance for its new 532 nm Laser Delivery System for PicoSure for removing tattoos of all colors in fewer treatments.

The new 532 nm Laser Delivery System further builds on the clinical and commercial success of the 755 nm PicoSure for the removal of tattoos and benign pigmented lesions as well as the treatment of acne scars and wrinkles," said Cynosure Chairman and Chief Executive Officer Michael Davin.

The 532 nm Laser Delivery System for PicoSure is expected to be introduced at the American Academy of Dermatology's 2015 Annual Meeting March 20-24 in San Francisco. Initial shipments are expected to begin by the end of the second quarter of 2015, noted the company.

CYNO closed Tuesday's trading at $30.68, up 0.16%.

CymaBay Therapeutics Inc.'s (CBAY) phase 2b study of Arhalofenate has met the primary endpoint with a reduction of 46% in the flare rate for the Arhalofenate 800 mg group compared to the FDA-approved Allopurinol 300 mg group.

In a secondary analysis, Arhalofenate 800 mg showed a 41% lower flare rate than placebo, said the company.

According to the trial results, the reductions in serum uric acid for Arhalofenate 600 and 800 mg at 12 weeks vs. placebo were statistically significant, but did not result in a statistically significant number of patients reaching the goal of < 6 mg/dL.

The company's next step is to hold an end-of-phase 2 meeting with the FDA with the goal of starting phase 3 in early 2016.

CBAY closed Tuesday's trading at $9.98, down 18.53%.

Cytori Therapeutics Inc. (CYTX) has received a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products for its application for an orphan drug designation for ECCS-50.

The company plans to begin enrolling in an 80 patient phase 3 pivotal study of ECCS-50 for Scleroderma associated hand dysfunction this year in approximately 12 U.S. sites.

CYTX closed Tuesday's trading at $0.73, up 12.58%.

Flexion Therapeutics Inc. (FLXN) has completed enrollment in its pivotal phase 2b confirmatory clinical trial of FX006 as a treatment for relieving pain associated with OA of the knee.

The company recently initiated a Phase 3 clinical trial of FX006, which is designed to provide prolonged pain relief for the treatment of mild to moderate OA of the knee, while avoiding untoward systemic effects associated with immediate-release steroids.

Flexion expects to announce topline results from the pivotal phase 2b confirmatory clinical trial in the fourth quarter of 2015.

FLXN closed Tuesday's trading at $22.82, down 2.06%.

Infinity Pharmaceuticals Inc. (INFI) expects to report topline data from DYNAMO, a phase 2 study of Duvelisib in patients with refractory indolent non-Hodgkin lymphoma, in the second half of 2015. The study is scheduled to complete patient enrollment in the first half of the year.

Another clinical trial of Duvelisib that is underway is a phase III study in patients with relapsed/refractory chronic lymphocytic leukemia, and this is expected to complete enrollment in the second half of 2015.

Additionally, Infinity anticipates that three company-sponsored clinical studies of Duvelisib will be initiated in 2015.

INFI closed Tuesday's trading at $15.13, down 1.88%.

Shares of Nektar Therapeutics (NKTR) were up more than 5% in extended trading on Tuesday after the company reported better-than-expected results for the fourth quarter ended December 31, 2014.

The company's net loss for Q4-2014 narrowed to $45.7 million or $0.35 per share from $47.7 million or $0.41 per share in the fourth quarter of 2013. Revenue for the fourth quarter of 2014 declined to $19.6 million from $31.1 million in the fourth quarter of 2013 due to a decrease in non-cash royalty revenue and license revenue. Analysts polled by Thomson Reuters expected per-share loss of 36 cents and revenue of $17.27 million.

The company is scheduled to report top-line results from its phase III study of NKTR-102 in metastatic breast cancer next month.

NKTR closed Tuesday's trading at $13.48, down 0.81%. In after-hours, the stock rose 5.34% to $14.20.