It's A Ten For Humira, AMPE Drubbed By PIVOT Data, CYNA Awaits Data In Q3

(RTTNews) - AbbVie's (ABBV) HUMIRA has been greenlighted by the FDA for the treatment of non-infectious intermediate, posterior and panuveitis, thus becoming the first and only FDA-approved non-corticosteroid therapy available for adults with this disease.

The approval marks the 10th approved indication for HUMIRA in the United States and follows recent European Commission marketing authorization for this indication.

The other approved indications of HUMIRA include, moderate to severe rheumatoid arthritis (RA) in adults, moderate to severe polyarticular juvenile idiopathic arthritis in children 2 years of age and older, psoriatic arthritis in adults, ankylosing spondylitis in adults, moderate to severe Crohn's disease in adults and children 6 years of age and older and moderate to severe hidradenitis suppurativa (HS) in adults, moderate to severe ulcerative colitis in adults, moderate to severe chronic plaque psoriasis in adults, non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults.

Humira generated revenue of $14 billion in 2015 compared to $12.54 billion in 2014.

ABBV closed Thursday's trading at $61.91, up 0.16%.

Shares of Akers Biosciences Inc. (AKER) surged over 15% on Thursday, following completion of the company's clinical trial of PIFA/Chlamydia Rapid Assay, the first rapid test for Chlamydia diagnosis using a finger stick blood sample.

The company is pursuing FDA 510(k) market clearance for the US and is evaluating the regulatory requirements in the territories covered by its international distribution network.

AKER closed Thursday's trading at $15.83% to $3.22.

Shares of Ampio Pharmaceuticals Inc. (AMPE) plunged over 61% on Thursday, following the failure of the company's phase III trial of Ampion intra-articular injection in patients with pain due to osteoarthritis of the knee.

In the trial, dubbed PIVOT, the primary endpoint of the change in WOMAC A pain at week 12 compared to saline was not achieved.

AMPE closed Thursday's trading at $1.29, down 61.14%. In after-hours, the stock was up 4.65% to $1.35.

Aratana Therapeutics Inc. (PETX) has filed an administrative New Animal Drug Application with the FDA's Center for Veterinary Medicine seeking approval of NOCITA as a local post-operative analgesia for cranial cruciate ligament surgery in dogs.

The expected decision date on NOCITA is August 28, 2016. Aratana anticipates Nocita will be commercially available to veterinarians in the fall of 2016.

PETX closed Thursday's trading at $6.32, down 2.62%.

Cynapsus Therapeutics Inc.'s (CYNA) pivotal phase III efficacy study of APL-130277 to treat OFF episodes in patients with Parkinson's disease has enrolled the last patient.

Dose titration phase results from the study are expected in mid to late July and top-line data are expected to be released near the end of the third quarter of 2016.

CYNA closed Thursday's trading 9.19% higher at $16.75.

Intra-Cellular Therapies Inc. (ITCI) has completed enrollment in the second phase III clinical trial of its lead product candidate ITI-007 for the treatment of schizophrenia. Top line data from this study are expected to be available later this year.

ITCI closed Thursday's trading at $38.82, up 3.71%.

NeuroDerm Ltd. (NDRM) has started patient enrollment in the United States in an ongoing phase II efficacy trial of ND0612H for advanced Parkinson's disease. The study is expected to be completed in the second half of 2016.

NDRM closed Thursday's trading at $16.25, up 3.57%.

Shire plc's (SHPG) phase II study evaluating SHP607 did not meet its primary endpoint of reducing the severity of retinopathy of prematurity, a rare eye condition.

However, analysis of secondary endpoints has shown clinically relevant effects on severe complications related to lung and brain damage.

Shire plans to meet with regulatory authorities to discuss clinical path forward for phase III clinical program focusing on several complications of prematurity.

SHPG closed Thursday's trading at $184.08, up 1.89%.

Transition Therapeutics Inc. (TTHI) is all set to be acquired by OPKO Health Inc. (OPK) for approximately $60 million or $1.55 per share.

The transaction is expected to close during the second half of 2016, subject to approval of Transition Therapeutics stockholders and other customary conditions.

TTHI closed Thursday's trading at $1.47, up 110%.