BLPG Gets Into Rhythm, ADRO Opens Wallet, IMUC Gets Funds, A Win For Shire

(RTTNews) - Aratana Therapeutics Inc. (PETX) has a couple of catalysts coming its way in 2016.

A technical section complete letter for effectiveness for AT-001 for osteoarthritis pain in dogs was issued by the FDA's Center for Veterinary Medicine, or CVM, recently, and the company intends to submit an administrative New Animal Drug Application in the first quarter of 2016. Approval is anticipated in the second quarter of 2016 and is expected to enable Aratana to commence commercialization of the product in the fall of 2016.

A technical section complete letter for CMC (Chemistry, Manufacturing, and Controls) for AT-002 for inappetence in dogs is expected in late 2015 or shortly thereafter. A response from the CVM regarding the technical section for effectiveness for AT-002 is expected by February 22, 2016.

A study investigating the use of AT-004 in combination with abbreviated chemotherapy in canine B-cell lymphoma is underway, and the results are anticipated in mid-2016.

PETX closed Thursday's trading at $17.49, up 3.06%.

Shares of Bellerophon Therapeutics Inc. (BLPH) were up over 82% in extended trading on Thursday, following positive results from part 2 of its phase II long-term extension study of INOpulse for the treatment of Pulmonary Arterial Hypertension.

Bellerophon's INOpulse device delivers brief, controlled pulses of inhaled nitric oxide, which is a selective, short-acting pulmonary vasodilator. INOpulse is portable, which is intended to allow for treatment of ambulatory patients on daily basis outside the hospital.

Following 16 weeks of blinded therapy in Part 1 of the trial, in Part 2 of the trial 65 patients were randomized to receive INOpulse doses of either 25 or 75 mcg/kg ideal body weight per hour (iNO 25 or iNO 75). The interim analysis was performed after patients had completed between 8 and 12 months of INOpulse treatment.

There was a clinically significant and sustained benefit for patients on the higher iNO 75 dose, when combined with Long-Term Oxygen Therapy, according to the study results.

The FDA has issued a Special Protocol Assessment for the company's phase III program for INOpulse, which will include two confirmatory clinical trials, undertaken either sequentially or in parallel, with the first patient expected to be enrolled later this year.

The company went public on the NASDAQ Global Market on February 13, 2015, offering its shares at a price of $12 each. The stock closed Thursday's trading at $3.72, down 4.62%. In after hours, the stock was up 82.80% at $6.80.

Seeking to further strengthen and expand its immunotherapy capabilities, Aduro Biotech Inc. (ADRO) has agreed to acquire privately held BioNovion Holding B.V. for 29 million Euro.

Under the terms of the agreement, Aduro will pay BioNovion 14.5 million Euro in cash and 14.5 million Euro in Aduro stock. In addition, BioNovion shareholders are eligible to receive payments upon the completion of specific regulatory milestones.

Aduro went public on the NASDAQ Global Select Market as recently as April 15, 2015, priced at $17.00 per share. The stock closed Thursday's trading at $21.63, up 0.79%.

ImmunoCellular Therapeutics Ltd. (IMUC) has been awarded $19.9 million by the governing Board of the California Institute for Regenerative Medicine to support the company's phase 3 registration trial of ICT-107 in patients with newly diagnosed glioblastoma.

The company is on track to initiate the phase 3 ICT-107 trial in the fourth quarter of 2015, which will include approximately 120 clinical sites in the US, Europe and Canada, and will recruit about 400 patients.

IMUC closed Thursday's trading at $0.55, up 17.20%.

Sayana Press, an injectable contraceptive for administration via self-injection, developed by Pfizer Inc. (PFE) is now available to women in the United Kingdom. It was recently approved by the UK Medicines and Healthcare Products Regulatory Agency.

According to the company, Sayana Press is approved by regulatory authorities in the European Union and in a number of countries across the globe, including Bangladesh, Burkina Faso, Kenya, Niger, Nigeria, Senegal and Uganda. Additional regulatory submissions are being pursued.

Sayana Press, which provides contraception for at least 13 weeks, contains the same chemical as that in the controversial Depo-Provera, a long-acting hormonal form of birth control, which has been available in the U.S. since 1992. Depo-Provera, which gives protection against pregnancy for 12 weeks, sports a "black box" warning about the risk of significant loss of bone density associated with its prolonged use.

PFE closed Thursday's trading at $32.70, up 0.25%.

The Court of Appeals of the Federal Circuit has affirmed that patents covering Shire plc's (SHPG) Vyvanse, a prescription medicine used for the treatment of Attention-Deficit/Hyperactivity Disorder in patients 6 years and above, are valid until 2023.

The ruling bars generic versions of Vyvanse from entering market until patents expire.

Actavis LLC/Actavis Elizabeth LLC; Amneal Pharmaceuticals, LLC; Mylan Pharmaceuticals Inc./Mylan Inc.; Roxane Laboratories Inc.; and Sandoz Inc. have filed Abbreviated New Drug Applications with the FDA seeking to market generic versions of Vyvanse.

For the six months ended June 30, 2015, Vyvanse raked in sales of $841.6 million, up 18% over the comparable year-ago period.

SHPG closed Thursday's trading at $214.33, up 0.56%.

Xenon Pharmaceuticals Inc. (XENE) has initiated a phase I clinical trial of its lead proprietary program, XEN801, as a potential treatment for acne.

If all goes well as planned, the company plans to initiate a proof-of-concept phase II trial in patients with moderate-to-severe acne by the end of the year, with data expected in 2016.

XENE closed Thursday's trading at $8.58, down 1.04%.