VRTX Drug Gets Approval, AGTC Surges On Biogen Deal, PFE Gets A Date With FDA

(RTTNews) - Adaptimmune Therapeutics plc (ADAP) is all set to initiate an open label phase I/II study of its wholly-owned MAGE-A10 T therapeutic candidate in patients with non-small cell lung cancer, following the acceptance of the company's investigational new drug application by the FDA.

Site initiation activities are now underway, and the company anticipates that enrollment will begin in 2015.

The company went public on the NASDAQ Global Select Market as recently as May 6, 2015, priced at $17 per ADS.

ADAP closed Thursday's trading at $17.99, up 2.45%.

Shares of Applied Genetic Technologies Corp. (AGTC) surged over 17% on Thursday following a broad collaboration and license agreement with Biogen Inc. (BIIB) to develop gene-based therapies for multiple ophthalmic diseases.

The agreement entitles Applied Genetic Technologies to receive an upfront payment of $124 million and potential future milestone payments and royalties, exceeding $1 billion from Biogen.

The lead development programs in the collaboration include a clinical candidate for X-linked Retinoschisis (XLRS) and a pre-clinical candidate for the treatment of X-Linked Retinitis Pigmentosa (XLRP).

Biogen will be granted a license to the XLRS and XLRP programs and the option to license discovery programs for three additional indications at the time of clinical candidate selection.

The transaction is expected to close in the third calendar quarter of 2015.

AGTC closed Thursday's trading at $19.03, up 17.04%.

Arrowhead Research Corp. (ARWR) has dosed the first patient in part B of a phase I clinical trial of ARC-AAT, a drug candidate for the treatment of liver disease associated with the rare genetic disorder alpha-1 antitrypsin deficiency.

The part A of the study, conducted in healthy volunteers, has been completed. Part B of the study is to be conducted in patients with PiZZ genotype alpha-1 antitrypsin deficiency.

The clinical trial is currently enrolling patients at a single center in Australia, and the company intends to open additional sites for enrollment in Europe, pending regulatory permission to proceed.

The company expects to complete enrollment of the phase I study by the end of 2015.

ARWR closed Thursday's trading at $6.84, down 1.58%.

Navidea Biopharmaceuticals Inc.'s (NAVB) subsidiary Macrophage Therapeutics Inc., on Thursday, announced encouraging preclinical results of a Manocept Drug Conjugate in Kaposi's Sarcoma and Tumor Associated Macrophages.

The trial results demonstrated programmed cell death in Kaposi's Sarcoma tumor cells and anti-HIV activity, and reinforces therapeutic potential of targeting activated macrophages via the CD206 receptor, noted the company.

Navidea and Macrophage Therapeutics plan a webcast to provide investors with a complete look at the data being presented at the International Workshop on Kaposi's Sarcoma Herpesvirus (KSHV) and Related Agents conference on July 7, 2015.

NAVB closed Thursday's trading at $1.68, up 3.70%. In after-hours, the stock was up 4.76% at $1.76.

Pfizer Inc.'s (PFE) new drug application for XELJANZ 11 mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients who have had an inadequate response or intolerance to methotrexate has been accepted for review by the FDA.

The regulatory agency is scheduled to announce its decision on the once-daily formulation of XELJANZ in February 2016.

XELJANZ 5 mg twice daily was approved by the FDA in November 2012 for moderately to severely active rheumatoid arthritis. The drug generated sales of $308 million in 2014, up from $114 million in 2013.

PFE closed Thursday's trading at $33.37, down 0.95%.

Provectus Biopharmaceuticals Inc. (PVCT) has signed a Letter of Intent to collaborate with Boehringer Ingelheim (China) Investment Co. Ltd. in bringing PV-10, its investigational drug for cancer, to market in mainland China, Hong Kong and Taiwan.

PV-10 is under a phase III trial in melanoma patients.

Under the terms of the Letter of Intent, Boehringer will provide certain commercially reasonable support in the aspects of product registration with the China Food and Drug Administration, or CFDA, communication preparation, market intelligence and other assistance to Provectus in China to the extent that is within Boehringer's approved business scope and permissible by Chinese laws.

In return, Provectus will grant Boehringer the first priority to be the exclusive collaborator of Provectus in China for PV-10 in the event that PV-10 is successfully registered and approved by the CFDA.

PVCT closed Thursday's trading at $0.56, up 5.66%.

Vertex Pharmaceuticals Inc.s (VRTX) ORKAMBI has received FDA approval for the treatment of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation.

It is estimated that about 8,500 people in the U.S. are ages 12 and older and have two copies of the F508del mutation, the most common genetic form of the disease. People with two copies of the F508del mutation represent the largest group of people with cystic fibrosis.

ORKAMBI will be available for shipment to specialty pharmacies in the United States within days, according to the company.

VRTX closed Thursday's trading 4.02% higher at $131.26.