NBIX For The Long Haul, RegeneRx Catches Investors' Eyes, NewLink Inks New Deal

(RTTNews) - Auxilium Pharmaceuticals Inc.'s (AUXL) supplemental Biologics Application for XIAFLEX for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit has been approved by FDA.

XIAFLEX is already approved for the treatment of adult patients with Dupuytren's contracture with a palpable cord and for the treatment of adult men with Peyronie's disease.

XIAFLEX U.S. net revenues (for Peyronie's disease and Dupuytren's contracture combined) were $26.3 million in Q2, 2014, representing a 75 percent increase from the second quarter of 2013.

Auxilium Pharma is all set to be acquired by Endo International plc (ENDP) for roughly $2.6 billion ($33.25 per share), and the transaction is expected to close in the first half of 2015.

Dexcom Inc. (DXCM) has received FDA approval for its continuous glucose monitoring remote mobile communications device - Dexcom SHARE - the first of its kind to get regulatory approval.

With Dexcom SHARE, parents and personal caregivers can monitor a child's or loved one's glucose data from a remote location, giving them peace of mind and reassurance when they are apart, says the company.

DXCM closed Monday's trading at $42, up 3.30%.

Neurocrine Biosciences Inc. (NBIX) has initiated a phase III clinical trial of its drug candidate NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder or mood disorder.

The trial, dubbed Kinect 3 Study, is designed to enroll 240 subjects, and topline efficacy data are expected in the second half of 2015.

NBIX closed Monday's trading at $16.44, up 0.74%.

NewLink Genetics Corp. (NLNK) has entered into an exclusive worldwide license agreement with Genentech, a member of the Roche Group (RHHBY.OB), for the development of NLG919, NewLink's IDO pathway inhibitor.

The two companies have also entered into research collaboration for the discovery of next generation IDO/TDO compounds. (TDO is tryptophan-2,3-dioxygenase and IDO is indoleamine-2,3-dioxygenase).

The agreement entitles NewLink to receive an upfront payment of $150 million and over $1 billion in milestone payments based on achievement of certain predetermined milestones as well as escalating double-digit royalties on potential commercial sales of multiple products by Genentech.

NLNK closed Monday's trading at $31.44, up 7.12%.

Orexigen Therapeutics Inc.'s (OREX) recently approved prescription weight loss drug Contrave is now available across the United States.

Orexigen has licensed North American Contrave rights to Takeda Pharmaceuticals. In Europe and throughout the rest of the world outside of North America, Orexigen owns Contrave rights.

OREX closed Monday's trading at $4.06, down 0.49%.

Pharmacyclics Inc. (PCYC) is seeking FDA approval for IMBRUVICA in the expanded indication of Waldenstrom's macroglobulinemia, a slow-growing, currently incurable, rare type of B-cell lymphoma.

The company has submitted a supplemental New Drug Application to the FDA based on data from a phase II study evaluating IMBRUVICA in patients with Waldenstrom's macroglobulinemia, or WM.

There is no established standard of care - or approved therapeutic for Waldenstrom's macroglobulinemia.

IMBRUVICA is currently approved by the FDA for three indications - for the treatment of patients with mantle cell lymphoma or chronic lymphocytic leukemia who have received at least one prior therapy, and for CLL patients with a deletion of the short arm of chromosome 17 (del 17p), including treatment-naive and previously treated del 17p CLL patients.

PCYC closed Monday's trading at $114.83, up 2.33%.

RegeneRx Biopharmaceuticals Inc. (RGRX.OB) may begin phase III development of RGN-259 preservative-free eye drops for the treatment of patients with neurotrophic keratopathy by mid-2015.

The phase III program will include two pivotal trials and will enroll less than 90 patients.

RGRX.OB closed Monday's trading 8.70% higher at $0.15.