BioMarin Pharmaceutical Inc.'s (BMRN) phase II study of Talazoparib for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer has met the protocol-specified criteria to expand enrollment.
Accordingly, enrollment in the study, dubbed ABRAZO, has been expanded to 140 from 70 patients. The study is expected to be fully enrolled in the first quarter of 2016 with results expected by year end 2016.
A phase III trial comparing Talazoparib to protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations, known as EMBRACA, is now expected to be fully enrolled in the first half of 2016, and not by year end 2015 as previously estimated.
BMRN touched a new high of $151.75 on Monday before closing the day's trading at $149.13.
BioSpecifics Technologies Corp. (BSTC) touched another milestone in its globalization strategy for XIAFLEX, with the drug getting approved in Japan for the treatment of patients with Dupuytren's contracture in Japan.
Asahi Kasei Pharma Corp. has the rights to develop and market XIAFLEX in Japan through an agreement with BioSpecifics' partner Endo International plc (Endo).
BioSpecifics will receive a milestone payment upon commercial launch in Japan.
BSTC touched an all-time high of $59.14 on Monday before closing the day's trading at $58.50, up 11.24%.
Shares of Exelixis Inc. (EXEL) soared more than 50% on Monday, following positive top-line results from a primary analysis of phase III pivotal trial comparing Cabozantinib to approved drug Everolimus (Afinitor) in patients with metastatic renal cell carcinoma.
The trial, dubbed METEOR, met its primary endpoint of demonstrating a statistically significant increase in progression-free survival in the first 375 randomized patients. Cabozantinib reduced the risk of disease progression or death by 42 percent compared to the Everolimus arm, noted the company.
The trial will continue to the final analysis of overall survival anticipated in 2016.
EXEL closed Monday's trading at $5.88, up 50.38%.
Fibrocell Science Inc. (FCSC) and its partner Intrexon Corp. (XON) announced that an Investigational New Drug Application for FCX-007, Fibrocell's lead orphan gene-therapy drug candidate for the treatment of recessive dystrophic epidermolysis bullosa has been submitted to the FDA.
Fibrocell expects to initiate a phase I/II clinical trial by year-end to evaluate the safety, mechanism of action, and efficacy of FCX-007.
FCSC closed Monday's trading at $5.66, down 2.41%.
Horizon Pharma plc (HZNP) expects net sales for the second quarter ended June 30, 2015, to increase 160% compared to the second quarter of 2014, driven by rapidly accelerating prescription growth in its primary care and specialty business units and the continued addition of new patients to orphan disease drugs Ravicti and Actimmune.
Accordingly, net sales are estimated to be in the range of $170 to $172 million for the second quarter of 2015.
Looking ahead to full year 2015, Horizon Pharma has raised its net sales forecast to a range of $660 million to $680 million from its prior estimate range of $590 million to $610 million.
The company is scheduled to report second quarter 2015 financial results on Friday Aug. 7, 2015.
HZNP closed Monday's trading at $38.31, up 3.32%.
StemCells Inc. (STEM) has completed transplantation of the first subject in its phase II trial of HuCNS-SC platform technology for the treatment of geographic atrophy, the most advanced form of dry age-related macular degeneration.
The study, dubbed Radiant, is enrolling 63 patients between 50-90 years of age with bi-lateral GA-AMD (geographic atrophy associated with age related macular degeneration in both eyes).
STEM closed Monday's trading at $0.50, up 0.59%.
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