ARDX Knocked Down, Expanding Uses Of Humira, ALDR Passes Arthritis Drug Trial

(RTTNews) - AbbVie's (ABBV) approved biologic HUMIRA significantly lowered the risk of uncontrolled uveitis or vision loss in adult patients with active, non-infectious intermediate, posterior, or panuveitis despite corticosteroid therapy in a phase III trial.

The study, dubbed VISUAL-I, found that compared to placebo, patients on HUMIRA were less likely to experience treatment failure.

Another phase III trial, known as VISUAL II, evaluating the safety and efficacy of HUMIRA in patients with inactive, non-infectious intermediate, posterior, or panuveitis, is underway, and results from this trial are expected soon.

HUMIRA is already approved in the U.S. to reduce the signs and symptoms of moderate to severe rheumatoid arthritis 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; moderate to severe Crohn's disease in children 6 years of age and older; moderate to severe ulcerative colitis in adults and to treat moderate to severe chronic plaque psoriasis in adults.

ABBV closed Tuesday's trading at $63.86, down 1.27%.

Shares of Abiomed Inc. (ABMD) surged more than 15% on Tuesday, following record results for the quarter and fiscal year ended March 31, 2015, and an upbeat revenue outlook for fiscal year 2016.

Looking ahead to fiscal year 2016, the company has boosted its revenue outlook to a range of $285 million to $295 million from its prior estimate range of $260 million to $270 million. The revenue was $230.3 million in fiscal 2015.

ABMD closed Tuesday's trading at $75.47, up 15.86%.

Alder BioPharmaceuticals Inc.'s (ALDR) investigational drug Clazakizumab, previously known as ALD518, met its primary endpoint in a follow-on phase 2b, dose-ranging clinical trial in adults with moderate to severe rheumatoid arthritis who have experienced an inadequate response to TNF inhibitors.

ALDR closed Tuesday's trading at $27.16, down 2.37%.

Shares of Ardelyx Inc. (ARDX) plunged more than 17% in extended trading on Tuesday after the company announced that its phase 2a clinical trial evaluating Tenapanor in chronic kidney disease patients with Type 2 diabetes mellitus and albuminuria has failed to meet its primary endpoint.

The 154-patient phase 2a trial did not meet the primary endpoint of decreasing the urinary albumin-creatinine ratio in Tenapanor-treated patients compared to patients receiving placebo.

Ardelyx has a partnership with AstraZeneca plc (AZN) to develop and commercialize Tenapanor, which has been evaluated in other indications as well, such as constipation-predominant irritable bowel syndrome (IBS-C) and hyperphosphatemia.

Ardelyx is preparing for an end of phase 2 meeting for IBS-C with the FDA scheduled to occur in June.

ARDX closed Tuesday's trading at $10.91, down 0.46%. In after hours, the stock was down another 17.51% to $9.00.

Retrophin Inc's (RTRX) investigational drug RE-024 has been granted orphan drug designation by the FDA for the treatment of pantothenate kinase-associated neurodegeneration, or PKAN.

PKAN is a rare and lethal autosomal recessive neurodegenerative disorder believed to affect approximately one to three persons per million worldwide, with no approved treatment currently available.

The recently announced phase 1 trial of RE-024 is designed to evaluate the safety and tolerability of single oral doses of the compound.

RTRX closed Tuesday's trading at $21.62, down 7.09%. In after hours, the stock was up 4.26% to $22.54.

Globus Medical Inc. (GMED) now expects sales to be approximately $514 million in 2015, up from its previous forecast of $510 million.

For full year 2015, the company has boosted its earnings outlook to $1.02 per share from its prior guidance of $1.01 per share. Analysts polled by Thomson Reuters have forecast earnings of $1.02 per share and revenue of $511.64 million.

The company reported earnings of $0.97 per share and revenue of $474 million in 2014.

GMED closed Tuesday's trading at $23.51, down 1.47%.

MabVax Therapeutics Holdings Inc. (MBVX.OB) plans to advance its HuMab 5B1 antibody into phase 1 clinical trials in late 2015, now that it has successfully cleared an important early toxicology testing.

According to the company, the clinical development plan for HuMab 5B1 will include a phase I trial of HuMab 5B1 in subjects with metastatic pancreatic cancer as a single agent or in combination with the current standard of care, and a phase I trial of 89Zr-HuMab 5B1, a radiolabeled HuMab 5B1 antibody, as a next generation PET imaging agent for the diagnosis and management of pancreatic cancer.

MBVX.OB closed Tuesday's trading at $2.94, up 2.08%.

Pacific Biosciences of California Inc. (PACB) has earned a $10 million milestone payment from Roche for achieving a second development milestone under a license agreement with the Swiss pharmaceutical giant.

The development, commercialization and license agreement with Roche covers diagnostic products for clinical use, including sequencing systems and consumables based on Pacific Biosciences' Single Molecule, Real-Time (SMRT) technology. Under the agreement, Roche has the exclusive right to commercialize and sell the developed diagnostic products for clinical use, subject to certain terms and conditions.

Pacific Biosciences received from Roche a non-refundable up-front payment of $35 million in September 2013, and was eligible to receive up to an additional $40 million based upon the achievement of development milestones. Pacific Biosciences has now earned $20 million of the $40 million potential milestone payments pursuant to the agreement.

PACB closed Tuesday's trading at $5.83, down 3%. In after-hours, the stock gained 12.35% to $6.55.