ABBV Seeks New Cures From Old Drug, RARE Findings, Nanosphere Makes Giant Leap

(RTTNews) - AbbVie Inc.'s (ABBV) pivotal phase III study evaluating HUMIRA in the expanded indication of moderate-to-severe hidradenitis suppurativa has met the primary endpoint.

Hidradenitis suppurativa, or HS, is a painful, chronic inflammatory skin disease that impacts approximately 1 percent of the adult population worldwide with no approved treatment options available.

In the trial, dubbed PIONEER II, the second pivotal registration study, HUMIRA achieved a statistically significant improvement of hidradenitis suppurativa related abscesses and inflammatory nodules at 12 weeks.

Results from a previous study named PIONEER I, which were announced last month, have also demonstrated that moderate-to-severe HS patients treated with HUMIRA achieved a significantly greater response compared to placebo.

HUMIRA is a biologic treatment approved for 8 indications including moderate to severe rheumatoid arthritis in adults, moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older, psoriatic arthritis (PsA) in adults, ankylosing spondylitis (AS) in adults, moderate to severe adult Crohn's disease (CD), moderate to severe Crohn's disease (CD) in children 6 years and older, moderate to severe ulcerative colitis in adults and moderate to severe chronic plaque psoriasis (Ps) in adults.

ABBV closed Monday's trading at $53.62, down 2.46%.

CytoDyn Inc. (CYDY.OB) announced that its ongoing phase 2b treatment substitution trial has demonstrated 100% success in suppressing the viral load among patients who had weekly injections of PRO 140 for 4 weeks of monotherapy.

The phase 2b clinical study was designed to investigate the potential of allowing patients to enjoy treatment interruption from their current HAART regimen concurrent with a monotherapy consisting of weekly injections of PRO 140.

CYDY.OB closed Monday's trading at $0.80, up 3.23%.

Intra-Cellular Therapies Inc. (ITCI) announced positive top line results from Part I portion in a phase I/II clinical trial of low doses of its lead drug candidate, ITI-007 in healthy geriatric subjects (trial Part 1) and in patients with dementia, including Alzheimer's disease (trial Part 2).

The initial results demonstrated that ITI-007 is safe and well-tolerated in healthy geriatric subjects and met the primary objectives of the study.

The company noted that additional data, including Part 2 of the trial, will be presented at a future scientific conference.

ITCI closed Monday's trading at $14.72, up 2.65%.

Nanosphere Inc. (NSPH) has received 510(k) clearance from FDA for additional viral targets on its Verigene Enteric Pathogens Test.

The bacterial portion of the company's Verigene Enteric Pathogens Nucleic Acid Test was cleared by regulatory agency earlier this summer.

Verigene EP is an automated in vitro diagnostic test that simultaneously identifies a broad panel of common community-acquired pathogenic enteric bacteria and genetic virulence markers directly from a stool sample, two to three days faster than the time- and labor-intensive conventional identification methods.

NSPH closed Monday's trading 88.68% higher at $1.23. In after-hours, the stock lost 17.07% to $1.02.

Quidel Corp. (QDEL) has received FDA clearance for yet another of its assay - this time for Lyra Adenovirus Assay, a real-time polymerase chain reaction test for the qualitative detection of human adenovirus viral DNA isolated from nasal swab and nasopharyngeal swab specimens.

The Lyra assays yield highly sensitive, quantitative PCR results within 75 minutes, according to the company.

Quidel now offers FDA-cleared Lyra assays for a dozen different infectious agents, including eight molecular tests for respiratory disease (Strep A, Strep C+G, Influenza A, Influenza B, human metapneumovirus (hMPV), respiratory syncytial virus (RSV), and adenovirus (HAdV)) and four other PCR assays for other serious infectious disease pathogens (herpes simplex virus (HSV) types 1 and 2, varicella zoster virus (VZV) and C. difficile).

QDEL closed Monday's trading at $27.07, up 5.09%.

Ultragenyx Pharmaceutical Inc. (RARE) announced that in a phase II extension study of sialic acid extended-release (SA-ER, UX001) tablets where hereditary inclusion body myopathy patients received 12 grams/day of the drug candidate for 24 weeks, the 12 gram daily dose of SA-ER appeared to be generally safe and well tolerated with no drug-related serious adverse events. However, the 12 gram per day dose did not appear to have a clear advantage over the 6 gram per day dose.

Hereditary inclusion body myopathy, or HIBM, is a rare, severe and progressive genetic muscle disease.

In a previous phase II study, the results of which were announced in April 2014, SA-ER at a dosage of 6 grams/day of achieved a statistically significant difference in the upper extremity composite of muscle strength at 48 weeks compared to 3 grams/day dosage.

Based on the 48-week and extension study data, Ultragenyx intends to discuss with regulatory authorities a potential pivotal study of SA-ER in HIBM patients. The company will also continue to treat patients in the ongoing extension study.

RARE closed Monday's trading at $47.22, down 5.37%.