AERI Awaits Data In Q3, FDA Approves Another TAF-based HIV Drug, CTIX On Watch

(RTTNews) - Aerie Pharmaceuticals Inc. (AERI) expects the 90-day topline interim efficacy readout from its first phase III trial for Roclatan, an investigational therapy for glaucoma, to be announced in the third quarter of 2016.

The company expects to commence the second phase III clinical trial for Roclatan later this month.

AERI closed Tuesday's trading at $16.76, down 0.48%.

Alexion Pharmaceuticals Inc.'s (ALXN) SBC-103, an investigational enzyme replacement therapy for Sanfilippo B syndrome in children, has produced encouraging results in an ongoing phase I/II trial.

According to the trial results, there was a 26.2% mean reduction from baseline in total heparan sulfate levels in cerebrospinal fluid of children with Sanfilippo B syndrome at 24 weeks in the highest dose studied with SBC-103.

Sanfilippo B syndrome is caused by genetic mutations that result in a marked decrease in N-acetyl-a-D-glucosaminidase enzyme activity, leading to abnormal accumulation of heparan sulfate in the brain and other organs. This results in severe neurocognitive decline, behavioral disturbances, speech loss, increasing loss of mobility, and premature death.

ALXN closed Tuesday's trading at $150.83, up 7.12%.

Avinger Inc. (AVGR) has received 510(k) clearance from the FDA for an enhanced version of its Pantheris lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of peripheral artery disease.

The Pantheris system received FDA clearance for the treatment of patients with peripheral artery disease last October.

The enhanced version of Pantheris is expected to be launched immediately.

AVGR closed Tuesday's trading at $15.92, up 3.18%.

BioMarin Pharmaceutical Inc.'s (BMRN) investigational gene therapy for the treatment of patients with hemophilia A, BMN 270, has been granted orphan drug designation by the FDA.

BMN 270 is currently under a phase 1/2 study in patients with severe hemophilia A and a program update is expected to be provided by the company in April.

BMRN closed Tuesday's trading at $87.57, up 6.96%.

Cellceutix Corp. (CTIX.OB) has completed dosing in its phase II trial of Prurisol for the treatment of mild to moderate chronic plaque psoriasis.

Prurisol is being developed under the 505(b)(2) regulatory pathway, which can help expedite a drug's approval by relying, in part, on clinical data from an already approved drug.

The company expects top-line data from the study in May of this year.

CTIX.OB closed Tuesday's trading at $1.16, down 0.17%.

Gilead Sciences Inc.'s (GILD) three-drug cocktail Odefsey has been approved by the FDA for the treatment of HIV-1 infection in certain patients.

According to the company, Odefsey is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. The drug is also indicated as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.

Odefsey contains emtricitabine 200 mg, rilpivirine 25 mg and tenofovir alafenamide (TAF) 25 mg, and is the smallest single tablet regimen for the treatment of HIV. Emtricitabine 200 mg, marketed as Emtriva, and tenofovir alafenamide, an improved version of the marketed drug Viread, are from Gilead's stables. Rilpivirine 25 mg is marketed as Edurant by Johnson & Johnson (JNJ).

Odefsey is Gilead's second TAF-based single tablet regimen to receive FDA approval.

Last November, the FDA approved Genvoya, a single tablet regimen, which is a combination of Vitekta, Emtriva, Tybost and tenofovir alafenamide 10 mg.

GILD closed Tuesday's trading at $89.69, up 2.80%.

Roche Group's (RHHBY.OB) subsidiary Genentech announced that the supplemental Biologics License Application to extend the indication of Xolair in allergic asthma to pediatric patients has been accepted for review by the FDA.

Xolair is already approved in the U.S. for moderate to severe persistent asthma in patients 12 years of age and above with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids. The drug is also approved to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU) - chronic hives without a known cause - who continue to have hives that are not controlled by H1-antihistamine treatment.

The company expects the FDA's decision on the extended indication of Xolair later this year.

Xolair is jointly developed by Genentech and Novartis Pharma AG.

RHHBY.OB closed Tuesday's trading at $32.60, up 1.72%.

Zimmer Biomet Holdings Inc. (ZBH) has completed the acquisition of Colorado-based Ortho Transmission LLC. The financial terms of the transaction were not revealed.

The acquisition adds Ortho Transmission's transcutaneous osseous integrated skeletal implant technology to Zimmer Biomet's portfolio. Zimmer has a collaboration with the U.S. Department of Defense for the development of a transcutaneous system for anchoring external prosthetic limbs, in order to restore the mobility of amputee patients.

Currently available systems for limb amputee patients involve the fastening of a limb prosthesis to a molded socket that fits over the patient's residual limb, which must be replaced periodically over the course of a lifetime. Transcutaneous systems are designed to provide reversible connection for ease of implantation, reliability, and relatively easy access for removal, while maximizing tissue ingrowth to reduce risk of infection and attendant adverse outcomes.

ZBH closed Tuesday's trading at $97.39, up 0.60%.