ONCE Braces For Busy Year, ELOS Rises After Hours, GWPH Under Scanner

(RTTNews) - Abiomed Inc. (ABMD) expects preliminary unaudited third quarter fiscal 2016 revenue to be roughly $85.8 million, an increase of 38%, compared to revenue of $62.0 million for the same period of fiscal 2015.

The company's primary revenue driver, the Impella device, is expected to rake in U.S. revenue of about $75.0 million, up from $51.9 million in the prior fiscal year. The company is scheduled to report its full financial results for the third quarter of fiscal 2016 on February 4, 2016.

ABMD closed Monday's trading at $85, up 0.50%. In after hours, the stock was up 1.76% at $86.50.

Achaogen Inc. (AKAO) has enrolled the first patient in its phase III trial of its drug candidate Plazomicin to treat complicated urinary tract infections including acute pyelonephritis.

The company hopes to release top-line results from this study, dubbed EPIC, and submit an NDA for Plazomicin in the second half of 2017.

The company has also commenced enrollment of patients in the second cohort of its phase III study, named CARE, which is evaluating Plazomicin in the treatment of patients with bloodstream infections (BSI) or pneumonia due to carbapenem-resistant Enterobacteriaceae (CRE).

AKAO closed Monday's trading at $5.30, down 1.67%.

Aimmune Therapeutics Inc. (AIMT) has enrolled the first patient in a pivotal phase III trial of its lead product candidate, AR101 for the treatment of peanut allergy.

The trial, dubbed PALISADE, is designed to enroll approximately 500 peanut-allergic patients 4-55 years of age. The company expects to complete enrollment in PALISADE in the second half of 2016 and complete the trial in the second half of 2017.

AIMT closed Monday's trading at $15.81, down 5.16%.

BioMarin Pharmaceutical Inc.'s (BMRN) interim results from a phase II trial of Reveglucosidase alfa for the treatment of late-onset Pompe disease have shown positive trends in respiratory muscle strength, indicating a possible halt in decline or improvement in lung capacity and endurance in late-onset Pompe disease.

In the trial, dubbed INSPIRE, the interim efficacy and safety analysis was based on 24 patients who previously had been on treatment with the enzyme replacement therapy, alglucosidase alfa, and were switched to Reveglucosidase alfa.

Pompe Disease is an autosomal recessive metabolic disorder which damages muscle and nerve cells throughout the body.

The company's investigational drug Kyndrisa for the treatment of patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping is under FDA review, and a decision is expected this month.

BMRN closed Monday's trading at $93.29, down 2.57%.

Cidara Therapeutics Inc.'s (CDTX) phase I multiple ascending dose clinical trial results of its antifungal drug candidate, CD101 IV, in healthy volunteers have reinforced safety and tolerability of the compound.

According to the trial results, CD101 was well tolerated systemically across the entire dose range; no serious or severe adverse events were seen. No clinical chemistry or hematology safety concerns were observed at any dose. All patients completed dosing in this multiple dose study, noted the company.

CDTX closed Monday's trading at $15.15, down 2.26%.

Coherus BioSciences Inc.'s (CHRS) phase III trial of CHS-0214, a proposed biosimilar of Amgen Inc.'s (AMGN) Enbrel, met its primary endpoint in patients with moderate-to-severe rheumatoid arthritis.

The primary efficacy endpoint was the proportion of subjects achieving ACR20 (20% improvement according to the American College of Rheumatology criteria) at Week 24. The study continues as planned until Week 52, according to the company.

Results for the second phase III study of CHS-0214 in patients with rheumatoid arthritis are expected in the first quarter of 2016.

Coherus and Baxalta initiated a collaboration to develop and commercialize CHS-0214 in September of 2013.

CHRS closed Monday's trading at $17.71, down 3.07%.

GW Pharmaceuticals plc (GWPH) touched a 52-week low on Monday, following investigations by Block & Leviton LLP, a securities litigation firm, for potential securities law violations.

The company in its annual report had stated that it had a material weakness in its internal control over financial reporting for the year ended September 30, 2015.

GWPH touched a 52-week low of $52.92 on Monday before closing the day's trading at $56.31, down 5.93%.

Insulet Corp. (PODD) has teamed up with Eli Lilly and Co. (LLY) to develop a new version of its OmniPod tubeless insulin delivery system, specifically designed to deliver Lilly's Humalog 200 units/mL insulin.

Humalog U200 is a concentrated form of insulin used by higher insulin-requiring patients with diabetes that provides the same dose of insulin in half the volume of Lilly's Humalog U100 insulin.

Insulet is partnering with Lilly on a clinical development program designed to evaluate the use of the Humalog U200 insulin formulation in Insulet's leading OmniPod tubeless insulin delivery system.

PODD closed Monday's trading at $34.21, down 1.61%. In after hours, the stock was up 2.31% at $35.00.

Mesoblast Ltd.'s (MESO) ongoing phase III trial size of its proprietary cell-based medicine MPC-150-IM in chronic heart failure has been reduced to approximately 600 patients from 1,165 due to a proposed change in the primary endpoint.

The revised primary endpoint will be a comparison of recurrent heart failure-related major adverse cardiovascular events (HF-MACE) between patients treated with MPC-150-IM and controls, noted the company.

MESO touched a 52-week high of $6.32 on Monday before closing the day's trading at $6.05.

Spark Therapeutics Inc. (ONCE) is bracing for a busy 2016 as several catalysts are lined up over the coming months.

The company's most advanced gene therapy product candidate is SPK-RPE65 for the treatment of RPE65-mediated inherited retinal dystrophies (IRDs). Last October, positive results were reported from a pivotal phase III trial of SPK-RPE65 for genetic blinding conditions. According to the trial results, SPK-RPE65 demonstrated restoration of functional vision and improvement in light sensitivity in subjects previously progressing toward complete blindness.

The company expects to submit a Biologics License Application filing for SPK-RPE65 in the second half of 2016 and a Marketing Authorization Application filing in early 2017.

Next in the pipeline is SPK-CHM, which is under a phase 1/2 trial for choroideremia, a rare inherited disorder that causes progressive vision loss, ultimately leading to complete blindness. The initial safety and efficacy data from this trial are anticipated in the second half of 2016.

The initial efficacy data of another investigational product SPK-FIX from a phase 1/2 trial for hemophilia B are expected in mid-2016.

The company has plans to submit an Investigational New Drug filing for SPK-FVIII in hemophilia A, and an IND filing for SPK-TPP1 for TPP1 deficiency, a form of Batten disease, in the second half of 2016.

Spark ended 2015 with more than $305 million in cash and equivalents, including the $15 million milestone payment from Pfizer that was earned in December 2015.

ONCE closed Monday's trading at $30.16, down 12.04%.

Shares of Syneron Medical Ltd. (ELOS) were up over 9% in extended trading on Monday as investors welcomed the news that the aesthetic device company's total revenue for the fourth quarter 2015 is expected to be up about 5% to 7% year-over-year.

The company expects its total revenue for the fourth quarter 2015 to be in the range of $78 to $79 million compared to $74.1 million in the fourth quarter 2014 and analysts' consensus estimate of $74.81 million.

Syneron is scheduled to report its fourth quarter financial results next month.

ELOS closed Monday's trading at $6.94, up 0.43%. In after hours, the stock was up 9.65% at $7.61.