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APHB Is A Good Shot, ASND Keeps Inching Along, SKLN Soars, INSM To File ALIS NDA


Today's Daily Dose brings you news about the number of STREAMWAY system sold by Skyline Medical in 2017; Zynerba's renewed focus on rare and near-rare neurological and psychiatric disorders; FDA clearance of Zimmer's Sidus Stem-Free Shoulder system; Ascendis Pharma's progress in TransCon Growth Hormone study; OvaScience's encouraging data on fertility treatment OvaPrime, and positive results of AmpliPhi Biosciences' lead product candidates, AB-SA01 and AB-PA01.

Read on...

Shares of AmpliPhi Biosciences Corporation (APHB) soared more than 20% in after-hours on Wednesday, following positive interim results of its lead product candidates, AB-SA01, for Staphylococcus aureus infections, and AB-PA01, for Pseudomonas aeruginosa infections.

In a single-patient expanded access program, of the seven patients with serious, life-threatening infections, not responding to antibiotics, who were treated with AB-SA01 or AB-PA01, the Company revealed that six patients achieved treatment success.

The Company noted that it intends to treat up to an additional 20 patients during the first half of 2018 and discuss the findings with the FDA to determine a development path forward to registration.

APHB closed Wednesday's trading at $1.12, up 10.89%. In after-hours, the stock was up 21.43% to $1.36.

Ascendis Pharma A/S (ASND) has reached its target enrollment in a phase III study of once-weekly TransCon Growth Hormone for children with growth hormone deficiency, dubbed heiGHt. Over 160 subjects are expected to be randomized in the trial.

Based on one-year follow-up, top-line results from the heiGHt study are anticipated to be available in the first quarter of 2019.

Patients completing the heiGHt Trial may enroll in the enliGHten Trial, the Company's open-label long-term extension study. Ascendis Pharma is also conducting the fliGHt Trial to evaluate TransCon Growth Hormone in patients who have previously been treated with daily growth hormone therapy as part of the pivotal TransCon Growth Hormone phase III program.

ASND closed Wednesday's trading at $39.87, up 0.18%.

Bellerophon Therapeutics Inc. (BLPH) has enrolled the first patient in its phase 2b study evaluating INOpulse in patients with Pulmonary Hypertension associated with Interstitial Lung Disease.

The trial is designed to enroll a total of 40 subjects. The study design includes a 1-week run-in period, followed by an 8-week double-blinded treatment period. The primary endpoint of the study is the change in 6 Minute Walk Distance from baseline to week 8. The trial will include several additional endpoints, including the change in Right Ventricular Function.

The Company expects to report top-line results from this study by the end of 2018.

BLPH closed Wednesday's trading at $2.64, up 4.35%.

Insmed Inc. (INSM), on Wednesday, announced new data from its phase III clinical program evaluating ALIS (Amikacin Liposome Inhalation Suspension) in adult patients with Nontuberculous Mycobacterial (NTM) lung disease, which provide confirmation of the initial positive clinical data released last September.

NTM lung disease is a rare and serious disorder where patients may experience a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum, and fatigue.

The Company said it will file its New Drug Application for accelerated approval of ALIS with the FDA before the end of March.

INSM touched a new 52-week high of $33.54 on Wednesday, before closing the day's trading at $32.99, up 1.63%.

OvaScience's (OVAS) phase I trial of OvaPrime in women with primary ovarian insufficiency (POI) and poor ovarian response (POR) has demonstrated that OvaPrime is generally safe and well-tolerated.

OvaPrime is one of the three fertility treatments, and the other two being OvaTure and AUGMENT.

Based on the encouraging data, the Company has decided to advance OvaPrime into a multi-center Phase 1b/2a trial in women with POI or POR. Patient enrollment in this trial is scheduled to begin in the first half of 2018, with initial clinical data expected in 2019.

OVAS closed Wednesday's trading at $1.47, up 8.89%.

Shares of Skyline Medical Inc. (SKLN) soared more than 30% in extended trading on Wednesday, following an update on commercial activities for its STREAMWAY System.

The Company's STREAMWAY system is an FDA-cleared direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures.

The Company noted that it sold 5 STREAMWAY Systems in the fourth fiscal quarter of 2017, which brings the total units sold in 2017 to 10.

A further six STREAMWAY units have been booked for sale in January 2018, and will be shipped to customers during the month, the Company added.

The Company's revenue for the nine months ended September 30, 2017 was $434,523, compared with $316,931 in the year-ago period. Revenue is generated from sales of STREAMWAY Systems and STREAMWAY disposable products.

SKLN closed Wednesday's trading at $0.97, up 0.46%. In after-hours, the stock was up 33.33% to $1.30.

VistaGen Therapeutics Inc.'s (VTGN) AV-101, being developed as a potential adjunctive treatment for Major Depressive Disorder, has been granted Fast Track Designation by the FDA.

The Company is on track to dose the first patient in its phase II trial of AV-101 as an adjunctive treatment for Major Depressive Disorder in the first quarter of 2018.

VTGN closed Wednesday's trading at $1.18, up 1.72%.

Heading into 2018, Zynerba Pharmaceuticals Inc. (ZYNE) plans to concentrate on rare and near-rare neurological and psychiatric disorders. The Company has discontinued its investment into the capital-intensive pain space.

The Company plans to initiate a pivotal Phase 2/3 program for ZYN002 in Fragile X syndrome (FXS) in mid-year 2018, with data readout in 2019.

The other milestones, which Zynerba expects to achieve this year, are:

-- Initiate a phase II study of ZYN002 in developmental and epileptic encephalopathies in the first half of 2018. The study is designed to enroll approximately 48 pediatric and adolescent patients.
-- Initiate a Phase 2B double-blind placebo controlled clinical trial of ZYN002 in adult refractory focal epilepsy, a subcategory of epilepsy, in the second half of 2018.
-- Complete Phase 1 evaluation of multiple formulations of ZYN001 in the first half of 2018.
-- Initiate Phase 2 development of ZYN001 in Tourette Syndrome by year end 2018.

ZYNE closed Wednesday's trading at $13.46, up 3.58%. In after-hours, the stock was down 1.19% to $13.30.

Zimmer Biomet Holdings Inc. (ZBH) has received FDA clearance for Sidus Stem-Free Shoulder system as a total shoulder arthroplasty solution for suitable patients.

The Sidus Stem-Free Shoulder system is designed to anatomically restore a patient's anatomy, preserve bone stock and allow for improved pre to post-operative patient outcomes.

The Sidus system will be available in the United States beginning this quarter, noted the Company. Sidus was launched in Europe in 2012.

For the fourth quarter of 2017, the Company expects revenue in the range of $2.01 billion to $2.05 billion, and adjusted EPS to be in a range of $2.08 to $2.14. The Company had reported revenue of $2.01 billion and adjusted EPS of $2.14 in the fourth quarter of 2016.

ZBH closed Wednesday's trading at $124.92, up 0.69%.

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