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FDA Nod For Innovus' Kit, PLSE Soars On SK Data, Keep An Eye On ARNA

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Today's Daily Dose brings you news about FDA clearance of Innovus' GlucoGorx Glucose Monitoring Test Kit; Nymox securing equity capital; progress in Pfizer's Duchenne muscular dystrophy trial; encouraging data from Pulse Biosciences' first human study of Nano-Pulse Stimulation (NPS) technology for the treatment of seborrheic keratosis lesions, and Vermillion's stock offering.

Read on…

Arena Pharmaceuticals Inc. (ARNA) will be presenting data from a post-hoc analysis of the 22-week Phase 2 clinical study for its investigative drug candidate Ralinepag at the International Society for Heart and Lung Transplantation 2018 Annual Meeting on April 14.

Ralinepag is in development for the treatment of pulmonary arterial hypertension (PAH).

Arena previously announced top line phase II results for Ralinepag in PAH last July. In the trial, Ralinepag demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance compared to placebo. Ralinepag also demonstrated numerical improvement in 6-minute walk distance relative to placebo.

ARNA closed Thursday's trading at $35.33, down 2.40%.

Innovus Pharmaceuticals Inc. (INNV.OB) has received FDA clearance for its GlucoGorx Glucose Monitoring Test Kit that includes a glucose meter, test strips and lancet device.

The product is expected to be launched in the second half of 2018.

INNV.OB closed Thursday's trading at $0.15, down 1.32%.

Nymox Pharmaceutical Corp. (NYMX) has secured $16.25 million in new equity capital with qualified long-time investors.

The Company believes that with the new funds, it will be adequately financed well beyond expected outcome timings for its regulatory submissions in Europe and the U.S. for its novel treatment, Fexapotide Triflutate for the treatment of the symptoms of benign prostatic hyperplasia (BPH, prostate enlargement).

The Company filed for marketing approval for Fexapotide Triflutate for benign prostatic hyperplasia in Europe last May, and plans to submit the NDA for Fexapotide in the U.S. later this year.

NYMX closed Thursday's trading at $4.13, down 2.36%.

Pfizer Inc. (PFE) has initiated a phase IB clinical trial for its mini-dystrophin gene therapy candidate, PF-06939926, in boys with Duchenne muscular dystrophy (DMD).

The phase IB clinical trial, which is a multi-center, open-label, non-randomized, ascending dose study of a single intravenous infusion of PF-06939926, is designed to enroll approximately 12 ambulatory boys aged 5 to 12 years with DMD.

Early data from this trial are expected in the first half of 2019, once all patients have been evaluated for one full year post-treatment.

PFE closed Thursday's trading at $36.32, up 1.48%.

Shares of Pulse Biosciences Inc. (PLSE) soared more than 32% in extended trading on Thursday, following positive clinical efficacy results of its first multi-center study of Nano-Pulse Stimulation (NPS) technology for the treatment of seborrheic keratosis lesions (SKs) in humans.

Seborrheic keratosis (SK) typically appears as a raised skin lesion with a waxy, scaly texture that can vary in color from light tan to dark brown or black, and is often associated with aging skin. More than 80 million people in the United States have seborrheic keratosis.

In the clinical trial, 82% of 174 lesions treated with Nano-Pulse Stimulation technology were rated as clear or mostly clear after 106 days in 58 adult patients. An independent, blinded photographic review of lesion images scored 71% of lesions as clear or mostly clear. Patients rated 78% of lesion outcomes as satisfied or mostly satisfied, closely mirroring investigator ratings, noted the Company.

Pulse Biosciences featured in our Company Spotlight column on February 17, 2017 when it was trading around $12.

PLSE closed Thursday's trading at $18.18, up 3.35%. In after-hours, the stock was up 32.01% to $24.00.

Tetra Bio-Pharma Inc. (TBP.V) (TBPMF.OB) has provided a status report on its encapsulated cannabis oils (PPP005) clinical trials.

A phase I clinical trial assessing safety, tolerability and pharmacokinetics of single and multiple dose of encapsulated cannabis oil (10 mg THC with 10 mg CBD) is expected to be completed soon.

A phase II clinical trial that is being conducted to obtain safety and efficacy data to help drive the sales of encapsulated cannabis oil products for the treatment of chronic pain is expected to be completed by fall 2018.

TBPMF.OB closed Thursday's trading at $0.57, up 0.48%.

Vermillion Inc. (VRML) slumped over 15% in extended trading on Thursday after the Company announced that it intends to offer shares of its common stock and convertible preferred stock in concurrent but separate underwritten public offerings.

Piper Jaffray & Co. is the sole underwriter for the offerings. The underwriter has a 30-day option to purchase up to an additional 15% of the shares of common stock being offered at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any.

VRML closed Thursday's trading at $1.30, up 2.36%. In after-hours, the stock fell 15.32% to $1.10.

by RTTNews Staff Writer

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