17.08.2017 07:14:04

ABIO To Report Data In Q1; IOVA Fired Up, PMD In Iowa, VRX All Cleared

(RTTNews) - Today's Daily Dose brings you news about Acadia Healthcare's secondary offering; ARCA's progress in GENETIC-AF trial; Iovance's milestone that has boosted investor optimism; Psychemedics' role to play testing of drugs of abuse; Seattle Genetics' upcoming regulatory catalyst and inspection classification of Valeant's Bausch + Lomb manufacturing facility in Tampa, Florida.

Read on...

Acadia Healthcare Co. Inc. (ACHC) has announced a secondary offering of 2.82 million shares of its common stock, par value $0.01 by investment funds affiliated with Waud Capital Partners, L.L.C., investment funds affiliated with Bain Capital Investors, LLC, and certain current officers and directors of the Company.

The Company will not receive any proceeds from the offering.

ACHC closed Wednesday's trading at $51.68, down 0.63%. In after-hours, the stock was down 2.28% to $50.50.

ARCA biopharma Inc. (ABIO) has completed enrollment in its GENETIC-AF trial.

GENETIC-AF is a phase 2B/3 double-blind, clinical superiority trial comparing the safety and efficacy of ARCA bio's investigational drug Gencaro to an approved drug TOPROL-XL for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF).

The Company expects to report top-line data from GENETIC-AF trial late in the first quarter of 2018.

ABIO closed Wednesday's trading at $1.20, up 4.35%.

Shares of Iovance Biotherapeutics Inc. (IOVA) jumped more than 17% in extended trading on Wednesday following an important milestone related to the Company's experimental therapy LN-145.

The Company noted that the first patient was dosed in its phase II trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma. Initial data from the study is expected in 2018.

Patient dosing is going on in two other phase II trials - in the second cohort of phase II trial of LN-144 for the treatment of patients with metastatic melanoma and in phase II trial of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

IOVA closed Wednesday's trading at $4.45, down 5.32%. In after-hours, the stock was up 17.98% to $5.25.

A pilot study Pluristem Therapeutics Inc.'s (PSTI) PLX-R18 cell therapy will be initiated by the U.S. Department of Defense's Armed Forces Radiobiology Research Institute.

The study will examine the effectiveness of PLX-R18 as a treatment for Acute Radiation Syndrome (ARS) prior to, and within the first 24 hours of exposure to radiation.

The company recently reported positive data from studies of PLX-R18 cells as a treatment for ARS conducted by the National Institute of Allergy and Infectious Diseases. Data demonstrated improvement in survival rates and enhancement of blood lineages recovery.

PSTI closed Wednesday's trading at $1.19, up 5.31%.

Psychemedics Corp. (PMD) has become the first laboratory to be approved for the testing of drugs of abuse in hair by the State of Iowa.

A law allowing private sector pre-employment drug testing using hair samples came into effect in Iowa on July 1, 2017. Prior to this, Iowa only allowed private sector testing for drugs of abuse through urine, blood, and oral fluid.

PMD closed Wednesday's trading at $20.60, up 0.88%.

Seattle Genetics Inc.'s (SGEN) supplemental Biologics License Application for ADCETRIS in cutaneous T-cell lymphoma has been granted priority review by the FDA - with an action date set for December 16, 2017.

ADCETRIS is already approved for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma. The drug generated sales of $144.7 million in the first half of 2017 compared to $124.9 million in the year-ago period.

SGEN closed Wednesday's trading at $47.17, up 0.73%.

Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO) has received FDA confirmation of voluntary action indicated inspection classification for its Bausch + Lomb manufacturing facility in Tampa, Florida.

With this confirmation, manufacturing uncertainties related to current and upcoming regulatory submissions for products manufactured at the Tampa facility will be put to rest.

Early this month, the FDA issued a Complete response Letter for Vesneo, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.

In its CRL, the FDA only refers to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida. No efficacy or safety concerns regarding the product candidate were raised by the FDA.

VRX closed Wednesday's trading at $14.15, up 1.80%. In after-hours, the stock was up 1.20% to $14.32.

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Acadia Healthcare Co Inc 38,40 0,00% Acadia Healthcare Co Inc
Iovance Biotherapeutics 7,41 -2,91% Iovance Biotherapeutics