logo
Share SHARE
FONT-SIZE Plus   Neg

VICL Soars After-hours, DMTX Deems RARE Bid Superior, MDXG On Watch

Pharma-100217-lt.jpg

Today's Daily Dose brings you news about Allergan exploring new use for its intravenous antibiotic Avycaz; Boston Scientific's acquisition of privately-held Apama Medical; Dimension Therapeutics finalizing its suitor; trial date being set in MiMedx Group's patent infringement lawsuit; Sophiris' progress with its prostate cancer trial, and Limited Use Indication approval eligibility of Vical's antifungal.

Read on...

Allergan plc's (AGN) supplemental New Drug Application for AVYCAZ seeking to expand the current indications for the drug to include hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) in adult patients has been accepted for priority review by the FDA.

The regulatory agency's decision is expected in the first quarter of 2018.

AVYCAZ is already approved for the treatment of complicated intra-abdominal infections and complicated urinary tract infections. The drug's net revenues in the first half of 2017 was $25.8 million, up from $22.1 million in the year-ago period.

AGN closed Monday's trading at $210.98, up 2.94%.

Boston Scientific Corp. (BSX) has agreed to acquire Apama Medical Inc., a privately-held company, for $175 million in cash up-front and a maximum of $125 million in contingent payments over the period of 2018-2020.

Apama is developing Apama Radiofrequency (RF) Balloon Catheter System for the treatment of atrial fibrillation. This acquisition strengthens Boston Scientific's electrophysiology portfolio and expands into "Single-Shot" balloon pulmonary vein isolation treatments for patients with Atrial Fibrillation.

The Apama RF balloon is currently being studied in clinical trials in Europe to serve as the basis for CE mark approval, which is expected in late 2018.

The acquisition is projected to close during the fourth quarter of 2017, subject to customary closing conditions.

BSX closed Monday's trading at $29.47, up 1.03%.

Dimension Therapeutics Inc. (DMTX) has determined Ultragenyx Pharmaceutical Inc.'s (RARE) buyout offer to be superior to that of REGENXBIO Inc. (RGNX).

On August 25, 2017, REGENXBIO had offered to acquire Dimension in an all-stock transaction for an implied value of approximately $3.41 per share. The news sent Dimension shares soaring more than 160% to $3.15 that day. Since then, the share price of Dimension has been steadily climbing.

On September 18, 2017, Ultragenyx made a proposal to acquire all of the outstanding shares of common stock of Dimension Therapeutics for $5.50 per share, or approximately $138 million, in cash. Ultragenyx' offer price has been most recently raised to $6.00 per share.

After weighing the two options, Dimension has determined to take up the buyout offer of Ultragenyx. REGENXBIO is not going to enter the bid battle and has notified Dimension that it has no intention of increasing the buyout offer.

DMTX closed Monday's trading at $5.90, down 1.67%.

Esperion Therapeutics Inc. (ESPR) has completed patient enrollment in its pivotal phase III program for bempedoic acid, an oral, once-daily LDL-C lowering drug.

The ongoing phase III Program for Bempedoic acid includes four global pivotal studies that enrolled almost 3,600 high cardiovascular disease (CVD) risk patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), or who are high risk primary prevention, on optimized background lipid-modifying therapy and with elevated levels of LDL-C.

Top-line results from Studies 1, 3 and 4 are expected in the second quarter of 2018, with top-line results from Study 2 expected in the third quarter of 2018.

ESPR closed Monday's trading at $52.22, up 4.19%.

The United States District Court for the Northern District of Georgia has set a trial date of January 22, 2018 for MiMedx Group Inc.'s (MDXG) patent infringement lawsuit against Musculoskeletal Transplant Foundation Inc., Medline Industries Inc. and Liventa Bioscience Inc.

MiMedx Group had sued the above Defendants in April 2014 for alleged patent infringement.

Commenting on the trial date being set, Parker H. "Pete" Petit, Chairman and CEO of MiMedx Group, said, "We filed this lawsuit in April 2014, and are very pleased to finally have a hard date set for this trial. We are anxiously awaiting January 22nd, and look forward to presenting our patent infringement allegations against these defendants during the five day period the court has allocated for this trial. The numerous legal maneuvers to avoid trial that were employed by MTF, Liventa and Medline have failed, and we are highly confident in our case against these defendants."

MDXG closed Monday's trading at $12.79, up 7.66%.

Sophiris Bio Inc. (SPHS) expects its phase 2b study of Topsalysin as a treatment for men with clinically significant localized prostate cancer to be fully enrolled by the end of October.

The Company expects biopsy data from all patients dosed with the first administration of Topsalysin to be available late in the first quarter of 2018.

SPHS closed Monday's trading at $2.16, up 0.65%.

Shares of Vical Inc. (VICL) were up more than 40% in extended trading on Monday after being notified that its antifungal VL-2397 is eligible for limited use indication approval by the FDA based on a single phase II efficacy trial.

The Company plans to initiate a single phase II trial of VL-2397 for the treatment of invasive aspergillosis (IA) in acute leukemia patients and allogeneic hematopoietic cell transplant (HCT) recipients in the fourth quarter of 2017.

Vical will conduct a conference call and webcast on October 3, at noon Eastern Time, to discuss the phase II trial design.

VICL closed Monday's trading at $2.47, up 2.92%. In after-hours, the stock was up 42.11% to $3.51.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

comments powered by Disqus
Follow RTT