MBIO & Bubble Boy Disease Gene Therapy, Busy Months Ahead For EIGR, UMRX
(RTTNews.com) - Today's Daily Dose brings you news about Atossa's near-term catalyst; Acer's progress in EDSIVO in vascular Ehlers-Danlos syndrome; Eiger's phase II PRVENT study, and Mustang Bio's deal with St. Jude Children's Research Hospital for bubble boy gene therapy.
Atossa Genetics Inc. (ATOS) expects to announce preliminary results from its phase 1 study of topical Endoxifen in men by September 30, 2018.
The Phase 1 study of topical Endoxifen in men should serve as a foundation for future development into men's breast health, including male breast cancer and gynecomastia, according to the Company.
ATOS closed Monday's trading at $2.26, down 0.88%.
Acer Therapeutics Inc. ( ACER ) is continuing to progress towards finalizing the planned submission of a New Drug Application for EDSIVO in vascular Ehlers-Danlos syndrome early in the fourth quarter of this year.
Ehlers-Danlos syndrome (EDS) is a group of hereditary disorders of connective tissue.
The Company will be requesting priority review for EDSIVO which, if granted at the time of potential acceptance of NDA for filing, could result in a decision date of late second quarter 2019.
Cash and cash equivalents were $8.3 million as of June 30, 2018.
ACER closed Monday's trading at $29.00, up 3.98%.
The FDA, on August 10, approved Alnylam Pharmaceuticals Inc.'s (ALNY) ONPATTRO (patisiran) lipid complex injection, a first-of-its-kind RNA interference therapeutic, for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
The average Annual List Price of ONPATTRO is $450,000, and its average Effective Net Price is $345,000, according to the Company.
The Company expects Patisiran to be approved in the European Union next month.
ALNY closed Monday's trading at $90.95, down 6.59%.
Eiger BioPharmaceuticals Inc. (EIGR) has completed enrollment of its phase II study investigating the safety and durability of effect of subcutaneous Avexitide (formerly exendin 9-39) in post-bariatric surgical patients who experience dangerously low, postprandial blood glucose levels (hypoglycemia) known as post-bariatric hypoglycemia (PBH).
In this study, dubbed PREVENT, a total of 18 patients were enrolled across five study sites in the United States.
Top line results of the PREVENT study are expected to be reported later this year.
EIGR closed Monday's trading at $9.60, unchanged from the previous day's close.
Mustang Bio Inc. (MBIO), a Fortress Biotech (FBIO) Company, has partnered and entered into an exclusive worldwide license agreement with St. Jude Children's Research Hospital for the development of a first-in-class ex vivo lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease.
The financial terms of the deal have not been disclosed.
St. Jude's therapy, which includes a low dose of busulfan prior to reinfusion of the patients' own gene-modified blood stem cells, is currently being evaluated in a Phase 1/2 multicenter trial in infants under the age of two. The therapy is also being investigated in patients over the age of two in a second Phase 1/2 trial at the National Institutes of Health.
MBIO closed Monday's trading at $6.27, down 2.18%.
Regeneron Pharmaceuticals Inc.'s (REGN) supplemental Biologics License Application for EYLEA with a modified 12 week dosing schedule in patients with wet age-related macular degeneration has been turned down by the FDA.
EYLEA is currently approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.
REGN closed Monday's trading at $366.45, down 0.63%.
Unum Therapeutics Inc. (UMRX) has a couple of catalysts to watch out for in the coming months, one of which is the following.
The Company is preparing to initiate a multi-center Phase I trial for ACTR T cells in combination with Trastuzumab for the treatment of patients with HER2+ advanced cancers, called ATTCK-34-01, by the end of 2018.
Unum Therapeutics - So Far, So Good..
UMRX closed Monday's trading at $15.62, down 0.64%.
Viemed Healthcare Inc. (VMD.TO), a home medical equipment supplier that provides post-acute respiratory care services in the United States, announced record quarterly revenue for Q2, 2018.
Revenues for the quarter ended June 30, 2018 were approximately US$15.5 million, up 42% over the year-ago comparable quarter.
Looking ahead, the Company expects to generate total revenues of approximately US$16.3 million to US$16.7 million during the third quarter of 2018.
VMD.TO closed Monday's trading at C$5.10, up 3.66%.
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