AVEO Announces Exclusive Worldwide License Agreement for the Development and Commercialization of AV-380 and Related Antibodies

CAMBRIDGE, Mass.--- AVEO Oncology (AVEO) today announced an exclusive, worldwide license agreement with Novartis for the development and commercialization of AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), AV-380, and related antibodies, including modified or derivative forms of any such antibody (the “Product”).

Under the terms of the agreement, AVEO will receive an upfront payment of $15 million and will be eligible to receive reimbursement, clinical, sales and regulatory-based milestone payments totaling $311 million assuming successful advancement of the Product. AVEO will also be eligible to receive tiered royalties on product sales ranging from high single digits to a low double-digit. Novartis will be responsible for all clinical development, manufacturing and commercialization activities and costs associated with the Product.

Published: 17 August 2015
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Onconova Therapeutics Announces Submission of Investigational New Drug Application for Pivotal Phase 3 Trial for IV Rigosertib in Higher-Risk Myelodysplastic Syndromes

Key Milestone in Positioning Rigosertib on Approval Track for HR-MDS
Pivotal Phase 3 Trial Expected to Begin in Second Half of 2015

NEWTOWN, Pa., Aug. 13, 2015 -- Onconova Therapeutics, Inc. (ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IV rigosertib as a treatment for higher-risk myelodysplastic syndromes (HR-MDS) after failure of hypomethylating agent (HMA) therapy.  Upon clearance, the IND enables Onconova to initiate a randomized, controlled pivotal Phase 3 trial in patients with HR-MDS that have failed prior HMA therapy.

Published: 14 August 2015
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Galectin Therapeutics Receives U.S. Patent Notice of Allowance for Use of Pectin Compounds to Reduce Fibrosis in Multiple Diseases

Broad Coverage Includes Use of Various Pectin Compounds for Chronic Kidney Disease Associated with the Development of Fibrosis, Established Kidney Fibrosis, Chronic Lung Disease Associated with the Development of Fibrosis and Established Lung Fibrosis

NORCROSS, Ga., Aug. 13, 2015  -- Galectin Therapeutics Inc. (GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for patent application number 13/726,900, titled "Galactose-pronged polysaccharides in a formulation for antifibrotic therapies." When issued, the patent will extend coverage of the Company's pectin-derived compounds (including broad molecular weight ranges and other sources of pectin) to include treatment of chronic kidney disease associated with the development of fibrosis, established kidney fibrosis, chronic lung disease associated with the development of fibrosis and established lung fibrosis.

Published: 13 August 2015
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Enzymotec Ltd. Reports Second Quarter 2015 Results

Revenues and Adjusted EBITDA Increased for Fourth Consecutive Quarter
Q2 Net Revenues Increased 49.5% Year-Over-Year; Q2 Net Income of $0.10 Per Diluted Share

MIGDAL HA'EMEQ, Israel, Aug. 12, 2015  -- Enzymotec Ltd. (ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today reported financial results for the second quarter ended June 30, 2015.

Second Quarter Financial Highlights

Eleven Biotherapeutics Announces First Patients Dosed with EBI-005 in Phase 3 Study in Patients with Moderate to Severe Allergic Conjunctivitis

– Top-line Data Expected in First Quarter 2016 –

CAMBRIDGE, Mass.--- Eleven Biotherapeutics, Inc. (Nasdaq: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced dose administration for the first patients in a Phase 3 study of EBI-005 for the treatment of moderate to severe allergic conjunctivitis. This Phase 3 study was designed and initiated following the completion in October 2014 of a Phase 2 study in which EBI-005 exhibited biological activity in improving the symptoms of late-phase allergic responses in patients with moderate to severe allergic conjunctivitis. This included statistically significant improvements in mean change from baseline in patient reported ocular itching, tearing and associated nasal symptoms compared to vehicle-control at the second to last and final assessment time points following allergen exposure in a modified direct conjunctival allergen provocation test (CAPT) model.

Published: 12 August 2015
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