BioShares Biotechnology Clinical Trials (BBC): $18.87, -$0.45, -35.0% YTD
BioShares Biotechnology Products (BBP): $33.76, -$0.20, +9.5% YTD
Wall Street looked set to open higher on Wednesday, with investors looking for catalysts that would nudge the Dow Jones Industrial Average beyond 20,000, a level it has never breached. The blue-chip index came within 20 points of the psychological milestone on Tuesday, helped by gains in technology stocks, which also pushed the Nasdaq to a record high. However, with year-end celebrations around the corner, trading volumes are likely to remain light.
OSE Immunotherapeutics SA announced that the company has entered into a worldwide license option agreement with Servier for the development and commercialization of OSE Immunotherapeutics’ Effi-7, an antagonist of the interleukin-7 receptor. Under the terms of the agreement, OSE Immunotherapeutics grants Servier a license option on the exclusive worldwide rights for the development and commercialization of its product Effi-7. OSE Immunotherapeutics is eligible to receive up to €272 million including an upfront payment of €10.25 million and additional payments of €30 million upon the exercise of a two-steps option license. These steps will enable the development of Effi-7 up to the completion of a phase 2 clinical trial planned in ulcerative colitis, an autoimmune bowel disease. Further payments will be linked to the achievement of clinical development and registration in multiple indications, as well as sales milestones with double-digit royalties on sales.
AzurRx BioPharma will be making a company presentation at the Biotech Showcase conference in San Francisco at the Hilton San Francisco Union Square on Monday, January 9th.
Anthera Pharmaceuticals announced the top line results of the SOLUTION clinical study in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI). The study narrowly missed the CFA non-inferiority margin of the primary modified Intent to Treat (mITT) analysis; however, by additional pre-specified analyses of CFA (mITT-Baseline Observation Carried Forward and Per Protocol), Sollpura met the non-inferiority criterion. The study also confirmed that the ratio of the three enzymes in Sollpura demonstrated an appropriate response in the coefficient of nitrogen absorption (CNA). CNA is a measure of protein digestion and absorption and is a key requirement of Anthera’s planned US FDA regulatory submission. Anthera expects to release data from the extension phase of the study in Q1 2017.
Galena Biopharma announced the company has confirmed the regulatory pathway to advance GALE-401 (Anagrelide Controlled Release) into a pivotal, Phase III trial. After a productive meeting with the FDA, the Company has confirmed the development program and proposed clinical trial are appropriate for a NDA filing using the 505(b)(2) regulatory pathway.
Achillion Pharmaceuticals announced that it has received a $15 million milestone payment from Janssen Research & Development, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, related to enrollment in the OMEGA-1 Phase IIb global, clinical trial of JNJ-4178, a 3DAA combination of odalasvir, simeprevir, and AL-335 in patients with treatment-naive chronic hepatitis C virus infection (HCV) without cirrhosis.
ImmunoGen announced that results from the Phase I expansion cohort evaluating mirvetuximab soravtansine (IMGN853) in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology. The data demonstrate the potential clinical benefit of mirvetuximab soravtansine for the treatment of platinum-resistant ovarian cancer.
On December 26, 2016, Seattle Genetics entered into a Tenth Amendment to the Development and Supply Agreement dated February 23, 2004 between the Company and AbbVie (the successor in interest to Abbott Laboratories’ research-based pharmaceuticals business) (“AbbVie”) relating to the manufacture of the antibody component of ADCETRIS. Among other things, the Amendment extends the term of the Supply Agreement from August 22, 2021 through and including December 31, 2025, with an automatic one-year extension of the term unless either party provides written notice of termination.
Escend Pharmaceuticals announced that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for its lead product candidate, ES-3000, for the treatment of acute myeloid leukemia (AML). The FDA previously granted ES-3000 orphan designation for the treatment of chronic myeloid leukemia (CML).
Reuters reported that Immunocellular Therapeutics filed for an offering of up to $20 million of common units.
LifeSci Capital analyst Jerry Isaacson initiated coverage of OncoSec Medical.
Janney Capital analyst Ken Trbovich initiated coverage of Impax Laboratories with a “neutral” rating and $15 fair value estimate, citing Impax has done a nice job developing its CNS-focused branded specialty pharmaceutical business, but there some near-term risks.
HC Wainwright analyst Ed Arce initiated coverage of Ocera Therapeutics with a “buy” rating and $10 price target, citing Ocera’s lead drug, OCR-002, has the potential to become the gold standard for both the treatment and prevention of overt HE.