Friday, January 4, 2019
Miragen Therapeutics initiated at Baird
Miragen Therapeutics initiated with an Outperform at Baird. Baird analyst Madhu Kumar initiated Miragen Therapeutics with an Outperform rating, citing its near cash valuation, potential for its drug candidate in mycosis fungoides, and its undervalued MicroRNA platform. Kumar has a $10 price target on Miragen Therapeutics shares.
https://thefly.com/landingPageNews.php?id=2843853
OrthoPediatrics updates sales agency agreement with Hospithera
OrthoPediatrics announced their recently updated and signed agreement with Hospithera to act as OrthoPediatrics’ exclusive sales agency in Belgium and the Netherlands. Since 2015, Hospithera has been OrthoPediatrics’ stocking distributor, developing sales in these regions. Going forward, OrthoPediatrics will sell direct to hospitals in Belgium and the Netherlands with Hospithera as the company’s exclusive sales agency
https://thefly.com/landingPageNews.php?id=2843857
William Blair sees ‘exceptional entry point’ for Inogen shares
Shares of Inogen are down 55% from the summer highs despite the company beating the Street in Q3, providing new details on its soon-to-be-launched pipeline investments, and initiating 2019 guidance above consensus, William Blair analyst Margaret Kaczor tells investors in a research note. She believes investors have concerns around the company’s increase in sales and marketing investments and long-term market potential. The analyzed Inogen’s recent investments and came away believing that management’s 2019 guidance is likely conservative and that the market is large enough for Inogen to continue to grow at a “healthy” 20%-plus pace over the next several years. At 4.8 times her 2020 revenue target of $523.7M, Kaczor believes Inogen shares offer an “exceptional entry point despite the difficult market backdrop.” She keeps an Outperform rating on the name.
https://thefly.com/landingPageNews.php?id=2843869
Akari Therapeutics resumed with a Buy from Neutral at B. Riley FBR
https://thefly.com/landingPageNews.php?id=2843885
Momenta downgraded to Neutral from Overweight at JPMorgan
https://thefly.com/landingPageNews.php?id=2843887
ImaginAb in Immuno-Oncology License, Trial Collaboration with Nektar
ImaginAb Inc., an immuno-oncology imaging company, today announced that it has entered into a non-exclusive license and clinical trial collaboration with Nektar Therapeutics (Nasdaq: NKTR). Under the terms of the agreement, Nektar will use ImaginAb`s CD8 ImmunoPET technology to measure whole body and tumor CD8+ T cells` density and distribution in cancer patients. The collaboration will provide important mechanistic insight into various candidates in Nektar`s immuno-oncology portfolio.
“Our goal is to help companies accelerate the research and development of next-generation cancer immunotherapies, so clinicians can treat cancer patients more effectively,” said Martyn Coombs, Chief Executive Officer of ImaginAb. “Working with Nektar, one of the world`s leading biotechnology companies, will help us further develop CD8 ImmunoPET as an imaging agent and platform.”
Financial terms of the agreement were not disclosed.
“Novel PET biomarkers are essential to better understand and rationally develop next-generation immunotherapies, and ImaginAb`s CD8 ImmunoPET technology is designed to give us a non-invasive whole-body view of immune system activity,” said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Scientific Officer of Nektar. “Through this partnership with ImaginAb, we now have access to a novel and important technology that can simultaneously measure CD8+ T cells in multiple tissues, including all target and non-target tumor lesions. Since the proliferation and tumor-infiltration of CD8+ T cells is a key mechanistic feature of our pipeline candidates, including NKTR-214, we have the potential to use this technology in future clinical trials to potentially expedite the development of our immuno-oncology pipeline therapies.”
GENFIT, LabCorp to Expand Access to Innovative NASH Diagnostic Assay
LabCorp (NYSE: LH), a leading global life sciences company, and GENFIT (Euronext: GNFT), a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, have announced the signing of a licensing agreement between GENFIT and Covance, LabCorps drug development business. The agreement will expand access to an innovative non-alcoholic steatohepatitis (NASH) liver diagnostic test for the clinical research market.
NASH is a silent, asymptomatic disease that often progresses to more serious and life-threatening stages before a clinical diagnosis is made. Liver biopsy, a highly invasive procedure, is currently the clinical standard to formally diagnose NASH and stage fibrosis. Furthermore, there are currently no extensively validated non-invasive diagnostic tests in NASH to address evolving disease and therapeutic implications, providing clinical and market opportunities for new product innovations.
To address this pressing need, GENFIT has developed a novel, non-invasive test created specifically for NASH. This multi-parametric blood-based biomarker test, named NIS4, leveraged a rich biobank of samples from roughly 700 well-characterized patients to establish a novel combination of biomarkers to identify and monitor patients with NASH and significant fibrosis. The primary focus of the licensing agreement will be to deploy NIS4 in the clinical research space through Covances central laboratories to further validate the tests use for better identification and characterization of patients, and to generate new biological insights on NASH disease pathogenesis.
We are very enthusiastic to announce this agreement, which represents a major step in GENFITs commercial strategy in NASH. The expertise that LabCorp and Covance have in this field will add tremendous value to GENFITs pioneering work in developing this innovative technology. Im excited to see collaborations like this, which will help move the test toward the goal of being an in vitro diagnostic (IVD) to identify NASH patients who should be considered for therapeutic intervention, said Jean-Franois Mouney, chairman & CEO of GENFIT.
LabCorp and Covance will be able to leverage our experience in clinical trial biomarkers and diagnostics development to validate the NIS4 algorithm, said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. We are well-positioned to expand access to NIS4 to the global clinical research community through this agreement. Forward-thinking collaborations like this one enable early and efficient validation of diagnostics that have the potential to significantly impact patients with serious, life-changing unmet medical needs, including NASH.
GENFIT is a pioneer in NASH therapeutics and diagnostics development. Both LabCorp Diagnostics and Covance have been involved in the development of drugs and diagnostics for more than 20 years, and Covance is a recognized global leader in NASH clinical trials.
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