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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Pivotal GIST data pump up market enthusiasm for Deciphera's ripretinib

Aug. 14, 2019
By Michael Fitzhugh
Shares of Deciphera Pharmaceuticals Inc. (NASDAQ:DCPH) spiked Tuesday, rising 80% to $35.90 as results of a pivotal phase III study showed its lead candidate, ripretinib, enabled people with fourth-line and beyond gastrointestinal stromal tumors (GIST) to live a median of 6.3 months before disease progression vs. one month with a placebo. Ripretinib also reduced the risk of disease progression or death by 85%.
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Regeneron cocktail and Ridgeback MAb top Zmapp and Gilead candidate in first Ebola RCT

Aug. 13, 2019
By Michael Fitzhugh
Stopped early for favorable results, an African trial testing four Ebola drugs has found two of the therapies, Regeneron Pharmaceuticals Inc.'s REGN-EB3 and the NIH-developed MAb-114, gave Ebola-infected participants a greater chance of survival than either Gilead Sciences Inc.'s remdesivir or Zmapp (Mapp Biopharmaceutical Inc., Defryus Inc.), considered the standard of care based on the previous Prevail II trial.
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Kala readies for 2020 refile of dry eye NDA following anticipated CRL

Aug. 12, 2019
By Michael Fitzhugh
Kala Pharmaceuticals Inc. said it would look to data from a third phase III trial of its dry eye disease candidate, KPI-121 0.25%, to satisfy the request, in an FDA complete response letter (CRL), for efficacy data from an additional trial to support its NDA. The study, called STRIDE (Short Term Relief In Dry Eye) 3, is already underway with Kala targeting a top-line readout by year-end to support a resubmission in the first half of 2020.
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Bayer goes all in on Bluerock, paying $240M up front for cell therapy firm

Aug. 9, 2019
By Michael Fitzhugh
Bayer AG has agreed to pay $240 million in cash plus as much as $360 million in milestones for total ownership of Bluerock Therapeutics, a cell therapy company it launched and funded with Versant Ventures in 2016 with an initial $225 million series A investment. Valuing Bluerock at nearly $1 billion, the deal gives Bayer full rights to the startup's Cell+Gene platform, as well as a Parkinson's disease (PD) program expected to enter the clinic by year-end.
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Facing phase II delay and Servier breakaway, Miragen restructures

Aug. 9, 2019
By Michael Fitzhugh
Shares of Miragen Therapeutics Inc. (NASDAQ:MGEN) fell 17.2% to $1.30 Thursday on news that key phase II data for its lead candidate, cobomarsen for blood cancer, would be delayed until 2021 while support for another program, MRG-110 for heart failure, will be pulled by Les Laboratoires Servier SAS after a strategic review at the French pharma. 
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Emergo finds midstage success in developing flu-fighter norketotifen

Aug. 7, 2019
By Michael Fitzhugh
Emergo Therapeutics Inc., a Durham, N.C.-based startup that raised a $12 million series A last year, has successfully completed a phase IIa trial demonstrating positive data for its lead candidate, an oral formulation of norketotifen, in 36 people with allergen-induced allergic rhinitis.
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Rakuten invests $100M to expand light-activated cancer drug platform

Aug. 7, 2019
By Michael Fitzhugh
Rakuten Medical Inc., the developer of a precision photoimmunotherapy platform targeting head and neck cancer, has raised about $100 million in a series C-1 preferred stock financing from Rakuten Inc., a global internet services company headquartered in Japan that now owns 22.5% of the company. 
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Allakos shares boom on positive phase II results in rare inflammatory diseases

Aug. 6, 2019
By Michael Fitzhugh
Shares of California-based Allakos Inc. (NASDAQ:ALLK) rose 110.5% to a record close of $65.26 Monday amid a broader market plunge on positive phase II results with AK-002, its experimental therapy for people with two rare conditions, eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE). 
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Rakuten invests $100M to expand light-activated cancer drug platform

Aug. 5, 2019
By Michael Fitzhugh

Rakuten invests $100M to expand light-activated cancer drug platform

Aug. 5, 2019
By Michael Fitzhugh
Rakuten Medical Inc., the developer of a precision photoimmunotherapy platform targeting head and neck cancer, has raised about $100 million in a series C-1 preferred stock financing from Rakuten Inc., a global internet services company headquartered in Japan that now owns 22.5% of the company.
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