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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Benitec dropping HCV program, citing competition

Feb. 29, 2016
By Michael Fitzhugh
Benitec Biopharma Ltd. is winding down its lead program, the hepatitis C virus (HCV) candidate TT-034, terminating further development of the phase I/IIa drug.
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Forty Seven lands $75M series A round

Feb. 25, 2016
By Michael Fitzhugh
Forty Seven Inc., a young company moving a humanized IgG4 kappa anti-CD47 monoclonal antibody (MAb) through dual phase I studies, completed the first half of a committed $75 million series A financing led by Lightspeed Venture Partners and Sutter Hill Ventures. Clarus Ventures and GV (formerly Google Ventures) also participated in the financing.
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Another DMD setback: PTC's Translarna stung by refuse to file letter from FDA

Feb. 24, 2016
By Michael Fitzhugh
The FDA's refusal to accept a new drug application for PTC Therapeutics Inc.'s Duchenne muscular dystrophy (DMD) candidate Translarna (ataluren) left the company pondering next steps as its shares (NASDAQ:PTCT) plunged, falling 61.6 percent, or $17.42, to close at $10.84 on Tuesday.
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Mesoblast sees positive data for GVHD cell therapy

Feb. 24, 2016
By Michael Fitzhugh
Mesoblast Ltd., the developer of a cell therapy for steroid-refractory acute graft-vs.-host disease (GVHD), reported that a new analysis of long-term data shows that children treated with the cells demonstrated clinically meaningful responses and significantly increased survival, with an overall response rate of 65 percent at 28 days after treatment.
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Mesoblast sees positive data for GVHD cell therapy

Feb. 23, 2016
By Michael Fitzhugh
Mesoblast Ltd., the developer of a cell therapy for steroid-refractory acute graft-vs.-host disease (GVHD), reported that a new analysis of long-term data shows that children treated with the cells demonstrated clinically meaningful responses and significantly increased survival, with an overall response rate of 65 percent at 28 days after treatment.
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Strategia starts phase I of Fujifilm cancer candidate

Feb. 22, 2016
By Michael Fitzhugh
Strategia Therapeutics Inc., of Boston, has started a U.S.-based phase I trial of the antimetabolite agent FF-10502 in patients with advanced solid tumor cancers and lymphoma.
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Athersys shares gain ground on full-year stroke data

Feb. 19, 2016
By Michael Fitzhugh
A year after treatment with Athersys Inc.'s Multistem cell therapy in a phase II trial, 23 percent of people who suffered an ischemic stroke achieved a clinically rated "excellent outcome" vs. just 8.2 percent of patients who received placebo, the company told attendees of the 2016 International Stroke Conference in Los Angeles.
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Hepatitis C combo data buoys Regulus Therapeutics' shares

Feb. 18, 2016
By Michael Fitzhugh
Interim data suggesting that the length of direct-acting antiviral (DAA) treatment regimens for many hepatitis C (HCV) cases could be halved by adding Regulus Therapeutics Inc.'s microRNA antagonist, RG-101, pushed company shares (NASDAQ:RGLS) 19.3 percent higher to $7.49 by Wednesday's market close.
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Akarna lands $15M in series B round for NASH candidate

Feb. 17, 2016
By Michael Fitzhugh
Akarna Therapeutics Ltd. closed a $15 million series B preferred stock financing that the company said would accelerate the development of its lead farnesoid X receptor (FXR) agonist drug candidate through human proof-of-concept studies in patients with non-alcoholic steatohepatitis (NASH) and/or fatty liver disease.
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Proteostasis raises $50M in IPO, but with big discount

Feb. 12, 2016
By Michael Fitzhugh
Despite pricing well below range, an upsized IPO by cystic fibrosis drug developer Proteostasis Therapeutics Inc. (NASDAQ:PTI) fell 17 percent during its first day of trading Thursday, joining a small but intrepid class of four biotech IPOs this year, all of which have seen shares fall from their initial price. (See chart, below.)
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