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BioWorld - Wednesday, April 22, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Calithera files to raise up to $80 million in IPO

Aug. 27, 2014
By Michael Fitzhugh
Tumor metabolism and immunology specialist Calithera Biosciences Inc. on Tuesday revealed plans to raise up to $80 million in a yet-to-price initial public offering (IPO). The company will debut on Nasdaq under the symbol CALA and said it would use proceeds from the offering to advance CB-839, its phase I glutaminase inhibitor for triple-negative breast cancer and multiple myeloma as well as a preclinical arginase inhibitor.
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Immunovaccine reports success protecting animals from Ebola

Aug. 26, 2014
By Michael Fitzhugh
Shares of Immunovaccine Inc. (TSX:V:IMV) gained 14.4 percent Monday, to close at C$1.11 (US$1.01), after the Halifax, Nova Scotia-based company reported that monkeys dosed with an Ebola vaccine employing its Depovax formulation technology survived exposure to a lethal dose of the virus in a challenge study performed by the National Institute of Allergy and Infectious Diseases (NIAID).
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Regado wrecks, derailed by allergic events in pivotal trial

Aug. 26, 2014
By Michael Fitzhugh
Shares of Regado Biosciences Inc. (NASDAQ:RGDO) fell 60.2 percent Monday, closing at $1.13, after the company permanently terminated enrollment in a phase III trial of its lead program, the anticoagulant Revolixys Kit (REG1), following a string of serious allergic events found by its data and safety monitoring board (DSMB).
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Ampio's osteoarthritis of the knee data delayed by shipping temperature mishap

Aug. 21, 2014
By Michael Fitzhugh
A shipping glitch that might have chilled to near freezing study packages of Ampio Pharmaceuticals Inc.'s late-stage osteoarthritis of the knee (OAK) treatment, Ampion (aspartyl-alanyl diketopiperazine), will delay analysis of data from a pivotal study of the drug, the company said.
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Amicus Therapeutics paves path to reviews with positive phase III Fabry data

Aug. 20, 2014
By Michael Fitzhugh
Amicus Therapeutics Inc.'s shares (NASDAQ:FOLD) rocketed 20.4 percent Wednesday as the company delivered positive top-line data from a second phase III study of migalastat, its oral small-molecule chaperone for Fabry disease patients with a genetic mutation making them amenable to treatment.
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Oncothyreon shares start to stumble as tecemotide trips

Aug. 20, 2014
By Michael Fitzhugh
Oncothyreon Inc. shares (NASDAQ:ONTY) fell 17.3 percent to $2.30 by Tuesday's close after the company revealed that tecemotide, an immunotherapy it licensed to Merck KGaA, failed to improve overall survival or impact secondary endpoints progression-free survival, time to progression or time to failure in a phase I/II study of 178 patients with stage III non-small-cell lung cancer (NSCLC) conducted for Japanese regulators.
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Achillion Pharmaceuticals sets stage for future Sovaldi battle with proxy study

Aug. 18, 2014
By Michael Fitzhugh
Interim phase II data showing that an eight-week course of Achillion Pharmaceuticals Inc.'s NS5A inhibitor, ACH-3102, and Sovaldi (sofosbuvir, Gilead Sciences Inc.) in 12 hepatitis C virus (HCV) genotype 1 patients resulted in a complete sustained virologic response rate four weeks after treatment (SVR4) pushed company shares (Nasdaq:ACHN) up 9.6 percent to close at $9.25 Friday.
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Viva la IPO: Vitae files to raise up to $55 million

Aug. 15, 2014
By Michael Fitzhugh
Vitae Pharmaceuticals Inc., a drug discovery company partnered with Boehringer Ingelheim GmbH on its development-stage diabetes and Alzheimer's therapies, has filed to raise up to $55 million in an initial public offering (IPO), raising the total of global life sciences IPOs completed or pending this year to 91.
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Otonomy raises $100 million in IPO

Aug. 14, 2014
By Michael Fitzhugh
Ear specialist Otonomy Inc. raised $100 million in an upsized initial public offering (IPO) Wednesday, selling 6.25 million shares priced at $16 each and building on its substantial $45.9 million series C round, one of last year's top private financings.
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Intercept shares take wing on new NASH drug data

Aug. 13, 2014
By Michael Fitzhugh
Intercept Pharmaceuticals Inc. shares (NASDAQ:ICPT) climbed more than 25 percent in heavy midday trading, energized by new top-line data showing that obeticholic acid (OCA), its nonalcoholic steatohepatitis (NASH) therapy, met its primary endpoint in the phase IIb FLINT trial, improving nonalcoholic steatohepatitis (NASH) without worsening fibrosis.
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