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BioWorld - Friday, March 6, 2026
Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

Surprise pivotal trial news wounds Macrocure shares

Aug. 21, 2015
By Michael Fitzhugh
Macrocure Ltd. shares (NASDAQ:MCUR) hit an all-time low on Thursday after a futility analysis of partial data from a pivotal phase III study revealed that the company's sole candidate, the cell therapy Curexcell, is unlikely to meet its primary endpoint of helping heal venous leg ulcers (VLU) faster than a placebo, leaving the company without one of the key trials expected to underpin an FDA biologics license application planned for the second half of 2016.
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Intarcia's exenatide pump outperforms Januvia in phase III

Aug. 20, 2015
By Michael Fitzhugh
A head-to-head study pitting an implantable exenatide-filled osmotic pump developed by Intarcia Therapeutics Inc. against the blockbuster Januvia (sitagliptin, Merck & Co. Inc.) over a year of type 2 diabetes treatment proved the pump superior in reducing HbA1c levels and producing weight loss according to top-line data from the latest of several phase III studies the company has run, positioning Intarcia to file applications seeking approval of the drug-device combination, called ITCA-650, in the first half of 2016.
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Omeros readies rare clotting disease therapy for phase III

Aug. 19, 2015
By Michael Fitzhugh
Omeros Corp. (NASDAQ:OMER) shares rose to a record high Tuesday, climbing 72 percent overall to close at $25.03 after the company said OMS721, a therapy it’s developing for the treatment of thrombotic microangiopathies (TMAs), continued to perform well in a small midstage trial.
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Genentech paves path to anti-PDL1 filing with pivotal NSCLC study

Aug. 18, 2015
By Michael Fitzhugh
Genentech Inc.'s most advanced immunotherapy candidate, atezolizumab, met its primary endpoint in a pivotal phase II study, shrinking tumors in people with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose disease expressed programmed cell death ligand-1 (PD-L1), and setting the stage for an early 2016 registration filing.
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Kempharm touts pain pill's snorting smackdown ahead of Q4 NDA

Aug. 17, 2015
By Michael Fitzhugh
New data revealing the potential for Kempharm Inc.'s hydrocodone prodrug, KP-201 (benzhydrocodone), to deter abuse by yielding lower hydrocodone exposure when snorted vs. generic hydrocodone bitartrate moved the company closer to what it expects will be a fourth quarter FDA NDA filing.
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Immunocellular chases positive survival outcome in new SPA-governed phase III

Aug. 14, 2015
By Michael Fitzhugh
Reviving hopes for its experimental dendritic cell-based vaccine, ICT-107, Immunocellular Therapeutics Ltd. said it expects to soon begin enrolling newly diagnosed glioblastoma patients in a registrational phase III trial under a special protocol assessment (SPA) freshly agreed with the FDA.
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Eleven Biotherapeutics doses first patients in phase III of EBI-005

Aug. 12, 2015
By Michael Fitzhugh
Eleven Biotherapeutics Inc., which saw its shares (NASDAQ:EBIO) crushed after lead candidate EBI-005 eye drops failed a phase III trial in dry eye disease earlier this year, dosed the first patients in a new phase III study testing the same drug for the treatment of moderate to severe allergic conjunctivitis (AC), sending shares up $1.75, or 74.8 percent, to close at $4.09 on Wednesday.
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Orexigen settles Takeda dispute, seeks expanded reach for obesity drug in South Korea

Aug. 12, 2015
By Michael Fitzhugh
Orexigen Therapeutics Inc. reported higher-than-expected second quarter revenues, helped by royalties on U.S. sales of obesity drug Contrave (naltrexone and bupropion). Shares rose (NASDAQ:OREX) 35 cents, to $4.17 by Thursday's close as the company settled a dispute with its North American partner Takeda Pharmaceutical Co Ltd. and signed a new distribution deal for South Korea.
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Neurology start-up Ovid clinches $75M series B to tackle rare brain diseases

Aug. 12, 2015
By Michael Fitzhugh
Ovid Therapeutics Inc. has completed an oversubscribed $75 million series B financing to support its work to advance the oral extrasynaptic GABA A agonist OV-101 (gaboxadol) into phase II as a potential treatment for both Angelman and fragile X syndromes, as well as development of other internal candidates and pipeline expansions.
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Editas lands $120M to advance CRISPR/Cas9 platform in oversubscribed series B

Aug. 11, 2015
By Michael Fitzhugh
Genome-editing start-up Editas Medicine Inc. has raised $120 million in an oversubscribed series B financing to advance its discovery-stage programs and platform in one of the year's biggest private financings.
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