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BioWorld - Monday, March 2, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Salix tumbles on inventory debacle, CFO resignation, slashed forecast

Nov. 10, 2014
By Michael Fitzhugh
Salix Pharmaceuticals Ltd. shares (NASDAQ:SLXP) plunged 34 percent to $91.47 Friday as the company slashed its full-year sales forecast and revealed that inventories of key drugs were sharply higher than earlier thought, an issue that may have scuttled Allergan Inc.'s interest in acquiring the company.
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Avalanche of ASH abstracts draws swift reaction on Wall Street

Nov. 7, 2014
By Michael Fitzhugh
Investors and analysts scrambled Thursday to divine portent from a heap of newly released abstracts previewing December's American Society of Hematology (ASH) annual meeting. Karyopharm Therapeutics Inc. led the pack of abstract news gainers, with shares (NASDAQ:KPTI) rising 10.7 percent to $41.73 on news that its lead candidate, selinexor (KPT-330), demonstrated a disease control rate of 80 percent in 10 patients with relapsed and refractory aggressive non-Hodgkin's lymphoma (NHL).
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Earnings: Alkermes, Dyax, Gilead, Vertex report mixed picture

Oct. 30, 2014
By Michael Fitzhugh
Investors relished third quarter earnings Wednesday, pumping up shares of Alkermes plc and Dyax Corp., while cooling their outlooks on Gilead Sciences Inc. and Vertex Pharmaceuticals Inc., worried over lower-than-anticipated sales of their top drugs.
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Medicines Co. fends off Mylan's Angiomax ANDA

Oct. 29, 2014
By Michael Fitzhugh
A U.S. court cleared a major generic threat to The Medicines Co.'s top-seller, Angiomax (bivalirudin), ruling Monday that Mylan Inc.'s abbreviated new drug application (ANDA) infringed on a patent protecting the anticoagulant through 2028.
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Sarepta shares dive as FDA seeks more data on Duchenne's drug

Oct. 28, 2014
By Michael Fitzhugh
Sarepta Therapeutics Inc. shares (NASDAQ:SRPT) fell 32.5 percent Monday to $15.91 as it revealed FDA requests for new data on its late-stage Duchenne muscular dystrophy (DMD) candidate, eteplirsen, would delay until mid-2015 a planned new drug application (NDA) for the therapy.
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Vitae climbs as AD drug advances after promising early data

Oct. 27, 2014
By Michael Fitzhugh
Vitae Pharmaceuticals Inc. shares (NASDAQ:VTAE) picked up slightly Friday, gaining 46 cents, to close at $9.11, after soaring as high as $12.25, on positive top-line data from a phase I study in which an early stage experimental Alzheimer's disease (AD) therapy it co-developed with Boehringer Ingelheim GmbH reduced amyloid beta levels in cerebral spinal fluid (CSF) by more than 80 percent. Boehringer now will run additional phase I studies of the beta secretase (BACE) inhibitor, including a multiple-rising-dose trial expected to report data in the first half of 2015.
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Lilly sweetens Zymeworks deal, adds up to $375M

Oct. 24, 2014
By Michael Fitzhugh
Eli Lilly and Co. is expanding its January partnership with Zymeworks Inc., adding up to $375 million in milestones plus an equity investment to support development of several bispecific cancer immunotherapies.
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Biogen shares dip on Tecfidera sales, PML report

Oct. 23, 2014
By Michael Fitzhugh
Biogen Idec Inc. shares (NASDAQ:BIIB) sunk 5.4 percent Wednesday to $309.07 despite third quarter net earnings of $857 million, or $3.62 per diluted share, up 76 percent from last year's third quarter.
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Omeros puts the brakes on Huntington's study of OMS824 on preclinical concerns

Oct. 22, 2014
By Michael Fitzhugh
Omeros Corp. suspended a phase II dose-escalation study of its phosphodiesterase 10 (PDE10) inhibitor, OMS824, in Huntington's disease (HD) over FDA concern about higher-than-expected blood levels of the drug in a concurrent rat study, sending shares in the Seattle company (NASDAQ:OMER) down 12.3 percent to close at $12.12 Tuesday.
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Liberty from itching? Sanofi, Regeneron start pivotal dupilumab trials

Oct. 21, 2014
By Michael Fitzhugh
Regeneron Pharmaceuticals Inc. and Sanofi SA began dosing patients in the first of several planned phase III studies of the potential blockbuster dupilumab (REGN668/SAR231893).
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