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BioWorld - Friday, December 19, 2025
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Cerecor picks up $32 million series B for depression program

July 22, 2014
By Michael Fitzhugh
Cerecor Inc. closed the first tranche of a $32 million series B Monday with plans to advance CERC-301, its experimental adjunctive therapy for patients with severe major depressive disorder (MDD) who haven't adequately responded to other therapies and are considering suicide.
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Up-sized Sage IPO meets high demand

July 21, 2014
By Michael Fitzhugh
Shares of Sage Therapeutics Inc. (NASDAQ:SAGE), a specialist in rare central nervous system disorders, climbed 67 percent Friday as the Cambridge, Mass.-based company raised $90 million in an initial public offering (IPO) by selling 5 million shares at $18 each, before overallotments.
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Alkermes launches phase I in MS with eye on Biogen's Tecfidera

July 18, 2014
By Michael Fitzhugh
Alkermes plc is ramping up a phase I study of ALKS-8700, a small-molecule prodrug of monomethyl fumarate (MMF) for the treatment of multiple sclerosis.
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Rigel phase III takes fostamatinib to bat against bleeding disorder

July 17, 2014
By Michael Fitzhugh
Following Astrazeneca plc's decision to return fostamatinib rights to Rigel Pharmaceuticals Inc. last year, Rigel is pushing ahead with twin phase III studies of the oral spleen tyrosine kinase (SYK) inhibitor in patients with the tough-to-beat bleeding disorder, immune thrombocytopenic purpura (ITP).
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Restorgenex raises $35.6M to support diverse portfolio

July 16, 2014
By Michael Fitzhugh
Restorgenex Corp., a public specialty biopharma built from four small biotechs on the shell of a defunct sports and entertainment promoter, has closed the fifth and final round of a $35.6 million private placement.
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Exelixis therapy adds to Zelboraf's punch, pivotal trial shows

July 15, 2014
By Michael Fitzhugh
Roche AG reported Monday that a pivotal trial combining the MEK-inhibitor cobimetinib with Zelboraf (vemurafenib) met its primary endpoint, providing a statistically significant increase in progression-free survival (PFS) compared to Zelboraf alone for patients with previously untreated BRAF-positive metastatic melanoma.
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Fueling up: Auspex files to raise $60M to carry SD-809 to success

July 14, 2014
By Michael Fitzhugh
Just five months after raising about $94.8 million in a well-received initial public offering (IPO), Auspex Pharmaceuticals Inc. has priced a new follow-on offering expected to raise an additional $60.6 million to carry a new pivotal trial of its lead candidate, SD-809 (dutetrabenazine), in the movement disorder tardive dyskinesia and to support the company through at least the second quarter of 2016.
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Regeneron, Sanofi showcase positive phase IIb data on dupilumab

July 11, 2014
By Michael Fitzhugh
Regeneron Pharmaceuticals Inc. and partner Sanofi SA will launch pivotal studies of the potential blockbuster allergy therapeutic dupilumab (REGN668/SAR231893) by the end of this year on the heels of encouraging phase IIb data showing it helped clear skin lesions in patients with a serious, chronic and hereditary form of eczema called atopic dermatitis (AD).
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Salix buys into Ireland: Merger with Cosmo will lower taxes and expand GI pipeline

July 9, 2014
By Michael Fitzhugh
Salix Pharmaceuticals Ltd. is joining the tax inversion parade, with plans to beef up its gastrointestinal drug portfolio and trim its costs ahead of a planned supplemental new drug application for rifaximin and intentions to advance three new pipeline programs the merger delivers.
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FDA approves Anacor's first drug, Kerydin, for onychomycosis

July 9, 2014
By Michael Fitzhugh
Anacor Pharmaceuticals Inc. on Tuesday won earlier-than-expected FDA approval for its first drug, Kerydin (tavaborole), a topical antifungal for the treatment of the common toenail and nail bed infection onychomycosis.
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