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BioWorld - Monday, December 22, 2025
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Lion's pride: Shares soar with appointment of new CEO and $100M equity financing

June 6, 2016
By Michael Fitzhugh
Shares of Lion Biotechnologies Inc. (NASDAQ:LBIO) climbed 43.4 percent to $8.65 on Friday as the cancer immunotherapy developer announced the appointment of new President and CEO Maria Fardis and a $100 million equity financing led by Quogue Capital, Orbimed Advisors, Frazier Healthcare Partners and Broadfin Capital.
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Dermira looks to 2017 NDA for drug to reduce excessive sweating

June 3, 2016
By Michael Fitzhugh
Dermira Inc. reported positive top-line results from its phase III ATMOS-1 and ATMOS-2 pivotal trials for DRM04 (glycopyrronium tosylate), a topical candidate for patients with excessive underarm sweating, also known as primary axillary hyperhidrosis.
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Tackling Zika, one bit at a time

June 2, 2016
By Michael Fitzhugh
A new treatment for Zika virus could soon be brewing inside average computers and mobile phones. Virtual experiments, run on a globe-spanning supercomputer, are already blazing through millions of compounds against key target proteins. Once the field is winnowed, robots will test likely contenders.
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FDA OKs Ocaliva for PBC; Biogen, Abbvie see new MS drug approved

June 1, 2016
By Michael Fitzhugh
Patients living with primary biliary cholangitis (PBC), a rare chronic and gradually progressive liver disease, have gained a new second-line therapy with FDA approval for Intercept Pharmaceuticals Inc.'s Ocaliva (obeticholic acid).
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Reata’s IPO raises $52.5M to take AIM at regulatory proteins

May 27, 2016
By Michael Fitzhugh
Shares of Reata Pharmaceuticals Inc. (NASDAQ:RETA) climbed 18.8 percent to $13.07 from an IPO price of $11 on Thursday, in which the sale of 5.5 million shares raised net proceeds of $52.5 million. Funds from the offering, which had initially been slated to raise as much as $64 million, will be used to advance Reata’s lead antioxidant inflammation modulator (AIM), bardoxolone methyl, through a phase III trial and additional phase II programs. Another AIM, omaveloxolone, will also be moved through phase II.
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Seattle Genetics launches pivotal phase III for CD33-targeted ADC

May 26, 2016
By Michael Fitzhugh
Seattle Genetics Inc. (Seagen) started its second-ever phase III study, pitting a CD33-targeted antibody-drug conjugate paired with widely used hypomethylating agents (HMA) vs. HMAs alone in older patients with newly diagnosed acute myeloid leukemia (AML).
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Tackling Zika, one bit at a time with help from a global computer network

May 25, 2016
By Michael Fitzhugh

Niche HIV drug moves closer to market with phase III hit

May 25, 2016
By Michael Fitzhugh
Preliminary data from a pivotal phase III test of experimental HIV drug ibalizumab, developed by Taimed Biologics Inc. and slated for marketing by Theratechnologies Inc., helped 82.5 percent of patients receiving it meet the study's primary endpoint of a decrease of ≥ 0.5 log10 in viral load following a seven-day treatment period. Theratechnologies shares (TSX:TH) climbed 8.5 percent to close at C$2.55 (US$1.94) on Tuesday.
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Arbor Pharmaceuticals adds Horizant to neurology lineup in $467M Xenoport buy

May 24, 2016
By Michael Fitzhugh
Arbor Pharmaceuticals LLC, of Atlanta, has moved to buy Xenoport Inc. for $467 million in cash, adding the restless leg and postherpetic neuralgia drug Horizant (gabapentin enacarbil) to its neurology portfolio.
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Janssen executes 2nd Macrogenics bispecifics deal; $75M up front

May 19, 2016
By Michael Fitzhugh
Macrogenics Inc. shares (NASDAQ:MGNX) climbed 16.7 percent to $21.06 on Wednesday as Janssen Biotech Inc. extended its collaboration with the company, agreeing to pay $75 million up front for a global license to MGD015, a preclinical bispecific antibody targeting CD3 and an undisclosed tumor target for the potential treatment of various hematological malignancies and solid tumors.
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