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BioWorld - Monday, March 9, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Hand holding gear, dollar sign

$43M raised in series A revs Engine to advance precision oncology portfolio

June 1, 2021
By Michael Fitzhugh
Engine Biosciences Pte. Ltd., a Singapore and Silicon Valley-based company using machine learning, combinatorial genetics and other technologies to hasten the discovery of gene interactions and biological networks underlying disease, has raised $43 million in series A financing. Polaris Partners led the round, which the company said would help it expand its portfolio of precision oncology therapeutics, prepare for its first clinical programs, and scale its technology platform.
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Sanofi halts pivotal test of venglustat in ADPKD for futility

June 1, 2021
By Michael Fitzhugh
Interim findings that Sanofi SA's venglustat is unlikely to provide a meaningful benefit to people with autosomal dominant polycystic kidney disease (ADPKD) have caused the company to halt a phase II/III study of the candidate. Testing continues in other rare diseases, but the exit could be a boon for Otsuka Pharmaceutical Co. Ltd.'s Jynarque (tolvaptan), its generic competitors and ascendant novel ADPKD programs still underway.
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Bridgebio wins accelerated approval for cholangiocarcinoma therapy

May 28, 2021
By Michael Fitzhugh
Little more than two months after inking a $2 billion-plus commercialization deal with Swiss oncology specialist Helsinn Group around the fibroblast growth factor receptor (FGFR) inhibitor infigratinib, Bridgebio Pharma Inc.'s subsidiary, QED Therapeutics Inc., has won accelerated FDA approval for the therapy, to be marketed as Truseltiq. Approval for the oral medicine covers the treatment of patients with previously treated locally advanced chemotherapy-resistant bile duct cancer (cholangiocarcinoma) harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
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Biohaven's Nurtec becomes first oral CGRP for migraine prevention

May 28, 2021
By Michael Fitzhugh
The second oral CGRP antagonist to win FDA approval for acute migraine care is now the first to add preventive treatment to its label, marking a valuable win for Biohaven Pharmaceutical Holding Co. Ltd. and its oral dissolving tablet, Nurtec (rimegepant). The U.S. approval, for preventive treatment of episodic migraine, officially blesses a use for the medicine already adopted by many doctors, Piper Sandler analyst Christopher Raymond wrote, while opening up a potentially rich new stream of revenue for Biohaven.
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BMS adds ulcerative colitis to Zeposia’s U.S. label

May 28, 2021
By Michael Fitzhugh
Bristol Myers Squibb Co. said the FDA has approved Zeposia (ozanimod) as the first and only oral sphingosine 1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis (UC). The medicine, first FDA-approved in March 2020 for certain adults with multiple sclerosis, can now be used to treat patients with moderately to severely active UC.
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$43M raised in series A revs Engine to advance precision oncology portfolio

May 27, 2021
By Michael Fitzhugh
Engine Biosciences Pte. Ltd., a Singapore and Silicon Valley-based company using machine learning, combinatorial genetics and other technologies to hasten the discovery of gene interactions and biological networks underlying disease, has raised $43 million in series A financing. Polaris Partners led the round, which the company said would help it expand its portfolio of precision oncology therapeutics, prepare for its first clinical programs, and scale its technology platform.
Read More
Mosquito

Takeda files long-term dengue vaccine data to support EU, other applications

May 25, 2021
By Michael Fitzhugh
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
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Gold dollar sign

Biotheryx raises $92M to fund oncology-focused protein degrader pipeline

May 25, 2021
By Michael Fitzhugh
San Diego-based Biotheryx Inc. has raised $92 million in series E financing led by Farallon Capital Management to advance multiple molecular glues, proteolysis-targeting chimeras and monovalent degraders toward the clinic. Its first molecular glue program, BTX-1188, is expected to enter the clinic by the end of this year.
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Mosquito

Takeda files long-term dengue vaccine data to support EU, other applications

May 24, 2021
By Michael Fitzhugh
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
Read More

Annovis shares jump on midstage Alzheimer's study readout

May 21, 2021
By Michael Fitzhugh
Shares of Annovis Bio Inc. (NYSE:ANVS) leapt 127.3% to $60 May 21 on news that, following 25 days of treatment with its lead candidate, ANVS-401 (posiphen), 14 early Alzheimer's disease patients enrolled in its ongoing phase IIa study showed cognitive improvement of 22% vs. those who received placebo. Pending successful completion of the study, the company is targeting advancement to late-stage studies later this year.
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