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BioWorld - Wednesday, January 7, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

T cells

Roche strikes $3B+ deal with Adaptimmune to develop cell therapies for cancer

Sep. 7, 2021
By Michael Fitzhugh
A new deal between Adaptimmune Therapeutics plc and Roche Holding AG's Genentech Inc. aims to develop allogeneic cell therapies for up to five shared cancer targets. Should the agreement win regulatory clearance, still pending, Adaptimmune will receive $150 million up front and additional payments of $150 million over five years. In addition, it could be eligible for development, regulatory and commercial milestones payments from Roche exceeding $3 billion, plus royalties.
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Man scratching arm

Forte's atopic dermatitis bet sours on phase II failure, toppling shares

Sep. 3, 2021
By Michael Fitzhugh
Shares of Forte Biosciences Inc. (NASDAQ:FBRX) touched a 52-week low, diving 82.3% to close at $5.06 on Sept. 3 after its sole candidate, FB-401, failed to make a statistically significant difference in improving the severity of atopic dermatitis. The result, contrasting starkly with a smaller positive trial, led CEO Paul Wagner to announce the company would quit development of the FDA fast-tracked asset, licensed from the U.S. National Institute of Allergy and Infectious Diseases.
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Polyphor setbacks create opportunity for Enbiotix combination

Sep. 2, 2021
By Michael Fitzhugh
Swiss biotech Polyphor AG, left hindered by failures in advanced clinical programs it had pursued in breast cancer and bacterial pneumonia, has found a path forward in a planned merger with Enbiotix Inc. The combination would put Enbiotix Chairman and CEO Jeff Wager in charge of a publicly listed company advancing a combined portfolio of programs for rare disease and cancer, including Polyphor’s inhaled antibiotic, murepavadin, for infections in people with cystic fibrosis.
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Astellas stops dosing gene therapy for rare neuromuscular disease after trial's fourth SAE

Sep. 1, 2021
By Michael Fitzhugh
Astellas Pharma Inc. has halted further dosing of the experimental X-linked myotubular myopathy (XLMTM) gene therapy AT-132 (resamirigene bilparvovec) after one participant in the ongoing Aspiro study experienced a serious adverse event (SAE) of abnormal liver function.
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J&J winds down HIV vaccine trial over insufficient protection

Aug. 31, 2021
By Michael Fitzhugh
A closely watched phase IIb test of JNJ-9220, an investigational HIV vaccine regimen developed by Johnson & Johnson's Janssen Vaccines & Prevention BV, has been stopped because the regimen provided insufficient protection against HIV infection. Though safe, the candidate's efficacy was just 25.2%, according to statisticians who analyzed data from the study, called Imbokodo. Further analysis of the study will continue, and the study was deemed to have provided sufficient data for further immunological correlates research, according to J&J.
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RNA illustration

Laronde rounds up $440M to further advance 'endless' RNA platform

Aug. 30, 2021
By Michael Fitzhugh
Laronde Inc., a company developing a new class of closed-loop RNA constructs for future medicines, has raised $440 million in series B financing. Unfurling at a pivotal moment for RNA-based therapies and vaccines, the company's approach is a bet on early evidence that its "endless" RNA loops can produce stable, enduring and tunable protein expression to fight disease.
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Takeda adds second Genevant deal, boosting potential value of partnership beyond $900M

Aug. 24, 2021
By Michael Fitzhugh
Building on a March deal leveraging lipid nanoparticle (LNP) technology from Genevant Sciences Corp. to fight liver fibrosis, Takeda Pharmaceutical Co. Ltd. has signed a second agreement with the company for the development and commercialization of therapies for up to two rare liver diseases. The deal includes up to $303 million in up-front and potential milestone payments for Genevant, plus royalties on possible product sales, adding to the first deal's similarly structured $600 million package.
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Vertex taps Arbor CRISPR tech in potential $1.2B cell therapy development deal

Aug. 24, 2021
By Michael Fitzhugh
Facing inevitable challenges ahead beyond peak performance for its wildly successful cystic fibrosis franchise, Vertex Pharmaceuticals Inc. is continuing to look to the future, announcing Aug. 24 it licensed rights to CRISPR gene-editing technology from Arbor Biotechnologies Inc. Co-founded by Feng Zhang and David Walt, Arbor's tech could figure into new Vertex cell therapies for diabetes, hemoglobinopathies and other diseases.
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Takeda adds second Genevant deal, boosting potential value of partnership beyond $900M

Aug. 23, 2021
By Michael Fitzhugh
Building on a March deal leveraging lipid nanoparticle (LNP) technology from Genevant Sciences Corp. to fight liver fibrosis, Takeda Pharmaceutical Co. Ltd. has signed a second agreement with the company for the development and commercialization of therapies for up to two rare liver diseases. The deal includes up to $303 million in up-front and potential milestone payments for Genevant, plus royalties on possible product sales, adding to the first deal's similarly structured $600 million package.
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COVID-19 antibody therapies advance with new data, U.K. green light

Aug. 20, 2021
By Michael Fitzhugh
Astrazeneca plc, en route to potentially delivering a new protection against COVID-19 for people inadequately protected by or unable to be vaccinated, has cleared a crucial hurdle with its long-acting combination therapy, AZD-7442, which met the goals of a phase III pre-exposure prophylaxis trial. The U.K.-based pharma’s readout arrived just as Regeneron Pharmaceuticals Inc. announced the MHRA’s conditional marketing authorization for its Roche Holding AG-partnered COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), also known as REGEN-COV.
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