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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Janssen-Legend BCMA-targeting CAR T therapy crosses the line with US FDA approval

March 1, 2022
By Richard Staines and Michael Fitzhugh

Janssen Pharmaceutical Cos. Inc. has become the second company to get a BCMA-targeting CAR T therapy to market with the approval of ciltacabtagene autoleucel for adults with relapsed or refractory multiple myeloma (MM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.


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Brain and encephalography

Abbvie expanding neurosci portfolio with $1B Syndesi buyout

March 1, 2022
By Michael Fitzhugh
Abbvie Inc. has paid $130 million up front to acquire Syndesi Therapeutics SA, a company working on a new mechanism to mitigate synaptic dysfunction associated with cognitive deficits. The deal includes up to $870 million in milestone payments for Syndesi's first-in-class modulators of the synaptic vesicle protein 2A, which Abbvie said could have applications across a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer's disease and major depressive disorder.
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Single strand RNA

Remix RNA modulators draw $45M backing from Janssen for immunology, oncology targets

Feb. 17, 2022
By Michael Fitzhugh
Remix Therapeutics Inc., a company developing small molecules to manipulate RNA processing, stands to earn upward of $1 billion through a new strategic collaboration with Janssen Pharmaceutica NV. A Cambridge, Mass.-based startup, Remix last year patented new RNA splicing modulators. It will receive an initial payment of $45 million for research funding plus potential preclinical, clinical, commercial and sales milestone payments, and royalties. Janssen gains exclusive rights to three targets with applications in immunology and oncology.
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Kallyope raises $236M for drugs targeting gut-brain axis

Feb. 15, 2022
By Michael Fitzhugh
Kallyope Inc., a company leveraging connections between the gut and brain to develop new medicines for diabetes, obesity and other diseases, has raised $236 million in series D financing to support its work. Readouts of early clinical data for its most advanced programs, phase I small molecules for metabolic disease and gut barrier conditions, will start to arrive later this year, company CEO and President Jay Galeota told BioWorld.
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Considerations over 4th COVID-19 vaccine booster grow as protections for youngest delayed and defenses for adults expanded

Feb. 11, 2022
By Michael Fitzhugh
Delivering important but likely unwelcome news to Americans increasingly trying put the COVID-19 pandemic behind them, new research published Feb. 11 by the CDC suggested that "protection conferred by mRNA vaccines waned in the months after receipt of a third vaccine dose reinforces the importance of further consideration of additional doses to sustain or improve protection against COVID-19-associated [emergency department or urgent care (ED/UC)] encounters and COVID-19 hospitalizations."
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Arkuda raises $64M series B to advance lead neurodegeneration program

Feb. 10, 2022
By Michael Fitzhugh
Arkuda Therapeutics Inc., a company targeting lysosomal dysfunction to address neurodegeneration, has completed a $64 million series B financing co-led by Cormorant Asset Management and Pivotal Bioventure Partners. The funds will help advance its lead program, a small-molecule progranulin enhancer for frontotemporal dementia in people with an autosomal dominant mutation in the GRN gene, which codes for the protein.
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Nasal spray
Newco news

Xanadu Bio licenses Yale delivery tech for intranasal SARS CoV-2 vaccine booster

Feb. 8, 2022
By Michael Fitzhugh
Xanadu Bio, a Yale University spinout developing an intranasal SARS-CoV-2 mRNA vaccine booster, has secured an exclusive license from the school for a polymeric nanoparticle delivery platform to support the project. The delivery tech could potentially have future applications for influenza, respiratory syncytial virus and even cystic fibrosis.
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Deal illustration

Amgen strikes $500M+ protein degrader deal with Plexium

Feb. 3, 2022
By Michael Fitzhugh
Just weeks after signing a targeted RNA degrader deal with Arrakis Inc., Amgen Inc. has enlisted protein degrader specialist Plexium Inc. to a new deal in the high-profile field. "We're on the cusp of a new era of drug discovery, where medicines could function very differently than conventional ones do today," said Amgen's senior vice president of global research, Ray Deshaies.
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Doctor examining child in wheelchair

Capricor picks Nippon Shinyaku to sell DMD cell therapy, pending approval

Jan. 25, 2022
By Michael Fitzhugh
With a potentially pivotal trial of its Duchenne muscular dystrophy (DMD) candidate CAP-1002 starting up, Capricor Therapeutics Inc. has tapped Nippon Shinyaku Co. Ltd. subsidiary NS Pharma Inc. to sell and distribute the cell therapy, pending U.S. FDA approval. The deal brings Capricor $30 million up front to fund the phase III trial, while also lining it up for as much as $705 million in milestone payments from its Japanese partner, which launched its own DMD therapy, Viltepso (viltolarsen), in the U.S. in 2020. Capricor shares (NASADQ:CAPR) rose 21.6% to $3.44 Jan. 25.
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Non-Hodgkin lymphoma cells in the blood flow

Immpact Bio raises $111M to advance CAR T platform

Jan. 20, 2022
By Michael Fitzhugh
Cancer therapy developer Immpact Bio USA Inc. has raised $111 million to further its "logic gate"-based CAR T-cell platform, the source of a CD19/CD20 bispecific in phase I testing for B-cell non-Hodgkin lymphoma patients whose disease has returned or who has stopped responding to treatment. New data from that study, showing complete remissions in seven of eight patients treated, accompanied the appointment of a new president and CEO for the company as well as a new board chair.
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