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Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

Biopharma research illustration

Insilico signs Sanofi to $1.2B+ AI drug discovery deal

Nov. 8, 2022
By Michael Fitzhugh
AI drug discovery specialist Insilico Medicine Inc. has landed a multiyear research deal with Sanofi SA to develop candidates for up to six new targets in undisclosed indications. The collaboration included $21.5 million up front for Insilico, and as much as $1.2 billion in additional payments from Sanofi if key research, development and sales milestones are met. The agreement also includes mid-single to up to low double-digit tiered royalties for any products developed.
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Gold dollar sign inside gold cog

Emalex raises $250M series D to move Tourette syndrome drug to approval

Nov. 3, 2022
By Michael Fitzhugh
Emalex Biosciences Inc. closed an upsized and oversubscribed $250 million series D funding round intended to support a soon-to-start phase III trial and preparations for potential commercialization of ecopipam, its first-in-class drug for Tourette syndrome, a neurological disorder characterized by involuntary motor and vocal tics.
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Hand holding dollar sign

HI-Bio advances with $120M financing for immune-mediated disease therapies

Nov. 1, 2022
By Michael Fitzhugh
Human Immunology Biosciences (HI-Bio) Inc., a company developing targeted therapies for severe immune-mediated diseases, has secured $120 million in financing. Its initial pipeline is built around two clinical-stage immunology assets in-licensed from Morphosys AG in June 2022. The funds will help the company move through key inflection points over the coming years, in both in its ongoing clinical and discovery programs, where it's currently focused on the role of mast cells as a cellular driver of disease.
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US still awaiting first HDV drug after FDA hits Gilead’s Hepcludex with CRL

Oct. 28, 2022
By Jennifer Boggs and Michael Fitzhugh
The U.S. FDA declined to approve Gilead Sciences Inc.’s Hepcludex (bulevirtide), issuing a complete response letter (CRL) citing manufacturing and delivery concerns for the antiviral aimed at treating confirmed chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Acquired in Gilead’s 2021 buyout of Myr GmbH, Hepcludex received conditional approval from the European Commission in 2020 and would have been the first drug cleared for HDV in the U.S. Its delay, however, could give a boost to Eiger Biopharmaceuticals Inc., which is expected to report phase III data for lonafarnib by the end of 2022.
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LG Chem expands life sciences ambition with Aveo Oncology buy

Oct. 18, 2022
By Michael Fitzhugh
South Korea's LG Chem Ltd., seeking new growth opportunities in the life sciences and a concrete footprint in the U.S., has proposed an all-cash acquisition of Aveo Pharmaceuticals Inc., with a deal value of $519.2 million. 
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Tau neuron illustration

Taurx sees path to regulatory filings in AD, despite invalidation of phase III control arm

Oct. 6, 2022
By Michael Fitzhugh
Despite clinical responses undermining expectations for the placebo arm of its phase III Alzheimer's disease (AD) study, Lucidity, Taurx Pharmaceuticals Ltd. executives Oct. 6 said they still see the data as supporting their ability to pursue regulatory submissions for hydromethylthionine mesylate (HMTM), an oral tau aggregation inhibitor. For people with mild cognitive impairment especially, they said, "HMTM treatment resulted in sustained improvement in cognition over pretreatment baseline, and normalization of brain atrophy to a rate similar to healthy individuals."
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Biotech deal illustration

BMS taps Synthex in new degrader development deal

Oct. 4, 2022
By Michael Fitzhugh
Bristol Myers Squibb Co.'s ongoing investment in protein degradation, a field electrified by both high scientific interest and potentially big-dollar deals, expanded Oct. 4 to include a new research collaboration with Synthex Inc. Valued at up to $550 million for Synthex, plus possible royalties, the license agreement will see the pair use genetic engineering technologies to develop small-molecule degraders across multiple targets. BMS also made an up-front payment and investment in Synthex of undisclosed value.
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Handshake with DNA, molecules

Scribe, Vertex add to gene therapy's advance with $1B+ deal, near-term BLA

Sep. 27, 2022
By Michael Fitzhugh
CRISPR-based cell therapies continued to gain steam Sept. 27 with the announcements of a potentially valuable big pharma collaboration and an ambitious global regulatory push.
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Concept of business partnership

Basilea sells dual-kinase inhibitor rights to Sillajen in $334M deal

Sep. 20, 2022
By Michael Fitzhugh
Basilea Pharmaceutica Ltd., having advanced a first-in-class cancer drug through preclinical studies, is selling some rights and sublicensing others for the dual-kinase inhibitor to Sillajen Inc. 
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Lungs and bronchi

Eloxx CF trial misses efficacy endpoint, shifting focus to Alport trial

Sep. 15, 2022
By Michael Fitzhugh
After a midstage trial showed no benefit from adding ELX-02 (exaluren) to Kalydeco (ivacaftor, Vertex Pharmaceuticals Inc.) for certain cystic fibrosis (CF) patients, Eloxx Pharmaceuticals Inc. said it will discuss next steps for the program, its lead candidate, with the trial's sponsor, the CF Foundation. A proof-of-concept trial for EXL-02 in the rare kidney disease Alport syndrome will start later this year, the company said.
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