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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

3D dollar sign

Bioxcel lands launch budget for agitation drug, boxes I-O effort in new subsidiary

April 19, 2022
By Michael Fitzhugh
Just two weeks after winning U.S. FDA approval for the first orally dissolving formulation of dexmedetomidine for agitation in schizophrenia and bipolar disorders, Bioxcel Therapeutics Inc. has secured commitments for up to $260 million to support the product’s commercial launch, slated for this quarter in addition to a planned European marketing application.
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Hospital patient wearing pulse oximeter

Inflarx MAb misses mark in study of severe COVID-19 patients

March 31, 2022
By Michael Fitzhugh
A phase II/III trial testing Inflarx NV's vilobelimab, a monoclonal antibody the company is developing to control inflammatory response, showed a relative reduction in 28-day all-cause mortality of 23.9% vs. placebo (p=0.094) for mechanically ventilated COVID-19 patients, but missed statistical significance on the measure, the study's primary endpoint.
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Innovent, Lilly receive CRL for NSCLC candidate sintilimab

March 29, 2022
By Michael Fitzhugh

Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. 



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Brain illustration
Newco news

Ninnion forms SAB to navigate 'uncharted waters' of psychedelics development

March 29, 2022
By Michael Fitzhugh
Ninnion LLC, a startup developing psychedelic medicines focused on brain injury, chronic pain, inflammation and addiction disorders, has formed a new scientific board (SAB) that Chief Development Officer Bill Massey said will ”be a tremendous asset in navigating the uncharted waters of psychedelic drug development."
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Hand holding IPO, financial icons

AN2 IPO raises $69M to support rare chronic lung disease treatment

March 25, 2022
By Michael Fitzhugh
AN2 Therapeutics Inc., a company developing a once-daily treatment for people with chronic non-tuberculous mycobacterial lung disease, raised $69 million in an upsized IPO. The offering of 4.6 million shares (NASDAQ:ANTX), initially priced at $15 each, met a modest market reception, with shares rising to $15.40 by market close on March 25. The Menlo Park, Calif.-based company is developing epetraborole, a boron-containing small-molecule inhibitor of bacterial leucyl-tRNA synthetase, in-licensed from Anacor Pharmaceuticals Inc., now part of Pfizer Inc.
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Lung cancer illustration

Innovent, Lilly receive CRL for NSCLC candidate sintilimab

March 24, 2022
By Michael Fitzhugh

Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.



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Spotlight raises $36.5M to advance non-viral gene editing tech, lead I-O program

March 22, 2022
By Michael Fitzhugh
Spotlight Therapeutics Inc., a company developing cell-targeted in vivo CRISPR gene editing biologics, has raised $36.5 million in series B financing to support advancement of its first-in-class immuno-oncology program and further applications of its in-house technology platform. The financing round was co-led by new investors GordonMD Global Investments and Epiq Capital Group, with participation from Magnetic Ventures, as well as existing investors GV, Emerson Collective and others.
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Concept illustration of nano-capsules for virus trapping

Alnylam sues Pfizer, Moderna over lipid nanoparticle tech

March 17, 2022
By Michael Fitzhugh
Alnylam Pharmaceuticals Inc. has filed suits against both Pfizer Inc. and Moderna Inc. over alleged infringements of its patent on biodegradable cationic lipids that it said "are foundational to the success of the mRNA COVID-19 vaccines."
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Urinary tract with kidneys, adrenalin glands, ureter and vessels on light blue background

Venatorx turns screws on cUTI, proving 'Certain' superiority to standard therapy

March 10, 2022
By Michael Fitzhugh
A new antibiotic combination developed by Venatorx Pharmaceuticals Inc. "may represent a significant improvement over the standard of care" for adults with complicated urinary tract infections (cUTI), said Christopher Burns, the company's co-founder, president and CEO.
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Brain and DNA

Novartis options Voyager AAV capsids for CNS gene therapies in potential $1.7B-plus deal

March 8, 2022
By Michael Fitzhugh
Novartis AG, an early and active player in bringing gene therapies to market, has agreed to pay Voyager Therapeutics Inc. $54 million up front and up to $1.7 billion in fees and milestone payments for options to license up to five next-generation adeno-associated virus (AAV) capsids to use as gene therapy vectors for neurological diseases.
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