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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Mavupharma raises $20M series A for STING therapies

Dec. 22, 2017
By Michael Fitzhugh
Mavupharma Inc., a new company developing therapies for cancer and infectious diseases, recently secured a $20 million series A financing led by Frazier Healthcare Partners, joined by Alpine Bioventures.
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Jnana lands $50M financing to back discovery platform

Dec. 18, 2017
By Michael Fitzhugh
Jnana Therapeutics Inc., a Boston-based startup building a drug discovery platform targeting a family of proteins that serve as cellular "metabolic gates," has raised a $50 million series A financing backed by Polaris Partners, Avalon Ventures, Versant Ventures, Abbvie Ventures LLC and Pfizer Inc.
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Ampio shares climb as final pivotal data pave path to FDA filing

Dec. 15, 2017
By Michael Fitzhugh
New pivotal phase III results positioning the nonsteroidal anti-inflammatory Ampion for potential approval in severe osteoarthritis of the knee (OAK) pushed shares of its developer, Ampio Pharmaceuticals Inc. (NYSE:AMPE), to touch a 52-week high on Thursday before pulling back somewhat, closing 33.1 percent higher at $2.33.
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Regeneron, Sanofi kick off skin cancer drug BLA backed by new phase II data

Dec. 13, 2017
By Michael Fitzhugh

A new FDA filing for the PD-1 checkpoint inhibitor cemiplimab now underway represents more than simple progress for Regeneron Pharmaceuticals Inc. and Sanofi SA. The filing, supported by top-line results from a pivotal phase II trial in the world's second most deadly skin cancer, could lead to approval for a drug key to realizing strategic goals at both companies.


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CSL invests in key cardiovascular trial, option to buy transplant drug developer

Dec. 13, 2017
By Michael Fitzhugh
Australia's CSL Ltd. said it expects to spend between $450 million and $550 million on its largest-ever study, a phase III trial of CSL-112, an I.V. infusion formulation of human apolipoprotein A-I intended to reduce early recurrent cardiovascular events in heart attack survivors. Separately, the company paid $15 million up front to spark a collaboration and purchase option agreement with Canada's Vitaeris Inc. Together, the companies will work to expedite the development of clazakizumab, an anti-IL-6 monoclonal antibody, as a therapy for solid organ transplant rejection.
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Clementia starts first global phase III trial in ultra-rare bone disorder

Dec. 13, 2017
By Michael Fitzhugh
Just four months out from its $128.2 million August IPO, Montreal-based Clementia Pharmaceuticals Inc. is moving palovarotene, its lead candidate, into a registrational phase III trial testing its ability to treat fibrodysplasia ossificans progressiva (FOP), an ultra-rare bone disorder.
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Syros shares sink on interim results for lead AML, MDS therapy

Dec. 12, 2017
By Michael Fitzhugh
Syros Pharmaceuticals shares (NASDAQ:SYRS) lost nearly a third of their value Monday after investors learned that, by the end of October, just one out of 48 evaluable patients enrolled in an ongoing study of the company's lead gene control therapy, SY-1425 (tamibarotene), had achieved a complete response. The ongoing trial is evaluating SY-1425 for the treatment of genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). No patients with lower-risk MDS had achieved transfusion independence, another endpoint of the study, by the cut-off for reporting.
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AML endpoint eludes Erytech's Graspa

Dec. 11, 2017
By Michael Fitzhugh
Osmotic stress, key to Erytech Pharma SA's ability to stash therapeutic enzymes inside red blood cells, was joined by market stress Friday, as investors pushed company shares (NASDAQ:ERYP) more than 30 percent lower on news that a combination of its lead candidate, Graspa (eryaspase), and low-dose cytarabine (LDAC) failed to help people with acute myeloid leukemia (AML) live longer than treatment with LDAC alone.
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Vedanta embarks on testing new class of C. diff therapy

Dec. 8, 2017
By Michael Fitzhugh
Vedanta Biosciences Inc. has begun a phase Ia/Ib trial of VE-303, its oral immune-modulating bacterial consortia therapy. Study of the medicine, derived from the human microbiome, is expected to finish up in the first half of 2018. If all goes well, the company plans to initiate a phase II trial in 2018 for the treatment of recurrent Clostridium difficile infection (rCDI).
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Carmot's alchemy draws multiyear Amgen discovery deal

Dec. 7, 2017
By Michael Fitzhugh
Carmot Therapeutics Inc., a small-molecule lead-identification specialist and partner of Amgen Inc. since 2014, is extending its work for the Thousand Oaks, Calif.-based drugmaker to Parkinson's disease (PD) and other selected areas in a new multiyear deal. Clinical development, manufacturing and commercialization of any resulting molecules will be Amgen's job, while Carmot will receive an up-front payment of undisclosed value, research support and, potentially, milestone payments worth more than $240 million.
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