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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Fusion closes $105M series B to support radiotherapeutics for cancer

April 3, 2019
By Michael Fitzhugh
Fusion Pharmaceuticals Inc., a Canadian-born company developing targeted alpha-particle radiotherapeutics to treat cancer, has completed an oversubscribed $105 million series B financing led by Varian Medical Systems Inc. and new investor Orbimed. The company said the funds will be used to advance and broaden the scope of its ongoing clinical program and accelerate a pipeline of new radiopharmaceuticals and combination therapies.
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Astrazeneca to pay up to $6.9B for Daiichi-developed cancer ADC

April 2, 2019
By Michael Fitzhugh

Astrazeneca plc, faced with what CEO Pascal Soriot recently called "probably the largest patent expiry in the industry as a proportion of the total company," has agreed to pay Daiichi Sankyo Co. Ltd. up to $6.9 billion to jointly develop and commercialize an antibody-drug conjugate (ADC) for the potential treatment of multiple HER2-expressing cancers. The deal for trastuzumab deruxtecan (DS-8201), which could have big benefits for both companies, includes $1.35 billion up front for Daiichi Sankyo. It could also yield a further $5.55 billion in milestone payments to the Tokyo-based big pharma.


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Puma's EU licensing of Nerlynx nets $60M up front, but meets cool reception

April 2, 2019
By Michael Fitzhugh
Puma Biotechnology Inc. shares (NASDAQ:PBYI) fell 8.1 percent to $35.64 on Monday after a European licensing deal for its breast cancer drug, Nerlynx (neratinib), led to what analysts interpreted as disappointment among investors anticipating a sale of the company or asset instead. Licensor Pierre Fabre will pay Puma $60 million up front and up to $345 million in regulatory and commercial milestone payments for rights to develop and commercialize Nerlynx in Europe and parts of Africa. In addition, Puma will receive "significant double-digit royalties," it said. The product's first EU availability is expected in Germany later this year.
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Astrazeneca to pay up to $6.9B for Daiichi-developed cancer ADC

April 1, 2019
By Michael Fitzhugh
Astrazeneca plc, faced with what CEO Pascal Soriot recently called "probably the largest patent expiry in the industry as a proportion of the total company," has agreed to pay Daiichi Sankyo Co. Ltd. up to $6.9 billion to jointly develop and commercialize an antibody-drug conjugate (ADC) for the potential treatment of multiple HER2-expressing cancers. The deal for trastuzumab deruxtecan (DS-8201), which could have big benefits for both companies, includes $1.35 billion up front for Daiichi Sankyo. It could also yield a further $5.55 billion in milestone payments to the Tokyo-based big pharma.
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Genetic, autoimmune disorders top Clarivate's potential blockbuster list

March 27, 2019
By Michael Fitzhugh
Seven new drugs launched this year are projected to achieve more than $1 billion in sales by 2023, according to a new report published by Clarivate Analytics, which owns BioWorld. Abbvie Inc.'s rheumatoid arthritis candidate, upadacitinib, and Novartis AG's Avexis-sourced gene therapy, Zolgensma (onasemnogene abeparvovec), for spinal muscular atrophy (SMA) could lead the way, raking in $2 billion each, while Fibrogen Inc.'s anemia medicine, roxadustat, isn't far behind with anticipated sales of $1.97 billion in 2023. 
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Aldeyra Therapeautics' top-line, phase III allergic conjunctivitis win sets shares climbing

March 27, 2019
By Michael Fitzhugh
Top-line results from a phase III study of Aldeyra Therapeutics Inc.'s aldehyde-trapping reproxalap in allergic conjunctivitis showed two different concentrations of the drug driving statistically significant reductions in ocular itching vs. placebo. The outcome, which carried company shares (NASDAQ:ALDX) 36 percent higher to $9.71 Tuesday, put Aldeyra on track to advance what president and CEO Todd Brady said could potentially provide a new treatment option for the third of people who, without gaining relief from antihistamines, have to resort to topical corticosteroids. Once the company consults with regulators, another phase III study in allergic conjunctivitis could start as soon as the second half of this year.
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Proteostasis CF triplet heads to phase II, but shaded by Vertex Pharmaceuticals comps

March 26, 2019
By Michael Fitzhugh
Proteostasis Therapeutics Inc. investors keen to compare its experimental cystic fibrosis triplet therapy to combinations in development by Vertex Pharmaceuticals Inc. appeared rattled by phase I data Monday. Proteostasis reported its triplet improving a measure of lung function at two weeks with no plateau in sight. The outcome helped it identify doses of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators to use in planned phase II trials. But analysts suggested the data offered little challenge to Vertex's triplet, which they said has outshone the Proteostasis combo on the same measure. Proteostasis shares (NASDAQ:PTI) fell 67.8 percent in heavy trading Monday to close at $1.31 on Monday. Vertex shares (NASDAQ:VRTX) inched higher, closing up 1.3 percent at $183.85.
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Conatus shares crushed as emricasan suffers phase II setback in NASH

March 25, 2019
By Michael Fitzhugh
Another mid-stage trial failure for emricasan, the caspase inhibitor at the heart of a multimillion-dollar NASH deal between developer Conatus Pharmaceuticals Inc. and Novartis AG, appears to have shaken investor confidence in the program's future, sending Conatus shares (NASDAQ:CNAT) down 56 percent to $1.28 on Friday. A shortfall on ENCORE-NF's primary endpoint, improvement in a measure of liver scarring, is the second setback in the collaboration following the drug's failure to meet the primary endpoint of a separate portal hypertension study.
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New business models thriving as data-driven opportunities unfold

March 21, 2019
By Michael Fitzhugh

New business models thrive as data-driven opportunities unfold

March 21, 2019
By Michael Fitzhugh
SAN FRANCISCO – Investors and entrepreneurs at the 12th Annual Cooley Healthtech Conference, undaunted by the trenchant challenges of integrating new technologies into a slow-changing U.S. health care system, said they're finding increasing purchase for businesses built on rich and growing datasets, ever-present connectivity and, in some cases, the irreplaceable magic of the human touch. With the pressures of macroeconomic uncertainties weighing less heavily on the sector than at last year's end, optimism abounded during two presentations assessing med tech's progress at the Wednesday event.
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