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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Kriya lands $80M series A to back gene therapies for metabolic disease

May 12, 2020
By Michael Fitzhugh
Kriya Therapeutics Inc., a startup led by former Axovant Sciences Inc. executive Shankar Ramaswamy, has raised $80 million in series A financing expected to help advance a portfolio of gene therapies for diabetes and other chronic conditions.
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Lilly wins approval for first Loxo-sourced asset, Retevmo

May 11, 2020
By Michael Fitzhugh
About 15 months after closing its multibillion-dollar acquisition of Loxo Oncology Inc., Eli Lilly and Co. has secured an accelerated FDA approval for the first of the deal's headline assets, the RET kinase inhibitor selpercatinib, now branded as Retevmo.
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Face with digital focus on eye

Santen inks $252M license to Jcyte ocular cell therapy

May 8, 2020
By Michael Fitzhugh
Keen to address a rare vision-limiting disorder endured by nearly 1.9 million people globally, ophthalmology specialist Santen Pharmaceutical Co. Ltd. has negotiated a $252 million ex-U.S. licensing deal for Jcyte Inc.'s Jcell, a human retinal progenitor cell therapy initially aimed at treating retinitis pigmentosa.
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Biotech deal illustration

PTC lands Censa PKU program with $10M up front, plus stock

May 7, 2020
By Michael Fitzhugh

Passed up for acquisition by former partner Retrophin Inc., Censa Pharmaceuticals Inc. has found a new home in rare disease specialist PTC Therapeutics Inc., which has agreed to pay $10 million up front for the opportunity to develop CNSA-001 (sepiapterin), a candidate for orphan metabolic diseases, starting with phenylketonuria (PKU). The proposed transaction also includes up to 850,000 shares of PTC common stock (NASDAQ:PTCT), valued around $40 million, plus additional rewards for achieving development, regulatory and commercial milestones. Shares of PTC closed at $46.91 on May 7, down $1.31.


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Astrazeneca's Farxiga wins FDA approval to reduce heart failure risks

May 6, 2020
By Michael Fitzhugh
With new a FDA approval for a years-old type 2 diabetes drug, Astrazeneca plc's Farxiga (dapagliflozin) has become the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to be approved to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure patients with reduced ejection fraction, a measure of how much blood the left ventricle pumps out with each contraction.
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New phase III anemia drug data, Auryxia beat push Akebia shares higher

May 5, 2020
By Michael Fitzhugh
Marking a key advance for Akebia Therapeutics Inc. in the global race to establish a new class of medicines for chronic kidney disease-associated anemia, the first of its two pivotal phase III programs proved its lead candidate, vadadustat, noninferior to darbepoetin alfa in adults on dialysis.
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Sarizotan fails pivotal Rett syndrome trial

May 4, 2020
By Michael Fitzhugh
Shares of Newron Pharmaceuticals SpA (SIX:NWRN) fell more than 71% May 4 on news that sarizotan, its experimental therapy for the rare neurodevelopmental disorder Rett syndrome, failed to meet both the primary and secondary efficacy endpoints of the company's pivotal STARS study, leading it to terminate the program.
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Gilead's remdesivir wins FDA emergency use authorization for COVID-19

May 1, 2020
By Michael Fitzhugh
Citing "known and potential benefits" of using Gilead Sciences Inc.'s remdesivir for the treatment of COVID-19 that "outweigh the known and potential risks of the drug's use," the FDA has issued an emergency use authorization (EUA) for the antiviral, currently in limited supply, according to the company. Gilead CEO Daniel O’Day, who said the company is working with partners across the globe to ramp up supply, said his team is working with "urgency and responsibility" to meet global needs for the medicine.
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EU flag and pills
Rolling with remdesivir

EMA begins remdesivir review, as CHMP recommends eight new meds for approval

May 1, 2020
By Michael Fitzhugh
The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
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RA Session II, CEO, Taysha Gene Therapies

Taysha Gene Therapies seeded with $30M, Avexis lineage

April 30, 2020
By Michael Fitzhugh
Taysha Gene Therapies Inc., a new Dallas-based company reuniting former executives of Avexis Inc. and its funders, has launched with a $30 million seed financing intended to advance a pipeline of 15 new AAV-based candidates. Its team expects to file four INDs by the end of 2021, starting with one for GM2-gangliosidosis that could move to the clinic later this year.
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