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Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

Zymeworks prices $175M offering to fuel clinical ambitions

June 21, 2019
By Michael Fitzhugh
Zymeworks Inc. has filed to raise $175 million in a public offering that President and CEO Ali Tehrani told BioWorld will fund his team's "very ambitious plans" for two pivotal phase II/III trials for lead candidate ZW-25 in 2020 and a ramping-up of their study of a second candidate, ZW-49. "We did have the money," but with the additional funds, preparations will move much faster, he said.
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Gilead pays $45M up front to Nurix in discovery deal targeting therapies for cancer, other diseases

June 20, 2019
By Michael Fitzhugh

Further proof that targeted protein degradation is finding its moment in the spotlight arrived with word that Gilead Sciences Inc. has agreed to pay Nurix Therapeutics Inc. $45 million up front and as much as $2.3 billion in milestones to discover, develop and commercialize several new drugs for cancer and other challenging diseases. The multiyear collaboration is aimed at identifying new agents that leverage E3 ligases to induce degradation of specified targets, Nurix's specialty and the centerpiece of its 2015 deal with Celgene Corp.  


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Comet raises $28.5M in bid to build Coenzyme A therapeutics platform

June 20, 2019
By Michael Fitzhugh
Comet Therapeutics Inc., a startup working to build a portfolio of therapies for restoring dysregulated coenzyme A metabolism, has raised $28.5 million in series A financing co-led by Canaan Partners and Sofinnova Partners. 
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Blackthorn lands $76M to pursue development of targeted mental health meds

June 17, 2019
By Michael Fitzhugh

Arqule sees strength in early BTK inhibitor data; shares rise on phase I CLL news

June 17, 2019
By Michael Fitzhugh
Shares of Arqule Inc. (NASDAQ:ARQL) hit a 52-week high Friday on news that the company's Bruton's tyrosine kinase (BTK) inhibitor, ARQ-531, achieved partial responses in four of six heavily pretreated people with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) during an ongoing phase I trial.
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Blackthorn lands $76M to pursue development of targeted mental health meds

June 14, 2019
By Michael Fitzhugh
Blackthorn Therapeutics Inc., a San Francisco-based company seeking traction for a high-tech approach to targeted mental health therapy, has closed a $76 million series B financing expected to help carry a mood disorder program into phase II later this year and move an autism-focused asset into the clinic. Both new and previous investors backed the round.
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Catalyst sues FDA over approval of Jacobus LEMS drug

June 13, 2019
By Michael Fitzhugh
Florida's Catalyst Pharmaceuticals Inc. is suing the FDA to overturn approval of a competitor's drug for the rare autoimmune disorder Lambert-Eaton myasthenic syndrome (LEMS), alleging the green light – arriving just months after its own approval – was "arbitrary, capricious" and violated the company's rights to market exclusivity for the medicine.
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Genentech's lymphoma treatment Polivy wins accelerated FDA approval

June 11, 2019
By Michael Fitzhugh
The FDA granted Roche Holding AG's Genentech Inc. accelerated approval for Polivy (polatuzumab vedotin), a first-in-class anti-CD79b antibody-drug conjugate, to be taken with bendamustine and Rituxan (rituximab) for adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The medicine, approved for those who have received at least two prior therapies, got a go-ahead based on complete response rates observed in a randomized, controlled trial. The FDA said it is the first chemoimmunotherapy regimen for the indication.
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FDA issues draft guidance on enhancing diversity of trial participants

June 10, 2019
By Michael Fitzhugh

Platform plays offer opportunity, potential pitfalls

June 10, 2019
By Michael Fitzhugh
PHILADELPHIA – Big scientific goals, grand partnering ambitions, and a strong tolerance for risk are common hallmarks among the CEOs and founders of emerging platform companies. But what sets platform players apart from other biopharma ventures hasn't always been clear. Setting out to shed some light on the subject during the BIO convention, BioWorld asked the leaders of six dynamic companies about how they think about their businesses and what sets them apart.
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View All Articles by Michael Fitzhugh

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