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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Going public ticker

New SPAC deal moves to take Roivant public; expecting $7.3B market cap

May 3, 2021
By Michael Fitzhugh
A prolific builder of biopharma and health technology companies, Roivant Sciences Ltd. is poised to join Nasdaq through a newly proposed merger with a special purpose acquisition company (SPAC) sponsored by Patient Square Capital LLC. The deal, which values Roivant at $5 billion, includes $611 million of new money, composed of $411 million held in trust by the SPAC, Montes Archimedes Acquisition Corp., plus $200 million from a committed PIPE financing. The transaction, expected to peg Roivant's initial market cap at $7.3 billion, follows a September 2019 deal in which Roivant sold interests in five biopharmas to Sumitomo Dainippon Pharma Co. Ltd. (SDP) for $3 billion cash.
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IPO puzzle pieces

Vaccitech, Werewolf IPOs launch to divergent receptions

April 30, 2021
By Michael Fitzhugh
Vaccitech plc and Werewolf Therapeutics Inc. opened the last day of April with contrasting IPOs. Both priced mid-range, with Vaccitech raising $110.5 million, similar to Werewolf's $120 million haul. However, American depository shares of Vaccitech (NASDAQ:VACC), co-developer of Astrazeneca plc’s COVID-19 vaccine, fell 17.1% to $14.10 from a $17 open, while shares of cancer therapy developer Werewolf (NASDAQ:HOWL) boomed – until they didn't – climbing to $24 before closing about where they started, at $16.10.
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Preclinical through phase III, new COVID-19 therapy trials ramp up

April 30, 2021
By Michael Fitzhugh and Anette Breindl
Urgency to meet the world's worsening load of COVID-19 cases appeared unflagging Thursday, with four new trials kicking off to evaluate treatments aimed at keeping people from progressing to worsened disease and reports on two new variant-focused efforts yielding signs of preclinical promise.
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New COVID-19 therapy trials ramp up as weekly cases surpass previous peaks

April 29, 2021
By Michael Fitzhugh
Urgency to meet the world's worsening load of COVID-19 cases appeared unflagging Thursday, with four new trials kicking off to evaluate treatments aimed at keeping people from progressing to worsened disease and reports on two new variant-focused efforts yielding signs of preclinical promise.
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Alpha-galactosidase enzyme
Travel issues strike again

Protalix shares crumble on CRL for Fabry disease therapy

April 28, 2021
By Michael Fitzhugh
Shares of Protalix Biotherapeutics Inc. (NYSE:PLX) fell 33% to $3.93 on April 28 after the company reported receiving an FDA complete response letter (CRL) in answer to its BLA for pegunigalsidase alfa, a galactosidase enzyme replacement therapy it has long advanced for the potential treatment of Fabry disease.
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Enzyvant resubmits BLA for congenital athymia therapy

April 27, 2021
By Michael Fitzhugh
About a year and a half after Enzyvant Inc.'s tissue-based therapy for children born without a thymus met with a complete response letter over chemistry, manufacturing and controls concerns, its BLA is once again on track for FDA review, the company told BioWorld. Following a resubmission intended to fully address the agency's concerns, the application has a new PDUFA date of Oct. 8.
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Hand holding money plant
Newco news

Stuart Therapeutics raise $11M to back topical dry eye disease candidate

April 27, 2021
By Michael Fitzhugh
Stuart Therapeutics Inc., a company developing peptide therapeutics for ophthalmic disease, has completed an $11 million series A financing led by Infocus Capital Partners, an ophthalmology-focused life sciences venture capital fund, with significant participation by the Wisconsin Alumni Research Foundation, Mimo Capital and Biobrit.
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Infant examination

Sanofi, Astrazeneca post positive top-line RSV protection data

April 26, 2021
By Michael Fitzhugh
Respiratory syncytial virus, which puts millions of otherwise healthy infants in the hospital each year, could soon face a new foe. Top-line results from a phase III test of the extended half-life monoclonal antibody nirsevimab, developed by Astrazeneca plc and Sanofi SA, found it reduced lower respiratory tract infections requiring medical attention due to the virus in both healthy preterm and term infants.
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Inovio shares sink as DoD pulls support for phase III portion of COVID-19 vaccine study

April 23, 2021
By Michael Fitzhugh
Shares of Inovio Inc. (NASDAQ:INO) fell 25% to $6.85 on April 23 after the company said the U.S. Department of Defense scratched funding for the phase III portion of an ongoing trial of its COVID-19 vaccine candidate, INO-4800, in light of the broad availability of other COVID-19 vaccines in the U.S. The news followed recent phase I data showing '4800 performed about in line with already available competitors against SARS-CoV-2 variants now dominant in the U.S.
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ADC wins FDA accelerated approval for Zynlonta in diffuse large B-cell lymphoma

April 23, 2021
By Michael Fitzhugh
Nearly a full month ahead of the PDUFA date, ADC Therapeutics SA said Friday the FDA has granted accelerated approval for Zynlonta (loncastuximab tesirine), a CD19-targeted antibody-drug conjugate for the single-agent treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approved indication includes the treatment of patients with diffuse large B-cell lymphoma not otherwise specified and those with DLBCL arising from low grade lymphoma and high grade B-cell lymphoma, which ADC's CEO Chris Martin said would be an important point of differentiation for the product.
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