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693,846 Results for "applied stemcell inc".
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Business
Applied StemCell, Inc. Strengthens Executive Leadership with Two Key Appointments
Applied StemCell, Inc. is pleased to announce the addition of two accomplished professionals to its C-level executive team: George Hong (Chief Commercial Officer) and Timothy J. Largen (Chief Operating Officer).
December 4, 2023
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3 min read
Deals
QHP Capital Acquires Applied StemCell
QHP Capital, announced its acquisition of Applied StemCell, Inc., a leading cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry in developing and manufacturing cell and gene products.
October 9, 2023
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4 min read
Deals
STEMCELL Technologies Announces Acquisition of Propagenix Inc.
STEMCELL Technologies is pleased to announce the acquisition of Propagenix Inc.
January 19, 2024
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3 min read
Regulatory
FDA Warns Applied Therapeutics of ‘Objectionable Conditions’ in Govorestat Study
The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.
December 4, 2024
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2 min read
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Tristan Manalac
Biotech Bay
Applied StemCell Inc. Partners with CIRM to Provide Clinical-Grade iPSCs and Access to Its Proprietary Gene Editing Technologies to Accelerate the Development of Regenerative Therapies
Applied StemCell, Inc. and the California Institute for Regenerative Medicine have partnered as Industry Resource Partners.
June 13, 2023
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3 min read
Complete response letters
Applied Therapeutics Crashes After FDA Rejection of Rare Disease Drug
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.
December 2, 2024
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3 min read
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Tristan Manalac
Executive Appointments
After Month of Bad News, Applied Shuffles Leadership, Lays Out Uncertain Path for Rare Disease Drug
Following a 90% drop in share price due to an FDA rejection and a warning letter over Applied Therapeutics’ conduct during a clinical trial, the biotech’s CEO has stepped aside.
December 23, 2024
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2 min read
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Annalee Armstrong
Deals
Applied UV, Inc. Announces Closing of $2.76 Million Registered Direct and Private Placement
Applied UV, Inc. (NASDAQ: AUVI) (the “Company”), a leader in smart building technology solutions, today announced the closing of its previously announced registered direct offering and concurrent private placement with institutional investors.
April 1, 2024
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5 min read
Podcast
Biopharma’s Shopping Spree, Applied Crashes on Rejection, Skysona’s Safety Concerns, More
Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona.
December 4, 2024
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1 min read
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Heather McKenzie
Press Releases
Applied Therapeutics Appoints John H. Johnson as Executive Chairman
December 20, 2024
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12 min read
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