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509,710 Results for "applied genetic technologies corporation".
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Press Releases
PacBio Technology Powers Landmark Multiomic Study Published in Nature Genetics
January 30, 2025
·
5 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
·
3 min read
·
Tristan Manalac
Press Releases
Myriad Genetics Issues Quality, Innovation, and Corporate Responsibility Report
January 7, 2025
·
3 min read
Press Releases
Applied DNA Announces Fourth Quarter and Fiscal Year 2024 Financial Results, Announces Strategic Restructuring to Prioritize the Manufacture of Critical Starting Materials for Genetic Medicines
December 17, 2024
·
15 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
·
2 min read
·
Tristan Manalac
Press Releases
Generation Bio to Apply ctLNP Delivery Technology to Develop siRNA Therapeutics for T Cell-Driven Autoimmune Diseases
January 7, 2025
·
5 min read
BioMidwest
Applied Genetic Technologies Corporation Urges Shareholders to Tender Their Shares by November 28, 2022
Applied Genetic Technologies Corporation, President and Chief Executive Officer, Sue Washer, sent the following letter to stockholders.
November 14, 2022
·
5 min read
Press Releases
Applied DNA Reminds Shareholders to Vote Ahead of Special Meeting on February 14
February 11, 2025
·
3 min read
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
·
2 min read
·
Annalee Armstrong
BioMidwest
Applied Genetic Technologies Corporation Reminds Shareholders to Tender Their Shares by November 28, 2022
Applied Genetic Technologies Corporation, President and Chief Executive Officer, Sue Washer, sent the following letter to shareholders:
November 3, 2022
·
6 min read
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