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506,222 Results for "applied genetic technologies corporation".
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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
·
Tristan Manalac
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
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2 min read
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Tristan Manalac
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
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
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5 min read
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
Bio NC
Join Genetic Technologies’ Exclusive Live Investor Webinar and Q&A Session on June 27
Genetic Technologies Limited is pleased to invite investors to a webinar on June 27, 2024, at 4:15 p.m. ET.
June 21, 2024
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3 min read
Press Releases
Applied Therapeutics Appoints John H. Johnson as Executive Chairman
December 20, 2024
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12 min read
Press Releases
Microbix Assisting EMQN with Novel Genetic-Test EQA Program
December 10, 2024
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5 min read
Pharm Country
Applied DNA Announces Pricing of $12 Million Public Offering
Applied DNA Sciences, Inc., a leader in PCR-based DNA technologies, announced the pricing of a public offering with gross proceeds to the Company expected to be approximately $12.0 million, before deducting placement agent fees and other estimated expenses payable by the Company.
May 28, 2024
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5 min read
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