Applied Therapeutics says it received FDA's warning letter for genetic disease drug study
Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...
Applied Therapeutics: FDA Denial Of Govorestat NDA As Problematic As It Was Unexpected
Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...
BioSpace1 天
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’ ...
Applied Therapeutics Stock Plummets After FDA Rejects Metabolic Disease Drug
Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, ...
Applied Therapeutics stock craters 75% on FDA setback
Applied Therapeutics stock (APLT) was down 75% early Friday on news the FDA had declined to approve its drug govorestat, ...
FDA Rejects Applied Therapeutics' NDA for Govorestat, Citing Flaws; Shares Plunge 76%
Applied Therapeutics ( APLT, Financials) announced that the U.S. Food and Drug Administration issued a Complete Response ...
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
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Optimistic Outlook for Applied Therapeutics Despite FDA Setback
Leerink Partners analyst Joseph Schwartz has maintained their bullish stance on APLT stock, giving a Buy rating on November 29.Don't Miss our ...
FierceBiotech2 天
FDA rejects Applied filing for rare disease approval on clinical grounds, sinking stock
The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...
US FDA declines to approve Applied Therapeutics' genetic disease drug
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...
Applied Therapeutics因药物研究面临FDA审查
据该公司称,FDA的检查产生了某些观察结果,Applied Therapeutics已经做出回应,并认为已解决任何未决问题。公司表示,所提到的给药错误导致少数患者的药物水平略低于目标水平,但在维持剂量阶段之前已得到纠正。Applied Therapeutics坚持认为,所有必要的详细记录都按照FDA规定保存,并已提供给该机构。
BioPharma Dive1 天
Applied’s rare disease drug rejected by FDA
Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s ...