Applied Therapeutics CRL a ‘major setback,’ says William Blair
William Blair says Applied Therapeutics (APLT)’ complete response letter from the FDA for govorestat for the treatment of galactosemia is “unexpected and disappointing.” Given the lack of information ...
Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow.
The pharma company's shares are getting crushed after regulators decline to green light a drug to treat a rare disease.
Biopharmaceutical Company's Stock Plunges 75% After FDA Rejects New Drug
Applied Therapeutics' stock plummeted 75 percent after the Food and Drug Administration (FDA) rejected approving 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 ...
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, ...
Regulatory Setback For Applied Therapeutics' Lead Program, FDA Highlights Deficiencies In Clinical Application
FDA rejected Applied Therapeutics' Govorestat for galactosemia, citing NDA deficiencies. The company plans discussions for ...
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Stock Slump or Stepping Stone? What’s Next for Applied Therapeutics (APLT) After FDA’s Latest Blow
issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for govorestat, a drug aimed at treating Classic Galactosemia. As of Friday’s premarket session, Applied Therapeutics’ stock ...
The Pharma Letter2d
Applied Thera tanks, as FDA slaps CRL on govorestat NDA
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for ...
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 ...
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Applied Tx craters as FDA rejects lead product candidate
In a statement, Applied Tx said it is reviewing the complete response letter (CRL) from the FDA and "plans to immediately ...
Pharmaceutical Technology2d
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.
Applied Therapeutics’ NDA for govorestat receives negative response from FDA
Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter – CRL – for the New Drug Application – NDA – for ...