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 ...
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 ...
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FDA Denies Approval of Govorestat for Classic Galactosemia
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Applied Therapeutics regarding the New Drug Application (NDA) for govorestat for the treatment of classic ...
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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Applied Therapeutics, Inc. - APLT
Pomerantz LLP is investigating claims on behalf of investors of Applied Therapeutics, Inc. ("Applied Therapeutics" or the "Company") . Such investors are advised to contact Danielle Peyton at ...
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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 ...
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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’ ...
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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 ...
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 ...
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Biotech Stock Roundup: BBIO Stock Up on Drug Approval, SAVA, APLT Plunge on Setbacks & More
Pipeline and regulatory updates are in focus in the biotech sector. Among these, BridgeBio Pharma, Inc. BBIO gained on ...
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, ...