Why Is Gene Therapy Player PTC Therapeutics Stock Plunging Today?
Portfolio Pulse from Vandana Singh
PTC Therapeutics Inc (PTCT) reported a delay in the planned submission of sepiapterin in phenylketonuria (PKU) in its Q3 earnings release. The FDA has pushed the timeline for FDA approval, requiring a 26-week nonclinical mouse study before seeking authorization. This delay will push the filing for FDA approval to the third quarter of next year. PTCT shares are down 22.40% at $18.60 on the last check Friday.
October 27, 2023 | 5:00 pm
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POSITIVE IMPACT
BioMarin Pharmaceutical's Inc's (BMRN) rival drug Kuvan could potentially benefit from the delay in PTC Therapeutics' FDA approval for sepiapterin in PKU.
The delay in PTC Therapeutics' FDA approval for sepiapterin in PKU could potentially benefit BioMarin Pharmaceutical's Inc's rival drug Kuvan, as it may face less competition in the market in the short term.
CONFIDENCE 70
IMPORTANCE 60
RELEVANCE 50
NEGATIVE IMPACT
PTC Therapeutics Inc (PTCT) reported a delay in the planned submission of sepiapterin in phenylketonuria (PKU) in its Q3 earnings release. This delay will push the filing for FDA approval to the third quarter of next year. PTCT shares are down 22.40% at $18.60 on the last check Friday.
The delay in FDA approval for sepiapterin in PKU is a significant setback for PTC Therapeutics, pushing the filing to the third quarter of next year. This news has negatively impacted the company's stock price, which is down 22.40%.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100