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Samchundang Pharmaceutical Stock Plunges 29.92% in One Day After FDA Pre-ANDA Feedback Misinterpretation

2026-07-21 06:07:44

Samchundang Pharmaceutical-29.79%

According to Korea Exchange, Samchundang Pharmaceutical's stock plunged 29.92% on July 21, hitting the daily lower limit of 167,500 won after surging to 254,000 won the previous day. The sharp reversal came after investors reassessed the significance of the company's receipt of an FDA Pre-ANDA (Product Development Meeting) response letter regarding generic semaglutide development. While the company initially framed the response as confirmation that its U.S. market entry development was proceeding on schedule, investors later recognized that Pre-ANDA feedback does not constitute formal approval or a definitive approval pathway—these remain subject to future ANDA (Abbreviated New Drug Application) review, during which the FDA may request additional clinical data or supplementary materials.

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