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Samchundang Pharm Hits Upper Limit on Receiving FDA Pre-ANDA Response for Oral Semaglutide; Future Schedule Remains a Key Variable

Shares of Samchundang Pharm (000250) surged to close at the upper limit after news broke that the company received a Pre-ANDA response from the U.S. FDA regardi

Oseong Kwon
Staff Reporter
3 min read
Samchundang Pharm Hits Upper Limit on Receiving FDA Pre-ANDA Response for Oral Semaglutide; Future Schedule Remains a Key Variable
CBC News

Shares of Samchundang Pharm (000250) surged to close at the upper limit after news broke that the company received a Pre-ANDA response from the U.S. FDA regarding the development of oral semaglutide.

According to the Korea Exchange (KRX) on the 20th, Samchundang Pharm finished trading at 239,000 won, up 54,900 won (29.82%) from the previous session. Strong buying interest poured in from early in the session, pushing the stock to its daily price limit.

The sharp rally is interpreted to be driven by the company's receipt of a response related to Pre-ANDA, a pre-consultation process conducted ahead of filing an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for its orally administered semaglutide under development.

Market attention is now focused on the trading session on the 21st. However, with additional steps still remaining before actual commercialization, future FDA progress and timelines are cited as the key variables that will determine the stock's next direction.

[※ This article is based on market trends and regulatory disclosures and is not intended to recommend the purchase or sale of any specific stock or to solicit investment. Investment decisions and responsibilities lie solely with the investor.]

Oseong Kwon
Staff Reporter

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