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Giấy phép số 4978/GP-TTĐT do Sở Thông tin và Truyền thông Hà Nội cấp ngày 14 tháng 10 năm 2019 / Giấy phép SĐ, BS GP ICP số 2107/GP-TTĐT do Sở TTTT Hà Nội cấp ngày 13/7/2022.
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Today the 16th National Assembly opened the First Session, an especially important milestone marking the start of a new term for Vietnam’s People’s Representatives and the country’s highest state body. The session focuses on instituting and consolidating the state apparatus in line with the Constitution, while also institutionalizing the resolutions…
Levi & Korsinsky has notified investors that it has commenced an investigation into Disc Medicine, Inc. (NASDAQ: IRON) regarding potential violations of the federal securities laws.
The investigation follows Disc’s disclosure on February 13, 2026 that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for bitopertin, the company’s lead therapeutic candidate targeting erythropoietic protoporphyria (EPP), a rare genetic disorder marked by extreme photosensitivity.
A CRL indicates that the FDA has completed its review of a drug application and determined that it cannot approve the application in its current form. The letter requires additional data submissions before the agency will reconsider the application.
EPP is an orphan disease with limited treatment options. Bitopertin had been positioned as a potentially transformative therapy for approximately 4,000 EPP patients in the United States and beyond.
According to the notification, the FDA’s CRL effectively delays any potential approval until at least 2027. This delay removes near-term commercial revenue that analysts had incorporated into their valuation models.
After the CRL announcement, Disc shares declined 21.9%. The notification attributes the magnitude of the decline to how much the market had priced in a favorable FDA outcome based on the company’s prior public communications about the regulatory trajectory of the bitopertin program.
The investigation focuses on whether Disc and its senior executives made statements to investors about the bitopertin program’s regulatory prospects that did not fully reflect the risks and challenges the company was encountering in its interactions with the FDA prior to the CRL.
Premium gym chains are entering a “golden era” that is ending or already in decline, as rising operating costs collide with shifting consumer preferences toward more flexible, community-based ways to exercise. Long-term memberships are shrinking, margins are pressured by higher rents and facility expenses, and competition from smaller, more personalized…
