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Krystal Biotech Says EMA Validated MAA For VYJUVEK For Dystrophic Epidermolysis Bullosa

RTTNews | 639 dni temu

Krystal Biotech Says EMA Validated MAA For VYJUVEK For Dystrophic Epidermolysis Bullosa

(RTTNews) - Biotechnology company Krystal Biotech, Inc. (KRYS) announced Monday that the Company's Marketing Authorization Application (MAA) to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt or B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review. A CHMP opinion is anticipated in the second half of 2024.

In September 2023, Krystal Biotech received a positive opinion from the EMA Pediatric Committee on the Pediatric Investigation Plan for VYJUVEK for the treatment of DEB.

Based on this positive opinion, the Company would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval in the EU.

Previously, VYJUVEK received Orphan Drug Designation and PRIority Medicines (PRIME) eligibility from the EMA.

Tagi: KRYS

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Singapore Stock Market May Extend Wednesday's Gains

Singapore Stock Market May Extend Wednesday's Gains

The Singapore stock market bounced higher again on Wednesday, one day after snapping the five-day winning streak in which it had climbed almost 70 points or 1.6 percent. The Straits Times Index now sits just above the 4,245-point plateau and it may pick up steam on Thursday.

RTTNews | 13 minut temu

Malaysia Bourse May Add To Its Winnings On Thursday

Malaysia Bourse May Add To Its Winnings On Thursday

The Malaysia stock market rebounded on Wednesday, one day after ending the three-day winning streak in which it had collected almost 15 points or 0.9 percent. The Kuala Lumpur Composite Index now sits just above the 1,585-point plateau and it's expected to open in the green again on Thursday.

RTTNews | 43 minut temu

Higher Open Called For Japan Stock Market

Higher Open Called For Japan Stock Market

The Japan stock market bounced higher again on Wednesday, one session after ending the two-day winning streak in which it had advanced almost 200 points or 0.5 percent. The Nikkei 225 now rests just above the 42,520-point plateau and it's expected to open to the upside again on Thursday.

RTTNews | 58 minut temu

KOSPI May Reclaim 3,200-Point Level

KOSPI May Reclaim 3,200-Point Level

The South Korea stock market bounced higher again on Wednesday, one day after ending the three-day winning streak in which it had improved almost 80 points or 2.6 percent. The KOSPI now sits just shy of the 3,190-point plateau and it may tick higher again on Thursday.

RTTNews | 1g 13 minut temu

Korea Interest Rate Decision Due On Thursday

Korea Interest Rate Decision Due On Thursday

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RTTNews | 2g 13 minut temu

Swiss Franc Advances Against Majors

Swiss Franc Advances Against Majors

The Swiss franc climbed against its major counterparts in the New York session on Wednesday.

RTTNews | 3g 41 minut temu

European Stocks Close On Mixed Note

European Stocks Close On Mixed Note

European stocks turned in a mixed performance on Wednesday as investors largely stayed cautious, looking ahead to chipmaker Nvidia's quarterly earnings announcement, and continuing to assess the political situation in France.

RTTNews | 7g 19 minut temu

Euro Falls Amid Political Uncertainty

Euro Falls Amid Political Uncertainty

The euro weakened against other major currencies in the European session on Wednesday, as trader's concern about the collapse of France's government.

RTTNews | 11g 35 minut temu

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