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

RTTNews | 638天前
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.

read more
Japan Stock Market May See Renewed Support

Japan Stock Market May See Renewed Support

The Japan stock market on Tuesday halted the two-day winning streak in which it had advanced almost 200 points or 0.5 percent. The Nikkei 225 now rests just beneath the 42,400-point plateau although it's expected to open in the green on Wednesday. The global forecast for the Asian markets is cautiously optimistic, with tech shares likely to rise ahead of key earnings news later in the day. The European markets were down and the U.S. bourses were up and the Asian markets figures to follow the latter lead. The Nikkei finished sharply lower on Tuesday following losses from the financial shares, technology stocks and automobile producers. For the day, the index slumped 413.42 points or 0.97 percent to finish at 42,394.40 after trading between 42,137.62 and 42,703.27. Among the actives, Nissan Motor plummeted 6.25 percent, while Mazda Motor added 0.40 percent, Toyota Motor retreated 1.41 percent, Honda Motor tumbled 1.71 percent, Softbank Group dropped 0.91 percent, Mitsubishi UFJ Financial sank 0.72 percent, Mizuho Financial shed 0.45 percent, Sumitomo Mitsui Financial skidded 1.01 percent, Mitsubishi Electric tumbled 1.91 percent, Sony Group declined 1.87 percent, Panasonic Holdings slumped 1.11 percent and Hitachi contracted 1.63 percent.
RTTNews | 9分钟前
Rebound Tipped For South Korea Stock Market

Rebound Tipped For South Korea Stock Market

The South Korea stock market on Tuesday ended 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 3,180-point plateau although it may reverse those losses on Wednesday. The global forecast for the Asian markets is cautiously optimistic, with tech shares likely to rise ahead of key earnings news later in the day. The European markets were down and the U.S. bourses were up and the Asian markets figures to follow the latter lead.
RTTNews | 24分钟前
TSX Modestly Higher As Financials, Mining Stocks Move Up

TSX Modestly Higher As Financials, Mining Stocks Move Up

Despite concerns about global trade, and political uncertainty in Europe, the Canadian market is modestly higher Tuesday afternoon, supported by gains in materials, industrials and financials sectors.
RTTNews | 4小时59分钟前
Swiss Market Settles Weak

Swiss Market Settles Weak

After opening with a big negative gap Tuesday morning, the Swiss market gradually recovered some lost ground, and even managed a brief spell in positive territory midway through the session, but failed to sustain momentum and finally ended the day's session in the red.
RTTNews | 5小时16分钟前
U.S. Consumer Confidence Index Edges Lower In August

U.S. Consumer Confidence Index Edges Lower In August

A report released by the Conference Board on Tuesday showing a modest deterioration by consumer confidence in the U.S. in the month of August. The Conference Board said its consumer confidence index dipped to 97.4 in August from an upwardly revised 98.7 in July.
RTTNews | 9小时9分钟前