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

RTTNews | 1037 hari yang lalu
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.

baca selengkapnya
European Markets Fail To Hold Early Gains, Settle Weak

European Markets Fail To Hold Early Gains, Settle Weak

After trading in positive territory for much of the day's trading session, most of the markets in Europe ended weak on Tuesday, hurt by some brisk selling in the final hour. Despite oil's retreat, investors turned cautious amid continued uncertainty about Iran and the U.S. reaching an agreement to end their conflict anytime soon.
RTTNews | 7 menit yang lalu
U.S. Consumer Confidence Index Unexpectedly Slumps In September

U.S. Consumer Confidence Index Unexpectedly Slumps In September

A report released by the Conference Board on Tuesday unexpectedly showed a notable deterioration in U.S. consumer confidence in the month of September. The Conference Board said its consumer confidence index slumped to 81.9 in September from a downwardly revised 88.6 in August.
RTTNews | 3 jam 23 menit yang lalu
Bay Street Likely To Open With Positive Bias

Bay Street Likely To Open With Positive Bias

Canadian stocks may open with a positive bias on Tuesday as oil shed early gains and slipped into negative territory, and gold prices edged higher. According to a flash estimate, the Canadian GDP is expected to have expanded by 0.2% from the previous month in August.
RTTNews | 5 jam 1 menit yang lalu
Eurozone Economic Sentiment Weakens

Eurozone Economic Sentiment Weakens

Eurozone economic confidence weakened unexpectedly in September due to the fall in consumer sentiment, monthly survey data from the European Commission showed Tuesday. The economic sentiment index dropped to 97.9 in September from 98.4 in the previous month. The score was forecast to rise to 99.0.
RTTNews | 5 jam 7 menit yang lalu
Major European Markets Move Higher As Oil Pares Early Gains

Major European Markets Move Higher As Oil Pares Early Gains

The major European markets gained some ground in positive territory on Tuesday with investors picking up select stocks even as oil prices remained at elevated levels despite coming off early highs and bond yields continued to hover around multi-year highs.
RTTNews | 5 jam 25 menit yang lalu
UK Mortgage Approvals Fall To 32-Month Low

UK Mortgage Approvals Fall To 32-Month Low

UK mortgage approvals declined to a 32-month low in August amid higher borrowing costs, while consumer credit reached a record high, data from the Bank of England showed Tuesday. Net mortgage approvals for house purchases, an indicator of future borrowing, fell unexpectedly to 54,918 in August from 55,928 in the previous month.
RTTNews | 5 jam 52 menit yang lalu
Mixed Sentiment In Asian Markets

Mixed Sentiment In Asian Markets

Mixed sentiment prevailed in Asian markets on Tuesday tracking the negative sentiment in Wall Street on Monday. Market mood was impacted by worries about a broad slowdown in AI development. Markets also digested the rate hike by Reserve Bank of Australia. Renewed diplomatic push to end the Middle East crisis, the decline in crude oil prices and the easing in bond yields capped losses.
RTTNews | 5 jam 59 menit yang lalu