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Stealth Granted Pre-NDA Meeting For Elamipretide To Treat Barth Syndrome
(RTTNews) - Biotechnology company Stealth BioTherapeutics Corp (MITO) announced Tuesday its plan to meet with the U.S. Food & Drug Administration (FDA) Division of Cardiology and Nephrology (DCN) to discuss new clinical data that may inform a potential new drug application (NDA) submission for the treatment of Barth Syndrome.
The Company recently requested a Type B pre-NDA meeting to discuss new clinical data on patients treated with elamipretide for over 3.5 years in the open-label extension period of the Phase 2 TAZPOWER study.
In October 2021, the FDA had refused to file the Company's NDA for the treatment of Barth Syndrome.
The Company believes that the new data may support an NDA filing and approval of elamipretide as a treatment for Barth Syndrome.
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Stealth BioTherapeutics To Be Taken Private In All-cash Deal
Biotechnology company Stealth BioTherapeutics Corp (MITO) announced Monday that it has entered into a definitive Agreement and Plan of Merger with Stealth Parent Limited,, and Stealth Merger Sub Limited, a wholly-owned subsidiary of Parent, to be acquired by a consortium of investors led by Morningside Venture (I) Investments Ltd. and J. Wood Capital Advisors LLC in an all-cash transaction.
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Swiss Market Settles On Firm Note As Alcon, UBS Group Rise Sharply
The Switzerland market closed on a firm note on Friday, gaining in strength after a modestly positive start. Expectations of more monetary easing by the Federal Reserve, and optimism surrounding artificial intelligence helped keep investor sentiment fairly upbeat.
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European Markets Close On Firm Note On Rate Cut Hopes, AI Optimism
European markets closed higher on Friday as rising hopes of more interest rate cuts from the Federal Reserve, and optimism surrounding artificial intelligence outweighed concerns about any impact of the government shutdown in the U.S.
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U.S. Service Sector Activity Unchanged In September
Service sector activity in the U.S. was unchanged in the month of September, the Institute for Supply Management revealed in a report released on Friday. The ISM said its services PMI fell to 50.0 in September from 52.0 in August, with a reading of 50.0 serving as the breakeven point between expansion and contraction. Economists had expected the index to edge down to 51.7.
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Eurozone Private Sector Maintains Expansion
The euro area economy continued to expand in September, with broad-based growth in Germany, Italy and Spain, while France contracted further due to political uncertainty, final survey data from S&P Global revealed on Friday. The final HCOB composite output index rose moderately to 51.2 in September, in line with flash estimate, from 51.0 in the previous month.
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Bay Street Headed For Positive Start
Higher Canadian and U.S. futures and firm commodity prices point to a positive start for the Canadian market Friday morning. Optimism surrounding artificial intelligence and expectations of a rate cut by the Federal Reserve may help underpin sentiment.
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FTSE 100 Up Firmly In Positive Territory, Set To End Week On Strong Note
The U.K. stock market is up in positive territory Friday afternoon, supported by gains in banking and mining sectors. The benchmark FTSE 100 is well set to end the week with a gain of about 2%.
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CAC 40 Roughly Flat As Investors Focus On Economic Data
The French stock market is roughly flat Friday afternoon with stocks turning in a mixed performance as investors react to the latest batch of regional economic data, and continuing to assess the impact of the government shutdown in the U.S.
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