Stealth Granted Pre-NDA Meeting For Elamipretide To Treat Barth Syndrome

RTTNews | 939 dias atrás
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.

Marcadores : MITO
read more
Stealth BioTherapeutics To Be Taken Private In All-cash Deal

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.
RTTNews | 891 dias atrás
TSX Modestly Higher, Looks Set To End On Firm Note

TSX Modestly Higher, Looks Set To End On Firm Note

The Canadian market is modestly higher Wednesday afternoon thanks to technology and materials stocks. Healthcare, communications, consumer discretionary and utilities stocks are among the notable losers.
RTTNews | 5h 2min atrás
Fed Officials Prefer Careful Approach To Rate Decisions Amid Inflation Risks

Fed Officials Prefer Careful Approach To Rate Decisions Amid Inflation Risks

Many Federal Reserve officials believe a careful approach to interest rate decisions will be necessary over the coming quarters, according to the minutes of the central bank's December monetary policy meeting. The minutes said the careful approach will be needed due to a variety of factors, including increased upside risks to the outlook for inflation.
RTTNews | 5h 21min atrás
Swiss Market Ends Modestly Higher

Swiss Market Ends Modestly Higher

After a good spell till an hour past noon, Swiss stocks retreated, but emerged higher in the final hour thanks to selective buying to end the day's session on a positive note.
RTTNews | 6h 2min atrás
European Stocks Close Lower On Weak Economic Data

European Stocks Close Lower On Weak Economic Data

European stocks closed weak on Wednesday, weighed down by data showing a drop in eurozone economic sentiment in the month of December, and decline in German retail sales and factory orders.
RTTNews | 6h 21min atrás
Euro Falls On Tariff Concerns

Euro Falls On Tariff Concerns

The euro dropped against its most major counterparts in the New York session on Wednesday on concerns that implementation of new tariffs by the incoming Donald Trump administration could lift inflation.
RTTNews | 6h 47min atrás
U.S. Wholesale Inventories Dip 0.2% In November, In Line With Estimates

U.S. Wholesale Inventories Dip 0.2% In November, In Line With Estimates

Wholesale inventories in the U.S. dipped in line with estimates in the month of November, the Commerce Department revealed in a report released on Wednesday. The Commerce Department said wholesale inventories slipped by 0.2 percent in November, matching the preliminary estimate as well as economists' expectations.
RTTNews | 9h 39min atrás
U.S. Jobless Claims Unexpectedly Slip To Nearly Eleven-Month Low

U.S. Jobless Claims Unexpectedly Slip To Nearly Eleven-Month Low

With the more closely watched monthly jobs report looming, the Labor Department released a report on Wednesday unexpectedly showing another modest decrease by first-time claims for U.S. unemployment benefits in the week ended January 4th. The report said initial jobless claims slipped to 201,000, a decrease of 10,000 from the previous week's unrevised level of 211,000.
RTTNews | 10h 18min atrás