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Pasithea Announces Receipt Of FDA Response Of Pre-IND Meeting For PAS-004 Clinical Development

RTTNews | 614 days ago

Pasithea Announces Receipt Of FDA Response Of Pre-IND Meeting For PAS-004 Clinical Development

(RTTNews) - Biotechnology company Pasithea Therapeutics Corp. (KTTA) announced Wednesday receipt of written responses to questions submitted for a Type 2 pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding clinical development plan for PAS-004.

The FDA's positive feedback and guidance include a recommendation to begin dosing in patients who will benefit from treatment rather than in healthy volunteers. PAS-004 was granted orphan drug designation for the treatment of NF1 in November 2020.

The company said it will begin dosing as early as the first quarter of 2024 following acceptance of the IND by the FDA.

PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies to support an IND application with the FDA that it plans to submit in the fourth quarter of 2023.

Tags: KTTA

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BoJ Minutes: Japan Economy Continues To Recover

BoJ Minutes: Japan Economy Continues To Recover

Members of the Bank of Japan's Monetary Policy Board felt that the country's economic recovery is continuing at an acceptable pace, minutes from the central bank's June 16-17 monetary policy meeting revealed on Tuesday - although it is starting to show signs of slowing.

RTTNews | 29 minutes ago

Singapore Shares Poised To Open To The Upside On Tuesday

Singapore Shares Poised To Open To The Upside On Tuesday

The Singapore stock market on Monday halted the six-day losing streak in which it had stumbled almost 120 points or 2.9 percent. The Straits Times Index now sits just beneath the 4,200-point plateau and it may extend its gains on Tuesday.

RTTNews | 30 minutes ago

Renewed Support Likely For Malaysia Stock Market

Renewed Support Likely For Malaysia Stock Market

The Malaysia stock market has alternated between positive and negative finishes through the last four trading days since the end of the three-day losing streak in which it had fallen more than 15 points or 1 percent. The Kuala Lumpur Composite Index now sits just above the 1,525-point plateau although it's likely to bounce higher again on Tuesday.

RTTNews | 1h 0min ago

Japan Stock Market May Stop The Bleeding On Tuesday

Japan Stock Market May Stop The Bleeding On Tuesday

The Japan stock market has moved lower in two straight sessions, tumbling almost 780 points or 1.8 percent along the way. The Nikkei 225 now sits just shy of the 40,300-point plateau although it's due for support on Tuesday.

RTTNews | 1h 15min ago

South Korea Inflation Rises 0.2% In July

South Korea Inflation Rises 0.2% In July

Overall consumer prices in South Korea were up a seasonally adjusted 0.2 percent on month in July, Statistics Korea said on Tuesday.

RTTNews | 1h 21min ago

Australia Services Sector Accelerates In July

Australia Services Sector Accelerates In July

The services sector in Australia continued to expand in July, and at a faster pace, the latest survey from S&P Global revealed on Tuesday with a services PMI score of 54.1.

RTTNews | 1h 27min ago

KOSPI May Add To Monday's Gains

KOSPI May Add To Monday's Gains

The South Korea stock market on Monday snapped the two-day slide in which it had stumbled more than 135 points or 3.9 percent. The KOSPI now sits just shy of the 3,150-point plateau and it may add to its winnings on Tuesday.

RTTNews | 1h 30min ago

BoJ Minutes On Tap For Tuesday

BoJ Minutes On Tap For Tuesday

The Bank of Japan will on Tuesday release the minutes from its June 16-17 monetary policy meeting, highlighting a modest day for Asia-Pacific economic activity.

RTTNews | 2h 30min ago

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