Carisma Says FDA Grants Fast Track Designation For CT-0525 In HER2-Overexpressing Solid Tumors

RTTNews | 351 dagar sedan
Stocktwits
Carisma Says FDA Grants Fast Track Designation For CT-0525 In HER2-Overexpressing Solid Tumors

(RTTNews) - Biopharmaceutical company Carisma Therapeutics, Inc. (CARM) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).

The Phase 1 clinical trial for CT-0525 is an open-label study designed to assess the safety, tolerability, and manufacturing feasibility of CT-0525.

This trial will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies. The initial study design will consist of two dose escalation cohorts.

Carisma said it is looking to work closely with the FDA to accelerate the development of CT-0525. It is currently enrolling patients in the Phase 1 clinical trial and remains on track to report initial clinical data by the end of 2024.

Taggar: CARM
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Sensex, Nifty Seen Lower As Investors Monitor Trade, Geopolitical Developments

Sensex, Nifty Seen Lower As Investors Monitor Trade, Geopolitical Developments

Indian shares look set to open lower on Thursday as oil prices climbed on signs of rising tensions in the Middle East and U.S. President Donald Trump said he would notify trading partners within the next one to two weeks about the new unilateral tariff rates, with the choice to accept or reject them.
RTTNews | 13 minuter sedan
Rally May Stall For Thai Stock Market

Rally May Stall For Thai Stock Market

The Thai stock market has moved higher in back-to-back sessions, collecting more than 6 points or 0.6 percent along the way. The Stock Exchange of Thailand now rests just above the 1,140-point plateau although it may be stuck in neutral on Thursday.
RTTNews | 47 minuter sedan
Japanese Market Notably Lower

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RTTNews | 1h 8minuter sedan
Indonesia Bourse May Extend Wednesday's Losses

Indonesia Bourse May Extend Wednesday's Losses

The Indonesia stock market on Wednesday ended the three-day winning streak in which it had gained almost 190 points or 2.7 percent. The Jakarta Composite Index now rests just above the 7,220-point plateau and the losses may accelerate on Thursday.
RTTNews | 1h 17minuter sedan
Australian Market Slightly Higher

Australian Market Slightly Higher

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RTTNews | 1h 29minuter sedan
Hong Kong Bourse May Hand Back Wednesday's Gains

Hong Kong Bourse May Hand Back Wednesday's Gains

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RTTNews | 1h 31minuter sedan
Lower Open Anticipated For Taiwan Stock Market

Lower Open Anticipated For Taiwan Stock Market

The Taiwan stock market has moved higher in three straight sessions, accelerating more than 810 points or 3.6 percent along the way. The Taiwan Stock Exchange now sits just above the 22,470-point plateau although it's expected to open under water on Thursday.
RTTNews | 2h 17minuter sedan
Continued Consolidation Called For Singapore Shares

Continued Consolidation Called For Singapore Shares

The Singapore stock market has moved lower in two straight sessions, sinking more than 15 points or 0.4 percent along the way. The Straits Times Index now sits just beneath the 3,920-point plateau and it may take further damage on Thursday.
RTTNews | 2h 47minuter sedan
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