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

RTTNews | 353 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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Antipodean Currencies Slide Amid Risk-off Mood; Safe-haven CHF, JPY Rises

Antipodean Currencies Slide Amid Risk-off Mood; Safe-haven CHF, JPY Rises

The antipodean currencies such as the Australia and the New Zealand dollars strengthened against their major currencies in the Asian session on Friday, amid heightening geopolitical tensions in the Middle East region after Israel launched a preemptive strike against Iran in a major escalation of the regional conflict. U.S. officials confirmed that the U.S. had no involvement or role in the operation. Tensions between the U.S. and Iran are also rising over the latter's nuclear developments.
RTTNews | 47 minuter sedan
Yen Rises Against Most Majors

Yen Rises Against Most Majors

The Japanese yen strengthened against most major currencies in the Asian session on Friday.
RTTNews | 1h 58minuter sedan
European Shares Set For Gap-down Open

European Shares Set For Gap-down Open

European shares are seen opening sharply lower on Friday as trade uncertainties and escalating geopolitical tensions sparked flight to safety.
RTTNews | 2h 37minuter sedan
European Economic News Preview: Eurozone Industrial Output, Trade Data Due

European Economic News Preview: Eurozone Industrial Output, Trade Data Due

Industrial production and foreign trade from the euro area and final inflation figures from Germany and France are the top economic news due on Friday. At 2.00 am ET, Destatis is scheduled to issue Germany's final consumer and harmonized prices and wholesale prices for May. The flash estimate showed that consumer price inflation remained unchanged at 2.1 percent.
RTTNews | 3h 25minuter sedan
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