Cullinan Therapeutics Receives U.S. FDA Clearance of Investigational New Drug Application for CLN-978 Administered Subcutaneously in Patients with Moderate to Severe Systemic Lupus Erythem...
Cullinan Therapeutics, Inc. (CGEM)
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Source: GlobeNewswire
CLN-978 is the first development stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases CAMBRIDGE, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) Application for CLN-978 and its global Phase 1 clinical trial may proceed in the U.S. to assess CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE). The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater and who have had an inadequate response to at least two treatments, including one immunosuppressive or biologic standard-of-care agent. Part A is a dose escalation phase that will determine the target dose for further development, with a starting dose of 10 micrograms. Part
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News
- Cullinan Therapeutics, Inc. (NASDAQ: CGEM) is now covered by analysts at UBS Group AG. They set a "buy" rating and a $30.00 price target on the stock.MarketBeat
- Cullinan Therapeutics, Inc. (NASDAQ: CGEM) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $28.00 price target on the stock.MarketBeat
- Cullinan Therapeutics, Inc. (NASDAQ: CGEM) had its "outperform" rating re-affirmed by analysts at Wedbush. They now have a $36.00 price target on the stock.MarketBeat
- Cullinan Therapeutics Receives Approval to Initiate its Global Phase 1 Clinical Trial of CLN-978 for the Treatment of Systemic Lupus ErythematosusGlobeNewswire
- Cullinan Therapeutics, Inc. (NASDAQ: CGEM) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $28.00 price target on the stock.MarketBeat
CGEM
Earnings
- 8/8/24 - Miss
CGEM
Sec Filings
- 10/31/24 - Form SCHEDULE
- 10/22/24 - Form SC
- 10/16/24 - Form 8-K
- CGEM's page on the SEC website