U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion M...
Cullinan Therapeutics, Inc. (CGEM)
NASDAQ:AMEX Investor Relations:
investorshub.advfn.com/consolidated-gems-inc-cgem-26232
Company Research
Source: Business Wire
NDA submission based on the Phase 2b REZILIENT1 clinical trial, which demonstrated clinically meaningful and durable responses in patients with relapsed EGFR exon 20 insertion–mutated NSCLCPrescription Drug User Fee Act (PDUFA) target action date is February 27, 2027 PRINCETON, N.J. & TOKYO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.This press release features multimedia. View the full release here: https://
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News
- Cullinan Therapeutics (CGEM) had its "buy" rating reaffirmed by BTIG Research. They now have a $38.00 price target on the stock.MarketBeat
- Cullinan Therapeutics (CGEM) had its price target raised by HC Wainwright from $27.00 to $30.00. They now have a "buy" rating on the stock.MarketBeat
- Cullinan Therapeutics (CGEM) had its "sell (d-)" rating reaffirmed by <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Cullinan Therapeutics (CGEM) had its price target raised by Wedbush from $34.00 to $36.00. They now have an "outperform" rating on the stock.MarketBeat
- Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial ResultsGlobeNewswire
CGEM
Earnings
- 3/10/26 - Beat
CGEM
Sec Filings
- 3/10/26 - Form S-8
- 3/10/26 - Form 10-K
- 3/10/26 - Form 8-K
- CGEM's page on the SEC website