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CARGO Therapeutics, Inc. (NASDAQ: CRGX) is a clinical-stage biotechnology company dedicated to advancing next-generation, potentially curative cell therapies for cancer patients. The company focuses on the development of innovative CAR T-cell therapies designed to address the key limitations of currently approved treatments, such as limited durability of effect, suboptimal safety, and unreliable supply chains.
Core Business: CARGO Therapeutics' lead program, CRG-022, is a novel CAR T-cell product candidate targeting CD22, a tumor antigen expressed in the majority of B-cell malignancies. This program aims to overcome resistance mechanisms, especially in patients whose disease has relapsed or is refractory to CD19 CAR T-cell therapies.
Recent Achievements: In a transformative year, CARGO expanded its leadership team, commenced a Phase 2 clinical trial of CRG-022, and became a publicly traded company. The Phase 2 trial, known as FIRCE-1, investigates CRG-022 in patients with relapsed or refractory large B-cell lymphoma (LBCL) who have progressed after CD19-directed therapy.
Current Projects: The company is currently running a potentially pivotal Phase 2 clinical study for CRG-022, with interim results expected in the first half of 2025. Additionally, a Phase 1 trial conducted by Stanford University has shown promising results, with a complete response rate of 52% at the current dose level.
Financial Condition and Partnerships: CARGO has fortified its financial position through successful private financing and an IPO. The company collaborates with leading institutions like Stanford University to further its research and development efforts.
Products and Pipeline: Beyond CRG-022, CARGO is leveraging its cell engineering platform to develop a pipeline of therapies incorporating multiple transgene therapeutic 'cargo' aimed at enhancing CAR T-cell persistence and trafficking to tumor lesions, as well as combating tumor resistance and T-cell exhaustion.
For more information, please visit the CARGO Therapeutics website and follow them on LinkedIn and Twitter (@CARGOTx).
CARGO Therapeutics (NASDAQ: CRGX), a clinical-stage biotech company focused on developing next-generation cell therapies for cancer patients, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The conference will take place from January 13-16, 2025, in San Francisco, California.
President and CEO Gina Chapman will deliver a presentation on Monday, January 13, at 10:30 a.m. PT. The presentation will be accessible via live webcast in the Investors section of CARGO's website under News & Events, with a replay available for approximately 30 days following the presentation.
CARGO Therapeutics (NASDAQ: CRGX) reported Q3 2024 financial results and business updates. The company has dosed 57 patients in its Phase 2 FIRCE-1 study of firi-cel, with interim analysis expected in 1H25. Their cash position stands at $404.8 million, projected to fund operations through 2026. Q3 financial results show R&D expenses of $35.9 million and G&A expenses of $11.2 million, with a net loss of $41.9 million ($0.88 per share). The company plans to submit an IND for CRG-023 in Q1'25 and will present pre-clinical data at ASH 2024. CFO Anup Radhakrishnan has been appointed as COO while retaining his CFO role.
CARGO Therapeutics (NASDAQ: CRGX), a clinical-stage biotechnology company focused on developing next-generation cell therapies for cancer patients, has announced its participation in two upcoming investor conferences. Gina Chapman, President and CEO, will participate in fireside chats at the Jefferies London Healthcare Conference on November 20 at 11:00 a.m. GMT, and at the Piper Sandler 36th Annual Healthcare Conference on December 4 at 10:30 a.m. EST. Live webcasts will be available in the Investors section of CARGO's website, with replays accessible for approximately 90 days after the presentations.
CARGO Therapeutics announced its first abstract on CRG-023, a novel tri-specific CAR T-cell therapy targeting CD19, CD20, and CD22 B-cell antigens, will be presented at ASH 2024. CRG-023 is designed to provide durable responses by addressing common relapse causes in existing CAR T therapies.
The preclinical data demonstrated sustained anti-tumor activity, resistance to exhaustion during repeated tumor challenges, and robust anti-lymphoma activity at low doses. The therapy features a unique tri-cistronic design expressing three independent CARs from a single vector, each with distinct co-stimulatory domains. The company is actively preparing for an IND submission based on encouraging results.
CARGO Therapeutics (NASDAQ: CRGX) reported Q2 2024 financial results and provided a business update. Key highlights include:
- 38 patients dosed in the potentially pivotal Phase 2 FIRCE-1 study of firicabtagene autoleucel (firi-cel)
- Completed a $110 million private placement equity financing, extending cash runway through 2026
- $443.5 million in cash, cash equivalents, and marketable securities as of June 30, 2024
- Q2 2024 net loss of $44.3 million, or $1.02 per share
- R&D expenses of $37.5 million and G&A expenses of $11.9 million for Q2 2024
The company expects to complete its interim analysis and report results for the FIRCE-1 study in H1 2025.
CARGO Therapeutics announced that data from their Phase 1 clinical study of Firi-cel CAR T-cell therapy has been published in The Lancet. The study focused on patients with relapsed or refractory large B-cell lymphoma (LBCL) who did not respond to CD19 CAR T-cell therapy. Results showed a 68% overall response rate (ORR) and a 53% complete response (CR) rate, with a median follow-up of 23.3 months.
Notably, 36% of patients previously refractory to all therapies achieved CR. The selected dose for the Phase 2 study, DL1, had a 66% ORR and a 52% CR rate, showing an estimated one- and two-year survival rate of 57% and 52%, respectively. The therapy showed no severe cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome.
These results underscore the promising efficacy and safety profile of firi-cel, which has received Breakthrough Therapy Designation from the FDA. The ongoing Phase 2 study, FIRCE-1, is on track for interim analysis in the first half of 2025.
CARGO Therapeutics has appointed Jane Pritchett Henderson as an Independent Director to its Board. Henderson brings extensive experience in healthcare investment banking and executive leadership in biotech companies.
She will also serve on the audit and compensation committees. This appointment comes as CARGO advances its Phase 2 clinical study for the CAR T-cell therapy candidate, firicabtagene autoleucel (firi-cel), and progresses the CRG-023 program incorporating tri-specific CAR T-cells with CD2 co-stimulation.
Henderson has a strong background in finance and operations, having held key roles at Apogee Therapeutics, Adagio Therapeutics, Turnstone Biologics, and Voyager Therapeutics. Her current board positions include Akero Therapeutics and Ventus Therapeutics.
CARGO Therapeutics (NASDAQ: CRGX) announced its participation in two major investor conferences: the TD Cowen 5th Annual Oncology Innovation Summit and the Jefferies Global Healthcare Conference. Gina Chapman, President and CEO, will take part in virtual fireside chats on May 28 and June 5, respectively. These events will provide insights into the company's advancements in next-generation cell therapies for cancer. Webcasts of the presentations will be available on CARGO's website under the News & Events section, with replays accessible for 30 days post-event.
CARGO Therapeutics announced a $110 million private placement equity financing, involving new and existing investors like EcoR1 Capital, Woodline Partners, and Novo Holdings. This funding supports the BLA preparation for the Phase 2 FIRCE-1 study of firicabtagene autoleucel (CRG-022) and IND-enabling studies for CRG-023. The financing is expected to extend CARGO's cash runway through 2026. The private placement, set to close on May 30, 2024, involves the sale of 6,471,000 shares at $17.00 per share, in accordance with Nasdaq rules. Jefferies, TD Cowen, and Piper Sandler acted as joint placement agents for this transaction.
CARGO Therapeutics (NASDAQ: CRGX) released its Q1 2024 financial results and business update. The FIRCE-1 Phase 2 clinical study of firicabtagene autoleucel (firi-cel) is advancing with 26 sites activated and over 20 patients dosed, with interim results expected in 1H25. The Independent Data Monitoring Committee (IDMC) recommended the study continue without modifications. Data from the Stanford Phase 1 study, to be presented at the 2024 EHA Congress, shows a median overall survival of 25.7 months and favorable safety at the dose level selected for Phase 2. CARGO’s cash position is $375.9 million, providing runway into 2026. R&D expenses for Q1 2024 were $30.5 million, and G&A expenses were $10.3 million, leading to a net loss of $35.8 million or $0.87 per share.
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