| Cullinan Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results |
Company received approval from European Medicines Agency (EMA) for CLN-978; Phase 1 study in active, difficult-to-treat rheumatoid arthritis to initiate in Q2 2025 |
globenewswire.com |
2025-05-08 11:00:00 |
Czytaj oryginał (ang.) |
| Wall Street Analysts Predict a 292.51% Upside in Cullinan Therapeutics (CGEM): Here's What You Should Know |
The mean of analysts' price targets for Cullinan Therapeutics (CGEM) points to a 292.5% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock. |
zacks.com |
2025-05-01 14:55:36 |
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| Cullinan Therapeutics to Initiate Study of CLN-978, a Bispecific CD19 T Cell Engager Administered Subcutaneously, in Patients with Sjögren's Disease in the United States |
CLN-978 is the first and only development-stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases Sjögren's disease represents the third indication under development for CLN-978, and is a disease with high unmet need and no currently approved therapies CAMBRIDGE, Mass., April 29, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the Company is initiating a study of CLN-978 in patients with Sjögren's disease (SjD) in the U.S. The Company previously received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) Application clearance to study the CD19 T cell engager in patients with moderate to severe systemic lupus erythematosus (SLE) and European Medicines Agency (EMA) approval to study CLN-978 in active, difficult-to-treat rheumatoid arthritis. |
globenewswire.com |
2025-04-29 11:00:00 |
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| Cullinan Therapeutics to Present Results from REZILIENT1, a Phase 1/2 Trial of Zipalertinib in Patients with Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Received Prior Therapy, at ASCO 2025 |
Cullinan and Taiho previously announced the Phase 2b portion of the study met the primary endpoint of overall response rate Cullinan and Taiho previously announced the Phase 2b portion of the study met the primary endpoint of overall response rate |
globenewswire.com |
2025-04-23 14:14:00 |
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| Cullinan Therapeutics Receives Approval from European Medicines Agency to Initiate Phase 1 Trial of CLN-978, a Bispecific CD19 T Cell Engager Administered Subcutaneously, in Patients with Rheumatoid Arthritis |
Company-sponsored clinical trial will be initiated at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Q2 2025 |
globenewswire.com |
2025-04-16 11:00:00 |
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| Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results |
Initial clinical data from global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) expected in Q4 2025; CLN-978 remains the first and only development-stage CD19 T cell engager in an autoimmune disease clinical trial in the U.S. Zipalertinib pivotal Phase 2b study met primary endpoint; full results mid-year 2025 and NDA submission planned H2 2025, pending regulatory discussions Cash and investments of $606.9 million as of December 31, 2024, continues to provide runway into 2028 CAMBRIDGE, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported recent and anticipated business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2024. |
globenewswire.com |
2025-02-27 09:00:00 |
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| Cullinan Therapeutics to Participate in Upcoming Investor Conferences |
CAMBRIDGE, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced its participation in the following upcoming investor conferences: Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, M.D. |
globenewswire.com |
2025-02-24 09:00:00 |
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| Taiho Pharmaceutical, Taiho Oncology, and Cullinan Therapeutics Announce Primary Endpoint Met in Phase 2b Trial of Zipalertinib in Patients with Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Received Prior Therapy |
TOKYO, PRINCETON, N.J. and CAMBRIDGE, Mass. |
prnewswire.com |
2025-01-28 21:00:00 |
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| Cullinan Therapeutics' CLN-978 And Zipalertinib Look Promising In NSCLC |
Cullinan Therapeutics focuses on unaddressed or unmet needs in oncology and autoimmune conditions. In particular, Zipalertinib and CLN-978 stand out as its most promising product candidates. Zipalertinib targets a tiny niche in the large NSCLC market. Management expects to report its Phase 2b results by mid-2025. Similarly, CLN-978 is a first-in-class T-cell engager targeting SLE and RA. It can also potentially be expanded into other B-cell-mediated indications eventually. |
seekingalpha.com |
2025-01-10 01:11:54 |
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| Cullinan Therapeutics: Casting A Wide Net With Their Pipeline |
Cullinan Therapeutics is a multifocal biotech with promising programs in precision medicine and immunotherapy, despite recent market sentiment declines. Zipalertinib shows potential in treating exon 20 insertion mutation-positive NSCLC, with a 40% objective response rate in early phase trials. CGEM has a strong financial position with cash reserves projected to fund operations into 2028, reducing the need for immediate equity raises. |
seekingalpha.com |
2025-01-08 19:26:16 |
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| Cullinan Therapeutics Announces Preclinical Data for CLN-978, a CD19-directed T Cell Engager, to be Presented at ACR Convergence 2024 |
Cullinan will present new in vitro preclinical data that provide further strong rationale for broad clinical development of CLN-978 in autoimmune diseases |
globenewswire.com |
2024-11-14 12:01:00 |
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| Cullinan Therapeutics to Participate in Fireside Chat at Stifel 2024 Healthcare Conference |
CAMBRIDGE, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, M.D., M.B.A., Chief Medical Officer, will participate in a fireside chat at the Stifel 2024 Healthcare Conference, being held in New York on November 18 and 19, 2024. |
globenewswire.com |
2024-11-05 09:00:00 |
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| Cullinan Therapeutics to Present Preclinical Data for CLN-978, a CD19-directed T Cell Engager, at ACR Convergence 2024 |
CAMBRIDGE, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced the upcoming presentation of preclinical data for CLN-978, a novel CD19xCD3 bispecific T cell engager, at American College of Rheumatology (ACR) Convergence 2024, taking place in Washington, D.C. from November 14-19, 2024. |
globenewswire.com |
2024-11-04 09:00:00 |
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| 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 Erythematosus |
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). |
globenewswire.com |
2024-10-16 11:00:00 |
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| Cullinan Therapeutics Receives Approval to Initiate its Global Phase 1 Clinical Trial of CLN-978 for the Treatment of Systemic Lupus Erythematosus |
Phase 1 clinical trial is designed to assess the safety, pharmacokinetics and initial clinical activity of CLN-978 for patients with systemic lupus erythematosus |
globenewswire.com |
2024-09-17 11:00:00 |
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| Cullinan Therapeutics Presents Positive Updated Data from Module C of Zipalertinib Pivotal Phase 2b Study at ESMO 2024 |
Updated data show consistent objective response rate of 40% and manageable safety profile in patients with non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutations treated with zipalertinib who progressed on or after prior amivantamab treatment |
globenewswire.com |
2024-09-14 08:15:00 |
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| Cullinan Therapeutics to Participate in Upcoming Investor Conferences |
CAMBRIDGE, Mass., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced its participation in the following upcoming investor conferences: |
globenewswire.com |
2024-08-28 12:00:00 |
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| Cullinan Therapeutics Announces Positive Initial Data from Pivotal Phase 2b REZILIENT1 Study of Zipalertinib |
Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment |
globenewswire.com |
2024-06-01 11:00:00 |
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| Cullinan Therapeutics to Participate in Fireside Chat at TD Cowen 5th Annual Oncology Innovation Summit |
CAMBRIDGE, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that Nadim Ahmed, Chief Executive Officer and Jeffrey Jones, MD, MBA, Chief Medical Officer, will participate in a fireside chat at the TD Cowen 5th Annual Oncology Innovation Summit: Insights for ASCO & EHA, being held virtually on May 28 and 29, 2024. |
globenewswire.com |
2024-05-24 12:00:00 |
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| Cullinan Therapeutics to Present First Data for CLN-619, a Novel Anti-MICA/B Antibody, in Combination with a Checkpoint Inhibitor and Updated Monotherapy Data at ASCO 2024 |
Preliminary data from CLN-619 in combination with checkpoint inhibitor pembrolizumab show objective responses in patients with tumor types that are typically unresponsive to pembrolizumab, such as non-small cell lung cancer (NSCLC) with oncogenic mutations |
globenewswire.com |
2024-05-23 21:04:00 |
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| Cullinan Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results |
Combination and monotherapy solid tumor dose escalation data for CLN-619 to be presented in a poster session at ASCO 2024 Annual Meeting |
globenewswire.com |
2024-05-15 20:05:00 |
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| Cullinan Therapeutics Announces Appointment of Mary Kay Fenton as Chief Financial Officer |
CAMBRIDGE, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted therapies, today announced the appointment of Mary Kay Fenton as Chief Financial Officer, beginning April 29. |
globenewswire.com |
2024-04-29 11:00:00 |
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| Cullinan Therapeutics to Present Clinical Data from Phase 1 Study Evaluating Novel Anti-MICA/B Antibody, CLN-619, as Monotherapy and in Combination with a Checkpoint Inhibitor in Patients with Advanced Solid Tumors at ASCO 2024 |
CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted therapies, today announced that clinical data from its Phase 1 trial of CLN-619 in patients with advanced solid tumors will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31-June 4, 2024. The data will include first results from the dose escalation cohort of CLN-619 in combination with checkpoint inhibitor pembrolizumab and updated results from the monotherapy dose escalation cohort in patients with advanced solid tumors. |
globenewswire.com |
2024-04-24 14:09:00 |
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| Cullinan Therapeutics Announces Strategic Expansion into Autoimmune Diseases |
CLN-978 clinical development to focus exclusively on autoimmune diseases, pursuing systemic lupus erythematosus as a first indication |
globenewswire.com |
2024-04-16 11:00:00 |
Czytaj oryginał (ang.) |
| Cullinan Therapeutics Announces Oversubscribed $280 million Private Placement |
Financing includes new and existing leading life sciences institutional investors Proceeds, along with existing cash and cash equivalents, are expected to extend cash runway into 2028 Cullinan to host a virtual investor event on April 16 at 8:00 am ET CAMBRIDGE, Mass., April 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (formerly Cullinan Oncology, Inc.) (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that it has entered into a stock purchase agreement with certain institutional and accredited investors for a private placement of approximately $274.0 million of shares of its common stock at a price of $19.00 per share and, in lieu of common stock to certain investors, $6.0 million of pre-funded warrants to purchase shares of its common stock at a price of $18.999 per pre-funded warrant. |
globenewswire.com |
2024-04-16 10:59:00 |
Czytaj oryginał (ang.) |
| Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results |
Cullinan remains on track to report additional solid tumor dose escalation data for CLN-619 in the second quarter of 2024 and recently received FDA clearance for an IND to evaluate CLN-619 in relapsed/refractory multiple myeloma |
globenewswire.com |
2024-03-14 09:00:00 |
Czytaj oryginał (ang.) |
| Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma |
Company will initiate Phase 1 study of CLN-619 for relapsed or refractory multiple myeloma, first MICA/B antibody clinical study in hematologic malignancies |
globenewswire.com |
2024-03-01 09:00:00 |
Czytaj oryginał (ang.) |
| Cullinan Oncology to Participate in Upcoming Investor Conferences |
CAMBRIDGE, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan Oncology”) a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced its participation in the following upcoming investor conferences: |
globenewswire.com |
2024-02-27 10:00:00 |
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| Cullinan Oncology to Present at the 42nd Annual J.P. Morgan Healthcare Conference |
CAMBRIDGE, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan Oncology”) a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced that Chief Executive Officer, Nadim Ahmed, will present at the 42nd Annual J.P. Morgan Healthcare Conference, being held January 8-11, 2024 in San Francisco, CA. Mr. Ahmed's presentation is scheduled for Thursday, January 11, at 10:30 am PST (1:30 pm EST). |
globenewswire.com |
2023-12-18 18:53:00 |
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| Cullinan Oncology Announces First Patient Dosed in Phase 1 Trial Evaluating CLN-617, a Novel Fusion Protein Uniquely Harnessing Both IL-2 and IL-12 Cytokines |
CAMBRIDGE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic, targeted oncology therapies, today announced that the first patient has been dosed with CLN-617 in a Phase 1 clinical trial. This is a first-in-human, multi-center, open label study designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CLN-617 alone and in combination with pembrolizumab, a programmed death receptor-1 (PD-1) targeted checkpoint inhibitor, in patients with advanced solid tumors. |
globenewswire.com |
2023-12-14 18:30:00 |
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