Latest News for: her2

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Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for First Line Treatment of HER2-positive Breast Cancer

PR Newswire 13 Feb 2026
The trial is evaluating the company's developed IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) as a first-line treatment for patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
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Kelun-Biotech Announces Fourth Indication for Sacituzumab Tirumotecan (sac-TMT) Approved by NMPA in HR+/HER2- Breast Cancer

PR Newswire 06 Feb 2026
According to BICR-assessed PFS results, the hazard ratios in the HER2-zero and HER2-low (IHC 1+ or IHC 2+/ISH-) subgroups were 0.39 (95% CI.
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Medical-imaging company Imagion Biosystems Lodges IND with FDA for Phase 2 Trial of MagSense� HER2 ...

Business Wire 04 Feb 2026
MELBOURNE, Australia--(BUSINESS WIRE)---- $IBX #FDA--Imagion Biosystems, Ltd. announced that the company has lodged an IND application with the FDA for its MagSense� targeted imaging agent ... .
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Relay Therapeutics Announces Zovegalisib Granted Breakthrough Therapy Designation by U.S. FDA for PIK3CA-mutant, HR+/HER2- Advanced ...

Nasdaq Globe Newswire 03 Feb 2026
Designation supported by robust clinical�data from ReDiscover trial with 600mg BID fasted and 400mg BID fed doses of zovegalisib in combination with fulvestrant ... .
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Relay Therapeutics Announces Zovegalisib Granted Breakthrough Therapy Designation by U.S. FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer (Form 8-K) (Relay Therapeutics Inc)

Public Technologies 03 Feb 2026
for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer ... "Approximately 40% of patients with HR+/HER2- advanced breast cancer harbor PIK3CA ... About PIK3CA-mutated, HR+/HER2- Advanced Breast Cancer.
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New Data Demonstrate CD47 Expression Level Helps Predict Response to ALX Oncology’s Evorpacept in Combination with Ziihera (zanidatamab-hrii) in Advanced HER2-Positive Breast Cancer (Form 8-K) (ALX Oncology Holdings Inc)

Public Technologies 30 Jan 2026
Advanced HER2-Positive Breast Cancer. - Exploratory analysis from Phase 1b/2 breast cancer trial reinforces CD47 as a predictive biomarker for response, as previously observed in the ASPEN-06 trial in HER2-positive gastric cancer -.
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ENHERTU® Approved in China as the First and Only HER2 Directed ADC for the Second-Line Treatment of Patients with HER2 Positive Metastatic Gastric Cancer (Daiichi Sankyo Co Ltd)

Public Technologies 22 Jan 2026
Press Release ENHERTU®Approved in China as the First and Only HER2 Directed ADC for the Second-Line Treatment of Patients with HER2 Positive Metastatic Gastric Cancer ... About HER2 Positive Gastric Cancer ... only) is a HER2 directed ADC.
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Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

Nasdaq Globe Newswire 20 Jan 2026
... human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-type advanced breast cancer (“ABC”).
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Agendia Announces NCCN Guideline Update Recognizing MammaPrint to Guide Personalized Anthracycline Use in HR+/HER2- Early‑Stage ...

Business Wire 20 Jan 2026
IRVINE, Calif. and AMSTERDAM--(BUSINESS WIRE)-- #Agendia--New NCCN guidelines recognize the utility of MammaPrint for guiding anthracycline therapy selection in HR+/HER2- early-stage breast cancer ... .
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HER2-Negative Metastatic Breast Cancer Market to Evolve Rapidly Over the Next Decade by 2034, DelveInsight ...

GetNews 17 Jan 2026
To Know in detail about the HER2-Negative Metastatic Breast Cancer market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; ... Since HER2 is not overactive, HER2-targeted therapies like trastuzumab are ineffective.
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Boehringer Ingelheim announces clinical collaboration with Jazz Pharmaceuticals to advance HER2-targeted therapy in breast cancer

Nasdaq Globe Newswire 12 Jan 2026
Boehringer and Jazz Pharma partner to combine two unique HER2-targeted approaches, aiming to offer new breast cancer treatment options ... .
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