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U.S. FDA grants accelerated approval to Boehringer’s HERNEXEOS® as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC

This press release is not intended for UK media. HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 75% (N=71), as demonstrated in the Beamion-LUNG 1 clinical trial1 Accelerated approval follows Priority Review and Breakthrough Therapy Designation granted by the U.S. FDA for the treatment of patients with HER2 (ERBB2)-mutant advanced non-small cell [...]

Boehringer and Click Therapeutics’ investigational prescription digital therapeutic CT-155 meets primary endpoint in CONVOKE study for negative symptoms in schizophrenia

CT-155 showed a reduction in experiential negative symptoms as an adjunct to standard of care antipsychotic therapy from baseline to week 16, as measured by CAINS-MAP. CT-155 is an investigational prescription digital therapeutic being evaluated to target negative symptoms of schizophrenia in a registrational randomized clinical trial.1,2 Often underappreciated and less recognized, negative symptoms impact [...]

Boehringer Ingelheim and Re-Vana Therapeutics Announce Strategic Collaboration to Develop Long-Acting Ophthalmic Therapies

● Up to three development programs per year leading to a potential total deal value exceeding $1 billion contingent on milestone achievements. Ingelheim, Germany, Tampa, Florida, USA, and Belfast, Northern Ireland, UK [28 July 2025] – Boehringer Ingelheim and Re-Vana Therapeutics, a US and UK based developer of ocular therapeutics and ocular drug delivery technologies, today announced [...]

First half of 2025: Solid growth, investments and pipeline progress pave the way for two key launches in H2

Boehringer Laboratory Group net sales grow by 6.3%* to EUR 14.0 billion, driven by Human Pharma (EUR 11.3 billion) and Animal Health (EUR 2.6 billion) Regulatory submissions underway for zongertinib and nerandomilast, with launches expected in H2 2025 Strategic investments in R&D and global manufacturing to drive innovation and support future growth Boehringer Ingelheim, a leading research-driven biopharmaceutical company, reported positive [...]

Boehringer Ingelheim initiates Phase II study of BI 1815368, a potential first-in-class oral treatment for diabetic macular edema

Ingelheim, Germany, July 7, 2025 – Boehringer Ingelheim today announces the start of the THULITE Phase II clinical study (NCT06962839). It will investigate the efficacy, safety and tolerability of BI 1815368 as a potential oral treatment to improve vision in people with diabetic macular edema (DME).1 DME is a leading cause of vision loss in people [...]

Boehringer Ingelheim and Eko Health Inc. enter digital health collaboration to improve heart murmur detection in dogs

A novel canine-specific detection algorithm is designed to improve early identification of heart disease and expand access to life-extending cardiac care for dogs Ingelheim, Germany, and San Francisco, Calif., June 10, 2025 | Boehringer Ingelheim, a global leader in animal health, and Eko Health, a pioneer in applying artificial intelligence (AI) for early detection of [...]

Boehringer Ingelheim to present early clinical evidence of innate immune modulation and anti-tumor activity via SIRPα blockade in two ongoing trials at ASCO 2025

BI 765063 in combination with programmed cell death-1 (PD1) inhibitor antibody ezabenlimab + cetuximab demonstrated a well-tolerated safety profile and potentially promising efficacy signals as second-line treatment in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Next generation SIRPα inhibitor BI 770371 was shown to be well tolerated alone and in combination with PD1 [...]

Global phase III trials demonstrate that nerandomilast slowed lung function decline in IPF and PPF, with similar discontinuation rates to placebo

Nerandomilast, an investigational agent, met the primary endpoint of both phase III trials, FIBRONEER™-IPF and FIBRONEER™-ILD, significantly reducing the decline in forced vital capacity (FVC) [mL] by absolute change from baseline at week 52, compared to placebo.1,2 Nerandomilast’s safety and tolerability profile was consistent across both trials, with similar rates of permanent treatment discontinuation to [...]

Breaking new ground in mental health research: Oxford University, Boehringer Ingelheim, and Cumulus Neuroscience launch first of its kind study investigating the day-to-day experience of patients with psychiatric disorders

Ingelheim, Germany, Oxford and Belfast, UK, April 29, 2025 (Korea Bizwire) – Boehringer Ingelheim, the University of Oxford, and Cumulus Neuroscience are joining forces to provide insights into the day-to-day experiences of people living with psychiatric disorders, and how these experiences relate to their brain activity. The first-of-its-kind study will use novel technology to quantify brain activity, mood, and behavior at home in people who have been diagnosed [...]

Boehringer’s new zongertinib data demonstrate durable and clinically meaningful results in patients with HER2 (ERBB2)-mutant advanced NSCLC

Ingelheim, Germany / Ridgefield, Conn., U.S., April 28, 2025 (Korea Bizwire) New data from the Phase Ib Beamion LUNG-1 trial were presented at AACR and simultaneously published in The New England Journal of Medicine Data presented included an objective response rate (ORR) of 71%, with 7% of patients achieving complete responses (CR), and a 96% disease [...]