BOEHRINGER-INGELHEIM
2.6.2021 14:02:09 CEST | Business Wire | Press release
Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078) today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the GLP-1/glucagon dual agonist BI 456906 for adults with non-alcoholic steatohepatitis (NASH). The Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need. BI 456906 is currently being evaluated in a Phase II study in adults with NASH and liver fibrosis (F2/F3) with and without diabetes.
“The FDA Fast Track Designation for our dual agonist is an important step forward in addressing the high unmet medical need among the up to 444 million adults estimated to be living with NASH,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Together with our partner Zealand Pharma, we look forward to working closely with the FDA as we explore the potential of the GLP-1/glucagon agonist to improve outcomes for adults with NASH.”
“Boehringer Ingelheim and Zealand Pharma are committed to delivering innovative solutions that address public health challenges of cardiometabolic diseases, including NASH,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “By combining Boehringer Ingelheim’s expertise in drug development in the cardio-metabolic area with our strength in the discovery of innovative peptide-based medicines, we have the potential to bring forward a novel therapy option in an area with limited available treatments.”
The GLP-1/glucagon compound derived from the natural gut hormone oxyntomodulin activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions. The dual agonist BI 456906 has the potential to be a new, once-weekly treatment that may offer therapeutically relevant benefits compared to currently available treatments. It is also being investigated as a potential treatment option for adults living with diabetes and for adults living with obesity. It is part of Boehringer Ingelheim’s research and development portfolio in the cardiometabolic disease areas.
Please click on the following link for ‘Notes to Editors’:
http://www.boehringer-ingelheim.com/press-release/fast-track-designation-nash
View source version on businesswire.com: https://www.businesswire.com/news/home/20210602005582/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Dompé Doses First Patient in Phase 3 Study of Cenegermin-bkbj in NAION14.7.2026 14:00:00 CEST | Press release
Non-arteritic anterior ischemic optic neuropathy (NAION) is a loss of blood flow to the optic nerve which causes spontaneous and rapid vision loss, for which there are currently no FDA-approved treatments. Given the substantial unmet need for effective treatments in NAION, in October 2025, Dompé was awarded a Commissioner’s National Priority Review Voucher (CNPV) by the US FDA to accelerate a potential Biologics License Application for intranasal nerve growth factor (NGF) in NAION. Dompé, a biopharmaceutical company with operations in Italy and the US, announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). Involving more than 130 centers globally, the Phase 3 trial, “Galassia-NAION-301” is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION. “Our NGF R&D program continues to accelerate with our third clinical study of 202
CE-IVDR Mark for Hologic’s Aptima® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening14.7.2026 14:00:00 CEST | Press release
New indication in the European Union and the UK offers alternative method of screening especially for women who are not currently participating Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714358586/en/ Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%.2 However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25%
Cover Genius Raises USD $100M Backed by Vista Credit Partners, Reaching USD $1.9 Billion Valuation as it Advances AI-First Platform and Global Expansion14.7.2026 14:00:00 CEST | Press release
Accelerating the AI roadmap and next era of embedded protection Cover Genius, the global infrastructure for embedded protection, today announced a USD $100M capital raise, backed by Vista Credit Partners, a subsidiary of Vista Equity Partners and strategic financing partner focused on enterprise software. The raise values the business at USD $1.9 billion, advancing a new chapter for the company. Cover Genius operates a B2B2C embedded protection platform that connects 200+ partners with 50+ global insurance carriers to protect over 70 million end customers at the point of sale across travel, retail, ticketing and logistics. Unlike traditional insurers, Cover Genius dynamically adapts product design, pricing, and presentation in real time to match each merchant's unique customer journey and geography mix. “We’ve spent more than a decade building the trust layer the world’s largest digital companies rely on to protect their customers. Today’s raise is about broadening possibilities: movin
Esri to Debut the Power of Where Collection at 2026 Esri User Conference14.7.2026 14:00:00 CEST | Press release
New Titles Expand on Landmark Work to Showcase How GIS Drives Better Decisions Across Water and Land Management Esri will debut the Power of Where Collection at the 2026 Esri User Conference. The collection builds on the 2024 book The Power of Where by Jack Dangermond, extending its ideas into real-world GIS applications. New titles in the collection highlight GIS uses in water forecasting, land records, infrastructure planning, and economic development. The series demonstrates how spatial analysis helps organizations address challenges including sustainability, climate resilience, and governance. Esri, the global leader in location intelligence, will debut the Power of Where Collection at the 2026 Esri User Conference in July. The collection builds on the ideas introduced in The Power of Where: A Geographic Approach to the World's Greatest Challenges, by Esri president Jack Dangermond, published in 2024. The new collection expands these foundational concepts into focused, real-world a
Esri Introduces ArcGIS for ServiceNow, Bringing Location Intelligence into Everyday Enterprise Workflows14.7.2026 14:00:00 CEST | Press release
New Integration Connects Platforms, Enabling Real-Time Mapping Directly Within Existing Systems Esri is launching ArcGIS for ServiceNow, an integration that connects ServiceNow, the AI control tower for business reinvention, with ArcGIS, bringing location intelligence into everyday enterprise workflows. The solution supports organizations across commercial, government, health care, utilities, energy, telecom, and other sectors. Users can visualize incidents, assets, work orders, facilities, and other business data on maps in real time within ServiceNow or ArcGIS, improving decision-making and operational efficiency. The integration eliminates data duplication by enabling seamless data sharing between systems, bridging business records with geographic context. ArcGIS for ServiceNow will debut in beta shortly after Esri User Conference. Esri, the global leader in geographic information system (GIS) technology, has announced ArcGIS for ServiceNow, connecting the two platforms for the firs
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom