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
LabPMM® Launches Global KMT2A MRD Testing Service to Support Menin Inhibitor Development and Acute Leukemia Care4.8.2026 09:10:00 CEST | Press release
LabPMM®, an Invivoscribe® subsidiary, today announced the global availability of its new KMT2A measurable residual disease (MRD) testing service. The highly sensitive digital PCR service is available to healthcare providers, clinical researchers, and biopharmaceutical partners through LabPMM’s global laboratory network, with CAP/CLIA-accredited testing available in the U.S. The service addresses a growing need for accurate molecular monitoring in acute leukemias.1,2,3 KMT2A rearrangements (KMT2Ar) are oncogenic drivers in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).4 These rearrangements are present in about 80% of infant cases and 5-15% of childhood and adult leukemia cases.5 KMT2Ar leukemias are associated with chemotherapy resistance, high relapse rates, and poor clinical outcomes.5 The emergence of menin inhibitors is transforming the therapeutic landscape for patients with AML and ALL, particularly those with KMT2A-rearranged and NPM1-mutated disease.6 The
“HATSUNE MIKU LIGHTS TOKYO” Debuts on July 254.8.2026 09:00:00 CEST | Press release
Giant Hatsune Miku Returns to Light Up Tokyo’s Night! The Tokyo Metropolitan Government has been presenting year-round projection mapping displays on the Tokyo Metropolitan Government Building, using light and sound to showcase a wide range of artistic expressions as part of its efforts to create new nighttime tourism attractions in Tokyo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260802298570/en/ © Crypton Future Media, INC. On Saturday, July 25, "HATSUNE MIKU LIGHTS TOKYO", featuring the globally beloved virtual singer Hatsune Miku, held its first screening. The work brings the world of the popular song “M@GICAL☆CURE! LOVE ♥ SHOT!” to life across the entire façade of the Tokyo Metropolitan Government Building. Since its launch in February 2024, “TOKYO Night & Light” has welcomed visitors from Japan and around the world, with total attendance surpassing 1.55 million. As one of Tokyo’s emerging landmark attractions, the
Mosaic Therapeutics appoints Dr Allison Jeynes as Chair of the Board4.8.2026 09:00:00 CEST | Press release
Accomplished life sciences leader with a proven track record of driving successful development of novel therapeutics, joins Mosaic to guide its next phase of growthAllison brings three decades of drug development, board and executive leadership experience to support Mosaic’s transition towards a clinical-stage company Mosaic Therapeutics, Ltd, (‘Mosaic’, or ‘the Company’) an oncology therapeutics company developing novel, targeted drug combinations across a range of haematological and solid cancers, today announced the appointment of Dr Allison Jeynes as Chair of the Board to support its next phase of growth and advancement towards clinical development. Allison succeeds Dr Edward Hodgkin, who remains a Non-Executive Director of the Board. Allison is a UK-trained oncologist and highly-experienced life sciences leader, and brings over three decades of drug development and executive experience to Mosaic Therapeutics. As CEO of Avillion, a clinical development company, for the last 13 year
TOHKnet and Adtran conduct Japan’s first 50G PON trial on a live network4.8.2026 09:00:00 CEST | Press release
News summary: TOHKnet is exploring next-generation PON to meet enterprise demand while maintaining continuity across its regional fiber network Using Adtran technology, the trial validated 50G PON, XGS-PON and EPON operating together on a single fiber network Results show a practical path to evolve networks, enabling phased upgrades while maximizing fiber assets and avoiding service disruption Adtran today announced that TOHKnet has completed Japan’s first live network trial demonstrating the coexistence of 50G PON, XGS-PON and EPON on a single fiber. Conducted in Sendai using Adtran’s SDX 6400 Series OLT, the demo showed how the platform enables three generations of PON technology to operate together in a live service environment. The results highlight a realistic path for operators to introduce 50G PON capacity while maintaining continuity for existing services, maximizing the value of deployed fiber assets and reducing the complexity and disruption typically associated with network
Evexta Bio Announces Clinical Trial Collaboration and Supply Agreement with Roche to Evaluate Rupitasertib in Combination with a Selective Estrogen Receptor Degrader in Advanced / Metastatic Breast Cancer4.8.2026 09:00:00 CEST | Press release
Study to evaluate rupitasertib, Evexta Bio’s first-in-class oral dual-node, S6K and AKT1/3 inhibitor in combination with giredestrant in second-line ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer; expected to initiate in Q4 2026First clinical collaboration and supply agreement for Evexta Bio with rupitasertib and for Roche with giredestrant; results to inform future strategy for rupitasertib combination in ER+ HER2- advanced /metastatic breast cancer Evexta Bio S.A., a precision oncology company, founded by Truffle Capital (founder of Abivax and Carvolix), and focused on the discovery and development of targeted therapies, today announced a clinical collaboration and supply agreement with plans to initiate a Phase 1b study combining its lead investigational compound, rupitasertib, with Roche’s investigational compound giredestrant, a selective estrogen receptor degrader (SERD), for the treatment of ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer. Rupitasertib
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