Core Viewpoint - DNO ASA, a Norwegian oil and gas operator, has engaged Arctic Securities AS, DNB Carnegie, and Pareto Securities AS as Joint Bookrunners to arrange fixed income investor meetings, potentially leading to a new subordinated hybrid bond issue depending on market conditions and acceptable terms [1]. Company Overview - DNO ASA is an oil and gas operator based in Norway, active in the Middle East, North Sea, and West Africa [1]. - The company was founded in 1971 and is listed on the Oslo Stock Exchange [1]. - DNO ASA holds stakes in various onshore and offshore licenses at different stages of exploration, development, and production in regions including the Kurdistan region of Iraq, Norway, the United Kingdom, Côte d'Ivoire, and Yemen [1].

Core Viewpoint - Sandoz has launched WYOST® and Jubbonti®, the first and only interchangeable FDA-approved denosumab biosimilars in the US, aimed at improving access to treatment for osteoporosis and cancer-related skeletal events [2][7]. Company Overview - Sandoz is a global leader in generic and biosimilar medicines, with a growth strategy focused on pioneering access for patients. The company recorded net sales of USD 10.4 billion in 2024 and has a portfolio of approximately 1,300 products [21]. Product Launch Details - WYOST® and Jubbonti® are approved for all indications of the reference medicines XGEVA® and Prolia®, respectively, and are integral to Sandoz's growth strategy in the biosimilar market [2][3]. - The products are designed to provide high-quality, cost-effective treatment options, enhancing patient access and affordability in the US [3][5]. Patient Impact - The introduction of these biosimilars is expected to significantly improve treatment access for over 10 million US adults aged 50 and older living with osteoporosis, as well as for approximately 330,000 individuals with bone metastases [5][6]. - Sandoz is providing comprehensive support resources for patients prescribed these medications, including reimbursement and financial assistance [4]. Regulatory Approval - Both WYOST® and Jubbonti® have been approved as interchangeable with their reference medicines, ensuring they have the same dosage form, route of administration, and dosing regimen [3][6].

Core Viewpoint - Zealand Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog aimed at treating short bowel syndrome (SBS) in adults [1][2]. Company Overview - Zealand Pharma A/S is a biotechnology company focused on developing innovative peptide-based medicines, with more than 10 drug candidates in clinical development, including two that have reached the market [12][13]. Product Development - Glepaglutide is designed as a liquid product for subcutaneous administration, intended to reduce or eliminate the need for parenteral support in SBS patients [4]. - The MAA submission is based on results from the pivotal Phase 3 trial (EASE-1) and interim results from ongoing long-term extension trials (EASE-2 and EASE-3) [2][3]. Clinical Trial Results - EASE-1 trial involved 106 SBS patients, showing that glepaglutide administered twice weekly significantly reduced weekly parenteral support volume by 5.13 liters compared to 2.85 liters in the placebo group [6]. - In EASE-1, 9 patients treated with glepaglutide achieved enteral autonomy, while no patients in the placebo group were able to discontinue parenteral support [6]. - EASE-2 continues to evaluate the efficacy of glepaglutide, with interim analyses indicating maintained or improved clinical responses [8]. Future Plans - Zealand Pharma plans to initiate the EASE-5 Phase 3 trial in the second half of 2025 to gather further confirmatory safety and efficacy data for regulatory submission in the U.S. [3][11].

Regulated information Ipsen initiates a share buy-back program to cover its free employee share-allocation plan PARIS, FRANCE, 2 June 2025 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that it has appointed an investment-services provider to purchase an aggregate number of Ipsen S.A. shares up to 600,000, or about 0.72% of the share capital, over a maximum period of six months. The shares purchased under this agreement will be allocated mainly to cover Ipsen’s free employee share-allocation plan. T ...

Core Insights - The SACHI Phase III study demonstrated that the combination of savolitinib and osimertinib significantly improves progression-free survival (PFS) in patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) with MET amplification compared to chemotherapy [1][4][9] Study Overview - SACHI is a Phase III clinical trial focusing on the combination of savolitinib and osimertinib for treating patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after progression on first-line EGFR inhibitor therapy [2] Efficacy Results - In the intention-to-treat population, the median PFS was 8.2 months for the savolitinib plus osimertinib group versus 4.5 months for the chemotherapy group, with a hazard ratio (HR) of 0.34 [4] - The independent review committee assessed median PFS at 7.2 months for the combination therapy compared to 4.2 months for chemotherapy, with an HR of 0.40 [4] - The objective response rate (ORR) was 58% for the combination group compared to 34% for chemotherapy, and the disease control rate (DCR) was 89% versus 67% [5] Safety Profile - The combination therapy exhibited a tolerable safety profile, with treatment-emergent adverse events of Grade 3 or above occurring in 57% of patients in both the savolitinib plus osimertinib and chemotherapy groups [7][8] Regulatory Status - The Independent Data Monitoring Committee concluded that the study met its primary endpoint of PFS, leading to the conclusion of patient enrollment [9] - A New Drug Application (NDA) for the combination therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA) [9] Company Background - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [13]

Core Insights - Nxera Pharma has achieved a significant development milestone in its collaboration with Eli Lilly, which is expected to result in a milestone payment in Q3 of the fiscal year ending December 2025 [1][2] - The collaboration, initiated in 2022, leverages Nxera's GPCR-focused drug design capabilities alongside Lilly's expertise in development and commercialization [2] - Nxera is eligible for up to US$694 million in development and commercial milestones, in addition to tiered royalties on global sales [3] Company Overview - Nxera Pharma is a biopharma company focused on developing specialty medicines for unmet medical needs, particularly in Japan and the broader APAC region [5] - The company has an extensive pipeline of over 30 active programs targeting areas such as neurology, metabolic diseases, and immunology, utilizing its proprietary NxWave™ discovery platform [6] - Nxera employs approximately 400 people across key locations including Tokyo, Osaka, London, Cambridge, Basel, and Seoul [7]

Core Viewpoint - Kura Oncology and Kyowa Kirin have announced the acceptance of a New Drug Application (NDA) for ziftomenib by the FDA, targeting adult patients with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, with a PDUFA target action date set for November 30, 2025 [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline of small molecule drug candidates [7] - Kyowa Kirin is a Japan-based global specialty pharmaceutical company with over 70 years of experience in drug discovery and biotechnology innovation [8] Drug Development - Ziftomenib is an investigational menin inhibitor that has received Breakthrough Therapy Designation (BTD), Fast Track, and Orphan Drug Designations from the FDA for the treatment of adult patients with R/R AML with an NPM1 mutation [3][6] - The NDA is based on positive results from the Phase 2 KOMET-001 trial, which achieved its primary endpoint of complete remission and demonstrated a favorable safety profile with limited myelosuppression [2][3] Clinical Trial Insights - The KOMET-001 trial is designed to assess the clinical activity, safety, and tolerability of ziftomenib, and full data analyses will be presented at the 2025 ASCO Annual Meeting and the 2025 EHA Congress [3][4] - Adult patients with R/R NPM1-m AML have a poor prognosis, with only 30% overall survival at 12 months in the relapsed setting, highlighting the urgent need for innovative treatment options [4][5] Market Potential - There are currently no FDA-approved therapies specifically targeting NPM1-m AML, indicating a significant market opportunity for ziftomenib if approved [5][6]

Core Viewpoint - Cenovus Energy Inc. is updating its Oil Sands operations in response to ongoing wildfires in northern Alberta, emphasizing the safety of its personnel and the integrity of its assets, with no reported damage to infrastructure and an anticipated full restart of operations at Christina Lake in the near term [1][2]. Group 1: Operational Impact - The company has shut in production at the Christina Lake oil sands asset as of May 29, with only essential personnel remaining on site, impacting approximately 238,000 barrels per day of production [2]. - Operations will resume when it is deemed safe, and the company will provide updates regarding the restart [2]. Group 2: Safety and Monitoring - Cenovus is actively monitoring the wildfire situation in Alberta and appreciates the efforts of its teams and provincial emergency management teams in ensuring safety [3]. Group 3: Company Overview - Cenovus Energy Inc. is an integrated energy company involved in oil and natural gas production in Canada and the Asia Pacific, as well as upgrading, refining, and marketing operations in Canada and the U.S., committed to safe and responsible asset development [7].

Core Insights - Transgene and NEC Corporation presented positive data on TG4050, an individualized neoantigen therapeutic vaccine, at ASCO 2025, demonstrating 100% disease-free survival after a minimum of 2-year follow-up in patients with HPV-negative locally advanced head and neck cancer [1][6][2] - The Phase I trial met all endpoints, including safety, feasibility, immune activation, and disease-free survival, confirming the clinical proof of principle for TG4050 [2][3] - TG4050 is based on Transgene's myvac® platform and utilizes NEC's AI capabilities for optimizing antigen selection, showcasing the potential of individualized cancer vaccine programs [3][9] Company Overview - Transgene is a biotechnology company focused on developing virus-based immunotherapies for cancer treatment, with TG4050 as its lead asset [8][11] - The company is advancing its myvac® platform, which allows for the creation of personalized immunotherapies tailored to individual patients [9][10] - NEC Corporation contributes its AI expertise to enhance the neoantigen prediction system, which is crucial for the development of TG4050 [15][16] Clinical Development - The ongoing Phase I/II clinical trial of TG4050 aims to confirm the encouraging results in a larger patient population, with approximately 80 patients expected to be enrolled [4][5] - The Phase II part of the trial is currently underway, focusing on both immunological and clinical outcomes [5][4] - The trial is designed to evaluate the treatment benefits of TG4050 in patients at risk of relapse after surgery and adjuvant therapy [14][13]

Core Insights - Bicara Therapeutics presented updated data from its Phase 1/1b clinical trial of ficerafusp alfa combined with pembrolizumab for treating first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), showing promising efficacy and overall survival rates [1][2][4] Efficacy Data - The median duration of response (DOR) was reported at 21.7 months, with 80% of responders achieving a deep response defined as ≥80% tumor shrinkage [1][4] - The median overall survival (OS) was 21.3 months, with a 2-year OS rate of 46% in HPV-negative patients [2][4] - The objective response rate (ORR) was 54% (15 out of 28 patients), with a complete response rate of 21% (6 out of 28 patients) [4] Clinical Significance - The results indicate a significant improvement over historical controls for HPV-negative recurrent/metastatic HNSCC, addressing a critical unmet need in this patient population [3][4] - The combination therapy demonstrated a median progression-free survival of 9.9 months and a disease control rate of 89% [4] Mechanism of Action - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both the epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β), which helps remodel the tumor microenvironment [8][10] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing transformative bifunctional therapies for solid tumors, with ficerafusp alfa being its lead program [10]