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MorphoSys AG (NASDAQ: MOR) is a premier biopharmaceutical company headquartered in Planegg, Germany, with a significant presence in Boston, Massachusetts through its subsidiary MorphoSys US Inc. Established in 1992, the company focuses on the discovery, development, and commercialization of innovative therapies for cancer and autoimmune diseases. MorphoSys has made substantial strides in biopharmaceutical research and development, positioning itself as a leader in the industry.
One of MorphoSys' key achievements is the development of Tremfya (guselkumab), which is marketed by Janssen Biotech for the treatment of plaque psoriasis. It became the first drug based on MorphoSys' antibody technology to receive regulatory approval. Another significant product is Monjuvi (tafasitamab-cxix), which received accelerated approval from the U.S. Food and Drug Administration for the treatment of a certain type of lymphoma in combination with lenalidomide.
The company's latest financial update highlights preliminary Monjuvi U.S. net product sales of $92 million for 2023, with a gross margin of 69%. MorphoSys projects 2024 Monjuvi U.S. net product sales to be between $80 and $95 million. New indications for Monjuvi are currently being explored through Phase 3 trials.
MorphoSys continues to innovate with its clinical programs, such as pelabresib (CPI-0610), an investigational treatment for myelofibrosis. Following successful Phase 3 MANIFEST-2 trial results, MorphoSys is preparing regulatory filings for 2024.
In February 2024, MorphoSys announced a Business Combination Agreement with Novartis, which includes plans for Novartis to acquire MorphoSys and obtain exclusive rights to pelabresib and tulmimetostat. Concurrently, MorphoSys will transfer all rights related to tafasitamab to Incyte Corporation.
As MorphoSys continues to advance its pipeline and optimize operations, the company remains committed to bringing more life to people living with cancer. For further information, visit MorphoSys' website and follow them on Twitter and LinkedIn.
MorphoSys and Incyte presented final five-year follow-up data from the Phase 2 L-MIND study at the American Association for Cancer Research Annual Meeting 2023. The study focused on the effectiveness of Monjuvi, an immunotherapy, combined with lenalidomide, in treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Key findings included an overall response rate of 57.5%, with a complete response in 41.2% of patients. Importantly, the median overall survival was reported at 33.5 months. No new safety concerns arose, with most adverse events being grade 1 or 2. This data reinforces Monjuvi's potential as a viable treatment option for patients who are not candidates for autologous stem cell transplants.
MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported significant financial results for Q4 and the full year 2022. U.S. net product sales of Monjuvi reached $25.3 million in Q4 and $89.4 million for the full year, with total revenues of €81.6 million in Q4 and €278.3 million for 2022, up 54% year-over-year. Despite a consolidated net profit of €329.4 million in Q4, driven by recognized finance income, the company announced an operating loss of €68.4 million. For 2023, MorphoSys projects Monjuvi sales between $80 million and $95 million and R&D expenses between €290 million and €315 million, prioritizing clinical trials in its oncology pipeline.
MorphoSys AG will release its 2022 financial results on March 15, 2023, at 09:00 pm CET. Following this, a conference call is scheduled for March 16, 2023, at 01:00 pm CET, where the management team will discuss the results and provide a 2023 outlook. The session will include a presentation and a Q&A segment. The event will be accessible via a live webcast on the Investors section of MorphoSys' website. Participants can register for phone access in advance. A replay will be available post-event. MorphoSys aims to transform cancer treatment through innovative therapies.
MorphoSys AG has announced the cessation of its pre-clinical research programs to optimize costs, resulting in a 17% workforce reduction at its headquarters in Planegg, Germany. Despite promising data from these programs, the company needs significant investment to move them forward. MorphoSys aims to concentrate its resources on its mid- to late-stage oncology pipeline while exploring alternative options for the halted research. This strategic shift is part of ongoing efforts to enhance efficiency and focus on key clinical developments.
MorphoSys AG has announced the cessation of its pre-clinical research programs to streamline its cost structure. Although the existing data from these programs show promise, significant investments would be required to advance them to clinical trials. This decision will lead to a reduction of approximately 17% of the workforce at its headquarters in Germany. The company's focus will now shift to its mid- to late-stage oncology pipeline, including three Phase 3 trials. The most notable is the MANIFEST-2 study of pelabresib, with topline data expected in early 2024. MorphoSys aims to direct resources toward enhancing patient care in oncology.
MorphoSys AG announced that topline data from the Phase 3 MANIFEST-2 study, investigating pelabresib in combination with ruxolitinib for myelofibrosis, is now expected in early 2024. This is a slight delay from previous estimates of the first half of 2024. CEO Jean-Paul Kress expressed optimism based on Phase 2 results indicating pelabresib's potential to improve treatment outcomes. Further details will be shared at the upcoming J.P. Morgan Healthcare Conference on January 11, 2023, highlighting the company’s ongoing commitment to oncology innovation.
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