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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 AG (FSE:MOR; NASDAQ:MOR) will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 5:15 p.m. EST. The presentation will be available via live audio on their website, and a replay will be accessible afterward. MorphoSys, headquartered in Planegg, Germany, focuses on innovative cancer treatments using advanced science and technologies. The company aims to improve the lives of cancer patients globally.
MorphoSys presented promising data from the Phase 2 MANIFEST study of pelabresib, a potential treatment for myelofibrosis, at the 63rd American Society of Hematology Annual Meeting. The study showed that 68% of treatment-naïve patients receiving pelabresib combined with ruxolitinib achieved a ≥35% spleen volume reduction at week 24. Additionally, 56% demonstrated a significant reduction in symptoms. Safety analysis showed no new adverse events, with thrombocytopenia and anemia being the most common. MorphoSys is advancing pelabresib into the Phase 3 MANIFEST-2 trial, reinforcing its potential as a first-line treatment.
MorphoSys US and Incyte announced findings from the RE-MIND2 study, showing that the combination of tafasitamab (Monjuvi) and lenalidomide significantly improves overall survival (OS) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The OS for tafasitamab plus lenalidomide was 20.1 months versus 7.2 months for Pola-BR (p=0.038) and 24.6 months versus 7.4 months for R2 (p=0.014). Results suggest tafasitamab plus lenalidomide could be a future backbone therapy for DLBCL, with oral presentations planned at the ASH 2021 meeting.
MorphoSys and Incyte announced significant findings from the RE-MIND2 study on tafasitamab (Monjuvi) combined with lenalidomide for treating relapsed or refractory DLBCL. Results showed an overall survival (OS) of 20.1 months versus 7.2 months for Pola-BR (p=0.038) and 24.6 months versus 7.4 months for R2 (p=0.014). The objective response rate (ORR) was 63.6% compared to 30.3% for R2 (p=0.013). These findings suggest tafasitamab plus lenalidomide could become a backbone therapy for DLBCL, especially for patients not eligible for transplant.
MorphoSys has announced its financial reporting dates for 2022. Key dates include:
- Year-End Results 2021: March 16, 2022 (10 PM CET), Conference Call on March 17, 2022 (2 PM CET)
- First Quarter Interim Statement: May 4, 2022 (10 PM CEST), Conference Call on May 5, 2022 (2 PM CEST)
- Half-Year Report: August 3, 2022 (10 PM CEST), Conference Call on August 4, 2022 (2 PM CEST)
- Third Quarter Interim Statement: November 16, 2022 (10 PM CET), Conference Call on November 17, 2022 (2 PM CET)
Annual General Meeting is scheduled for May 18, 2022.
MorphoSys AG (NASDAQ: MOR) announced its third-quarter financial results for 2021, reporting net product sales of Monjuvi at €18.6 million ($22 million), marking a 22% quarter-over-quarter growth. Total revenues reached €41.2 million, an 87% increase year-over-year, albeit a 57% drop for the first nine months to €126.7 million due to a previous collaboration payment. R&D expenses surged to €64.4 million, contributing to a consolidated net loss of €112.8 million. MorphoSys plans to present data at the ASH conference, showcasing progress in its clinical trials.
MorphoSys AG (FSE:MOR)(NASDAQ:MOR) announces the resignation of Roland Wandeler, COO, effective December 31, 2021. Dr. Wandeler joined the company in May 2020 and played a significant role in the launch of Monjuvi (tafasitamab-cxix), an FDA-approved therapy for lymphoma. Following his departure, U.S. commercial operations will report directly to CEO Jean-Paul Kress. The company acknowledges Dr. Wandeler's contributions while emphasizing its readiness for future growth in the biopharmaceutical sector.
MorphoSys AG presented interim results from the M-PLACE study of felzartamab at the 2021 Annual Meeting of the American Society of Nephrology. This Phase 1b/2a study focuses on treating patients with anti-PLA2R positive membranous nephropathy, an autoimmune kidney disease. Of the 27 evaluable patients, 24 experienced rapid antibody titer reduction within a week, with some achieving substantial decreases after 12 weeks. Early signs of kidney function improvement were noted. The safety profile was consistent with expectations, indicating promising potential for felzartamab in this challenging patient population.
MorphoSys announced updates on its clinical research at the 2021 ASH Annual Meeting from December 11-14. Key data from the MANIFEST phase 2 trial includes findings on JAK naïve patients treated with pelabresib and ruxolitinib, as well as pelabresib monotherapy results for myelofibrosis. Additionally, the RE-MIND2 study expanded its dataset comparing tafasitamab plus lenalidomide against other treatments for diffuse large B-cell lymphoma. MorphoSys continues to enhance its hematology-oncology portfolio, showcasing its commitment to developing innovative cancer therapies.
MorphoSys AG (FSE:MOR; NASDAQ:MOR) reported Q3 2021 revenues from product sales of Monjuvi(R) (tafasitamab-cxix) of €18.6 million (US$ 22 million) and €46.4 million (US$ 55.5 million) for the first nine months. The drug is co-commercialized with Incyte. MorphoSys will release its complete financial results on November 10, 2021, followed by a conference call on November 11, 2021, at 2:00pm CET (8:00am EST) to discuss these results and future outlook.
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