Associated tags: Cancer, BET, Ruxolitinib, Gene, Patient, MorphoSys, Pharmaceutical industry, FSE, JAK, Tafasitamab, ASH, Society, Food
Bone marrow,
BET,
Congress,
Safety,
JAK,
MorphoSys,
EZH1,
EZH2,
ASCO,
Ruxolitinib,
Patient,
Society,
Annual general meeting,
Pharmaceutical industry The issuer is solely responsible for the content of this announcement.
Key Points:
- The issuer is solely responsible for the content of this announcement.
- MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced that new efficacy and safety data from the Phase 3 MANIFEST-2 trial of pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis will be highlighted during an oral presentation on Friday, May 31, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
- The congress is being held in Chicago, Illinois, from May 31 to June 4, 2024.
- Additionally, new data from the Phase 2 study of tulmimetostat, an investigational next-generation dual inhibitor of EZH2 and EZH1, in patients with advanced solid tumors or hematologic malignancies will be showcased in a poster presentation at ASCO 2024.
Biotechnology,
Pharmaceutical,
Health,
Oncology,
Sale,
FDA,
Bone marrow,
BET,
Research and development,
EDT,
Investment,
Safety,
JAK,
Food,
EZH1,
Research,
Marketing,
EZH2,
Administration,
ASCO,
Novartis,
Ruxolitinib,
Patient,
Supervisory board,
Society,
Acquisition,
Operating cost,
Annual general meeting,
G&A,
European Medicines Agency MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the first quarter of 2024.
Key Points:
- MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the first quarter of 2024.
- The financial results presented for the first quarter of 2024 relate to continuing business operations of MorphoSys.
- Full Year 2024 Financial Guidance:
As a consequence of the sale and transfer of tafasitamab to Incyte on February 5, 2024, MorphoSys' 2024 financial guidance published on January 30, 2024, cannot be maintained and therefore was revoked.
- MorphoSys Group Key Figures (IFRS, end of the first quarter: March 31, 2024)
Retrieved on:
Wednesday, April 10, 2024
Novartis,
ASH,
Tafasitamab,
Webcast,
Purchasing,
EZH1,
EDT,
Acquisition,
Standard of care,
BET,
Business analyst,
EZH2,
Ruxolitinib,
Exposition,
Society,
Safety,
Anemia,
GMT,
MorphoSys,
JAK,
Annual general meeting,
Pharmaceutical industry “Now, in 2024, we are pleased that Novartis is committing to the future of our promising pipeline.
Key Points:
- “Now, in 2024, we are pleased that Novartis is committing to the future of our promising pipeline.
- With its ample resources, additional scientific expertise and global footprint, Novartis can help accelerate pelabresib's potential worldwide.
- Total revenues for the fourth quarter 2023 were € 59.0 million compared to € 81.6 million for the same period in 2022.
- The decrease resulted first and foremost from prior year revenues stemming from the execution of an out-licensing agreement with Novartis.
Retrieved on:
Wednesday, March 13, 2024
Oncology,
Health,
Clinical Trials,
Research,
Science,
Pharmaceutical,
Biotechnology,
Tafasitamab,
Novartis,
Operating cost,
Sale,
G&A,
Asset,
Trial of the century,
Marketing,
European Medicines Agency,
Ruxolitinib,
Investment,
FDA,
Food,
Cryptocurrency Cost of Sales: For the full year 2023, cost of sales were € 58.4 million compared to € 48.6 million in 2022.
Key Points:
- Cost of Sales: For the full year 2023, cost of sales were € 58.4 million compared to € 48.6 million in 2022.
- R&D Expenses: For the full year 2023, R&D expenses were € 283.6 million compared to € 297.8 million in 2022.
- SG&A Expenses: Selling expenses for the full year 2023 were € 81.4 million compared to € 92.4 million in 2022.
- MorphoSys Group Key Figures (IFRS, end of financial year: December 31, 2023)
Retrieved on:
Tuesday, February 6, 2024
Slate,
Partnership,
Supervisory board,
Centerview Partners,
Immediate,
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Tafasitamab,
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EZH2,
Ruxolitinib,
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BET,
Workforce,
GMT,
EZH1,
Federal Financial Supervisory Authority,
Disease,
Acquisition,
AG,
EST,
Business analyst,
Webcast,
Cancer,
Schedule,
Pharmaceutical industry Separately, MorphoSys entered into a Purchase Agreement to sell and transfer all rights worldwide related to tafasitamab to Incyte Corporation (“Incyte”).
Key Points:
- Separately, MorphoSys entered into a Purchase Agreement to sell and transfer all rights worldwide related to tafasitamab to Incyte Corporation (“Incyte”).
- “Novartis shares our steadfast commitment to develop and deliver transformative medicines that address the dire needs of cancer patients.
- Novartis intends to offer MorphoSys’ shareholders € 68.00 per share in cash, for a total equity value of € 2.7 billion.
- Creates New Opportunities for MorphoSys’ Colleagues: The agreement between Novartis and MorphoSys includes employee commitments.
Retrieved on:
Tuesday, January 30, 2024
MorphoSys Reports Preliminary 2023 Monjuvi U.S. Net Product Sales and Gross Margin, Provides 2024 Financial Guidance and Reduces Financial Liability
Key Points:
- MorphoSys Reports Preliminary 2023 Monjuvi U.S. Net Product Sales and Gross Margin, Provides 2024 Financial Guidance and Reduces Financial Liability
The issuer is solely responsible for the content of this announcement.
- MorphoSys Reports Preliminary 2023 Monjuvi U.S. Net Product Sales and Gross Margin, Provides 2024 Financial Guidance and Reduces Financial Liability
Preliminary 2023 Monjuvi U.S. net product sales of US$ 92.0 million (€ 85.0 million) and preliminary gross margin for Monjuvi U.S. net product sales of 69%
Preliminary unaudited financial liability from the collaboration with Incyte of approximately € 114 million, representing a reduction of € 112 million
MorphoSys AG (FSE: MOR; NASDAQ: MOR) today reported preliminary Monjuvi® (tafasitamab-cxix) U.S. net product sales and gross margin for Monjuvi U.S. net product sales for the full year of 2023 and provides its 2024 financial guidance.
- For the full year of 2024, MorphoSys expects Monjuvi U.S. net product sales in the range of US$ 80 to 95 million, aligned with the company’s original 2023 guidance.
- Further, preliminary 2023 gross margin for Monjuvi U.S. net product sales is 69%, which is impacted by the recognition of one-time write-offs for inventory.
Retrieved on:
Saturday, December 30, 2023
Spleen,
Patient,
EST,
Food,
TNF,
Survival,
Constipation,
Bone marrow,
BET,
Prognosis,
Diarrhea,
Plasma,
Anemia,
Fatigue,
Headache,
Disease,
Nausea,
GMT,
Ruxolitinib,
Thrombocytopenia,
Weakness,
Dizziness,
ASH,
JAK,
MorphoSys,
COVID-19,
Periodic breathing,
European Medicines Agency,
IL-6,
PST,
Development,
Fibrosis,
Cough,
Dysgeusia,
FACP Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.
Key Points:
- Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.
- Increased cytokine levels are associated with all four disease hallmarks; increased IL-8 levels are also associated with worse survival outcomes.
- Discontinuation rates due to adverse events were 10.7% with pelabresib and ruxolitinib and 6.5% with placebo plus ruxolitinib.
- “The four hallmarks of myelofibrosis – enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms – have a strong impact on a patient’s life.
Retrieved on:
Thursday, December 28, 2023
MANIFEST-2 met its primary endpoint, as the combination therapy demonstrated a statistically significant and clinically meaningful improvement in the proportion of patients achieving at least a 35% reduction in spleen volume (SVR35) at week 24.
Key Points:
- MANIFEST-2 met its primary endpoint, as the combination therapy demonstrated a statistically significant and clinically meaningful improvement in the proportion of patients achieving at least a 35% reduction in spleen volume (SVR35) at week 24.
- The key secondary endpoints assessing symptom improvement – proportion of patients achieving at least a 50% reduction in total symptom score (TSS50) and absolute change in total symptom score (TSS) from baseline at week 24 – showed a strong positive trend favoring the pelabresib and ruxolitinib combination.
- “Importantly, we saw significant symptom improvements for the vast majority of patients in the study.
- “The pelabresib and ruxolitinib combination therapy significantly reduced spleen volume – the best prognostic indicator we have at our disposal for long-term myelofibrosis patient outcomes.
Retrieved on:
Monday, December 11, 2023
Biotechnology,
Health,
Pharmaceutical,
Clinical Trials,
Oncology,
Cough,
FACP,
Spleen,
PST,
Food,
European Medicines Agency,
JAK,
GMT,
ASH,
Headache,
Plasma,
Disease,
Constipation,
IL-6,
Fatigue,
MorphoSys,
Patient,
Thrombocytopenia,
CET,
Periodic breathing,
Weakness,
COVID-19,
Prognosis,
Diarrhea,
Nausea,
Survival,
EST,
Dysgeusia,
TNF,
Anemia,
Fibrosis,
Ruxolitinib,
BET,
Bone marrow,
Dizziness,
Vaccine,
Dietary supplement,
Medical imaging Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.
Key Points:
- Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.
- Increased cytokine levels are associated with all four disease hallmarks; increased IL-8 levels are also associated with worse survival outcomes.
- Discontinuation rates due to adverse events were 10.7% with pelabresib and ruxolitinib and 6.5% with placebo plus ruxolitinib.
- “The four hallmarks of myelofibrosis – enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms – have a strong impact on a patient’s life.
Retrieved on:
Monday, November 20, 2023
Biotechnology,
Health,
Pharmaceutical,
Clinical Trials,
Oncology,
FSE,
Ruxolitinib,
MorphoSys,
Patient,
TSS,
BET,
JAK,
Pharmaceutical industry,
Medical imaging MANIFEST-2 met its primary endpoint, as the combination therapy demonstrated a statistically significant and clinically meaningful improvement in the proportion of patients achieving at least a 35% reduction in spleen volume (SVR35) at week 24.
Key Points:
- MANIFEST-2 met its primary endpoint, as the combination therapy demonstrated a statistically significant and clinically meaningful improvement in the proportion of patients achieving at least a 35% reduction in spleen volume (SVR35) at week 24.
- The key secondary endpoints assessing symptom improvement – proportion of patients achieving at least a 50% reduction in total symptom score (TSS50) and absolute change in total symptom score (TSS) from baseline at week 24 – showed a strong positive trend favoring the pelabresib and ruxolitinib combination.
- “Importantly, we saw significant symptom improvements for the vast majority of patients in the study.
- “The pelabresib and ruxolitinib combination therapy significantly reduced spleen volume – the best prognostic indicator we have at our disposal for long-term myelofibrosis patient outcomes.
