MorphoSys
🇩🇪Germany
- Country
- 🇩🇪Germany
- Ownership
- Public, Subsidiary
- Established
- 1992-01-01
- Employees
- 524
- Market Cap
- $2.8B
- Website
- http://www.morphosys.de
- Introduction
MorphoSys AG is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapies for people living with cancer and autoimmune diseases. MorphoSys is advancing its own pipeline of new drug candidates and has created antibodies that are developed by partners in different areas of unmet medical need. Tremfya (guselkumab) - developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc. for the treatment of plaque psoriasis - became the first drug based on MorphoSys antibody technology to receive regulatory approval. The U.S. Food and Drug Administration granted accelerated approval of the company's proprietary product Monjuvi (tafasitamab-cxix) in combination with lenalidomide for patients with a certain type of lymphoma.
Pharma Leadership Shuffle: Key Executive Moves in Early 2025 Reshape Industry Landscape
• The pharmaceutical industry has experienced significant leadership changes in early 2025, with major transitions at companies including Pfizer, Boehringer Ingelheim, and Takeda.
• Former FDA CDER Director Patricia Cavazzoni's move to Pfizer as Chief Medical Officer has sparked "revolving door" criticisms, highlighting ongoing concerns about regulatory-industry transitions.
• Several biotechnology firms have strengthened their executive teams with specialized expertise in clinical development, particularly in areas like stroke treatment, antibody-drug conjugates, and neuropsychiatric therapies.
Lupus Nephritis Market Expected to Grow as Novel Therapies Enter Clinical Trials
• The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions.
• Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations.
• Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.
TREMFYA Becomes First IL-23 Inhibitor to Reduce Structural Damage in Psoriatic Arthritis
• Johnson & Johnson's TREMFYA (guselkumab) achieved both primary and secondary endpoints in Phase 3b APEX study, demonstrating significant reduction in symptoms and structural damage progression in active psoriatic arthritis at 24 weeks.
• As the first and only IL-23 inhibitor to show significant inhibition of structural damage, TREMFYA offers a crucial treatment option for patients at risk of irreversible joint damage who have not responded to standard therapies.
• The dual-acting monoclonal antibody, which blocks IL-23 while binding to CD64 receptor, maintained its established safety profile with no new safety signals identified during the trial.
Knight Therapeutics Launches Minjuvi for Relapsed/Refractory DLBCL in Mexico
• Knight Therapeutics has launched Minjuvi (tafasitamab) in Mexico for adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for autologous stem cell transplantation.
• The approval was based on the L-MIND Phase 2 trial, which demonstrated a 60% objective response rate and 43% complete response rate when Minjuvi was used in combination with lenalidomide.
• Minjuvi, a humanized Fc-modified CD19-targeting monoclonal antibody, is recognized in the 2025 NCCN Guidelines as a preferred second-line treatment option for transplant-ineligible DLBCL patients.
Biogen Initiates Phase 3 TRANSCEND Trial of Felzartamab for Late Antibody-Mediated Kidney Transplant Rejection
• Biogen has begun dosing in the Phase 3 TRANSCEND study evaluating felzartamab against placebo in approximately 120 adult kidney transplant recipients with late antibody-mediated rejection (AMR).
• The trial's primary endpoint is the percentage of participants achieving AMR resolution by biopsy at 6 months, with key secondary endpoints including changes in microvascular inflammation scores.
• Late AMR is a leading cause of kidney transplant failure with limited effective treatment options, affecting approximately 23,000 patients in the U.S. alone.
InnoCare's BCL2 Inhibitor ICP-248 Combination Therapy Advances to Phase III Trial for First-line CLL/SLL Treatment in China
• China's NMPA has approved InnoCare's registrational Phase III trial of BCL2 inhibitor ICP-248 (Mesutoclax) combined with orelabrutinib for first-line CLL/SLL treatment.
• The ICP-248 and orelabrutinib combination demonstrated promising efficacy and safety in Phase II trials, offering potential for deeper remission in treatment-naïve CLL/SLL patients.
• With global CLL incidence at 191,000 new cases annually and rising rates in China, this fixed-duration combination therapy represents a significant advancement in treatment options.
Incyte Reports Strong 2024 Growth with $4.2B Revenue, Outlines Ambitious 2025 Pipeline Milestones
• Incyte achieved total revenues of $4.2 billion in 2024, marking a 15% year-over-year growth, driven by strong performance of Jakafi ($2.8B) and Opzelura ($508M).
• The company anticipates four new product launches in 2025, including Niktimvo for chronic GVHD and expanded indications for existing therapies in atopic dermatitis and lymphoma.
• Incyte's R&D pipeline shows significant advancement with plans for four pivotal study readouts, three Phase 3 study initiations, and seven proof-of-concept study results expected in 2025.
Merck & Co. to Acquire WuXi Biologics' Vaccine Facility in Ireland for $500 Million
• Merck & Co. has announced the acquisition of WuXi Biologics' vaccine manufacturing facility in Ireland for $500 million, expanding its production capabilities.
• The acquisition will allow Merck to enhance its vaccine manufacturing capacity to meet growing global demand for critical vaccines.
• WuXi Biologics' sale of the Ireland facility aligns with its strategic focus on other areas of biopharmaceutical development and manufacturing.
• The deal is expected to close in the coming months, pending regulatory approvals and customary closing conditions.
Incyte and Indaptus Announce Key Milestones and Strategic Goals for 2025
• Incyte anticipates a transformational 2025 with multiple potential drug launches and pivotal trial readouts across its oncology and inflammation & autoimmunity portfolio.
• Indaptus Therapeutics plans to launch a combination cohort trial of Decoy20 with BeiGene's tislelizumab and expand clinical trial sites in the first half of 2025.
• Indaptus' Decoy20 demonstrated a broad immune response across multiple tumor types, showing potential as a monotherapy and in combination with checkpoint inhibitors.
PharmaEssentia's Besremi Shows Phase III Success for Essential Thrombocytopenia
• PharmaEssentia reports positive Phase III trial results for Besremi in treating essential thrombocytopenia, a platelet disorder.
• The company plans to seek label expansion for Besremi, which is already approved for polycythemia vera.
• This expansion could provide a new treatment option for patients with essential thrombocytopenia, addressing an unmet medical need.
Novartis to Close MorphoSys Sites, Cut 330 Jobs Amid Pelabresib Development Challenges
• Novartis announces closure of MorphoSys facilities in the US and Germany, affecting 330 jobs, following its $2.9 billion acquisition of the German biotech company.
• Development timeline for pelabresib, a potential myelofibrosis treatment, faces significant delays with regulatory submission pushed back to at least 2027 due to additional data requirements.
• Despite emerging safety concerns and mixed trial results for pelabresib, Novartis maintains commitment to the drug's development while restructuring operations.
Monjuvi Combination Shows Promise in Relapsed/Refractory Follicular Lymphoma
• The combination of Monjuvi, Revlimid, and Rituxan significantly reduces the risk of disease progression or death in relapsed/refractory follicular lymphoma patients.
• The inMIND phase 3 trial demonstrated a median progression-free survival of 22.4 months with the Monjuvi combination, compared to 13.9 months with Revlimid and Rituxan alone.
• The Monjuvi combination showed improved objective response rates and duration of response compared to the Revlimid and Rituxan doublet.
• Incyte plans to file for FDA approval of Monjuvi combination for relapsed/refractory follicular lymphoma based on the inMIND trial results.
Incyte Highlights New Tafasitamab Data in Follicular Lymphoma at ASH 2024
• Incyte will present new data from its oncology portfolio at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego.
• A late-breaking oral presentation will feature results from the Phase 3 inMIND study evaluating tafasitamab in relapsed or refractory follicular lymphoma (FL).
• Incyte will host a virtual analyst and investor event on December 12, 2024, to discuss key data presentations from ASH.
Tango Therapeutics' PRMT5 Inhibitor TNG462 Shows Promise in Early Trials, Combination Studies Planned
• Tango Therapeutics' TNG462 demonstrates clinical activity in NSCLC and pancreatic cancer, with a 43% ORR in cholangiocarcinoma, showcasing a favorable safety profile.
• Tango plans to initiate combination trials of TNG462 with RAS(ON) inhibitors from Revolution Medicines, osimertinib, and pembrolizumab in 1H 2025.
• TNG908 shows clinical activity in non-CNS cancers, particularly pancreatic cancer, but development is deprioritized in favor of TNG462 due to its superior profile.
• Tango's next-generation brain-penetrant PRMT5 inhibitor, TNG456, is set to begin phase 1/2 trials in 1H 2025, targeting glioblastoma and brain metastases.
Incyte Halts Urticaria Drug Trial After Toxicology Findings, Scraps Liver Disease Program
• Incyte paused enrollment for INCB000262, a drug being tested for chronic urticaria, due to concerning toxicology results from an animal study.
• The company discontinued development of INCB000547 after Phase 2 results showed it was ineffective for treating itching associated with liver disease.
• These setbacks impact Incyte's strategy to diversify beyond its top-selling drug, Jakafi, and could affect a potential $1.8 billion revenue opportunity.
• Despite these challenges, Incyte anticipates Phase 3 results for povorcitinib in hidradenitis suppurativa next year, which remains a key focus.
Novartis and Apellis Advance C3G Therapies Towards FDA Submission
• Novartis' Fabhalta (iptacopan) demonstrated significant proteinuria reduction in the Phase III APPEAR-C3G trial, meeting its primary endpoint and supporting regulatory submissions.
• Apellis' Empaveli (pegcetacoplan) showed a substantial reduction in proteinuria and C3c deposit clearance in the Phase III VALIANT trial, indicating early efficacy in C3G patients.
• Nephrologists express a strong interest in new C3G therapies that can slow eGFR decline and reduce proteinuria, addressing the urgent need for innovative treatments.
• Spherix data suggests treatment preferences may be influenced by administration route, with Fabhalta's oral administration potentially offering an advantage.
Caligan Partners Takes Stake in Verona Pharma, Citing Ohtuvayre's Potential
• Caligan Partners LP has acquired a stake in Verona Pharma, recognizing the potential value of its drug Ohtuvayre (ensifentrine) for COPD treatment.
• Ohtuvayre, a dual inhibitor of PDE3 and PDE4, has shown promising Phase III data with significant lung function improvement and reduced exacerbations.
• Caligan anticipates substantial revenue potential for Ohtuvayre, especially with possible expansion into non-cystic fibrosis bronchiectasis (NCFB) treatment.
• Caligan's investment is based on Verona's potential to capture a significant share of the COPD market and the possibility of a lucrative acquisition.
T-Cell Malignancy Pipeline Shows Promise with Novel Therapies and Approvals
• The T-cell malignancies market is experiencing growth driven by increased incidence, treatment advancements, and strategic biopharma partnerships.
• Several companies, including Corvus Pharmaceuticals and Kymera Therapeutics, are advancing novel therapies through clinical trials, targeting unmet needs in T-cell lymphomas.
• Regulatory milestones, such as FDA Fast Track Designation for soquelitinib and EMA Orphan Drug Designation for SLS009, are accelerating the development of new treatments.
• Research and development efforts, highlighted by presentations at major conferences like EHA, are yielding promising clinical data for drugs like KT-333.
Novartis Delays Submission of Myelofibrosis Drug Pelabresib Amid Data Concerns
• Novartis has increased its full-year operating profit growth forecast due to strong sales of key drugs.
• The submission of pelabresib, an experimental drug for myelofibrosis acquired from MorphoSys, will be delayed by a couple of years.
• Ongoing questions regarding the drug's data profile are the reason for the delay, pushing back the original plan for submission this year.
Roche Terminates Alzheimer's Partnership with UCB, Returns Rights to Bepranemab
• Roche has ended its collaboration with UCB, relinquishing rights to bepranemab, a Phase 2a Alzheimer's candidate, marking the second Alzheimer's partnership termination this year.
• The initial agreement in July 2020 involved a $120 million upfront payment and potential milestone payments up to $2 billion for bepranemab development.
• UCB will proceed with the Phase 2a trial of bepranemab, presenting the results at the Alzheimer's Clinical Trials Conference 2024 in Spain.
• Roche's exit follows the failure of gantenerumab in 2022, but the company continues to focus on early Alzheimer's diagnosis and other early-stage assets like trontinemab.
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