4SC AG

Today, we received Orphan Drug Status for #resminostat (#Kinselby) in cutaneous T-cell lymphoma from Swissmedic in Switzerland. Resminostat has already received #OrphanDrugDesignation in Europe and the US from the #EMA and #FDA. The ODS provides benefits including fee reductions and a faster review process. You can read more using the link in the comments below. #OrphanDrugStatus #CTCL #RareDiseases

Check out our CEO Jason Loveridge as he speaks with Stephen Adams of Optimum Strategic Communications in the latest episode of #optimumtv 📺!   📢Listen in as Jason discusses how 4SC AG is creating a new treatment paradigm for #CutaneousTCellLymphoma (CTCL), a rare type of non-Hodgkin lymphoma that affects the skin.   👀 Watch the full episode below 👇 and follow #4SC on LinkedIn to learn more about our lead asset #resminostat (#Kinselbly) which is clinically proven to prevent relapse and postpone progression in patients with advanced #CTCL.   #RESMAINStudy #RareDiseases 

Today we held our Annual General Meeting reporting 4SC AG's positive progress over the past 18 months. It has been an incredibly busy and successful period for the Company, with key highlights including #resminostat's topline data from our pivotal #RESMAIN study which demonstrated a statistically significant improvement in progression free survival in #CTCL patients of 97.6%. Following this, we remain on track for our Marketing Authorisation Application (MAA) for resminostat and received initial feedback from the EMA last month. For the remainder of 2024, we will continue to have discussions with potential partners regarding the market entry of resminostat (#Kinselby) in the EU and longer-term commercialisation. #CutaneousTCellLymphoma #RESMAINstudy 

In case you missed it, here are the key takeaways from Professor Stadler Rudolf's presentation on the #RESMAIN study findings presented at the the 5th World Congress of Cutaneous Lymphomas (#WCCL) in California.   Resminostat (Kinselby) showed:   - Maintenance therapy is clinically proven to postpone disease progression in advanced Cutaneous T-Cell Lymphoma (CTCL) - Statistically significant improvement in progresion free survival of 97.6% compared to placebo - Median time to next treatment vs placebo showed a significant improvement, more than doubling (8.8 vs 4.2 months)   To learn more about #resminostat (#Kinselby), listen to Professor Julia Scarisbrick, Head of Cutaneous Lymphoma Service at University Hospitals Birmingham, or use the link in the first comment below.   #RESMAINstudy #RareDiseases #CutaneousTCellLymphoma #ISCL #EORTC

Today we published our Q1 report, a busy and productive period for 4SC AG.   Highlights include filing our Marketing Authorisation Application for #Kinselby (resminostat) with the European Medicines Agency and a pre-New Drug Application (NDA) meeting request with the US FDA.   We are actively exploring commercialisation options for resminostat in the EU and are working with our Japanese partner Yakult Honsha Co., Ltd. to support ongoing efforts. We expect Q2 2024 to be another busy quarter for 4SC AG.   #resminostat is an oral maintenance treatment which has been clinically proven to improve progression free survival in advanced-stage cutaneous T-cell lymphoma (#CTCL).   To read the full report, use the link in the first comment below.   #RESMAINstudy #RareDiseases #CutaneousTCellLymphoma 

We are excited to have been granted a Paediatric Investigation Plan (PIP) waiver from the UK Medicines and Healthcare products Regulatory Agency (#MHRA) for #resminostat (#Kinselby), 4SC AG’s maintenance treatment which has been clinically proven to improve progression free survival in advanced-stage cutaneous T-cell lymphoma (#CTCL).   This is a significant milestone for 4SC as the waiver removes the requirement to conduct paediatric clinical studies, enabling a quicker and more cost-effective pathway to advancing our Marketing Authorisation Application for resminostat in the UK.   Learn more about resminostat, 4SC’s revolutionary maintenance treatment for #CutaneousTCellLymphoma (#CTCL), using the link in the first comment below.

We are excited to have been granted a Paediatric Investigation Plan (PIP) waiver from the UK Medicines and Healthcare products Regulatory Agency (#MHRA) for #resminostat (#Kinselby), 4SC AG’s maintenance treatment which has been clinically proven to improve progression free survival in advanced-stage cutaneous T-cell lymphoma (#CTCL).   This is a significant milestone for 4SC as the waiver removes the requirement to conduct paediatric clinical studies, enabling a quicker and more cost-effective pathway to advancing our Marketing Authorisation Application for resminostat in the UK.   Learn more about resminostat, 4SC’s revolutionary maintenance treatment for #CutaneousTCellLymphoma (#CTCL), using the link in the first comment below.

Renowned dermato-oncology expert, Professor @Rudolf Stadler, will be presenting data from @4SC's pivotal #RESMAIN study at the 5th Annual World Congress of Cutaneous Lymphomas (#WCCL) at the City of Hope in California, USA, from April 11-13.   The study demonstrated that #resminostat (#Kinselby) is clinically proven to postpone disease progression in patients with cutaneous T-cell lymphoma (#CTCL) - a new treatment paradigm in CTCL.    The #WCCL is sponsored by @International Society for Cutaneous Lymphomas (ISCL) on behalf of the @UNITED STATES CUTANEOUS LYMPHOMA CONSORTIUM (#USCLC) and @EORTC - European Organisation for Research and Treatment of Cancer - Cutaneous Lymphoma Task Force (#CLTF), organized by the @City of Hope.   To learn more about the findings from the landmark RESMAIN study, use the link in the comments below.    #RareDiseases #CutaneousTCellLymphoma #ISCL #EORTC   Find out more by visiting our website: https://www.4sc.com/

Renowned dermato-oncology expert, Professor @Rudolf Stadler, will be presenting data from @4SC's pivotal #RESMAIN study at the 5th Annual World Congress of Cutaneous Lymphomas (#WCCL) at the City of Hope in California, USA, from April 11-13.   The study demonstrated that #resminostat (#Kinselby) is clinically proven to postpone disease progression in patients with cutaneous T-cell lymphoma (#CTCL) - a new treatment paradigm in CTCL.    The #WCCL is sponsored by @International Society for Cutaneous Lymphomas (ISCL) on behalf of the @UNITED STATES CUTANEOUS LYMPHOMA CONSORTIUM (#USCLC) and @EORTC - European Organisation for Research and Treatment of Cancer - Cutaneous Lymphoma Task Force (#CLTF), organized by the @City of Hope.   To learn more about the findings from the landmark RESMAIN study, use the link in the comments below.    #RareDiseases #CutaneousTCellLymphoma #ISCL #EORTC   Find out more by visiting our website: https://www.4sc.com/

Renowned dermato-oncology expert, Professor @Rudolf Stadler, will be presenting data from @4SC's pivotal #RESMAIN study at the 5th Annual World Congress of Cutaneous Lymphomas (#WCCL) at the City of Hope in California, USA, from April 11-13. The study demonstrated that #resminostat (#Kinselby) is clinically proven to postpone disease progression in patients with cutaneous T-cell lymphoma (#CTCL) - a new treatment paradigm in CTCL.  The #WCCL is sponsored by @International Society for Cutaneous Lymphomas (ISCL) on behalf of the @UNITED STATES CUTANEOUS LYMPHOMA CONSORTIUM (#USCLC) and @EORTC - European Organisation for Research and Treatment of Cancer - Cutaneous Lymphoma Task Force (#CLTF), organized by the @City of Hope. To learn more about the findings from the landmark RESMAIN study, use the link in the comments below.  #RareDiseases #CutaneousTCellLymphoma #ISCL #EORTC Find out more by visiting our website: https://www.4sc.com/