Spherix Global Insights

UCB Receives FDA Approval for BIMZELX? (bimekizumab-bkzx) HCP? as the first and only treatment targeting both IL-17A and IL-17F for adults with moderate to severe hidradenitis suppurativa (HS). This approval is supported by positive Phase 3 trial results showing significant and sustained improvements in disease signs and symptoms. Hidradenitis suppurativa is a chronic and debilitating condition with limited treatment options, and this approval marks a major step forward for patients.? ? BIMZELX is now the fifth FDA-approved indication for bimekizumab-bkzx in the U.S., further solidifying UCB's commitment to advancing care in IL-17 mediated diseases. ? Read more: https://lnkd.in/eBmr4P7X ? #Dermatology #hidradenitissuppurativa #HS #FDAapproval

We’re excited to announce that Spherix Global Insights CEO, Dan Barton, along with Bob Shewbrooks, Franchise Head of Ophthalmology, and Jake Pirri, Financial Services, will be attending the OIS XIV Innovation Summit in San Diego, CA, this weekend, November 22-23. Our team is eager to engage in dynamic discussions and share valuable insights in the ever-evolving field of ophthalmology. We look forward to connecting with you at the event! Reach out to Bob Shewbrooks or Jake Pirri to schedule a time to meet onsite and learn more about how Spherix can support your needs with our latest research! #Ophthalmology #OIS

Astellas Pharma has received a Complete Response Letter (CRL) from the FDA regarding its supplemental new drug application (sNDA) for Izervay in geographic atrophy (GA), which sought to expand its label to include dosing every-other-month and remove the current 12-month usage restriction. The CRL was not related to safety or benefit/risk concerns but stemmed from a statistical issue regarding labeling language. Astellas has three potential pathways to address this issue: revising analyses per FDA requirements, conducting an additional study to support the proposed language, or providing supplementary data from existing studies. A resolution is anticipated within 3-4 months. In the interim, Astellas may enhance sampling strategies to sustain market share as patients approach the 12-month treatment threshold. Read more: https://lnkd.in/d5TMPXNG #Ophthalmology #geographicatrophy #GA

Adverum Biotechnologies has shared exciting new data from its LUNA Phase 2 trial, 4-year OPTIC long-term study, and pivotal phase 3 (ARTEMIS) program plans for Ixo-vec, a one-time intravitreal injection designed to transform treatment for wet age-related macular degeneration (wet AMD). The latest results highlight Ixo-vec's potential to significantly reduce the need for frequent injections, offering over an 80% reduction in injection burden and achieving more than 50% injection-free rates. At the same time, patients maintained strong visual and anatomic outcomes. Impressively, 100% of patients in the OPTIC study and those in the LUNA trial who received steroid prophylaxis were inflammation-free at key milestones. These findings position Ixo-vec as a game-changer, potentially extending vision-preserving benefits for years with just a single treatment. In recognition of the need for new treatment options for wet AMD, the FDA granted Fast Track designation for Ixo-vec for the treatment of wet AMD. Ixo-vec has also received PRIME designation from the European Medicines Agency (EMA) and the Innovation Passport from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for the treatment of wet AMD. ARTEMIS remains on track and is expected to initiate in 1H 2025. Read more: https://lnkd.in/d7dp6Dcu #wetAMD #EMA #Ophthalmology

Fierce Pharma highlights Spherix's latest research on the competitive landscape of IL-23 inhibitors in the ulcerative colitis market. ? In polling 100+ gastroenterologists, Spherix found Tremfya has made a strong debut, with J&J’s IL-23 inhibitor projected to outpace Omvoh in the coming months, though Skyrizi remains the class leader. As the UC market continues to evolve, differentiation will be key to capturing market share among these therapies. ? To read the full analysis, check out the article here: https://lnkd.in/gvMAXRKh ? #IL23Inhibitors #UlcerativeColitis #Gastroenterology

Spherix's Rheumatology team will be attending the American College of Rheumatology (ACR) Convergence 2024 in Washington, DC, from November 14-19, 2024. ? Reach out to Lynn Price or Allie Hope to schedule a time to meet onsite and learn more about how Spherix can support your rheumatology needs with our latest insights and research! #rheumatology #ACR24

Fierce Pharma highlights Spherix's newest whitepaper regarding the importance of new biologic therapies in hidradenitis suppurativa (HS) and the need for continued innovation with the use of biologics increasing by 27% year over year. ? In addition to starting biologics in HS treatments earlier, innovation is needed as over 90% of physicians stated there is still an unmet need among severe HS cases with the most interest shown in therapies with long-term safety, sustained efficacy, and the ability to reduce specific symptoms.? ? Read more: https://lnkd.in/ep3pQrVG ? #HidradenitisSuppurativa #HS #Dermatology

?? Out Now ?? Spherix’s white paper, Earlier Diagnosis and Treatment: ?????????????? ?????????????????? ?????? ??????????????????: ?????? ?????? ???? ???????????? ???????????????? ???? ???????????????????????? ??????????????????????, authored by Dermatology Head Gianna Melendez, M.S., in collaboration with experts Joseph F. Merola, M.D. MMSc, and Alice Gottlieb, M.D., Ph.D., is now available. ? The paper highlights the urgent need for early intervention in hidradenitis suppurativa (HS), a chronic condition that significantly affects patient quality of life and increases healthcare costs. ? Access the publication now on the Spherix Global Insights website: https://lnkd.in/exUzAAk8 ? #Dermatology #HidradenitisSuppurativa #HS #WhitePaper

Fierce Pharma highlights insights from Spherix, noting that Madrigal Pharmaceuticals Rezdiffra is gaining traction, with over 60% of specialists already prescribing it for the treatment of Metabolic Associated Steatohepatitis (MASH). Despite being the only approved treatment, there’s a significant unmet need for new therapies.? ? Analysts predict a surge in options, including potential GLP-1 approvals like semaglutide and tirzepatide. With MASH prevalence expected to rise by 65% by 2030, the landscape is primed for growth! ? Read more here: https://lnkd.in/eEZqAhgE ? ?#MASH #Gastroenterology

?? Coming Soon ?? ? We’re excited to announce that Spherix’s Dermatology Head, Gianna Melendez, M.S., has joined forces with esteemed experts Joseph F. Merola, M.D. MMSc, and Alice Gottlieb, MD, PhD, to create a new white paper: ?????????????? ?????????????????? ?????? ??????????????????: ?????? ?????? ???? ???????????? ???????????????? ???? ???????????????????????? ??????????????????????. This pivotal work underscores the importance of timely diagnosis and early intervention for hidradenitis suppurativa (HS), a chronic, often misdiagnosed skin condition that significantly impacts patient well-being. The paper also reveals how diagnostic delays increase both physical and emotional burdens, along with rising healthcare costs. ? Don’t miss out—visit the press release section on the Spherix Global Insights website in the coming days to access the full publication! ? View our press releases here: https://lnkd.in/eX5rkx4R ? #Dermatology #HealthcareInnovation #HidradenitisSuppurativa #HS