Latest news with #ILAP
Business Wire
14-05-2025
- Business
- Business Wire
Compass Pathways to Participate in 2025 RBC Capital Markets Global Healthcare Conference
LONDON & NEW YORK--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference at 10:30 am ET on May 20 th, 2025. A live audio webcast of the presentation will be accessible from the 'Events' page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.
Associated Press
11-03-2025
- Business
- Associated Press
Compass Pathways to Participate in Stifel Virtual CNS Forum
LONDON & NEW YORK--(BUSINESS WIRE)--Mar 11, 2025-- Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will present at the Stifel Virtual CNS Forum at 11:30 am ET on March 18 th, 2025. A live audio webcast of the presentation will be accessible from the 'Events' page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. SOURCE: Compass Pathways plc Copyright Business Wire 2025. PUB: 03/11/2025 06:30 AM/DISC: 03/11/2025 06:33 AM
Associated Press
30-01-2025
- Business
- Associated Press
Comanche Biopharma Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for CBP-4888, an Investigational siRNA Drug Candidate for the Treatment of sFlt1-mediated Preterm Preeclampsia
ILAP aims to accelerate time to market, facilitating faster patient access to clinically important and promising medicines being developed to address significant health needs Preeclampsia is a serious obstetric complication that threatens the life of both mother and baby, often resulting in preterm delivery Globally, preeclampsia is a leading cause of maternal and infant morbidity and mortality and can result in lifelong consequences A novel investigational drug candidate, CBP-4888 leverages the precise targeting ability of siRNAs to downregulate sFlt1 in the placenta, a key pathogenic mediator of preeclampsia CONCORD, Mass., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Comanche Biopharma Corp. today announced that the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group has awarded an Innovation Passport to CBP-4888, Comanche Biopharma's investigational drug candidate for the treatment of sFlt1-mediated preterm preeclampsia. ILAP comprises the Innovation Passport designation, a target development profile, and a toolkit to support the design, development and approvals process. The pathway also features enhanced input and interactions with the Medicines and Healthcare products Regulatory Agency (MHRA) and its partner agencies. 'We are grateful to the Innovative Licensing and Access Pathway (ILAP) Steering Committee for awarding the Innovation Passport designation to CBP-4888. We look forward to collaborating with U.K. regulators to help accelerate the development of this important therapeutic for pregnant patients,' said Allison August, M.D., Chief Medical Officer at Comanche Biopharma. 'For hundreds of years, the treatment of preeclampsia has remained unchanged. The awarding of this designation amplifies the significant unmet need that preeclampsia presents for pregnant women and their babies in the U.K. and globally and signals the innovation our siRNA therapeutic candidate could potentially deliver.' Preeclampsia is a serious obstetric complication that threatens the life of both mother and baby, often resulting in preterm delivery. Globally, preeclampsia is a leading cause of maternal and infant morbidity and mortality and can result in lifelong consequences. Overexpression of the protein sFlt1 is regarded as a key pathogenic mediator of preeclampsia. When produced in excess by the placenta, sFlt1 is toxic, severely damaging the mother's blood vessels and impairing the growth of new ones. This overproduction of sFlt1 and subsequent vascular damage result in the common maternal signs and symptoms of preeclampsia and in fetal growth restriction. CBP-4888 is designed to achieve sufficient uptake by the placenta to selectively downregulate the disease-causing overexpression of the sFlt-1 protein in patients with sFlt-1-mediated preterm preeclampsia. CBP-4888 is being investigated for the potential to ameliorate the acute, potentially life-threatening maternal symptoms of preterm preeclampsia. This, in turn, may enable the safe prolongation of pregnancy and continued fetal maturation, thereby minimizing the short- and long-term mortality and morbidity associated with prematurity. About ILAP The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) launched ILAP at the start of 2021 in order to accelerate the development and access to promising medicines in the early stages of development. The pathway features enhanced input and interactions with MHRA and its partner agencies, including the All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). Other benefits of ILAP include access to a range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and continuous benefit risk assessment. More information about ILAP can be found here. About Preeclampsia Preeclampsia is a prevalent and serious pregnancy complication that affects up to 8% of pregnancies worldwide. It can lead to a range of complications for both the mother and the baby, including multi-organ damage, seizures and premature birth. Globally, there are an estimated 76,000 maternal deaths and 500,000 fetal and newborn deaths annually due to this pregnancy complication. While preeclampsia can develop in any pregnancy, it disproportionately affects black individuals and those living in low resource settings. The signs and symptoms of preeclampsia can vary and include high blood pressure, acute kidney injury, swelling of the hands and face, severe headaches, vision changes and abdominal pain. Currently, premature delivery of the baby is the only available option for stopping the progression of preeclampsia. About Comanche Biopharma Corp. Comanche Biopharma is a clinical stage biopharmaceutical company working to make every pregnancy around the world safer through innovative and equitable solutions. We are currently developing CBP-4888, an innovative siRNA therapeutic candidate that, if approved, would be the world's first treatment for preeclampsia, an obstetric complication globally responsible for a significant burden of maternal and infant morbidity and mortality. At Comanche, we are committed to the ethical representation of people of all colors and economic status globally in our clinical development programs. We plan to prioritize ensuring access to our solutions for those who need them most. Visit us at Media Contact: Liz Melone
