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The purpose of this study is to determine whether treatment with OP-1250 as a monotherapy will result in improvement of progression-free survival (PFS) and overall survival (OS) compared to SOC ET and assess the safety of treatment with OP-1250 in participants with ER+, HER2– advanced or MBC with and without estrogen receptor 1 gene (ESR1) activating mutation(-s) whose disease has relapsed or progressed on 1 or 2 prior lines of SOC ET, including a cyclin-dependent kinase (CDK) 4/6 inhibitor.

This is a non-randomized, open label, multi-site, single dose, Phase 3 study in approximately 35 adults and pediatric subjects > 2 and < 50 years of ages with SCD. The study will evaluate hematopoietic stem cell (HSC) transplantation (HSCT) using LentiGlobin BB305 Drug Product, an autologous CD34+ cell-enriched population that contains hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector (LVV) encoding beta A-T87Q-globin gene, suspended in cryopreservation solution in the final immediate container for the intended medical use.

The primary objective is to evaluate the efficacy of levosimendan TNX-103 compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance from Day 1 to Week 12. This is a multicenter, parallel, double-blind study in subjects with PH-HFpEF and will be screened for a 1:1 ratio to receive an oral dose of 2 mg/day levosimendan or placebo for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12.

RGN-259 eye drops compared to placebo eye drops 5 times per day in both eyes for the treatment of Neurotrophic Keratopathy. Percentage of subjects achieving complete healing (defined as 0 mm lesion size) of the Persistent Epithelial Defect (PED) at Visit 5 (Day 29) determined by corneal fluorescein staining captured by corneal photography and analyzed by a central reading center

This study aims to compare the effects of inhaled isoflurane sedation with the standard of care IV sedative propofol. Patients enrolled on this study will be on a ventilator (breathing machine) for more than 12 hours and require continuous sedation to keep the patient comfortable which can range from a state of drowsiness and relaxtion to a state of unconsciousness.

The purpose of the study is to assess the efficacy and safety of SAR442168 compared with teriflunomide (Aubagio) in participants with relapsing multiple sclerosis (RMS).

The experimental drug works in the blood and in the brain where it blocks a molecule called “Bruton's tyrosine kinase (BTK)”, which is present in some cells involved in multiple sclerosis (immune cells known as B-cells and microglial cells). This mechanism of action may help stop the formation of new brain lesions in MS.

The purpose of the study is to see if the study drug, SAR442168, works to delay the progression of disability in people with NRSPMS compared to placebo and has an acceptable safety profile.

The purpose of the study is to see if the study drug, SAR442168, works to delay the progression of disability in people with PPMS compared to placebo and has an acceptable safety profile.

This is a Phase 3, randomized, double-blinded, placebo-controlled study to compare the efficacy and safety of sotatercept versus placebo when added to background pulmonary arterial hypertension (PAH) therapy for the treatment of PAH. The objective of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.

This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ravulizumab compared with placebo in participants with primary IgAN on optimal treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin II receptor blockers (ARBs) who are at risk of progressing to end stage kidney disease (ESKD).

This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background PAH therapy in newly diagnosed intermediate- and high-risk PAH patients.

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study. The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background PAH therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours, in participants with WHO FC III or FC IV PAH at high risk of mortality.

To assess the safety and efficacy of oral medication, deucravacitinib (DEUC) at 3 mg twice daily (BID) vs. 6 mg BID vs. the placebo in participants with active Sjögren’s syndrome (SjS).

This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available treatment (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available treatment with respect to durable clinicohematologic response (DCHR).

Metastatic lung cancer is the leading cause of cancer mortality worldwide with a 5-year survival of less than 5%. With the approval of programmed cell death 1 (PD-1) inhibitors in advanced lung cancer, such as pembrolizumab, there has been an improvement in  response rates and survival compared to chemotherapy.

However, there is still a need for improvement in response rates in first-line treatments for patients with stage 4 Non Small Cell Lung Cancer (NSCLC) without genetically targetable alterations, especially in those patients with PDL-1 <50%.

The purpose of this Phase II trial is to see if R3R01 is safe in patients with Alport Syndrome and Focal Segmental Glomerulosclerosis. This will be done by evaluating how efficient R3R01 is in decreasing proteinuria levels. 

The study will consist of a screening period, a treatment period, and a follow-up period. If you qualify, you will receive the study drug R3R01 for 12 weeks. We will then follow up with you after for an additional 12 weeks.

This phase II/III trial compares the side effects and activity of oral azacitidine in combination with the standard drug therapy (reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone [R-miniCHOP]) versus R-miniCHOP alone in treating patients 75 years or older with newly diagnosed diffuse large B cell lymphoma. R-miniCHOP includes a monoclonal antibody (a type of protein), called rituximab, which attaches to the lymphoma cells and may help the immune system kill these cells.

A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer. The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC).

The purpose of this study is to compare the usual treatment approach (surgery followed by chemotherapy) to using chemotherapy followed by surgery and then more chemotherapy

The study will evaluate the efficacy, safety and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to branch retinal vein occlusion (BRVO) up to the primary endpoint at Week 24.