Welcome to our dedicated page for Eledon Pharmaceuticals news (Ticker: ELDN), a resource for investors and traders seeking the latest updates and insights on Eledon Pharmaceuticals stock.
Eledon Pharmaceuticals, Inc. (NASDAQ: ELDN) is a clinical-stage biotechnology company dedicated to developing immune-modulating therapies for life-threatening conditions. The company's main focus lies in targeting the CD40L pathway, aiming to provide novel treatments for organ and cellular transplantation, autoimmune diseases, and neurodegenerative conditions.
At the core of Eledon's research is tegoprubart, a humanized IgG1 anti-CD40L antibody. Tegoprubart shows high affinity for CD40 Ligand (CD40L), a crucial biological target involved in generating pro-inflammatory responses in autoimmune diseases, transplant rejection, and neuroinflammation. The CD40/CD40L pathway is essential in both adaptive and innate immune responses, making it a prime target for non-lymphocyte depleting therapeutic interventions.
In 2023, Eledon achieved significant milestones, including presenting initial clinical evidence of tegoprubart's potential to prevent organ rejection while maintaining robust kidney function and a favorable safety profile. The company also played a pivotal role in the second-ever genetically modified heart transplant from a pig to a human, using tegoprubart as a key immunosuppressive component.
Looking forward to 2024, Eledon is committed to advancing its clinical programs. Key initiatives include ongoing development in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). The firm has several pivotal studies underway, including a Phase 1b trial for kidney transplantation, a long-term safety and efficacy extension study, and the Phase 2 BESTOW trial comparing tegoprubart to tacrolimus in kidney transplant patients.
Financially, Eledon reported a net loss of $40.3 million for 2023, slightly improved compared to the previous year's $88.0 million, which included a significant non-cash goodwill impairment charge. The firm's research and development expenses increased to $30.3 million, underscoring its commitment to advancing its clinical pipeline.
Eledon Pharmaceuticals is headquartered in Irvine, California, and continually seeks to build on its deep historical knowledge of anti-CD40L biology to develop groundbreaking therapies. For more information, visit www.eledon.com.
Eledon Pharmaceuticals has announced FDA clearance of its IND application for tegoprubart, aimed at treating IgA Nephropathy (IgAN). The Phase 2a clinical trial, now active in 10 countries including the U.S., will evaluate safety and efficacy in patients with severe proteinuria. The study's primary endpoint focuses on changes in urine protein levels after 24 weeks. Currently, IgAN affects around 150,000 Americans, underscoring the urgency for effective treatments amid limitations of standard therapies.
Eledon Pharmaceuticals, listed on NASDAQ as ELDN, announced its participation in two investor conferences. The first event is a fireside chat at the Gilmartin Group Emerging Growth Company Showcase on August 31, 2022, at 2:00 p.m. ET. The second event is a presentation at the H.C. Wainwright 24th Annual Global Investment Conference, available on-demand from September 12, 2022, at 7:00 a.m. ET. Webcast replays will be accessible on the company's website. Eledon focuses on developing treatments targeting the CD40 Ligand pathway, with its lead candidate being tegoprubart.
Eledon Pharmaceuticals (NASDAQ: ELDN) received FDA clearance for a Phase 2 trial of tegoprubart, aimed at preventing organ rejection in kidney transplant patients. The company has initiated a Phase 1b trial with the first patient dosed in Canada, the UK, and Australia. Positive topline results were reported from a Phase 2a trial of tegoprubart in ALS, showing safety, target engagement, and biomarker response. The drug also received Orphan Drug Designation for pancreatic islet cell transplantation. Eledon plans to provide further data in Q1 2023.
Eledon Pharmaceuticals, Inc. (NASDAQ: ELDN) plans to release its financial results for Q2 2022 on August 11, after market close. Management will host a conference call and webcast at 4:30 pm ET to discuss these results. Eledon specializes in developing treatments for organ transplantation, autoimmune diseases, and neurodegenerative disorders, focusing on its lead compound, tegoprubart. This anti-CD40L antibody targets a key biological pathway, promising significant therapeutic potential.
Eledon Pharmaceuticals (NASDAQ: ELDN) announced that the FDA has approved its Investigational New Drug (IND) application for tegoprubart to prevent kidney transplant rejection.
The phase 2 study will enroll around 120 participants, comparing tegoprubart to tacrolimus over 12 months. The main goal is to evaluate graft function via eGFR. Tegoprubart aims to improve graft survival and reduce side effects associated with current therapies.
Eledon Pharmaceuticals (NASDAQ: ELDN) has announced the dosing of the first patient in a Phase 1b study of tegoprubart for kidney transplantation. This open-label trial, authorized in Canada and the UK, aims to enroll 12 patients receiving tegoprubart along with standard induction therapy. It will assess safety, pharmacokinetics, and efficacy, including rates of acute rejection. The study addresses the challenges posed by existing immunosuppressive therapies associated with significant side effects. Eledon sees tegoprubart as a potential game-changer in managing kidney transplants.
Eledon Pharmaceuticals (NASDAQ: ELDN) announced the grant of inducement stock options to new employees covering 180,000 shares at an exercise price of $3.06, closing price on June 6, 2022. These options have a 10-year term and will vest over four years, with 25% vesting after one year. Eledon focuses on developing treatments for organ and cell transplantation, autoimmune diseases, and neurodegenerative disorders, primarily through its lead compound, tegoprubart, an anti-CD40L antibody targeting key therapeutic pathways.
Eledon Pharmaceuticals (NASDAQ: ELDN) announced that the FDA has granted orphan drug designation to tegoprubart for preventing allograft rejection in pancreatic islet cell transplantation. This designation follows its prior recognition for treating amyotrophic lateral sclerosis (ALS). Tegoprubart aims to enhance islet transplant outcomes by reducing reliance on calcineurin inhibitors (CNIs), which have adverse effects. The FDA's orphan designation offers financial incentives and a potential seven years of market exclusivity upon approval, marking a significant step for Eledon in developing innovative treatments.
Eledon Pharmaceuticals, a clinical stage biopharmaceutical company focused on innovative treatments for organ transplantation and autoimmune diseases, announced that CEO David-Alexandre C. Gros will present at the Jefferies Healthcare Conference on June 9, 2022, at 3:30 p.m. ET in New York City. Interested parties can register for the webcast in advance. Eledon is developing tegoprubart, an anti-CD40L antibody targeting CD40 Ligand, aimed at improving outcomes for patients in need of transplants and those suffering from neurodegenerative diseases.
Eledon Pharmaceuticals announced positive topline results from a Phase 2a clinical trial of tegoprubart in patients with amyotrophic lateral sclerosis (ALS). The study demonstrated that tegoprubart was well-tolerated with no serious drug-related adverse events. Dose-dependent reductions in pro-inflammatory biomarkers were observed, alongside a trend in slowing disease progression as assessed by ALSFRS slope. The trial enrolled 54 patients across 13 sites in the US and Canada, with promising implications for future clinical studies.
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