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Annexon, Inc. (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company that focuses on developing novel therapeutics aimed at treating complement-mediated neurodegenerative and autoimmune diseases. The company's unique scientific approach targets C1q, the initiating molecule of the classical complement pathway, to halt the inflammatory cascade before it starts, providing significant potential benefits across a range of diseases affecting the body, brain, and eye.
Annexon’s primary product candidates include:
- ANX005: A monoclonal antibody designed to block C1q, currently in pivotal Phase 3 trials for Guillain-Barré Syndrome (GBS) and showing promising results in reducing muscle strength loss and nerve damage.
- ANX007: An antigen-binding fragment aimed at treating geographic atrophy (GA) in the eye, demonstrating notable protection against vision loss and retinal damage in Phase 2 trials.
- ANX1502: An oral small molecule inhibitor targeting autoimmune diseases, expected to generate proof-of-concept data in the second half of 2024.
In recent developments, Annexon announced positive top-line results from their Phase 3 trial of ANX005 in GBS, showing significant improvements in clinical outcomes and muscle strength. This trial marks a major milestone as ANX005 could become the first targeted treatment for GBS in the U.S. The company also showcased ANX007's potential in preserving retinal structures and vision in GA patients, with Phase 3 trials set to commence in 2024.
Financially, Annexon maintains a robust balance sheet with approximately $260 million in cash and equivalents, providing a runway into mid-2026. The company recently completed a public offering to raise additional capital, further strengthening its financial position to advance its clinical programs.
Annexon continues to advance its pipeline rigorously, with multiple upcoming milestones that have the potential to generate substantial value for patients and shareholders alike.
Annexon completes enrollment in the Phase 2 ARCHER trial
Annexon (NASDAQ: ANNX) has successfully finished enrollment for its Phase 2 ARCHER trial, assessing ANX007 in patients with geographic atrophy (GA). Results on the primary endpoint are expected in the first half of 2023 after a 12-month treatment. GA affects approximately 1 million Americans, leading to potential blindness. The trial includes 270 patients and will examine both monthly and bi-monthly dosing. ANX007 previously showed promising results in a Phase 1b trial, demonstrating safety and full target engagement in the eye.
Annexon, Inc. (Nasdaq: ANNX) will have its president and CEO, Douglas Love, participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on April 11, 2022, at 3:45 p.m. ET. The event will be accessible via live webcast on the company's Investors page, with an archive available for 30 days post-event. Annexon focuses on developing unique complement medicines aimed at treating complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders. Their pipeline includes three clinical-stage candidates and innovative early-stage programs.
Annexon, a clinical-stage biopharmaceutical company (Nasdaq: ANNX), announced it will present preclinical data at the American Academy of Neurology Annual meeting from April 2-7, 2022. This data highlights their innovative approach to inhibiting C1q in complement-mediated diseases, which includes conditions like Guillain-Barré Syndrome and Huntington’s disease. Notable presentations include the efficacy of their therapy ANX005. The company aims to advance its clinical programs, leveraging its proprietary platform aimed at combating various complement-mediated disorders.
Annexon announced encouraging interim data from its Phase 2 study of ANX005 for Huntington’s Disease, showing positive tolerance and engagement at the six-month mark. Financially, the company reported a net loss of $37.4 million for Q4 2021, totaling $130.3 million for the year. As of December 31, 2021, Annexon had $242.7 million in cash, expected to fund operations into Q1 2024. Key milestones include further data releases for ANX005 and ANX009 in 2022, indicating a robust pipeline aimed at addressing complement-mediated diseases.
Annexon, a clinical-stage biopharmaceutical company (Nasdaq: ANNX), announced that CEO Douglas Love will join the “Orphan CNS Panel” at the Cowen 42nd Annual Healthcare Conference on March 8, 2022, at 2:10 p.m. ET. The panel focuses on complement-mediated conditions affecting the CNS. A live webcast will be available on Annexon's Investors page and will remain archived for 30 days post-event. Annexon is pioneering complement-targeting medicines aimed at autoimmune and neurodegenerative disorders, with a pipeline that includes three clinical-stage drug candidates and various early-stage programs.
Annexon, a clinical-stage biopharmaceutical company, announced the appointment of Bettina M. Cockroft, M.D., to its board of directors. Cockroft, who is currently the chief medical officer at Sangamo Therapeutics, brings nearly 20 years of experience in clinical organizations focused on neurodegenerative disorders. Annexon is advancing therapies for complement-mediated diseases, including Guillain–Barré Syndrome and Huntington’s Disease, with multiple data readouts expected over the next two years. This leadership change aims to enhance the company’s expertise in its novel complement-focused therapies.
Annexon (Nasdaq: ANNX) announced interim results from its ongoing Phase 2 trial of ANX005 for Huntington's disease (HD), showing encouraging safety and efficacy. The treatment demonstrated full target engagement of C1q in cerebrospinal fluid, with over 50% of evaluable patients maintaining clinical function. In patients with excess complement activity, 75% showed improvement in clinical measures. No serious adverse infections or deaths were reported. Full data is expected in Q2 2022, with plans for a Phase 3 trial pending results.
Annexon, a clinical-stage biopharmaceutical company (Nasdaq: ANNX), announced that its CEO, Douglas Love, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 3:45 p.m. ET. The presentation will focus on their innovative complement medicines targeting autoimmune and neurodegenerative disorders. A live webcast will be available on their website, with a replay accessible for 30 days post-event.
Annexon's pipeline includes product candidates like ANX005, ANX007, and ANX009, designed to disrupt the C1q pathway.
Annexon announced positive safety and dose-response results from its Phase 1 trial of ANX009, designed to block C1q in autoimmune diseases. The study, involving 48 healthy volunteers, showed no serious adverse events and effective C1q inhibition, supporting further trials. Additionally, preclinical findings presented at the ASH Annual Meeting indicated the classical complement pathway's role in warm autoimmune hemolytic anemia (wAIHA), with ongoing evaluations of ANX005 in a Phase 2 trial for this condition.
Annexon reported a net loss of $35.6 million or $0.93 per share for Q3 2021, compared to $15.6 million or $0.77 per share year-over-year. As of September 30, 2021, the company had $271.4 million in cash and investments, supporting operations into 2024. The FDA granted Orphan Drug designation for ANX005, aimed at treating Huntington's disease. The company is advancing three clinical-stage candidates in five trials, with initial data from ANX005 expected in Q4 2021. The leadership team has strengthened with new appointments, enhancing the company's research efforts.
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