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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 (Nasdaq: ANNX) will present analyses of ANX007 from the Phase 2 ARCHER trial in geographic atrophy (GA) at two major ophthalmology conferences. ANX007, a novel C1q-blocking Fab, demonstrated significant vision protection in standard and low light conditions, and preservation of photoreceptors in the fovea region. The company has initiated the Phase 3 ARCHER II pivotal trial, with data expected in the second half of 2026. Presentations will highlight ANX007's potential to be the first treatment to protect vision in GA, focusing on its mechanism of action and clinical results from the ARCHER trial.
Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on novel complement therapies for neuroinflammatory diseases, has expanded its senior leadership team with three key appointments:
1. Shikhar Agarwal, M.B.A. as SVP, Head of Commercial
2. Sunil B. Mehta, Pharm.D as SVP of Medical Affairs
3. Myoung Kim, Ph.D., M.A., M.B.A. as VP of Health Economics and Outcomes Research
These appointments aim to strengthen Annexon's commercial development for flagship programs in Guillain-Barré Syndrome (GBS) and geographic atrophy (GA). The new leaders bring extensive experience in product strategy, successful launches, and market development across various therapeutic areas.
Annexon Biosciences (Nasdaq: ANNX), a biopharmaceutical company focused on developing novel complement therapies for neuroinflammatory diseases, has announced its participation in two upcoming investor conferences in September 2024. Douglas Love, the company's president and CEO, will engage in fireside chats at the following events:
1. Wells Fargo Healthcare Conference on September 4, 2024, at 9:30 a.m. ET in Boston, MA
2. Cantor Global Healthcare Conference on September 17, 2024, at 3:05 p.m. ET in New York, NY
Live webcasts of both presentations will be available on the Annexon website under the 'Events & Presentations' section of the Investors page. Replays will be archived for 30 days following each presentation.
Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on developing novel complement therapies for neuroinflammatory diseases, has announced the granting of inducement awards to two new non-executive employees. These equity awards, approved on August 15, 2024, were granted under the company's 2022 Employment Inducement Award Plan in compliance with Nasdaq Listing Rule 5635(c)(4).
The new employees received options to purchase a total of 83,000 shares of Annexon common stock. These options have a ten-year term and an exercise price of $5.98 per share, which was the closing price of Annexon's stock on the grant date. The options will vest over 4 years, with 25% vesting on the first anniversary and an additional 1/48th vesting monthly thereafter, subject to continued employment.
Annexon (NASDAQ: ANNX) reported significant progress in its Q2 2024 portfolio and financial results. Key highlights include:
1. ANX005 for Guillain-Barré syndrome (GBS) showed accelerated patient recovery in a pivotal Phase 3 trial.
2. ANX007 for Geographic Atrophy (GA) initiated dosing in the ARCHER II registrational trial.
3. ANX1502, an oral C1s inhibitor, completed a bridging study to a twice-daily tablet formulation.
4. Strong financial position with $368.7 million in cash and investments as of June 30, 2024, providing runway into H2 2026.
5. Anticipated milestones include topline RWE data for ANX005 by year-end 2024, Phase 3 data for ANX007 in H2 2026, and proof-of-concept data for ANX1502 in Q4 2024.
Annexon Inc (ANNX) has initiated patient dosing in the global Phase 3 ARCHER II trial for ANX007, a C1q inhibitor targeting geographic atrophy (GA). The trial aims to evaluate ANX007's potential to protect vision in GA patients, with topline data expected in H2 2026. New data from the Phase 2 ARCHER trial showed:
1. Significant vision protection in standard and low light conditions
2. Structural protection in key retinal areas for visual acuity
3. Up to 60% protection of photoreceptors in the central fovea
4. 29% protection of photoreceptors across the full retinal field
ANX007 is the only GA therapy candidate to receive PRIME designation in the EU and Fast Track designation from the FDA. The Phase 3 trial will enroll approximately 630 patients, using best corrected visual acuity (BCVA) protection against ≥15-letter loss as the primary outcome measure.
Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on novel therapies for neuroinflammatory diseases, has granted an inducement award to a new non-executive employee. The equity award, approved on July 11, 2024, under the 2022 Employment Inducement Award Plan, includes an option to purchase 6,200 shares of Annexon common stock. The option has a ten-year term with an exercise price of $6.17 per share, equal to the closing price on July 15, 2024. It vests over 4 years, with 25% vesting on the first anniversary and 1/48th monthly thereafter, subject to continued service.
Annexon will present additional data from its Phase 2 ARCHER trial on ANX007 at the 42nd ASRS Annual Scientific Meeting in Stockholm, Sweden from July 17-20, 2024. The presentations will highlight the protective effects of ANX007 on visual acuity and anatomical measures in patients with geographic atrophy (GA), a condition causing irreversible vision loss. Dr. Glenn J. Jaffe and Dr. Joel Pearlman will discuss the trial's findings, showcasing ANX007's impact on the central macula's ellipsoid zone and retinal pigment epithelium. This trial is important for advancing therapies for neuroinflammatory diseases affecting vision.
Annexon announced positive results from its Phase 3 trial of ANX005, an immunotherapy targeting C1q for Guillain-Barré Syndrome (GBS). Presented at the 2024 PNS Annual Meeting, data showed faster and more complete recovery for ANX005-treated patients compared to placebo.
Significant improvements were noted in primary and multiple pre-specified endpoints from Week 1 through Week 26. Two and a half times more ANX005-treated patients returned to a normal/pre-disease state of health by Week 26 compared to placebo.
Patients with North American and European baseline characteristics experienced larger benefits in disability and muscle strength measures. A single infusion of ANX005 was generally well-tolerated, with a safety profile similar to placebo.
These findings underscore the potential of ANX005 to become the first targeted immunotherapy for GBS, offering a new treatment option for a significant unmet need in the GBS landscape.
Annexon will present pivotal Phase 3 data on ANX005, a novel C1q blocking antibody for Guillain-Barré Syndrome (GBS), at the 2024 Peripheral Nerve Society Annual Meeting from June 22-25 in Montréal, Canada.
The data shows significant improvements in multiple functional and prognostic measures, indicating expedited recovery for GBS patients. ANX005 has the potential to become the first targeted therapy approved for GBS treatment.
Presentations will include an oral session on June 25, a lunch symposium, a flash oral presentation on June 23, and two poster presentations on June 23 and 24.
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