ARCHER

Annexon Reports Fourth Quarter and Year-End 2023 Financial Results and Key Anticipated Milestones

Retrieved on: 
Tuesday, March 26, 2024
Diagnosis, Research, Brain, Geographic atrophy, Disease, RWE, International, Paratriathlon, Patient, ARCHER, G&A, Pivotal, EMA, Meta-analysis, Eye, European Medicines Agency, Medicine, Visual acuity, Immunoglobulin therapy, GBS, Facial muscles, Clinical trial, POC, Safety, Pharmacokinetics, Investment, SAD, FDA, BLA, AFL, CAD, Food, Pharmaceutical industry

BRISBANE, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress and reported fourth quarter and full year 2023 financial results.

Key Points: 
  • Finally, we anticipate clinical proof-of-concept data from our novel oral inhibitor ANX1502 later in the year.
  • ANX005 in GBS: First-in-class monoclonal antibody designed to block C1q and the entire classical complement pathway in both the body and the brain.
  • ANX005 in GBS: Topline data from pivotal, randomized, placebo-controlled Phase 3 trial expected in the second quarter of 2024.
  • Cash and operating runway: Cash and cash equivalents and short-term investments were $259.7 million as of December 31, 2023.

Cardiol Therapeutics Announces it has Exceeded 50% Enrollment in its Phase II ARCHER Trial in Acute Myocarditis

Retrieved on: 
Tuesday, January 9, 2024
Myocarditis, Patient, European, Therapy, Research, Viral disease, Survival, Facial muscles, Fatigue, ARCHER, Heart failure, Freedom, Lightheadedness, Prognosis, Rest, Arrhythmia, Risk, Cancer, TSX, Arthralgia, Disease, Safety, Fever, Genetically modified bacteria, FDA, Inflammation, Biomarker, Marketing, Messenger, Clinical trial, Headache, Chest pain, CRDL, Pharmaceutical industry

Results from the ARCHER trial will assist in further understanding the therapeutic potential of CardiolRx™ and will complement the important clinical data from our ongoing MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis."

Key Points: 
  • Results from the ARCHER trial will assist in further understanding the therapeutic potential of CardiolRx™ and will complement the important clinical data from our ongoing MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis."
  • The ARCHER trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence.
  • The trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in North America, France, Brazil, and Israel.
  • Orphan drug designation programs were established to provide life sciences companies with incentives to develop new therapies for rare diseases.

Annexon Outlines 2024 Priorities with Late-Stage Clinical Milestones Across Upstream Complement Portfolio for Autoimmune, Ophthalmic and Neurodegenerative Diseases

Retrieved on: 
Monday, January 8, 2024
Patient, Geographic atrophy, Initiate, Conference, Outline, ARCHER, Immunoglobulin therapy, GBS, PRIME, EMA, Research, Paratriathlon, Cold agglutinin disease, AMD, CAD, Complement component 1s, Brain, Facial muscles, Eye, Clinical trial, Inflammation, Pharmacokinetics, Nerve, Death, Nervous system, Guillain, SAD, Complement component 1q, Webcast, Safety, Meta-analysis, Pharmaceutical industry

BRISBANE, Calif., Jan. 07, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for people living with devastating inflammatory-related diseases, today outlined its strategic priorities for 2024 with late-stage clinical milestones, including ANX005 for Guillain-Barré syndrome (GBS), ANX007 for geographic atrophy (GA) and its first-in-kind oral small molecule complement inhibitor, ANX1502, for a range of autoimmune indications.

Key Points: 
  • The study completed enrollment in 2023 and the company is on-track to report Phase 3 data in the first half of 2024.
  • Annexon also plans to initiate the ARROW clinical trial, an injection-controlled head-to-head study against SYFOVRE® (pegcetacoplan injection) in late 2024.
  • A live webcast of the event can be accessed under the ‘Events & Presentations’ section on the Investors page at www.annexonbio.com.
  • A replay of the webcast will be archived on the Annexon website for 30 days following the presentation.

Annexon Reports Significant Progress with its Priority Programs and Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Molecule, Ophthalmology, Visual acuity, Investment, HD, EMA, Research, Kidney, Autoimmune disease, Driver, C3, Conference, R, Facial muscles, Inflammation, Treatment, Meta-analysis, American Academy, American Society of Nephrology, G&A, Guillain, Society, Letter, Paratriathlon, European Medicines Agency, American Academy of Ophthalmology, Professional, C4, AAO, System, Nephrology, AMD, Immunoglobulin therapy, PACA, Plasma, Disease, Complement component 1q, Medicine, Complement system, FDA, Geographic atrophy, GBS, ARCHER, C5, HIV disease progression rates, Risk management, Pharmaceutical industry, Vaccine, Cryptocurrency, Patient, LN, ALS

EMA orphan drug designation requires that a novel rare disease therapeutic demonstrates the potential for significant benefit over available therapies.

Key Points: 
  • EMA orphan drug designation requires that a novel rare disease therapeutic demonstrates the potential for significant benefit over available therapies.
  • Importantly, Annexon also announced that it has achieved target enrollment of 225 patients in the randomized, double-blind, placebo-controlled Phase 3 trial of ANX005 in patients with GBS.
  • Research and development (R&D) expenses: R&D expenses were $27.9 million for the quarter ended September 30, 2023, reflecting the advancement of the company’s priority programs, including GBS, GA and ANX1502, compared to $27.9 million for the quarter ended September 30, 2022.
  • General and administrative (G&A) expenses: G&A expenses were $6.9 million for the quarter ended September 30, 2023, compared to $8.2 million for the quarter ended September 30, 2022.

Annexon Receives PRIME Designation from the EMA for ANX007 for the Treatment of Geographic Atrophy

Retrieved on: 
Tuesday, October 24, 2023
Physician, AMD, European Medicines Agency, Geographic atrophy, GA, EMA, ARCHER, Visual acuity, Medical imaging, Pharmaceutical industry, Patient, EU

BRISBANE, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX) a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced that the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to ANX007 for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The EMA granted this designation, which provides enhanced development support for priority medicines that target an unmet need, based on the Phase 2 ARCHER trial data that showed a statistically significant, durable, and dose-dependent preservation of visual function in patients with GA, as well as preclinical data supporting the protective effect of ANX007 against photoreceptor damage.

Key Points: 
  • “GA is a progressive disease impacting millions of elderly people worldwide, which severely limits their independence.
  • There is a need for a treatment that provides the benefit both patients and physicians most desire —preservation of vision,” said Douglas Love, president and CEO of Annexon.
  • We believe PRIME designation supports the potential for ANX007 to address this critical need.
  • These medicines are considered priority medicines by the EMA, whose aim is to optimize development plans and speed up evaluations so these medicines that address significant unmet medical needs can reach patients faster.

Cardiol Therapeutics Announces All Collaborating Clinical Research Centers Now Initiated and Eligible to Enroll Patients in ARCHER, a Phase II Trial of CardiolRx(TM) for the Treatment of Acute Myocarditis

Retrieved on: 
Tuesday, September 19, 2023
CRDL, Heart failure, Myocarditis, Marketing, Season, Chest pain, Prognosis, Research, Arrhythmia, Facial muscles, Patient, European, Viral, TSX, Rare, Therapy, Safety, Pharmaceutical industry, ARCHER

Toronto, Ontario--(Newsfile Corp. - September 19, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announces that all collaborating research centers have been initiated and are eligible to enroll patients in ARCHER, the Company's Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. ARCHER is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel.

Key Points: 
  • ARCHER is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel.
  • The ARCHER trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence.
  • The trial is now enrolling patients at over 35 pre-eminent cardiovascular research centers in North America, France, Brazil and Israel.
  • Products with orphan drug designation also frequently qualify for accelerated regulatory review.

Sweden Awards BAE Systems $ 500 Million Contract for Additional 48 ARCHER Artillery Systems

Retrieved on: 
Wednesday, September 13, 2023
Defense, Other Defense, Military, Other Manufacturing, Contracts, Technology, Manufacturing, Other Technology, RMMV, BAE Systems Platforms & Services, Army, Rheinmetall, Swedish Defence Materiel Administration, Swedish Army, ARCHER, Multimedia, DSEI, BAE Systems, BAE Systems AB, United Kingdom, FMV, Excalibur, Swedish, Arms industry

BAE Systems signed a contract with the Swedish Defence Materiel Administration (FMV) worth approximately $500 million for 48 new ARCHER artillery systems for the Swedish Army.

Key Points: 
  • BAE Systems signed a contract with the Swedish Defence Materiel Administration (FMV) worth approximately $500 million for 48 new ARCHER artillery systems for the Swedish Army.
  • (Photo: Business Wire)
    The ARCHER mobile artillery system, designed and produced by BAE Systems Bofors in Sweden, is already in service in the Swedish Army and has achieved the highest technical and manufacturing readiness levels.
  • “This important milestone establishes ARCHER as the basis of the Swedish Army’s new divisional artillery forces,” said Lena Gillström, president of BAE Systems Bofors.
  • Sweden has also donated ARCHER to Ukraine, and the system has been down-selected in Switzerland’s procurement of new artillery.

Annexon Highlights Recent Pipeline and Business Progress and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 7, 2023
Molecule, HD, Drug development, Geographic atrophy, ARCHER, G&A, Regulatory Agencies, Inflammation, Pivotal trial, LN, Differentiation, Complement component 1q, HIV disease progression rates, Investment, Appointment, Annual general meeting, GBS, R, Research, Visual acuity, ALS, Society, ASRS, Fine chemical, Pharmaceutical industry, EU, Patient

BRISBANE, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today highlighted recent progress across its business and portfolio of complement therapies and reported second quarter 2023 financial results.

Key Points: 
  • Together, these data demonstrate the differentiated mechanism of inhibiting C1q to provide functional benefits for patients living with complement-mediated diseases.
  • Annexon plans to provide pipeline updates and outline key milestones across its business and portfolio of complement-targeted therapies during an R&D Day in the second half of 2023.
  • Following encouraging preliminary results which showed slowing of disease progression, additional data are expected in the second half of 2023.
  • General and administrative (G&A) expenses: G&A expenses were $7.4 million for the quarter ended June 30, 2023, compared to $8.3 million for the quarter ended June 30, 2022.

Annexon Presents ARCHER Trial Results at ASRS 2023 Highlighting Potential of ANX007 as a Differentiated Treatment for Geographic Atrophy

Retrieved on: 
Sunday, July 30, 2023
FAF, CNV, AMD, Retinal vasculitis, EM, Geographic atrophy, Macular degeneration, EOM, Patient, Physician, Intravitreal administration, Acute posterior multifocal placoid pigment epitheliopathy, Annual general meeting, Webcast, Paratriathlon, Letter, Visual acuity, Safety, Society, ASRS, Choroidal neovascularization, Communications satellite, Pharmaceutical industry, Medical imaging, Dietary supplement, Birth control, ARCHER

BRISBANE, Calif., July 30, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today presented results from the ongoing ARCHER trial in patients with geographic atrophy (GA), underscoring ANX007’s potentially distinct neuroprotective mechanism of action and demonstration of consistent protection from vision loss. Data were presented during an oral presentation titled, “Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration with Intravitreal ANX007: Results of the ARCHER Study,” at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.

Key Points: 
  • Data were presented during an oral presentation titled, “Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration with Intravitreal ANX007: Results of the ARCHER Study,” at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.
  • “The results from ARCHER demonstrated dose and time dependent protection of visual function in GA across multiple measures.
  • Annexon conducted additional analyses to further evaluate the effect of ANX007 treatment on BCVA and GA lesion area.
  • The six-month off-treatment follow-up period of the ARCHER trial is ongoing, and Annexon plans to report final results following study conclusion.

Annexon to Report ARCHER Phase 2 Trial Results in Geographic Atrophy at ASRS 2023

Retrieved on: 
Monday, July 24, 2023
Geographic atrophy, Macular degeneration, ARCHER, GA, Patient, Intravitreal administration, Annual general meeting, Webcast, Society, ASRS, Pharmaceutical industry

BRISBANE, Calif., July 24, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced the company will present results from the ongoing ARCHER Phase 2 trial in patients with geographic atrophy (GA) at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.

Key Points: 
  • BRISBANE, Calif., July 24, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced the company will present results from the ongoing ARCHER Phase 2 trial in patients with geographic atrophy (GA) at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.
  • The webcast and accompanying slides will be available under the ‘Events & Presentations’ section on the Investors & Media page at www.annexonbio.com.
  • A replay of the webcast will be archived on the Annexon website for 30 days.
  • Dial-in information for conference participants may be obtained by registering for the event here .