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Allakos Inc. (Nasdaq: ALLK) is a clinical-stage biotechnology company headquartered in Fremont, California. The company is pioneering the development of therapeutic antibodies designed to target immunomodulatory receptors on immune effector cells, which are pivotal in allergic, inflammatory, and proliferative diseases.
The company’s lead candidate, AK006, is engineered to inhibit the Siglec-6 receptor on mast cells. This receptor plays a critical role in controlling mast cell activation, which is a key driver in many severe diseases affecting various organs, including the gastrointestinal tract, eyes, skin, and lungs. AK006 not only inhibits mast cell activation but also reduces their numbers, offering a potentially comprehensive treatment approach.
Recently, Allakos has made significant strides with AK006, completing dosing in its Phase 1 trials for both intravenous (IV) and subcutaneous (SC) administrations in healthy volunteers and patients with chronic spontaneous urticaria (CSU). The company is on track to report top-line data from these studies by the end of 2024.
Allakos previously developed lirentelimab (AK002) but has discontinued its development following unsatisfactory trial outcomes. The company has since restructured to focus all resources on AK006 and other preclinical programs, aiming to extend its cash runway into mid-2026.
Moreover, Allakos continues to engage in active scientific research, underscored by their recent publications in reputable journals and presentations at key medical conferences, such as the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. These efforts highlight AK006’s unique mechanism of action and its broad inhibitory effects on mast cells through multiple pathways, including IgE and MRGPRX2-mediated activation.
For more detailed information, visit Allakos' official website.
Allakos Inc. (Nasdaq: ALLK) announced results from the Phase 1 study of subcutaneous AK006 in healthy volunteers. AK006, a Siglec-6 monoclonal antibody, selectively inhibits mast cells and is being developed for mast cell-driven diseases. Key findings include:
- Subcutaneous AK006 showed approximately 77% bioavailability
- Estimated half-life of 12-22 days
- High levels of receptor occupancy in skin tissue mast cells
- 720 mg dose showed 98% receptor occupancy at day 113
- Well-tolerated with a favorable safety profile
- No serious adverse events or discontinuations due to treatment
The ongoing Phase 1 study includes a CSU arm with top-line results expected in early Q1 2025. This arm will evaluate the efficacy of 720 mg IV AK006 Q4W in antihistamine refractory CSU patients.
Allakos Inc. (Nasdaq: ALLK) has provided a business update and financial results for Q2 2024. Key highlights include:
1. Initiation of a Phase 1 trial for IV AK006 in chronic spontaneous urticaria patients
2. Completion of dosing in the SC AK006 cohort for healthy volunteers
3. Presentation of preclinical data on AK006 at EAACI 2024
4. Q2 2024 ended with $123.1 million in cash, cash equivalents, and investments
5. Reiteration of financial outlook and cash runway into mid-2026
6. Q2 2024 net loss of $26.7 million, or $0.30 per share
The company expects to report SC AK006 trial results in Q3 2024 and CSU trial data by year-end 2024.
Allakos has announced positive results from the Phase 1 trial of AK006, a Siglec-6 monoclonal antibody being developed to treat mast cell-driven diseases. The drug demonstrated high receptor occupancy on mast cells and a favorable safety profile, with no serious adverse events. Healthy volunteers received single and multiple ascending doses up to 720 mg, achieving serum concentrations consistent with inhibitory activity shown in preclinical experiments. High levels of receptor occupancy were confirmed through skin biopsies. AK006 showed dose linear exposure and an estimated half-life of 21 days for the 720 mg IV dose. The ongoing trial also includes a cohort of patients with chronic spontaneous urticaria (CSU), with preliminary efficacy data expected by year-end 2024.
Allakos (Nasdaq: ALLK) announced the first patient dosing in a Phase 1 trial of AK006 for chronic spontaneous urticaria (CSU). The trial is designed to assess the safety, tolerability, and pharmacokinetics of AK006, and evaluate its therapeutic effects through the urticaria activity score (UAS7) over 14 weeks. Top-line results are expected by the end of 2024. CSU is caused by the inappropriate activation of mast cells in the skin, with both IgE-dependent and IgE-independent pathways implicated. AK006 targets these pathways, potentially benefiting a broader patient population.
Allakos Inc. provided a business update and reported financial results for the first quarter of 2024. The company completed dosing in various trials for its AK006 drug, published preclinical research, and presented data at a major conference. Upcoming milestones include reporting trial results and financial outlook remains stable. Allakos ended the quarter with $139.3 million in cash, showing a net decrease of $31.5 million. The company reported increased R&D expenses due to manufacturing costs and a non-cash impairment charge, resulting in a net loss of $71.1 million.
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