FDA Events for Allakos (ALLK)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Allakos (ALLK).
Over the past two years, Allakos has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AK006. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AK006 - FDA Regulatory Timeline and Events
AK006 is a drug developed by Allakos for the following indication: In patients with CSU.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AK006
- Announced Date:
- January 27, 2025
- Indication:
- In patients with CSU
Announcement
Allakos Inc. announced topline results from its phase 1 clinical trial of AK006 in chronic spontaneous urticaria (CSU).
AI Summary
Allakos Inc. recently announced the topline results from its phase 1 trial of AK006 for treating chronic spontaneous urticaria (CSU). In this study, 34 adult patients with moderate-to-severe CSU, who had not responded well to antihistamines, were treated with either AK006 or a placebo. Although the drug was found to be well tolerated with only mild side effects, AK006 did not show the hoped-for clinical benefits in reducing the symptoms of CSU.
Due to the lack of therapeutic effectiveness, Allakos has decided to stop further development of AK006. As part of this decision, the company plans to reduce its workforce by about 75% and look into other strategic options. The management will discuss these results and next steps during a conference call and webcast scheduled for today at 8:30 am Eastern Time.
Read Announcement- Drug:
- AK006
- Announced Date:
- October 10, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- In patients with CSU
Announcement
Allakos Inc. announced that Top-line Phase 1 results of Intravenous AK006 in patients with CSU are expected in early Q1 of 2025 –
AI Summary
Allakos Inc. announced that top-line Phase 1 results for intravenous AK006 in patients with chronic spontaneous urticaria (CSU) are expected in early Q1 2025. This study will enroll up to 60 adult patients who have not responded well to antihistamines, randomizing them to receive 720 mg of IV AK006 or a placebo every four weeks. The main goal is to measure changes in the urticaria activity score (UAS7) at week 14. Previously, subcutaneous administration of AK006 in healthy volunteers showed roughly 77% bioavailability and prolonged receptor occupancy on mast cells, suggesting the potential for infrequent dosing due to its half-life of 12-22 days. In addition, the treatment was well-tolerated with a favorable safety profile. These results could help guide further development of AK006 as a targeted treatment approach for mast cell-driven diseases like CSU.
Read Announcement- Drug:
- AK006
- Announced Date:
- October 10, 2024
- Indication:
- In patients with CSU
Announcement
Allakos Inc. announced results from the Phase 1 study of subcutaneous AK006 in healthy volunteers. AK006 is a Siglec-6 monoclonal antibody that selectively inhibits mast cells.
AI Summary
Allakos Inc. announced positive Phase 1 results for subcutaneous AK006, a Siglec-6 monoclonal antibody that selectively inhibits mast cells. In the study with healthy volunteers, subcutaneous AK006 demonstrated approximately 77% bioavailability and an estimated half-life of 12–22 days. Skin biopsies showed high receptor occupancy on mast cells, with a 720 mg dose achieving 98% occupancy at day 113, indicating the potential for infrequent dosing. The treatment was well-tolerated, with no serious adverse events reported and only mild-to-moderate side effects such as headache and dysmenorrhea. These results support the continued clinical development of AK006 for mast cell-driven diseases, including conditions like chronic spontaneous urticaria, food allergies, and asthma. The data underscore the promise of AK006 as a targeted therapy aimed at curbing inappropriate mast cell activation.
Read Announcement
Allakos FDA Events - Frequently Asked Questions
As of now, Allakos (ALLK) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Allakos (ALLK) has reported FDA regulatory activity for AK006.
The most recent FDA-related event for Allakos occurred on January 27, 2025, involving AK006. The update was categorized as "Top-line results," with the company reporting: "Allakos Inc. announced topline results from its phase 1 clinical trial of AK006 in chronic spontaneous urticaria (CSU)."
Currently, Allakos has one therapy (AK006) targeting the following condition: In patients with CSU.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ALLK) was last updated on 7/11/2025 by MarketBeat.com Staff
