Avalo Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Avalo Therapeutics (AVTX).
Over the past two years, Avalo Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AVTX-009. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AVTX-009 FDA Regulatory Timeline and Events
AVTX-009 is a drug developed by Avalo Therapeutics for the following indication: For the treatment of hidradenitis suppurativa (HS).
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:
- AVTX-009
- Announced Date:
- March 20, 2025
- Indication:
- For the treatment of hidradenitis suppurativa (HS)
Announcement
Avalo Therapeutics, Inc provided Recent Business Updates
AI Summary
Avalo Therapeutics recently provided key business updates during its year-end financial review for 2024. The company highlighted the progress of its lead asset, AVTX-009, by discussing the initiation of the Phase 2 LOTUS trial for treating hidradenitis suppurativa. This global trial plans to evaluate different dosing regimens in approximately 180 adults, with topline data expected in 2026. In addition to the trial, Avalo is investigating a second indication for AVTX-009 in other immune-mediated diseases.
Another important update is the appointment of Jennifer Riley as Chief Strategy Officer, effective January 1, 2025. Riley will be responsible for guiding the company’s strategic planning and pipeline development in the HS and inflammatory disease markets. With approximately $135 million in cash as of December 31, 2024, Avalo expects its current funds to support operations into at least 2027.
Read Announcement- Drug:
- AVTX-009
- Announced Date:
- October 8, 2024
- Indication:
- For the treatment of hidradenitis suppurativa (HS)
Announcement
Avalo Therapeutics, Inc announced that Topline data expected in 2026
AI Summary
Avalo Therapeutics announced the start of its Phase 2 LOTUS trial, which is designed to evaluate the safety and effectiveness of its drug candidate AVTX-009 in treating hidradenitis suppurativa. This study will enroll about 180 adults to compare two dose regimens of AVTX-009 against a placebo during a 16-week treatment period. The trial will focus on the proportion of patients achieving significant clinical responses, with multiple endpoints measuring improvements in condition severity and pain reduction. The company expects to release the topline data from this trial in 2026. AVTX-009 is a humanized monoclonal antibody that targets interleukin-1β, an important driver in the disease’s inflammatory process. Avalo Therapeutics believes that by effectively neutralizing this cytokine, AVTX-009 could become a best-in-class treatment option for patients suffering from hidradenitis suppurativa.
Read Announcement- Drug:
- AVTX-009
- Announced Date:
- October 8, 2024
- Indication:
- For the treatment of hidradenitis suppurativa (HS)
Announcement
Avalo Therapeutics, Inc announced that the first patient has been dosed in the Company's Phase 2 LOTUS trial of AVTX-009 in hidradenitis suppurativa (HS).
AI Summary
Avalo Therapeutics has reached an important milestone by dosing the first patient in its Phase 2 LOTUS trial for AVTX-009, an investigational monoclonal antibody targeting interleukin-1β, in patients with hidradenitis suppurativa (HS). HS is a chronic skin condition that causes painful abscesses, nodules, and tunnels, deeply impacting patients' quality of life. In this randomized, double-blind, placebo-controlled trial, approximately 180 adults with moderate to severe HS will receive one of two different dosing regimens of AVTX-009 or a placebo during a 16‐week treatment period. The primary goal is to evaluate the effectiveness of AVTX-009 by measuring the proportion of patients who achieve significant clinical improvement by Week 16. Avalo Therapeutics is optimistic that the high potency of AVTX-009 may provide a best-in-class treatment option, with topline data expected in 2026.
Read Announcement- Drug:
- AVTX-009
- Announced Date:
- July 9, 2024
- Indication:
- For the treatment of hidradenitis suppurativa (HS)
Announcement
Avalo expects to enroll the first patient in its Phase 2 LOTUS Trial this year.
AI Summary
Avalo Therapeutics announced that its IND application for AVTX-009 is now active, allowing the company to begin its Phase 2 LOTUS trial. The trial will study the safety and efficacy of AVTX-009 in about 180 adults who suffer from moderate to severe hidradenitis suppurativa, a painful chronic skin condition marked by painful nodules and abscesses.
Avalo expects to enroll the first patient in the LOTUS trial later this year. The trial is designed as a randomized, double-blind, placebo-controlled study that will compare two different dosing levels of the drug. The company believes that AVTX-009’s unique attributes, including its long half-life and high potency, may offer a more effective treatment option for patients with hidradenitis suppurativa, potentially improving quality of life and treatment convenience.
Read Announcement- Drug:
- AVTX-009
- Announced Date:
- July 9, 2024
- Indication:
- For the treatment of hidradenitis suppurativa (HS)
Announcement
Avalo Therapeutics, Inc announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1β monoclonal antibody (mAb), for the treatment of hidradenitis suppurativa (HS) is now active, permitting the Company to commence its Phase 2 (LOTUS) clinical trial in patients with HS.
AI Summary
Avalo Therapeutics, Inc. announced that its IND application for AVTX-009, an anti-IL-1β monoclonal antibody, is now active. This approval allows the company to begin its Phase 2 (LOTUS) clinical trial to evaluate the treatment in patients with hidradenitis suppurativa (HS). The LOTUS Trial is designed as a randomized, double-blind, placebo-controlled study that will assess the safety and effectiveness of two dosing regimens of AVTX-009 in about 180 patients suffering from moderate to severe HS. The primary goal of the study is to measure the proportion of patients achieving a significant clinical response at Week 16.
Dr. Garry Neil, CEO and Chairman of Avalo Therapeutics, highlighted that reaching this milestone in just over three months since acquiring the candidate is a major achievement. The company believes AVTX-009 may offer strong efficacy and convenient dosing, potentially making it a best-in-class treatment for HS.
Read Announcement
Avalo Therapeutics FDA Events - Frequently Asked Questions
As of now, Avalo Therapeutics (AVTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Avalo Therapeutics (AVTX) has reported FDA regulatory activity for AVTX-009.
The most recent FDA-related event for Avalo Therapeutics occurred on March 20, 2025, involving AVTX-009. The update was categorized as "Provided Update," with the company reporting: "Avalo Therapeutics, Inc provided Recent Business Updates"
Currently, Avalo Therapeutics has one therapy (AVTX-009) targeting the following condition: For the treatment of hidradenitis suppurativa (HS).
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:AVTX) was last updated on 7/31/2025 by MarketBeat.com Staff
