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Avalo Therapeutics Expands Pipeline with AVTX-010, a Long-Acting Next-Generation Anti-IL-1β Antibody

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Avalo Therapeutics (Nasdaq: AVTX) is advancing AVTX-010, a long-acting next-generation anti-IL-1β monoclonal antibody for potential use in hidradenitis suppurativa (HS) and other inflammatory diseases.

AVTX-010 is engineered for extended dosing intervals and may enhance Avalo’s IL-1β-focused pipeline and intellectual property. An IND submission is planned for the first half of 2027.

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News Market Reaction – AVTX

-1.85%
14 alerts
-1.85% Session close to close
+10.7% Peak in 29 hr 10 min
$814.77M Market Cap
0.6x Rel. Volume

In the Jun 16 session, AVTX declined 1.85%, reflecting a mild negative market reaction. Argus tracked a peak move of +10.7% during that session. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds AVTX‑010, a long-acting anti‑IL‑1β antibody, to Avalo’s pipeline with an IND ...
Analysis

This announcement adds AVTX‑010, a long-acting anti‑IL‑1β antibody, to Avalo’s pipeline with an IND planned for the first half of 2027. It builds on prior Phase 2 LOTUS success for abdakibart in hidradenitis suppurativa and follows substantial equity financings supported by a large shelf registration. Investors may focus on execution toward first-in-human studies, design of the planned Phase 3 program for abdakibart, and future use of the shelf to fund these initiatives.

Key Figures

IND timing: First half of 2027
1 metrics
IND timing First half of 2027 Planned IND submission for AVTX-010

Historical Context

5 past events · Latest: May 22 (Neutral)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
May 22 Inducement option grant Neutral -2.0% New employee stock option award under Nasdaq inducement rules.
May 13 Earnings and updates Positive -0.5% Q1 2026 results plus positive LOTUS data and major equity raise.
May 05 Public offering priced Neutral +34.1% Pricing of $375M underwritten equity and pre-funded warrant offering.
May 05 Offering launched Neutral +34.1% Proposed public offering to fund abdakibart Phase 3 and operations.
May 05 Phase 2 LOTUS topline Positive +34.1% Positive Phase 2 LOTUS results for abdakibart in hidradenitis suppurativa.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Positive clinical and financing events on May 5, 2026 saw a strong upside reaction, while later financing, earnings, and administrative items drew flat-to-negative responses, suggesting the stock has rewarded major efficacy milestones more than routine updates.

Recent Company History

Over the last few months, Avalo progressed abdakibart with positive Phase 2 LOTUS data on May 5, 2026, coinciding with a public offering and a 34.13% price gain. Subsequent proposed and priced offerings, Q1 2026 results with a $19.6M net loss, and an inducement option grant were followed by modest to negative moves. Today’s AVTX-010 announcement extends the IL‑1β pipeline beyond abdakibart, building on this earlier clinical and financing groundwork.

Key Terms

monoclonal antibody, mab, hidradenitis suppurativa, investigational new drug, +1 more
5 terms
monoclonal antibody medical
"a long-acting next-generation anti-IL-1β monoclonal antibody (mAb)"
A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.
mab medical
"anti-IL-1β monoclonal antibody (mAb) with the potential"
A mAb (monoclonal antibody) is a lab-made protein designed to recognize and bind a specific target on cells or pathogens, like a custom-made key that fits one lock. Investors care because mAbs are often developed as therapies or diagnostic tools whose clinical trial results, regulatory approvals, production capacity, and patent status can drive significant revenue swings and affect a company’s valuation and risk profile.
hidradenitis suppurativa medical
"for development in hidradenitis suppurativa (HS) as well as"
A chronic skin disease marked by recurring, painful lumps and tunnels under the skin that often leak and leave scars; it behaves like a slow-burning, recurring infection in areas with many sweat glands. For investors, it matters because the condition has few consistently effective treatments and causes long-term healthcare use, making successful new drugs, devices, or diagnostics potentially high-value opportunities while also carrying clinical-trial, regulatory and reimbursement risks.
investigational new drug regulatory
"expects to submit an Investigational New Drug (IND) application for AVTX-010"
An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.
immune-mediated inflammatory diseases medical
"treatments for immune-mediated inflammatory diseases, today announced"
Immune-mediated inflammatory diseases are chronic conditions in which the body's defense system mistakenly attacks healthy tissues, causing ongoing inflammation and organ damage — think of the immune system as a guard that starts targeting its own house. They matter to investors because they create long-term demand for treatments, influence drug development and regulatory decisions, and can generate steady revenue streams or clinical and approval risks depending on therapy effectiveness and safety.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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  • IND submission for AVTX-010 planned for the first half of 2027

WAYNE, Pa., June 16, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced the advancement of AVTX-010, a long-acting next-generation anti-IL-1β monoclonal antibody (mAb) with the potential for development in hidradenitis suppurativa (HS) as well as additional inflammatory disorders.

“Building on the strength of our abdakibart Phase 2 LOTUS topline data and our conviction in the IL-1β pathway, we believe developing a long-acting next-generation molecule is a natural and strategically important step in maximizing the full potential of our pipeline,” said Garry Neil, MD, Chief Executive Officer of Avalo Therapeutics. “Less frequent dosing is an important driver of physician and patient preference in chronic inflammatory diseases, and we believe AVTX-010 may further strengthen our potential in HS, while creating opportunities to expand into additional indications where extended dosing intervals may improve treatment convenience, adherence, and overall patient experience. We are also encouraged by the productive engagement with FDA, which enables a streamlined path to bring AVTX-010 to first-in-human studies. With the transformational financing completed in May, Avalo is excited to advance abdakibart into a pivotal phase 3 registrational program as well as expand our pipeline starting with AVTX-010.”

AVTX-010 is an engineered anti-IL-1β mAb designed to extend dosing intervals and build upon the differentiated profile established by abdakibart. AVTX-010 also has the potential to strengthen Avalo’s intellectual property position. The Company expects to submit an Investigational New Drug (IND) application for AVTX-010 in the first half of 2027.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, abdakibart, is an anti-IL-1β monoclonal antibody (mAb). Positive topline data was recently reported for abdakibart in a Phase 2 clinical trial in hidradenitis suppurativa (HS). In addition to HS, we’re exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. We are also advancing AVTX-010, an engineered anti-IL-1β mAb designed to extend dosing intervals and build upon the differentiated profile established by abdakibart. For more information about Avalo, please visit www.avalotx.com.

About Abdakibart

Abdakibart is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a pro-inflammatory cytokine that plays a central role in the pathogenesis of a wide range of human diseases.1 It activates immune cells that generate proinflammatory cytokines, including IL-6, TNF-α, and IL-17. Dysregulated IL-1β signaling is a major driver of inflammation, contributing to the progression of autoimmune disorders. IL-1β inhibition has proven effective in multiple immune-mediated inflammatory diseases. 1-3

References:1Dinarello CA. Immunol Rev. 2018;281(1):8-27. 2Kany S et al. Int J Mol Sci. 2019;20(23):6008. 3Kimball AB et al. Presented at: American Academy of Dermatology; March 8-12, 2024; San Diego, CA.

Forward-Looking Statements

This press release includes forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond our control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to our plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: therapeutic potential, clinical benefits and safety profiles of abdakibart (AVTX-009); plans to advance abdakibart into a registrational phase 3 program; plans to advance AVTX-010 into clinical trials; the timing of an IND submission for AVTX-010 in the first half of 2027; expectations regarding timing, success and data announcements of ongoing preclinical studies and clinical trials; drug development costs, reliance on investigators and enrollment of patients in clinical trials; and our plans to develop and commercialize our current and any future product candidates and the implementation of our business model and strategic plans for our business.

Any forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements including, without limitation, risks associated with: the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of our product candidates; the risk that the results of prior preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical studies and clinical trials, including those for abdakibart and AVTX-010; the timing and outcome of any interactions with regulatory authorities; obtaining, maintaining and protecting our intellectual property; the availability of funding sufficient for our operating expenses and capital expenditure requirements, reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in our filings with the Securities and Exchange Commission, available at www.sec.gov. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In addition, any forward-looking statements represent our view only as of today and should not be relied upon as representing its views as of any subsequent date. You should not rely upon forward-looking statements as predictions of future events and actual results or events could differ materially from the plans, intentions and expectations disclosed herein. Except as required by applicable law, we expressly disclaim any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For media and investor inquiries
Christopher Sullivan, CFO
Avalo Therapeutics, Inc.
ir@avalotx.com
410-803-6793

or

Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com


FAQ

What is AVTX-010 in Avalo Therapeutics' (AVTX) pipeline?

AVTX-010 is a long-acting next-generation anti-IL-1β monoclonal antibody in Avalo Therapeutics’ pipeline. According to Avalo Therapeutics, it is engineered to extend dosing intervals and build on the differentiated profile established by abdakibart for immune-mediated inflammatory diseases.

When does Avalo Therapeutics (AVTX) plan to file the IND for AVTX-010?

Avalo Therapeutics expects to submit the IND for AVTX-010 in the first half of 2027. According to Avalo Therapeutics, productive FDA engagement is supporting a streamlined path toward first-in-human studies for this long-acting anti-IL-1β antibody candidate.

How could AVTX-010 benefit hidradenitis suppurativa (HS) patients and Avalo (AVTX) investors?

AVTX-010 is intended for potential development in hidradenitis suppurativa and other inflammatory disorders. According to Avalo Therapeutics, its long-acting design targets less frequent dosing, which may improve treatment convenience, adherence, and overall patient experience, potentially enhancing the company’s HS-focused portfolio.

How does AVTX-010 relate to abdakibart in Avalo Therapeutics' (AVTX) strategy?

AVTX-010 is designed to build upon the differentiated profile established by abdakibart. According to Avalo Therapeutics, the new molecule leverages positive Phase 2 LOTUS topline experience and focuses on the IL-1β pathway while aiming for extended dosing intervals and broader indication opportunities.

What role does intellectual property play in Avalo Therapeutics’ (AVTX) AVTX-010 program?

AVTX-010 may strengthen Avalo Therapeutics’ intellectual property position. According to Avalo Therapeutics, the engineered long-acting anti-IL-1β monoclonal antibody is intended to expand the company’s IL-1β-based treatment portfolio and support its strategic focus on immune-mediated inflammatory diseases.

How does recent financing support Avalo Therapeutics’ (AVTX) work on AVTX-010?

Recent transformational financing is expected to help fund Avalo’s pipeline priorities. According to Avalo Therapeutics, this capital will support advancing abdakibart into a pivotal Phase 3 registrational program and expanding the pipeline, beginning with development of AVTX-010 toward first-in-human studies.