AEON Biopharma Reports BPD Type 2a Meeting with FDA and Shareholder Approval of the November Transactions

Rhea-AI Summary

AEON (NYSE: AEON) held its scheduled BPD Type 2a meeting with the FDA on Jan. 21, 2026 and is awaiting the official meeting minutes, expected within approximately 30 days, which the company says will inform next steps for development of ABP-450, a biosimilar to BOTOX.

On the same day shareholders approved the November transactions, enabling the Daewoong note exchange to close and substantially reduce outstanding debt, and clearing the way for the second closing of the PIPE financing on or around Jan. 27, 2026 subject to customary closing conditions.

Positive

• Held BPD Type 2a meeting with FDA on Jan. 21, 2026
• Daewoong note exchange closed, substantially reducing outstanding debt
• Shareholders approved transactions enabling PIPE second closing ~Jan 27, 2026

Negative

• Second PIPE closing is subject to customary closing conditions
• Awaiting FDA meeting minutes (~30 days) before disclosing substantive next steps

News Market Reaction

+13.33% 7.7x vol

16 alerts

+13.33% News Effect

+8.2% Peak Tracked

-15.1% Trough Tracked

+$2M Valuation Impact

$17M Market Cap

7.7x Rel. Volume

On the day this news was published, AEON gained 13.33%, reflecting a significant positive market reaction. Argus tracked a peak move of +8.2% during that session. Argus tracked a trough of -15.1% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $17M at that time. Trading volume was exceptionally heavy at 7.7x the daily average, suggesting very strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

FDA minutes timeline: 30 days Second PIPE closing target date: January 27, 2026

2 metrics

FDA minutes timeline 30 days Expected timeframe to receive BPD Type 2a meeting minutes

Second PIPE closing target date January 27, 2026 Expected date for second closing of PIPE financing

Market Reality Check

Price: $1.16 Vol: Volume 507,767 is elevate...

high vol

$1.16 Last Close

Volume Volume 507,767 is elevated at 2.36x the 20-day average, signaling strong pre-news interest. high

Technical Price $1.20 is trading above the $0.79 200-day MA, reflecting a rebound from prior lows.

Peers on Argus

AEON gained 5.26% while peers APRE (-1.62%), CSCI (-8.11%), DWTX (-1.44%), PCSA ...

AEON gained 5.26% while peers APRE (-1.62%), CSCI (-8.11%), DWTX (-1.44%), PCSA (-6.09%), and RNAZ (-1.8%) declined, indicating a stock-specific reaction rather than a sector move.

Historical Context

4 past events · Latest: Dec 19 (Neutral)

Pattern 4 events

Date	Event	Sentiment	Move	Catalyst
Dec 19	Inducement grants	Neutral	-3.7%	RSU inducement grants to new non-executive employees under 2025 plan.
Dec 15	Debt exchange deal	Positive	+5.1%	Daewoong note exchange to convert <b>$15M</b> debt and cut >90% of outstanding debt.
Nov 20	PIPE & FDA update	Positive	-12.8%	First PIPE closing and rescheduled BPD Type 2a FDA meeting to Jan 21, 2026.
Nov 14	Q3 results & data	Positive	-3.8%	Q3 results with positive ABP-450 biosimilarity data and new financings.

Pattern Detected

Recent positive financing and development updates have often seen mixed or negative next-day reactions, with only one of four prior events showing aligned upside.

Recent Company History

Over the past few months, AEON has focused on financing and restructuring to support ABP-450’s biosimilar path. In Nov–Dec 2025, it announced a PIPE first closing, a Daewoong note exchange expected to cut >90% of debt, and inducement RSU grants. The Nov 20 PIPE/FDA scheduling update and Q3 2025 report both triggered negative price reactions despite positive program details, while the Dec 15 exchange agreement drew a +5.1% move. Today’s completion of the BPD Type 2a FDA meeting and shareholder approval of the November transactions advances those same themes.

Market Pulse Summary

The stock surged +13.3% in the session following this news. A strong positive reaction aligns with A...

Analysis

The stock surged +13.3% in the session following this news. A strong positive reaction aligns with AEON’s progress on both regulatory and balance sheet fronts. The completed BPD Type 2a FDA meeting and shareholder approval of November’s PIPE and Daewoong exchange advance earlier plans to reduce debt and fund ABP‑450 development. However, prior updates on similar themes saw negative moves despite constructive news, suggesting enthusiasm could fade if execution or future financing steps disappoint. Investors have also faced significant dilution and restructuring over the past year, which may cap sustained upside.

Key Terms

fda, private investment in public equity ("pipe"), pipe financing, convertible notes, +2 more

6 terms

fda regulatory

"it held its BPD Type 2a Meeting with the FDA, in line with prior guidance"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

private investment in public equity ("pipe") financial

"the Company’s private investment in public equity (“PIPE”) financing and the related exchange"

A private investment in public equity (PIPE) is a deal where a public company sells new shares or similar securities directly to a small group of private investors, often at a discount, to raise cash quickly. It matters to investors because it provides an immediate funding boost but can reduce existing shareholders’ ownership percentage and may include extra rights like warrants, so it affects future share value and voting power much like taking a targeted loan paid in ownership.

pipe financing financial

"including the consummation of the PIPE financing and the related Daewoong note exchange"

Pipe financing is a way for companies to raise money quickly by selling new shares or bonds directly to investors, often before their stock is publicly traded or in the early stages of a project. It’s similar to a company securing a loan from investors, providing quick capital needed for growth or operations. For investors, it can offer opportunities for early involvement and potentially higher returns, but it may also carry increased risk due to the immediate nature of the deal.

convertible notes financial

"the related exchange of the Company’s convertible notes held by Daewoong"

Convertible notes are a type of short-term loan that a company receives from investors, which can later be turned into company shares instead of being paid back in cash. They matter to investors because they offer a way to support a company early on while giving the potential to own a stake in its success if the company grows and later raises more funding.

biosimilar medical

"developing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX"

A biosimilar is a medicine created to be highly similar to an existing complex drug made from living cells, matching its safety and effectiveness while allowing for small, natural variations. For investors, biosimilars matter because they introduce lower-cost competition when patents end, which can cut prices, shift market share, and change revenue forecasts for companies selling the original drugs, much like a generic version does for simpler chemical medicines.

u.s. food and drug administration regulatory

"official meeting minutes from the U.S. Food and Drug Administration (“FDA”)"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

AI-generated analysis. Not financial advice.

- AEON confirmed that earlier today it held its BPD Type 2a Meeting with the FDA, in line with prior guidance, and is now awaiting official meeting minutes -

- Separately, AEON shareholders today voted in favor of the proposals required to complete the transactions announced in November, including the consummation of the PIPE financing and the related Daewoong note exchange -

IRVINE, Calif., Jan. 21, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company seeking accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX^® (onabotulinumtoxinA), today reported on two separate positive events for the Company:

• AEON confirmed that earlier today it held its scheduled BPD Type 2a meeting with FDA, in line with prior guidance. The Company looks forward to commenting on the meeting’s substance and outcome following receipt of the official meeting minutes from the U.S. Food and Drug Administration (“FDA”).
• AEON also held today a special meeting at which shareholders voted to approve the completion of the transactions announced in November, including the remaining issuances related to the Company’s private investment in public equity (“PIPE”) financing and the related exchange of the Company’s convertible notes held by Daewoong Pharmaceutical Co., Ltd. (“Daewoong”). As previously disclosed, the Daewoong note exchange, which closed today following shareholder approval, will substantially reduce the Company’s outstanding debt and further simplify AEON’s capital structure. AEON expects to proceed with the second closing of the PIPE financing on or around Tuesday, January 27, 2026, subject to customary closing conditions.
  
  

“We are encouraged by the continued progress we are making early in 2026. The completion of our BPD Type 2a meeting with FDA represents an important procedural milestone, and we now look forward to receiving the official meeting minutes within approximately 30 days, which we expect will help inform next steps for the development of ABP-450, our biosimilar to BOTOX^®,” said Rob Bancroft, President & Chief Executive Officer of AEON. “Additionally, we are thankful to our shareholders for their support of the transactions we announced in November, which strengthen our balance sheet, simplify our capitalization structure and position the company to continue executing on our biosimilar program.”

About the U.S. Biosimilar Pathway

The U.S. Food and Drug Administration (“FDA”) regulates biosimilars under the Public Health Service Act’s 351(k) pathway, which require developers to demonstrate that a proposed product is highly similar to an approved reference biologic with no clinically meaningful differences in safety, purity, or potency. Analytical similarity is the scientific foundation of this process, representing the most critical and data-intensive phase of development. Once analytical comparability across key quality attributes is established, subsequent FDA interactions focus on confirming whether any residual uncertainty requires limited clinical evaluation.

About AEON Biopharma

AEON Biopharma is a biopharmaceutical company seeking accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX^®. The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. The Company’s lead asset is ABP-450 for debilitating medical conditions. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau^®. ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada, and European Medicines Agency. The product is approved as a biosimilar in India, Mexico, and the Philippines. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. To learn more about AEON, visit www.aeonbiopharma.com.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, the satisfaction of remaining closing conditions for the PIPE financing, regulatory developments, and other risks described in the Company’s filings with the Securities and Exchange Commission.

Contacts

Investor Contact:
Laurence Watts
New Street Investor Relations
+1 619 916 7620
laurence@newstreetir.com

Source: AEON Biopharma

FAQ

What did AEON announce about its Jan. 21, 2026 FDA BPD Type 2a meeting (AEON)?

AEON confirmed it held the BPD Type 2a meeting with FDA on Jan. 21, 2026 and expects official meeting minutes within ~30 days.

How does the Daewoong note exchange affect AEON's balance sheet (AEON)?

The Daewoong note exchange closed following shareholder approval and will substantially reduce outstanding debt and simplify capital structure.

When is AEON expecting the second closing of the PIPE financing (AEON)?

AEON expects to proceed with the second closing of the PIPE financing on or around Jan. 27, 2026, subject to customary closing conditions.

What is ABP-450 and how is it referenced after the FDA meeting (AEON)?

ABP-450 is AEON's biosimilar to BOTOX; the company said the FDA meeting's minutes will help inform next development steps.

Did AEON shareholders approve the November transactions (AEON)?

Yes; shareholders voted to approve the proposals required to complete the November transactions, enabling related issuances and exchanges.

What are the immediate uncertainties investors should note after AEON's Jan. 21, 2026 updates (AEON)?

Investors should note the second PIPE closing remains subject to customary conditions and AEON is awaiting FDA meeting minutes before disclosing substantive outcomes.