Celularity Reiterates Strategic Commercialization Partnership with NEXGEL Focused on Building Biomaterials Franchise with Established Commercial Products and New 510(k) Pathway Product Opportunities

Rhea-AI Summary

Celularity (Nasdaq: CELU) reiterated its strategic commercialization partnership with NEXGEL (Nasdaq: NXGL) to license established biomaterial products and three 510(k) pathway programs. Celularity will be the exclusive manufacturer at its FDA-compliant Florham Park, New Jersey facility.

The transaction is expected to close no later than April 15, 2026, subject to customary closing conditions, and aims to leverage renewed regulatory and reimbursement clarity for placental-derived biomaterials.

Positive

• Exclusive manufacturing agreement at FDA-compliant Florham Park facility
• Established commercial products licensed to NEXGEL (Biovance, Natalin, Interfyl, Acelagraft, Centaflex)
• Three 510(k) pipeline programs (SPARK, FUSE, ORCHID) with potential market impact
• Transaction expected to close by April 15, 2026

Negative

• Transaction subject to customary closing conditions, creating execution risk
• Pipeline programs described as potential disruptors but lack clear regulatory approvals

News Market Reaction – CELU

-0.78%

4 alerts

-0.78% News Effect

+3.0% Peak Tracked

-11.9% Trough Tracked

-$313K Valuation Impact

$39.80M Market Cap

0.3x Rel. Volume

On the day this news was published, CELU declined 0.78%, reflecting a mild negative market reaction. Argus tracked a peak move of +3.0% during that session. Argus tracked a trough of -11.9% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $313K from the company's valuation, bringing the market cap to $39.80M at that time.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement reiterates a commercialization partnership with NEXGEL, transferring established b...

Analysis

This announcement reiterates a commercialization partnership with NEXGEL, transferring established biomaterial brands and three 510(k)-pathway programs while keeping Celularity as exclusive manufacturer. It reinforces a strategy of monetizing placental-derived assets through partners and leveraging the FDA-compliant Florham Park facility. Investors may watch for closing by April 15, 2026, evidence of sales traction under NEXGEL, and how this supports Celularity’s shift toward longevity-focused cellular therapeutics.

Key Figures

510(k) programs: 3 programs 510(k) pathway: 510(k) Expected closing date: April 15, 2026

3 metrics

510(k) programs 3 programs SPARK, FUSE, ORCHID medical device pathway products licensed to NEXGEL

510(k) pathway 510(k) Planned regulatory route for SPARK, FUSE, and ORCHID devices

Expected closing date April 15, 2026 Target latest closing date for Celularity–NEXGEL transaction

Previous Partnership Reports

1 past event · Latest: Jul 09 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 09	Strategic partnership	Positive	+12.2%	Partnership with Fountain Life to supply stem cell therapies under new Florida law.

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

Pattern Detected

Partnership news previously drew a positive price reaction, suggesting investors have rewarded collaboration-driven growth catalysts.

Recent Company History

This announcement builds on Celularity’s history of leveraging partnerships and external programs to monetize its placental-derived platform. A prior July 9, 2025 partnership with Fountain Life for stem cell therapies in Florida produced a 12.17% next-day gain. More recently, the company has executed licensing and financing deals to focus on longevity-focused therapeutics while keeping its New Jersey facility central to manufacturing and commercialization strategies.

Key Terms

510(k), medical device, fda-compliant, contract manufacturing, +1 more

5 terms

510(k) regulatory

"Three pipeline 510(k) medical device pathway programs SPARK, FUSE, and ORCHID"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

medical device regulatory

"Three pipeline 510(k) medical device pathway programs SPARK, FUSE, and ORCHID"

Tools, instruments, or machines used to diagnose, treat or monitor health conditions—ranging from simple items like bandages and thermometers to complex machines such as imaging scanners or implantable devices. Investors care because a device’s safety, effectiveness, and approval by health regulators affect sales, legal risk and ongoing costs; think of a medical device like a new appliance whose market success hinges on reliable performance, safety reviews and customer adoption.

fda-compliant regulatory

"exclusive manufacturer of the licensed products at its FDA-compliant facility in Florham Park"

FDA-compliant means a product, manufacturing process, labeling, or clinical practice meets the U.S. Food and Drug Administration’s requirements for safety, effectiveness, quality, and proper marketing. For investors, FDA compliance is like a vehicle passing a safety inspection: it enables legal market access, reduces the risk of costly recalls or fines, and influences how quickly and reliably a company can generate revenue from regulated products.

contract manufacturing financial

"focus on a core strength—contract manufacturing—where we have demonstrated over many years"

Contract manufacturing is when a company hires a specialized outside firm to produce its products or components instead of making them itself. For investors this matters because it can lower upfront costs and speed growth, but also creates dependencies on suppliers that affect profit margins, quality control, and supply-chain risk—think of it like having a neighborhood bakery bake and pack your recipe so you can sell more without buying ovens.

reimbursement regulatory

"capitalize on renewed regulatory and reimbursement clarity around placental-derived biomaterials"

Reimbursement is the payment a healthcare payer (like an insurance company or government program) provides to a patient, doctor, or company for the cost of a medicine, device, or medical service. It matters to investors because whether and how much a payer will cover a product determines how many patients can afford it and how much revenue the maker can realistically earn—think of it like whether a preferred credit card covers a purchase, which affects how often customers buy it.

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

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• Biovance, Biovance 3L, Natalin, Acelagraft, Interfyl and Centaflex licensed to NEXGEL are established commercial products widely used today in wound care, orthopedics and other indications.
  
• Three pipeline 510(k) medical device pathway programs SPARK, FUSE, and ORCHID licensed to NEXGEL are potential market disruptors.
  
• Celularity will be the exclusive manufacturer of the licensed products at its FDA-compliant facility in Florham Park, New Jersey, where its vertically integrated manufacturing infrastructure is designed to support scalable, quality-driven production for both commercial-stage products and next-generation placental-derived cellular therapeutics.
  

FLORHAM PARK, N.J., March 12, 2026 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a regenerative and cellular medicine company focused on longevity science, today reiterated that its strategic commercialization partnership with NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: NXGL) is a focused effort by the two companies to rapidly capitalize on renewed regulatory and reimbursement clarity around placental-derived biomaterials and build sales and market share. The transaction is expected to close no later than April 15, 2026, subject to customary closing conditions.

“This strategic deal with NEXGEL allows Celularity to focus on a core strength—contract manufacturing—where we have demonstrated over many years our ability to scale and execute cost efficient biomaterial production at a pharmaceutical-like grade,” said Robert J. Hariri, M.D., Ph.D., Chairman and Chief Executive Officer. “NEXGEL is the ideal partner to take these biomaterial products to the next level, with a disciplined, entrepreneurial approach and proven ability to drive value and market growth across industry verticals. Congratulations to the Celularity and NEXGEL teams as we look forward to closing the transaction in April.”

About Celularity

Celularity Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous cell therapies derived from the postpartum placenta. Celularity leverages the placenta’s unique biology, immunologic properties, and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease.

For more information, please visit www.celularity.com.

Forward-Looking Statements

Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the anticipated closing of the strategic commercialization partnership described herein and the expected timing thereof; the potential receipt of upfront consideration, milestone payments, royalties and manufacturing revenues associated with the transaction; the anticipated operational and strategic benefits of the partnership; Celularity’s strategic focus on longevity science, scalable manufacturing infrastructure and capital efficiency; the continued development, regulatory advancement and commercialization of the licensed biomaterials portfolio and development-stage programs; and Celularity’s plans to pursue commercial and clinical opportunities for its technologies in jurisdictions that permit investigational use under applicable law.

Forward-looking statements are based on Celularity’s current expectations and assumptions regarding future events and are subject to risks, uncertainties and changes in circumstances that are difficult to predict. Words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “should,” “will,” and similar expressions are intended to identify forward-looking statements.

Actual results may differ materially from those expressed or implied in forward-looking statements as a result of various risks and uncertainties, including, without limitation, the ability of the parties to satisfy closing conditions and complete the transaction on the anticipated timeline or at all; the ability to realize anticipated financial benefits of the transaction, including milestone payments, royalties or manufacturing revenues; variability in manufacturing volumes or product demand; regulatory developments affecting the development, manufacture or commercialization of Celularity’s products; the successful execution of Celularity’s strategic realignment and organizational restructuring; the development and commercialization of Celularity’s longevity-focused therapeutic programs; and the other risks and uncertainties described under the caption “Risk Factors” in Celularity’s Annual Report on Form 10-K and Form 10-K/A for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on May 8, 2025, and May 21, 2025, respectively, and in Celularity’s other filings with the SEC.

Forward-looking statements speak only as of the date of this press release. Except as required by law, Celularity undertakes no obligation to update or revise any forward-looking statements contained herein to reflect events or circumstances occurring after the date of this press release.

Investor Contact
Carlos Ramirez, Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com

FAQ

What did Celularity (CELU) announce about its partnership with NEXGEL on March 12, 2026?

Celularity reiterated a strategic commercialization partnership licensing established biomaterials and 510(k) programs to NEXGEL. According to Celularity, the deal includes exclusive manufacturing at its Florham Park FDA-compliant facility and targets faster commercialization under clarified regulatory and reimbursement conditions.

Which products and programs did Celularity license to NEXGEL in the CELU announcement?

Celularity licensed established products including Biovance, Biovance 3L, Natalin, Acelagraft, Interfyl, and Centaflex. According to Celularity, three pipeline 510(k) programs—SPARK, FUSE, and ORCHID—were also licensed to NEXGEL.

When is the Celularity and NEXGEL transaction expected to close for CELU shareholders?

The companies expect the transaction to close no later than April 15, 2026. According to Celularity, completion remains subject to customary closing conditions and regulatory steps before the listed date.

What manufacturing role will Celularity (CELU) play after the NEXGEL deal?

Celularity will serve as the exclusive manufacturer for the licensed products at its Florham Park facility. According to Celularity, its vertically integrated, FDA-compliant infrastructure will support scalable, quality-driven production for these biomaterials.

How do the licensed 510(k) programs (SPARK, FUSE, ORCHID) affect CELU's business strategy?

The 510(k) programs add potential near-term device opportunities to the licensed portfolio while Celularity focuses on manufacturing. According to Celularity, these programs are positioned as potential market disruptors under NEXGEL's commercialization plan.