Emergent BioSolutions Receives U.S. FDA Approval of Supplemental New Drug Application (sNDA) for NARCAN® Nasal Spray Multipacks

Rhea-AI Summary

Emergent BioSolutions (NYSE: EBS) announced FDA approval of an sNDA on Feb 12, 2026, for OTC NARCAN® Nasal Spray multipacks in new 6-count and 24-count configurations.

The multipacks are designed for higher-volume distribution, will be sold to public interest customers via NARCANDirect, and complement a January 2026 FDA approval of the NARCAN carrying case. Existing product formats will remain available. Since 2016, more than 85 million doses have been distributed in the U.S. and Canada.

Positive

• FDA approved sNDA for 6-count and 24-count multipacks (Feb 12, 2026)
• New multipacks enable higher-volume distribution for community programs
• Availability through NARCANDirect for public interest customers
• Complements Jan 2026 FDA approval of NARCAN carrying case
• Over 85 million NARCAN doses distributed since 2016

Negative

• None.

Key Figures

Share price: $10.85 Daily move: -1.63% 52-week range: $4.02–$14.06 +5 more

8 metrics

Share price $10.85 Pre-news trading level for EBS

Daily move -1.63% Change over the last 24 hours before this news

52-week range $4.02–$14.06 52-week low and high before this news

Multipack sizes 6-count and 24-count New OTC NARCAN® Nasal Spray multipack configurations approved by FDA

Doses distributed >85 million NARCAN® Nasal Spray doses distributed in U.S. and Canada since 2016

Volume vs average 458,880 vs 824,983 Today’s volume vs 20-day average (0.56x)

Market cap $579,295,203 Equity value before this announcement

Prior FDA move 3.04% 24h reaction to Jan 14, 2026 NARCAN® sNDA approval

Market Reality Check

Price: $10.85 Vol: Volume 458,880 is about 4...

low vol

$10.85 Last Close

Volume Volume 458,880 is about 44% below the 20-day average of 824,983 (relative volume 0.56x). low

Technical Shares at $10.85 are trading above the 200-day MA of $8.96 and about 22.83% below the 52-week high of $14.06.

Peers on Argus

EBS slipped 1.63% while peers were mixed: KMDA up 1.66%, ETON up 3.9%, EOLS down...

EBS slipped 1.63% while peers were mixed: KMDA up 1.66%, ETON up 3.9%, EOLS down 2.95%, CGC down 4.63%, SIGA roughly flat. Moves do not indicate a unified sector reaction.

Previous Clinical trial,fda approval Reports

1 past event · Latest: Jan 14 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	Move	Catalyst
Jan 14	FDA sNDA approval	Positive	+3.0%	FDA cleared NARCAN Nasal Spray for packaging in a new compact carrying case.

Pattern Detected

Prior same-tag FDA supplemental approval news saw a modest positive reaction of about 3.04% the next day.

Recent Company History

Recent history for Emergent shows continued FDA-related enhancements to the NARCAN® Nasal Spray franchise. On Jan 14, 2026, a supplemental NDA approval for a new carrying case aimed at everyday preparedness led to a 3.04% gain over 24 hours. Today’s multipack sNDA approval further extends accessibility and distribution options, aligning with this earlier regulatory milestone and reinforcing a theme of incremental product-format expansion rather than new active ingredients.

Historical Comparison

clinical trial,fda approval

+3.0 %

Average Historical Move

Historical Analysis

In the past 6 months, EBS had 1 prior FDA-related sNDA news for NARCAN® Nasal Spray, with an average next-day move of 3.04%. Today’s approval continues that pattern of incremental label and format expansions for the same product line.

Typical Pattern

The company has progressed from securing FDA approval for a discreet NARCAN® carrying case to gaining approval for 6-count and 24-count OTC multipacks, emphasizing broader accessibility and large-volume distribution.

Market Pulse Summary

This announcement adds 6-count and 24-count OTC multipacks to the NARCAN® Nasal Spray line, targetin...

Analysis

This announcement adds 6-count and 24-count OTC multipacks to the NARCAN® Nasal Spray line, targeting higher-volume distributors and community programs. It follows the Jan 14, 2026 sNDA approval for a new carrying case, reinforcing a focus on accessibility. Investors may track how these formats affect ordering patterns through NARCANDirect®, overall naloxone volume growth, and subsequent regulatory or commercial updates around the more than 85 million doses already distributed.

Key Terms

supplemental new drug application, snda, over-the-counter, otc, +2 more

6 terms

supplemental new drug application regulatory

"announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA)"

A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.

snda regulatory

"has approved its supplemental New Drug Application (sNDA) for new multipack configurations"

A SNDA (Subordination, Non‑Disturbance and Attornment Agreement) is a legal pact among a property owner’s lender, the owner’s tenants, and sometimes the landlord that sets who keeps lease rights if the property is sold or a mortgage is enforced. Think of it as a rulebook that decides whether a tenant can stay and keep paying rent or must answer to a new owner after a foreclosure. For investors, an SNDA matters because it protects predictable rental income, clarifies who has priority on claims against a property, and therefore affects a property’s value and the security of related loans.

over-the-counter regulatory

"new multipack configurations of over-the-counter (OTC) NARCAN® Nasal Spray"

Over-the-counter describes securities or trades that occur directly between buyers and sellers rather than on a formal stock exchange. Think of it like buying at a flea market instead of a big supermarket: prices, rules and transparency can vary, which can mean lower liquidity, wider price swings and less regulatory oversight—factors investors watch because they affect ease of trading and risk level.

otc regulatory

"new multipack configurations of over-the-counter (OTC) NARCAN® Nasal Spray"

OTC stands for "over-the-counter" and describes securities that trade directly between dealers or via dealer networks rather than on a formal stock exchange. It matters to investors because OTC listings typically have fewer reporting rules and lower trading volume, which can mean higher price swings, limited liquidity, and greater difficulty buying or selling shares—similar to shopping at a small flea market instead of a large, regulated supermarket.

naloxone medical

"specifically designed to meet the needs of partners distributing higher volumes of naloxone"

Naloxone is a fast-acting medication that temporarily reverses the life-threatening effects of opioid overdose by blocking opioids’ effects on the brain, like an emergency master key that unlocks someone from a dangerous drug-induced shutdown. It matters to investors because demand, pricing, regulatory approvals, product formulations (injectable, nasal spray), and government purchasing programs can drive sales, affect company valuations, and influence litigation and public-health-related revenue streams.

opioid overdose medical

"ready access to this life-saving medication in the event of an opioid overdose emergency"

An opioid overdose occurs when a person takes more of an opioid drug than their body can handle, causing dangerously slow or stopped breathing, loss of consciousness, and possible death; it can result from prescription painkillers, illegal opioids, or mixing with other sedatives. Investors should care because overdose trends drive regulatory action, litigation, demand for antidotes and safer therapies, and can materially affect sales, costs, reputations and underwriting risks for drugmakers, hospitals, insurers and others — like a safety failure that reshapes a company’s financial outlook.

AI-generated analysis. Not financial advice.

• Approval will broaden the NARCAN^® Nasal Spray portfolio, and improve cost-effectiveness by increasing flexibility and distribution efficiency of this life-saving medication 
  

GAITHERSBURG, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for new multipack configurations of over-the-counter (OTC) NARCAN^® Nasal Spray. This approval expands the NARCAN^® Nasal Spray product suite to include 6-count and 24-count multipack options, specifically designed to meet the needs of partners distributing higher volumes of naloxone. These new formats offer enhanced flexibility with the same trusted product, benefiting community programs and organizations operating large-scale, multi-site, or high-volume distribution programs.

“At Emergent, we work closely with our partners to develop solutions that help improve delivery, distribution and accessibility of NARCAN^® Nasal Spray,” said Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent. “The introduction of NARCAN^® Nasal Spray multipacks marks a significant step in empowering our partners on the front lines. They can now better streamline bulk distribution, support broad preparedness efforts, and ultimately ensure that more communities and individuals have ready access to this life-saving medication in the event of an opioid overdose emergency.”  

This approval builds on Emergent's ongoing commitment to enhancing NARCAN^® Nasal Spray accessibility and usability, complementing the recent FDA approval of the NARCAN^® Nasal Spray Carrying Case in January 2026. These efforts underscore Emergent’s comprehensive approach to equipping individuals and organizations with effective tools to combat opioid overdose deaths. The 6-count and 24-count multipacks will be made available soon to purchase for public interest customers through NARCANDirect^®, Emergent’s proprietary ordering and distribution platform. These multipacks are an addition to the current portfolio and will not replace existing product formats. Since the prescription launch of NARCAN^® Nasal Spray in 2016, more than 85 million doses have been distributed across the U.S. and Canada. Visit NARCAN.com and ReadytoRescue.com to learn more.

About NARCAN^® Nasal Spray
NARCAN^® Naloxone HCl Nasal Spray 4 mg is the first FDA-approved, over-the-counter (OTC) 4 mg naloxone product for the emergency treatment of opioid overdose. NARCAN^® Nasal Spray is not a substitute for emergency medical care. Repeat dosing may be necessary. Use as directed.

About Emergent BioSolutions
At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. 

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are forward-looking statements. We generally identify forward-looking statements by using words like "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "future," "goal," "intend," "may," "plan," "position," "possible," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.  

There are a number of important factors that could cause the company's actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements.

Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
lindahlr@ebsi.com

Media Contact:
Assal Hellmer
Vice President, Communications
mediarelations@ebsi.com

FAQ

What did Emergent (EBS) announce on Feb 12, 2026 about NARCAN multipacks?

Emergent announced FDA approval of OTC NARCAN multipacks in 6-count and 24-count formats. According to the company, the approval expands the product suite to support high-volume distribution and public interest customers via NARCANDirect.

How will the new 6-count and 24-count NARCAN multipacks be distributed by Emergent (EBS)?

The multipacks will be made available for purchase to public interest customers through NARCANDirect. According to the company, this is intended to streamline bulk distribution for community and multi-site programs.

Does the Feb 12, 2026 approval replace existing NARCAN product formats from Emergent (EBS)?

No, the new multipacks will not replace existing product formats. According to the company, the 6-count and 24-count options are an addition to the current NARCAN portfolio.

How does the Feb 12, 2026 multipack approval relate to other recent NARCAN approvals by Emergent (EBS)?

This approval complements the January 2026 FDA approval of the NARCAN carrying case. According to the company, both steps broaden accessibility and usability for overdose preparedness.

How many NARCAN doses has Emergent distributed since the prescription launch in 2016?

More than 85 million doses have been distributed across the U.S. and Canada since 2016. According to the company, this cumulative distribution underscores broad use of NARCAN products.