MannKind Shares FUROSCIX® Business Updates

Rhea-AI Summary

MannKind (Nasdaq: MNKD) announced FDA approval of FUROSCIX On-body Infusor for pediatric patients weighing 43 kg or more and reported issuance of five U.S. patents for the FUROSCIX ReadyFlow Autoinjector, extending IP protection potentially through 2040. The ReadyFlow autoinjector is under FDA review with a PDUFA target action date of July 26, 2026 and, if approved, would deliver an IV-equivalent subcutaneous furosemide dose (80 mg/mL) in under 10 seconds. The pediatric sNDA fulfillment completes post-marketing Pediatric Research Equity Act requirements for FUROSCIX, which previously had adult approvals for CHF (2022) and CKD (2025).

Positive

• FDA approved pediatric indication for patients ≥ 43 kg
• 5 USPTO patents issued for ReadyFlow, protection potentially through 2040
• PDUFA date set for ReadyFlow autoinjector: July 26, 2026
• ReadyFlow aims to deliver an IV-equivalent subcutaneous dose in <10 seconds

Negative

• ReadyFlow autoinjector approval is still pending FDA decision (PDUFA 7/26/2026)
• Pediatric approval limited to a narrow group: patients weighing 43 kg or more

Key Figures

Pediatric weight threshold 43 kg Minimum weight for FUROSCIX On-body Infusor pediatric indication

New U.S. patents 5 patents USPTO-issued patents protecting FUROSCIX ReadyFlow Autoinjector

IP horizon Through 2040 Patent protection timeframe for ReadyFlow high-concentration compositions

PDUFA date July 26, 2026 FDA target action date for FUROSCIX ReadyFlow sNDA

Furosemide concentration 80 mg/mL Subcutaneous dose in FUROSCIX ReadyFlow Autoinjector

Injection time Under 10 seconds Time to deliver IV-equivalent diuretic dose via ReadyFlow

Adult CHF approval 2022 Initial FDA approval of FUROSCIX On-body Infusor for adult chronic heart failure

Adult CKD approval 2025 FDA approval of FUROSCIX On-body Infusor for adult chronic kidney disease

Market Reality Check

$5.66 Last Close

Volume Volume 3,028,150 vs 20-day average 3,438,650 (relative volume 0.88) ahead of this update. normal

Technical Shares at $5.99, trading above 200-day MA at $4.77, sitting 15.28% below the 52-week high.

Peers on Argus

MNKD was up 2.57% while key biotech peers like VCEL and HRMY were also positive (3.09%, 3.71%), but no peers appeared in the momentum scanner and there were no same-day peer headlines, suggesting today’s drivers were stock-specific FUROSCIX updates rather than a coordinated sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 01	Regulatory pipeline update	Positive	+1.5%	FDA acceptance of FUROSCIX ReadyFlow sNDA with defined PDUFA action date.
Nov 11	Conference appearance	Neutral	+0.0%	Jefferies healthcare conference presentation and webcast availability update.
Nov 10	Clinical trial futility	Negative	-3.7%	Discontinuation of Phase 3 MNKD-101 trial after interim futility analysis.
Nov 06	Scholarship program launch	Positive	-5.9%	Launch of $100,000 diabetes-focused scholarship program for life sciences students.
Nov 05	Earnings and M&A update	Positive	+10.6%	Q3 2025 revenue growth and scPharmaceuticals acquisition financing details.

Pattern Detected

Recent MNKD news has mostly seen price moves align with the fundamental tone, with positive regulatory/earnings updates posting gains and negative clinical outcomes selling off, though there is at least one divergence on non-core CSR news.

Recent Company History

Over the last two months, MannKind has reported several important milestones. On Nov 5, 2025, Q3 results showed revenue growth and a business update tied to the scPharmaceuticals acquisition. A Phase 3 trial for MNKD-101 was discontinued on Nov 10, 2025 after futility, followed by a Jefferies conference appearance and acceptance of the FUROSCIX ReadyFlow sNDA with a July 26, 2026 PDUFA date. Today’s pediatric label expansion and new patents build directly on that FUROSCIX franchise trajectory.

Market Pulse Summary

This announcement expanded FUROSCIX On-body Infusor use to pediatric patients ≥43 kg and added five new U.S. patents potentially protecting ReadyFlow into 2040, while reaffirming a PDUFA date of July 26, 2026 for the autoinjector. Set against earlier acceptance of the ReadyFlow sNDA and recent financial growth, the news highlights MannKind’s focus on building a durable FUROSCIX franchise and underscores regulatory and execution milestones as key metrics to watch.

Key Terms

supplemental new drug application (sNDA) regulatory

"The FDA has approved a supplemental New Drug Application (sNDA) for FUROSCIX..."

A supplemental new drug application (snda) is a formal request made to regulatory authorities to make changes to an already approved medication, such as adding new uses, adjusting dosages, or improving manufacturing processes. It’s similar to updating a product’s packaging or instructions after it has been approved for sale. For investors, an snda signals ongoing development or improvements that could impact a company’s future sales or regulatory approval prospects.

pediatric research equity act regulatory

"This additional approval fulfills all post-marketing requirements... under the Pediatric Research Equity Act."

A U.S. law that requires drug makers to study certain medicines in children when a company plans to seek approval for the same drug in adults. Think of it as a rule that ensures children's needs are not ignored by asking for separate testing and data rather than assuming kids respond the same as adults. For investors, it matters because these mandatory studies can change development timelines, costs, and the size of the addressable market for a medicine.

u.s. food and drug administration (fda) regulatory

"The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application..."

The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.

u.s. patent and trademark office (uspto) regulatory

"The U.S. Patent and Trademark Office (USPTO) issued five patents with claims that protect..."

The U.S. Patent and Trademark Office (USPTO) is the federal agency that grants patents for inventions and registers trademarks for brand names and logos, acting like a national property office for ideas and brands. For investors it matters because issued patents and registered trademarks can create legal exclusivity, protect market share, enable licensing revenue, and affect a company’s valuation and risk of costly disputes—similar to owning deeded property for a business’s key assets.

pdufa regulatory

"The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date..."

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

orange book regulatory

"The patents would be listed in the FDA’s Orange Book, if the FUROSCIX ReadyFlow Autoinjector is approved..."

A publicly maintained FDA database that lists approved prescription drugs and notes which versions are considered interchangeable with brand-name products, along with key patent and exclusivity dates. Think of it as a product roster plus an expiration calendar: investors use it to see when a drug’s protection ends and generic competition can enter, which can directly affect a company’s sales, future revenue and stock value.

autoinjector technical

"FUROSCIX ReadyFlow Autoinjector Could Transform Care from Hours to Seconds..."

A prefilled, spring‑loaded medical device that automatically delivers a measured dose of medication beneath the skin when pressed against the body, like a self‑operating syringe packaged for quick use. Investors care because autoinjectors can increase patient safety, adherence and convenience — factors that drive demand, shape reimbursement and regulatory review, and affect a product’s market size, manufacturing complexity and competitive moat.

subcutaneous medical

"would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/mL)..."

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

AI-generated analysis. Not financial advice.

• FDA approves FUROSCIX^® for use in pediatric patients weighing 43kg or above
• USPTO issues five patents for FUROSCIX ReadyFlow^™ Autoinjector

WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced two business updates—approval of the FUROSCIX^® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage FUROSCIX ReadyFlow^™ Autoinjector, which is currently under review by the U.S. FDA.

FUROSCIX Expanded Treatment Options for Appropriate Pediatric Patients
The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FUROSCIX^® (furosemide) On-body Infusor, expanding the indication of this product to include pediatric patients weighing 43 kg or more. FUROSCIX was previously approved for the treatment of edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults. This additional approval fulfills all post-marketing requirements outlined in the original approval letter under the Pediatric Research Equity Act.

“We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria,” said Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation.

Five New U.S. Patents Provide Protection to FUROSCIX ReadyFlow Autoinjector
The U.S. Patent and Trademark Office (USPTO) issued five patents with claims that protect the FUROSCIX ReadyFlow Autoinjector. These patents cover the high-concentration liquid compositions of furosemide and associated methods of treatment potentially through 2040, further reinforcing MannKind’s intellectual property position around this innovative drug-device combination. The patents would be listed in the FDA’s Orange Book, if the FUROSCIX ReadyFlow Autoinjector is approved by the FDA.

The newly issued patents complement previously issued patents supporting FUROSCIX and the FUROSCIX ReadyFlow Autoinjector, creating a robust IP portfolio that is designed to protect the formulation and delivery approach for years to come.

FUROSCIX ReadyFlow Autoinjector Could Transform Care from Hours to Seconds
MannKind recently announced that the FDA accepted for review its sNDA for the FUROSCIX ReadyFlow Autoinjector for the treatment of edema in adults with CHF or CKD. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.

If approved, the FUROSCIX ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/mL) in under 10 seconds, providing a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROSCIX On-body Infusor was approved in 2022 for the treatment of edema in adult patients with chronic heart failure and, in 2025, for adult patients with chronic kidney disease in 2025.

“FUROSCIX ReadyFlow Autoinjector has the potential to redefine how patients manage fluid overload episodes,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “By delivering an IV-equivalent diuretic dose in seconds from the comfort of home, this innovation, if approved, could significantly reduce hospital visits, improve quality of life, and lower healthcare costs—creating meaningful value for patients, providers, and payers alike.”

About FUROSCIX
FUROSCIX^® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease, including the nephrotic syndrome.

IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives. 

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO₂, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.

Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.

In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.

Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.

The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Please see the full Prescribing Information (https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf) and Instructions for Use (https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf).

About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including statements about a potential regulatory action date, statements regarding the potential duration of patent protection and statements regarding the potential benefits of the administration of furosemide via an autoinjector for providers, patients and payors. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that issues that develop in the review by the FDA may subject us to unanticipated delays or prevent us from obtaining marketing approval, the risk that we may be unable to protect our proprietary rights as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

FUROSCIX is a registered trademark of scPharmaceuticals, a wholly owned subsidiary of MannKind Corporation.

MANNKIND is a registered trademark of MannKind Corporation.

MannKind Contacts:

Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com

Investor Relations:
Kate Miranda
(781) 301-6869
ir@mnkd.com

FAQ

What pediatric indication did MannKind (MNKD) receive for FUROSCIX on Dec 23, 2025?

The FDA approved FUROSCIX for pediatric patients weighing 43 kg or more to treat edema related to CHF or CKD.

How long will the new U.S. patents for the FUROSCIX ReadyFlow autoinjector potentially protect the product?

MannKind said five newly issued U.S. patents could protect the ReadyFlow autoinjector potentially through 2040.

When is the FDA decision expected for the FUROSCIX ReadyFlow autoinjector (MNKD)?

The ReadyFlow autoinjector has a PDUFA target action date of July 26, 2026.

What clinical delivery capability does the ReadyFlow autoinjector claim to offer if approved?

If approved, ReadyFlow would deliver an IV-equivalent subcutaneous furosemide dose (80 mg/mL) in under 10 seconds.

Does the recent pediatric approval satisfy MannKind's regulatory requirements for FUROSCIX?

Yes; the pediatric approval fulfills the post-marketing requirements under the Pediatric Research Equity Act.