MannKind Data at HFSA 2026 Highlights New Evidence Supporting Furoscix ReadyFlow™ for the Outpatient Management of Edema in Heart Failure (HF) and Chronic Kidney Disease (CKD)

Thigh and upper-arm injections met drug-exposure equivalence criteria, while comparisons between delivery devices involved separate study populations.

Rhea-AI Summary

MannKind (MNKD) announced new clinical analyses of Furoscix ReadyFlow showing comparable urine output to intravenous furosemide for outpatient fluid-overload treatment. The findings are scheduled for presentation at HFSA’s October 9–12, 2026 meeting in Phoenix.

A randomized crossover study met predetermined criteria for equivalent total drug exposure at thigh and upper-arm injection sites. Relative bioavailability was 91.3% in the thigh and 92.7% in the upper arm. Urine output and urinary sodium excretion were similar across treatments; the therapy was generally well tolerated. A separate post-hoc analysis found comparable responses between ReadyFlow and the Furoscix On-body Infusor, but comparisons require caution because studies involved separate populations.

ReadyFlow received FDA approval in July 2026 for fluid overload associated with heart failure or chronic kidney disease in adults and has launched in the United States.

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0 major · 2 points

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Positive

• Moderate pointReadyFlow received FDA approval in July 2026 for adult heart failure- or CKD-related fluid overload.
• Minor pointReadyFlow’s U.S. launch adds an autoinjector-based treatment option.
• Minor pointThigh and upper-arm injections met drug-exposure bioequivalence criteria, with relative bioavailability of 91.3% and 92.7%, respectively.
• Minor pointRandomized crossover study showed similar urine output and urinary sodium excretion across treatments.
• Minor pointReadyFlow was generally well tolerated in the randomized crossover study.
• Minor pointPost-hoc analysis found both subcutaneous formulations bioequivalent to IV furosemide, with comparable diuretic and sodium-excretion responses.

Negative

• Minor pointReadyFlow–On-body Infusor comparisons require caution because the studies involved separate populations.
• Minor pointFuroscix safety risks include dehydration, low blood pressure, increased blood glucose and hearing problems.

Key Figures

ReadyFlow dose concentration: 80 mg/mL Administration time: under 10 seconds Relative bioavailability: 91.3% +1 more

ReadyFlow dose concentration

80 mg/mL

Furoscix ReadyFlow autoinjector

Administration time

under 10 seconds

Full dose delivered by autoinjector

Relative bioavailability

91.3%

Thigh injection versus IV furosemide

Relative bioavailability

92.7%

Upper-arm injection versus IV furosemide

Historical Context

1 past event · Latest: Aug 05

1 event

1. Aug 05

   Quarterly results

   24h Move

   -5.1%

   Quarterly update cited ReadyFlow FDA approval before these product-specific clinical analyses.

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

Key Terms

pharmacokinetic, pharmacodynamic, bioequivalence, auc, +1 more

5 terms

pharmacokinetic medical

"further characterize the pharmacokinetic (PK) and pharmacodynamic (PD) performance"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

pharmacodynamic medical

"further characterize the pharmacokinetic (PK) and pharmacodynamic (PD) performance"

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

bioequivalence medical

"Both subcutaneous formulations achieved bioequivalence to IV furosemide"

When two medicines deliver the same amount of active ingredient into the bloodstream at about the same speed and level, they are considered bioequivalent. Investors care because bioequivalence is the regulatory test that allows generic or reformulated drugs to replace branded products without new safety trials, often opening large, lower‑cost market opportunities and changing a drug maker’s sales and competitive position—like two recipes that taste the same but sell at different prices.

auc medical

"met the pre-determined bioequivalence criteria for AUC compared to IV furosemide"

Area under the curve (AUC) measures the total exposure of the body to a drug over time by calculating the area beneath a plot of drug concentration versus time. For investors, AUC indicates how much of a medicine reaches and stays in the bloodstream, which affects dosing, safety and effectiveness—similar to measuring how much water flows through a pipe over a day rather than just its peak pressure.

natriuresis medical

"comparable diuretic and natriuretic responses"

The increased excretion of sodium in the urine. Natriuresis occurs when kidneys filter and secrete more sodium into urine than usual, a process that often reduces body water and blood volume because water follows sodium; it can be triggered by hormones, changes in kidney function, medications (like diuretics), or certain diseases and is measured to assess fluid and electrolyte balance.

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• New analyses on Furoscix ReadyFlow PK/PD performance delivered via an autoinjector demonstrated comparable urine output to IV furosemide
• Consistent bioavailability, diuresis and natriuresis across injection sites support flexible administration in clinical practice
• Cross-study analysis demonstrates comparable diuretic and natriuretic responses between Furoscix ReadyFlow and Furoscix^® (furosemide) On-body Infusor, supporting a seamless transition to ReadyFlow
• Data presentations build on the July 2026 FDA approval and U.S. launch of Furoscix ReadyFlow, the first and only autoinjector delivering IV-equivalent diuretic therapy for heart failure- and CKD-related edema (fluid overload)
  
  

WESTLAKE VILLAGE, Calif., Oct. 09, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today announced new clinical data related to Furoscix ReadyFlow (furosemide injection) that will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2026, taking place October 9-12, 2026, in Phoenix.

The presentations further characterize the pharmacokinetic (PK) and pharmacodynamic (PD) performance of Furoscix ReadyFlow, MannKind’s recently approved autoinjector designed to deliver an 80 mg/mL dose of furosemide in under 10 seconds. Together, the findings reinforce the therapy’s IV-equivalent exposure and diuretic effect while highlighting administration flexibility and the potential to support outpatient management of worsening congestion in patients with heart failure (HF) or chronic kidney disease (CKD).

“As healthcare providers seek ways to manage worsening congestion earlier and outside the hospital setting, these data add to the growing body of evidence supporting Furoscix ReadyFlow as an important treatment option for patients with heart failure or chronic kidney disease,” said Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation. “The findings presented at the HFSA ASM reinforce the consistent pharmacologic performance of Furoscix ReadyFlow while demonstrating flexibility that may help clinicians incorporate this innovative therapy into patient care.”

Key presentations:

Pharmacokinetic and Pharmacodynamic Profiles of Subcutaneous Furosemide Administered as a 5-Hour Infusion and 10-Second Injection
This post-hoc analysis juxtaposed PK and PD characteristics of the concentrated formulation of the subcutaneous furosemide autoinjector, formerly referred to as SCP-111 and now marketed as Furoscix ReadyFlow, and the Furoscix On-body Infusor. Both subcutaneous formulations achieved bioequivalence to IV furosemide and produced comparable diuretic and natriuretic responses. Cross-study comparisons should be interpreted cautiously because the two studies were conducted in separate populations. The findings demonstrate that both delivery approaches provide IV-equivalent outpatient diuresis while also demonstrating the rapid administration characteristics of the autoinjector.

Subcutaneous Injection of Furosemide: Consistent Pharmacokinetic and Pharmacodynamic Profiles Across Thigh and Arm Injection Sites Versus Intravenous Administration When Administered Via an Autoinjector
This randomized crossover study evaluated subcutaneous furosemide delivered via autoinjector in the thigh and in the upper arm compared with intravenous (IV) administration of furosemide. Furoscix ReadyFlow met the pre-determined bioequivalence criteria for AUC compared to IV furosemide at both injection sites, with relative bioavailability of 91.3% in the thigh and 92.7% in the upper arm. Measures of urine output and urinary sodium excretion were similar across treatments, and the therapy was generally well tolerated. These findings support the use of these alternative injection sites while maintaining consistent therapeutic performance.

“Patients living with heart failure and chronic kidney disease often experience recurrent episodes of worsening fluid overload that can lead to emergency department visits and hospitalization,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “With the recent launch of Furoscix ReadyFlow, healthcare providers now have access to a new autoinjector-based treatment option designed to deliver IV-equivalent diuretic therapy in seconds. These data presented at HFSA reinforce our commitment to advancing innovative solutions that may help patients receive treatment earlier and outside traditional hospital settings.”

Building on the Recent Approval and Launch of Furoscix ReadyFlow

In July 2026, the U.S. Food and Drug Administration approved Furoscix ReadyFlow for the treatment of fluid overload associated with heart failure or chronic kidney disease in adults. Furoscix ReadyFlow is the first and only autoinjector delivering subcutaneous furosemide with IV-equivalent exposure and diuretic effect, providing a full 80 mg/mL dose in a single administration in under 10 seconds. The therapy was designed to support earlier intervention for worsening fluid overload and may help expand treatment opportunities across outpatient, post-discharge and home-based care settings.

Visit MannKind at HFSA ASM 2026

MannKind’s commercial and medical affairs teams will be available at booth 428 throughout HFSA 2026 to discuss Furoscix and how it may support healthcare professionals managing fluid overload in patients with heart failure or chronic kidney disease.

What is Furoscix^® (furosemide injection) for subcutaneous use?
Furoscix is a prescription medicine used to treat fluid buildup, which can cause congestion or swelling (also known as edema), in pediatric patients who weigh at least 95 lbs. (43 kg) and adult patients with chronic heart failure or chronic kidney disease.

Furoscix ReadyFlow is not intended for use in children less than 18 years old.

Furoscix should be replaced with oral diuretics as directed by a healthcare provider. Follow the instructions provided by your physician when taking Furoscix.

IMPORTANT SAFETY INFORMATION
Before taking Furoscix, read the Instructions for Use and tell your healthcare provider about all your medical conditions, including if you have liver problems, trouble urinating, are allergic to furosemide or any of the ingredients in Furoscix, or if you are allergic to medical adhesives.

What are the possible side effects of Furoscix?
Dehydration: Furoscix can cause you to lose excess water and electrolytes. Symptoms of excess water and electrolyte loss include dry mouth, increased thirst, muscle pains or cramps, decreased urine output or urine more yellow than normal, headache, dry skin, nausea or vomiting. Your healthcare provider may check your electrolytes while receiving Furoscix.

Low Blood Pressure: Furoscix may cause your blood pressure to decrease temporarily. You may feel lightheaded or dizzy, particularly when you stand up. Getting up slowly may help.

High Blood Sugar: If you have diabetes mellitus, Furoscix may increase blood glucose levels.

Loss of Hearing: Furoscix can cause ringing in your ears. Tell your healthcare provider if you have trouble hearing while taking Furoscix.

Incomplete Dosing: When using the Furoscix ReadyFlow, if the viewing window does not turn completely yellow, or if you lift the Furoscix ReadyFlow off your skin too early, you may not receive a full dose. This could cause the medicine to not work as well as it should. If this happens call your healthcare provider for more instructions. Do not use another Furoscix ReadyFlow unless instructed to do so by your healthcare provider.

Getting the Furoscix On-body Infusor wet or moving your body so that it falls off or does not stick to your skin during treatment may stop the delivery of medicine before you receive a full dose. This could cause the medicine to not work as well as it should. If this happens call your healthcare provider for more instructions. Do not use a new On-body Infusor unless instructed to do so by your healthcare provider.

Your skin may be more sensitive to sunlight while taking Furoscix.

The most common side effects with Furoscix are administration site and skin reactions such as bruising, redness, swelling and administration site pain.

Call your healthcare provider for medical advice about side effects. You may report side effects to MannKind at 1-877-323-8505 or to the FDA at 1-800-FDA-1088.

For more information about Furoscix, please see the full Prescribing Information (www.furoscix.com/prescribing-information.pdf) and Instructions for use (www.furoscix.com/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
Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding opportunities to help patients receive treatment earlier and outside traditional hospital settings. 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 MannKind’s products may only achieve a limited degree of commercial success, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025 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, FUROSCIX READYFLOW and MANNKIND are trademarks of MannKind Corporation.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/b0c920d1-d4c8-470b-99e4-bd3af4869709

https://www.globenewswire.com/NewsRoom/AttachmentNg/6b71d5d0-822b-4c5e-a56c-002256924f7d

MannKind Contacts:

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

Investor Relations:
Kate Miranda
(617) 921-5461
ir@mnkd.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did MannKind’s Furoscix ReadyFlow injection-site study show?

ReadyFlow met predetermined criteria for equivalent total drug exposure to intravenous furosemide at both the thigh and upper arm. Relative bioavailability was 91.3% and 92.7%, respectively. Urine output and urinary sodium excretion were similar across treatments, and the therapy was generally well tolerated.

How did Furoscix ReadyFlow compare with the Furoscix On-body Infusor?

A post-hoc analysis found comparable diuretic and sodium-excretion responses between ReadyFlow and the On-body Infusor, with both formulations achieving bioequivalence to intravenous furosemide. The cross-study comparison requires caution because the studies were conducted in separate populations.

Can Furoscix ReadyFlow be used in children?

Furoscix ReadyFlow is not intended for children less than 18 years old. Its July 2026 FDA approval covers treatment of fluid overload associated with heart failure or chronic kidney disease in adults.