MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease

Rhea-AI Summary

MannKind (Nasdaq: MNKD) announced the U.S. FDA has accepted its supplemental NDA for FUROSCIX ReadyFlow Autoinjector (SCP-111) to treat edema in adults with chronic heart failure or chronic kidney disease.

The sNDA carries a PDUFA target action date of July 26, 2026. If approved, ReadyFlow would deliver a subcutaneous furosemide dose in under 10 seconds, compared with the on-body infusor's five-hour administration, potentially enabling at-home treatment and reduced hospital use.

The sNDA references an open-label crossover study in 21 healthy volunteers showing bioavailability of 107.3% (90% CI: 103.9–110.8) and similar urine output and electrolyte excretion versus IV furosemide, with tolerable injection-site pain.

Positive

• PDUFA date set for July 26, 2026
• ReadyFlow delivers dose in under 10 seconds versus five hours
• Study bioavailability 107.3% (90% CI 103.9–110.8)

Negative

• Pivotal study was in 21 healthy volunteers, not patients
• Study design was open-label, single-center, single-dose

News Market Reaction

+1.50%

1 alert

+1.50% News Effect

On the day this news was published, MNKD gained 1.50%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

PDUFA date: July 26, 2026 Dose concentration: 80 mg/ml Administration time: under 10 seconds +4 more

7 metrics

PDUFA date July 26, 2026 FUROSCIX ReadyFlow sNDA FDA review timeline

Dose concentration 80 mg/ml Subcutaneous furosemide injection via ReadyFlow Autoinjector

Administration time under 10 seconds ReadyFlow Autoinjector injection duration

Infusor duration five hours Existing FUROSCIX On-body Infusor administration time

Bioavailability 107.3% (90% CI 103.9–110.8) ReadyFlow vs IV furosemide pharmacokinetic study

Study size 21 volunteers Open-label crossover ReadyFlow pharmacokinetic study

Age range 45–80 years Participants in ReadyFlow pharmacokinetic study

Market Reality Check

Price: $5.63 Vol: Volume 3,466,037 vs 20-da...

normal vol

$5.63 Last Close

Volume Volume 3,466,037 vs 20-day average 2,840,587 (relative volume 1.22). normal

Technical Price $5.81 is trading above the 200-day MA at $4.74.

Peers on Argus

MNKD gained 1.21% while biotech peers were mixed: SRPT and AUPH rose, VCEL and A...

MNKD gained 1.21% while biotech peers were mixed: SRPT and AUPH rose, VCEL and ARDX fell, and HRMY was modestly positive, indicating a stock-specific reaction.

Historical Context

5 past events · Latest: Dec 01 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 01	Regulatory milestone	Positive	+1.5%	FDA acceptance of sNDA for FUROSCIX ReadyFlow with 2026 PDUFA date.
Nov 11	Conference appearance	Neutral	+0.0%	Announcement of Jefferies London Healthcare Conference presentation and webcast.
Nov 10	Clinical setback	Negative	-3.7%	Discontinuation of MNKD-101 Phase 3 trial after futility determination.
Nov 06	CSR initiative	Positive	-5.9%	Launch of Centennial Al Mann Scholarship supporting students with diabetes.
Nov 05	Earnings and pipeline	Positive	+10.6%	Q3 2025 revenue growth, scPharmaceuticals acquisition, and multiple pipeline milestones.

Pattern Detected

MNKD has mostly traded in line with news tone, with four aligned reactions and one divergence where a positive CSR-type update coincided with a selloff.

Recent Company History

Over recent months, MannKind has balanced financial progress with mixed clinical outcomes. Q3 2025 earnings showed revenue of $82.1M and strong YTD growth, which was rewarded with a 10.58% move. The company later discontinued the MNKD-101 Phase 3 trial for futility, prompting a -3.73% reaction. Regulatory milestones included Afrezza pediatric and FUROSCIX ReadyFlow submissions, generally drawing positive or modestly positive moves. Today’s FDA acceptance for ReadyFlow extends that regulatory momentum within the cardiorenal space.

Market Pulse Summary

This announcement details FDA acceptance of MannKind’s sNDA for FUROSCIX ReadyFlow, supported by a s...

Analysis

This announcement details FDA acceptance of MannKind’s sNDA for FUROSCIX ReadyFlow, supported by a study showing bioavailability of 107.3% and delivery in under 10 seconds versus a five-hour infusor. The defined PDUFA date of July 26, 2026 adds a clear regulatory milestone to watch. In context of recent earnings growth and mixed clinical outcomes, investors may monitor future data, competitive dynamics in heart failure and kidney disease, and subsequent regulatory feedback.

Key Terms

supplemental new drug application, snda, pdufa, subcutaneous, +4 more

8 terms

supplemental new drug application regulatory

"FDA has accepted the sNDA seeking approval for FUROSCIX ReadyFlow"

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

"FDA has accepted the sNDA seeking approval for FUROSCIX ReadyFlow"

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.

pdufa regulatory

"The application has been assigned a Prescription Drug User Fee Act (PDUFA)"

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.

subcutaneous medical

"developed to deliver a subcutaneous furosemide injection in under 10 seconds"

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.

bioavailability medical

"ReadyFlow Autoinjector demonstrated a bioavailability of 107.3% (90% CI"

Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.

open-label medical

"The study was an open-label, single-center, single-dose, randomized"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

randomized medical

"single-dose, randomized, two-way crossover study in 21 healthy volunteers"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

crossover study medical

"single-dose, randomized, two-way crossover study in 21 healthy volunteers"

A crossover study is a clinical trial design where the same participants receive two or more treatments one after the other, with a break between them, so each person acts as their own comparison. For investors, this matters because it can produce clearer comparisons with fewer participants and faster results than separate-group trials, helping assess a drug’s effectiveness or side effects sooner, though results can be affected if one treatment’s effects carry over into the next.

AI-generated analysis. Not financial advice.

• If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds
• Would potentially provide a cost-effective and convenient option to address episodes of fluid buildup at home, benefiting patients, providers and payors
• PDUFA target action date of July 26, 2026
  
  

WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA seeking approval for FUROSCIX ReadyFlow™ Autoinjector (SCP-111), developed to deliver a subcutaneous furosemide injection in under 10 seconds as an investigational alternative to the FDA-approved FUROSCIX^® (furosemide) On-body Infusor for treatment of edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.

“The FUROSCIX ReadyFlow Autoinjector marks a key milestone in expanding patient options and improving care. By delivering treatment in under 10 seconds, the ReadyFlow Autoinjector has the potential to transform how adults with chronic heart failure or chronic kidney disease manage episodes of fluid buildup—providing faster relief, reducing hospital admissions, and lowering overall healthcare costs,” said Michael Castagna, PharmD, Chief Executive Officer at MannKind Corporation. “We are excited about the opportunity to bring this innovation forward and empower patients with greater convenience and control in their treatment journey.”

If approved, FUROSCIX ReadyFlow Autoinjector would provide 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 for adult patients with edema in chronic heart failure in 2022 and in chronic kidney disease in 2025. The ReadyFlow Autoinjector would reduce administration time from five hours to under 10 seconds.

The sNDA is supported by positive study results announced in August 2024. Furosemide via the ReadyFlow Autoinjector demonstrated a bioavailability of 107.3% (90% CI: 103.9 – 110.8), achieving the 90% confidence interval limit of 80 to 125 percent. Additionally, participants who utilized ReadyFlow Autoinjector had similar urine output, urinary sodium excretion and urinary potassium excretion at 6, 8, and 12 hours compared to IV furosemide, and was generally well tolerated with respect to injection site pain.

The study was an open-label, single-center, single-dose, randomized, two-way crossover study in 21 healthy volunteers, ranging in age from 45 to 80. Each subject completed the screening, baseline, treatment, and follow-up phases. Subjects were randomly assigned in a 1:1 ratio to one of two treatment sequences (IV furosemide followed by furosemide via the ReadyFlow Autoinjector, or vice versa).

About FUROSCIX

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, 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 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.

For MannKind:
Media Relations
Christie Iacangelo
Email: media@mnkd.com

Investor Relations
Email: ir@mnkd.com

FAQ

What is the FDA PDUFA target action date for MannKind's FUROSCIX ReadyFlow Autoinjector (MNKD)?

The PDUFA target action date is July 26, 2026.

How fast does the FUROSCIX ReadyFlow Autoinjector deliver furosemide compared to the on-body infusor (MNKD)?

ReadyFlow would deliver the dose in under 10 seconds, versus the on-body infusor's approximately five-hour administration.

What clinical data supports MannKind's sNDA for ReadyFlow (MNKD)?

An open-label, randomized crossover study in 21 healthy volunteers showed bioavailability of 107.3% (90% CI 103.9–110.8) and similar urine and electrolyte effects versus IV furosemide.

Could ReadyFlow allow at-home treatment for edema in CHF or CKD patients (MNKD)?

If approved, ReadyFlow is intended to provide a subcutaneous option to manage fluid buildup at home rather than in hospital settings.

Were there tolerability findings for ReadyFlow in the study supporting MNKD's sNDA?

The study reported ReadyFlow was generally well tolerated with respect to injection-site pain.