MannKind Provides Business Updates and 2026 Growth Drivers

Rhea-AI Summary

MannKind (Nasdaq: MNKD) provided business updates and outlined 2026 growth drivers including commercial momentum, recent acquisition activity, and clinical progress.

Key points: a record fourth quarter with net revenue >$100 million, acquisition of scPharmaceuticals, multiple FDA review acceptances with PDUFA dates (Afrezza label update Jan 23, 2026; Afrezza pediatric sBLA May 29, 2026; FUROSCIX ReadyFlow sNDA July 26, 2026), first patient enrolled in INFLO-1 (nintedanib DPI) in Dec 2025, and ongoing collaborations with United Therapeutics including a planned Tyvaso DPI bridging study.

Positive

• Record Q4 net revenue exceeding $100 million
• Completed acquisition of scPharmaceuticals
• FDA accepted multiple submissions with specific PDUFA dates in 2026
• INFLO-1 nintedanib DPI Phase 1b study first patient enrolled in December 2025
• Expanded collaboration with United Therapeutics to develop a second dry powder molecule

Negative

• Multiple 2026 programs rely on FDA decisions with PDUFA dates (Jan–Jul 2026)
• Commercial launches depend on regulatory approvals for Afrezza pediatric and FUROSCIX ReadyFlow

News Market Reaction

+2.74%

31 alerts

+2.74% News Effect

+6.5% Peak in 54 min

+$53M Valuation Impact

$2.00B Market Cap

0.7x Rel. Volume

On the day this news was published, MNKD gained 2.74%, reflecting a moderate positive market reaction. Argus tracked a peak move of +6.5% during that session. Our momentum scanner triggered 31 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $53M to the company's valuation, bringing the market cap to $2.00B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Q4 2025 net revenue: >$100 million Afrezza label PDUFA date: January 23, 2026 Afrezza pediatric sBLA PDUFA: May 29, 2026 +5 more

8 metrics

Q4 2025 net revenue >$100 million Record-setting fourth quarter net revenue in 2025

Afrezza label PDUFA date January 23, 2026 FDA decision on Afrezza dose-conversion label update

Afrezza pediatric sBLA PDUFA May 29, 2026 FDA review deadline for pediatric Afrezza indication

FUROSCIX ReadyFlow PDUFA July 26, 2026 FDA review deadline for ReadyFlow Autoinjector sNDA

FUROSCIX dose 80 mg/mL Subcutaneous furosemide injection concentration in ReadyFlow Autoinjector

Injection time Under 10 seconds Time to deliver IV-equivalent FUROSCIX dose subcutaneously

Insulin therapy history 100+ years Afrezza would be first needle-free insulin option for pediatrics in this span

INFLO-2 timing Q2 2026 Anticipated first patient in Phase 2 INFLO-2 trial for nintedanib DPI

Market Reality Check

Price: $5.46 Vol: Volume 5,412,360 is 52% a...

high vol

$5.46 Last Close

Volume Volume 5,412,360 is 52% above the 20-day average of 3,567,964, indicating elevated interest ahead of 2026 catalysts. high

Technical Trading above the 200-day MA, with price at $5.86 vs 200-day MA of $4.80.

Peers on Argus

MNKD gained 4.09% with elevated volume, while key biotech peers like ARDX, AUPH,...

MNKD gained 4.09% with elevated volume, while key biotech peers like ARDX, AUPH, VCEL, HRMY, and SRPT also rose between 1–4%, but momentum scanners did not flag a coordinated sector move.

Historical Context

5 past events · Latest: Dec 23 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 23	Product/regulatory update	Positive	-1.0%	FUROSCIX pediatric approval and new patents extending ReadyFlow IP protection.
Dec 01	Regulatory filing	Positive	+1.5%	FDA acceptance of FUROSCIX ReadyFlow sNDA with defined PDUFA date.
Nov 11	Investor conference	Neutral	+0.0%	Planned Jefferies conference presentation and webcast availability.
Nov 10	Clinical trial update	Negative	-3.7%	Discontinuation of Phase 3 MNKD-101 trial after futility analysis.
Nov 06	CSR / philanthropy	Neutral	-5.9%	Launch of Centennial Al Mann Scholarship for students living with diabetes.

Pattern Detected

Recent news often aligns with price reaction, but there are notable divergences where positive or neutral updates coincided with weakness.

Recent Company History

Over the last few months, MannKind reported multiple regulatory and pipeline milestones, including FDA acceptance of the FUROSCIX ReadyFlow sNDA with a July 26, 2026 PDUFA date and pediatric approval and IP extensions for FUROSCIX. The company also discontinued the Phase 3 MNKD-101 trial for futility but advanced MNKD-102. Corporate communications ranged from conference participation to a diabetes-focused scholarship program. Today’s 2026 growth-driver update builds on these commercial, clinical, and strategic developments, including the completed scPharmaceuticals acquisition.

Market Pulse Summary

This announcement highlights MannKind’s 2026 growth drivers, including Afrezza label and pediatric s...

Analysis

This announcement highlights MannKind’s 2026 growth drivers, including Afrezza label and pediatric sBLA reviews, FUROSCIX ReadyFlow’s July 26, 2026 PDUFA date, and progression of nintedanib and bumetanide DPI programs. It also notes a record Q4 surpassing $100 million in net revenue and integration of scPharmaceuticals. Investors may watch upcoming FDA decisions, enrollment milestones, and execution of United Therapeutics collaborations using the Technosphere platform.

Key Terms

PDUFA, supplemental Biologics License Application (sBLA), supplemental New Drug Application (sNDA), Biologics License Application, +4 more

8 terms

PDUFA regulatory

"decision on Afrezza label update (dose conversion) anticipated with a 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.

supplemental Biologics License Application (sBLA) regulatory

"FDA accepted for review the supplemental Biologics License Application (sBLA) for Afrezza"

A supplemental biologics license application (sBLA) is a formal request to a drug regulator to approve a change to a biologic product that already has a license, such as a new use, manufacturing process, dosage form, or labeling update. Investors care because approval can expand sales or reduce costs, while rejection or delay can create regulatory risk and affect revenue; think of it as asking permission to alter a proven recipe before selling the new version.

supplemental New Drug Application (sNDA) regulatory

"Supplemental New Drug Application (sNDA) for FUROSCIX ReadyFlow Autoinjector accepted"

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.

Biologics License Application regulatory

"FDA accepted for review the supplemental Biologics License Application (sBLA) for Afrezza"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

Phase 1b medical

"Nintedanib DPI (MNKD-201) saw its first patient enrolled in December for the INFLO-1 Phase 1b study"

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

Phase 2 medical

"anticipates first patient in for INFLO-2 Phase 2 (global) in Q2 2026"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

dry powder medical

"Formulating a second dry powder investigational molecule under the expanded collaboration"

Dry powder is the cash or liquid assets that investors or funds keep on hand and are ready to deploy into new investments or to cover obligations. Think of it like a firefighter’s reserve of water: it lets investors act quickly when bargains appear or when markets turn sour, so it influences a fund’s ability to buy assets, support portfolio companies, or weather losses.

Autoinjector technical

"Supplemental New Drug Application (sNDA) for FUROSCIX ReadyFlow Autoinjector accepted"

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.

AI-generated analysis. Not financial advice.

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Jan. 08, 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 provided business updates and outlined anticipated growth drivers for 2026, including progress across its commercial programs and clinical development initiatives.

“MannKind closed 2025 on a high note, marked by milestones that reinforce our growth trajectory—including the acquisition of scPharmaceuticals and a record-setting fourth quarter surpassing $100 million in net revenue,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “With two high-potential launches on the horizon, 2026 is shaping up to be a catalyst-rich year that positions MannKind for long-term value creation.”

Major Catalysts Driving 2026:

Afrezza^® (insulin human) Inhalation Powder

• FDA decision on Afrezza label update (dose conversion) anticipated with a PDUFA target action date of January 23, 2026
  • Would update the initial dose for mealtime insulin when switching from subcutaneous rapid-acting insulin
• FDA accepted for review the supplemental Biologics License Application (sBLA) for Afrezza^® Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes with a PDUFA target action date of May 29, 2026
  • If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy

FUROSCIX^® (furosemide injection) for Subcutaneous Use

• Supplemental New Drug Application (sNDA) for FUROSCIX ReadyFlow^™ Autoinjector accepted for review by U.S. Food and Drug Administration (FDA) with a PDUFA target action date of July 26, 2026
  • If approved, it would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds

Pipeline

• Nintedanib DPI (MNKD-201) saw its first patient enrolled in December for the INFLO-1 Phase 1b study (U.S.) and anticipates first patient in for INFLO-2 Phase 2 (global) in Q2 2026
• Advancing Bumetanide DPI (MNKD-701) pre-clinical development

United Therapeutics Collaborations

• Tyvaso DPI bridging study anticipated following 1H 2026 readout of TETON-1 study
• Formulating a second dry powder investigational molecule under the expanded collaboration with United Therapeutics using MannKind’s proprietary Technosphere^® platform

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 potential product launches, ongoing clinical trials and preclinical studies, expected initiation and patient enrollment timelines, and the expected timing for trial results; the development of a new dry powder inhalation therapy and investigational molecule under the expanded collaboration with United Therapeutics and the planned preclinical studies thereof; the expected timing for regulatory events related to Afrezza and the FUROSCIX ReadyFlow Autoinjector; and other statements about future events. 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 unforeseen delays that may impact the timing of clinical trials and reporting data, the risk that issues develop in the review by the FDA that subject us to unanticipated delays or prevent us from obtaining the desired regulatory approval as well as other risks; detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), 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 Inc, a subsidiary of MannKind Corporation.

AFREZZA and MANNKIND are registered trademarks 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 PDUFA date does MannKind list for the Afrezza dose conversion label update (MNKD)?

The company lists a PDUFA target action date of January 23, 2026 for the Afrezza dose conversion label update.

When is the FDA decision targeted for the Afrezza supplemental BLA for pediatric patients (MNKD)?

The supplemental Biologics License Application for pediatric use has a PDUFA target action date of May 29, 2026.

What is the PDUFA date for the FUROSCIX ReadyFlow autoinjector sNDA (MNKD)?

The supplemental New Drug Application for FUROSCIX ReadyFlow has a PDUFA target action date of July 26, 2026.

How did MannKind perform commercially at year-end 2025 (MNKD)?

MannKind reported a record fourth quarter with net revenue surpassing $100 million.

What clinical progress did MannKind report for its nintedanib DPI program (MNKD-201)?

MannKind reported the first patient enrolled in the INFLO-1 Phase 1b study in December 2025 and anticipates INFLO-2 Phase 2 first patient in Q2 2026.

What collaboration activities with United Therapeutics did MannKind announce (MNKD)?

The company plans a Tyvaso DPI bridging study after a 1H 2026 readout of TETON-1 and is formulating a second dry powder investigational molecule under the expanded collaboration.