RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Promising Innovative Medicine (United Kingdom), Priority Review (United States)

Structure/Sequence

Sequence Code 1191632844

The sequence is quoted from: *****

Clinical Trials associated with Molgramostim inhalation(Savara Pharmaceuticals)

NCT06431776

/ RecruitingPhase 3

An Open-label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).

The goal of this open-label study is to study molgramostim as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP) in pediatric patients between age 6 and 18. The main questions it aims to answer are:
The effect of molgramostim on breathing tests and activity in pediatric patients with aPAP and the safety of molgramostim in pediatric patients with aPAP.
This is an open-label study: all participants will receive treatment with molgramostim.
Patients will:
* Take molgramostim once daily via nebulizer every day for 12 months.
* Visit the clinic approximately every 12 weeks for checkups and tests.
* Keep a diary of any oxygen use.

Start Date22 Oct 2025

Sponsor / Collaborator

Savara, Inc.

NCT04544293

/ Active, not recruitingPhase 3

A Randomized, Double-blind, Placebo-controlled Clinical Trial of Once-daily Inhaled Molgramostim Nebulizer Solution in Adult Subjects With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim (MOL) or placebo (PBO) for 48 weeks. Subjects completing the 48-week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 96 weeks.

Start Date19 May 2021

Sponsor / Collaborator

Savara, Inc.

NCT03597347

/ TerminatedPhase 2

An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection

A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.

Start Date20 Jun 2019

Sponsor / Collaborator

Savara, Inc.

100 Clinical Results associated with Molgramostim inhalation(Savara Pharmaceuticals)

100 Translational Medicine associated with Molgramostim inhalation(Savara Pharmaceuticals)

100 Patents (Medical) associated with Molgramostim inhalation(Savara Pharmaceuticals)

Literatures (Medical) associated with Molgramostim inhalation(Savara Pharmaceuticals)

22 Oct 2020·The New England journal of medicineQ1 · MEDICINE

Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis

Q1 · MEDICINE

Article

Author: Bonella, Francesco ; Inoue, Yoshikazu ; Trapnell, Bruce C ; Bendstrup, Elisabeth ; Veltkamp, Marcel ; Ganslandt, Cecilia ; Campo, Ilaria ; Jouneau, Stéphane ; Waterer, Grant ; Tarnow, Inge ; Ilkovich, Mikhail M ; Papiris, Spyros A ; Cetinkaya, Erdogan ; Baba, Tomohisa ; Kramer, Mordechai R ; Kreuter, Michael ; Jouhikainen, Taneli ; Yamaguchi, Etsuro ; Morgan, Cliff

BACKGROUND:

Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare disease characterized by progressive surfactant accumulation and hypoxemia. It is caused by disruption of granulocyte-macrophage colony-stimulating factor (GM-CSF) signaling, which pulmonary alveolar macrophages require to clear surfactant. Recently, inhaled GM-CSF was shown to improve the partial pressure of arterial oxygen in patients with aPAP.

METHODS:

In a double-blind, placebo-controlled, three-group trial, we randomly assigned patients with aPAP to receive the recombinant GM-CSF molgramostim (300 μg once daily by inhalation), either continuously or intermittently (every other week), or matching placebo. The 24-week intervention period was followed by an open-label treatment-extension period. The primary end point was the change from baseline in the alveolar-arterial difference in oxygen concentration (A-aDo₂) at week 24.

RESULTS:

In total, 138 patients underwent randomization; 46 were assigned to receive continuous molgramostim, 45 to receive intermittent molgramostim, and 47 to receive placebo. Invalid A-aDo₂ data for 4 patients (1 in each molgramostim group and 2 in the placebo group) who received nasal oxygen therapy during arterial blood gas measurement were replaced by means of imputation. For the primary end point - the change from baseline in the A-aDo₂ at week 24 - improvement was greater among patients receiving continuous molgramostim than among those receiving placebo (-12.8 mm Hg vs. -6.6 mm Hg; estimated treatment difference, -6.2 mm Hg; P = 0.03 by comparison of least-squares means). Patients receiving continuous molgramostim also had greater improvement than those receiving placebo for secondary end points, including the change from baseline in the St. George's Respiratory Questionnaire total score at week 24 (-12.4 points vs. -5.1 points; estimated treatment difference, -7.4 points; P = 0.01 by comparison of least-squares means). For multiple end points, improvement was greater with continuous molgramostim than with intermittent molgramostim. The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.

CONCLUSIONS:

In patients with aPAP, daily administration of inhaled molgramostim resulted in greater improvements in pulmonary gas transfer and functional health status than placebo, with similar rates of adverse events. (Funded by Savara Pharmaceuticals; IMPALA ClinicalTrials.gov number, NCT02702180.).

128

News (Medical) associated with Molgramostim inhalation(Savara Pharmaceuticals)

30 Jul 2026

·www.biospace.com

Savara Announces European and Australian Patent Offices Have Granted Patents for the Liquid Formulation of MOLBREEVI*, Providing Protection in Europe and Australia Until March 2041

-- In December 2025, Savara and PARI Were Granted a Joint European Patent Covering the Investigational Drug-Device Combination of MOLBREEVI, Delivered Via PARI’s Proprietary eFlow ® Nebulizer System, Through March 2043 -- LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the European Patent Office (EPO) has granted a patent covering the liquid formulation of MOLBREEVI, an orally inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). European patent No.4121000 provides protection for MOLBREEVI through March 2041. Separately, the Australian Patent Office has also granted a patent, No. 62/990,810, covering the liquid formulation of MOLBREEVI, and securing protection in Australia through the same date. “These patents further strengthen the Company’s intellectual property portfolio for MOLBREEVI, providing an additional layer of defense in markets with no approved alternatives,” said Kate McCabe, Chief Legal Officer, Savara. “Together, these patents reflect the strength of our liquid formulation IP across key ex-US markets. In parallel, we are advancing equivalent patent filings in the U.S., including a patent for the drug-device combination, with the aim of securing comprehensive protection across major commercial territories.” MOLBREEVI, delivered via the proprietary eFlow ® Nebulizer System, has been granted Fast Track and Breakthrough Therapy Designations by the U.S. Food and Drug Administration (FDA), Orphan Drug Designation by the FDA and by the European Medicines Agency (EMA), and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of autoimmune PAP. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via the proprietary investigational eFlow ® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at and LinkedIn. *MOLBREEVI is the proposed trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the impact of the patents and the duration of protection and that we are advancing equivalent patent filings in the U.S. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. 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 risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs ir@savarapharma.com

14 Jun 2026

·www.biospace.com

Savara Announces New Employment Inducement Grant - June 12, 2026

LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to new employees. On June 11, 2026, the Compensation Committee of Savara's Board of Directors granted the inducement awards to four new employees who recently joined the Company. The inducement awards consist of options to purchase 36,500 shares of the Company’s common stock, restricted stock units (RSUs) covering 42,500 shares of the Company’s common stock, and performance stock units (PSUs) covering 8,000 shares of the Company’s common stock. These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules as an inducement material to the employees’ acceptance of employment with the Company. The options have an exercise price of $5.27 per share, the closing trading price of the Company's common stock on the NASDAQ Global Market on the grant date. Each option has a 10-year term and vests as to 1/16 th of the number of shares subject to the option on each quarterly anniversary of the employee’s first day of employment, subject to the employee’s continued employment on each such vesting date. The RSUs vest in full on the two-year anniversary of the employee’s first day of employment, and PSUs vest in full upon the date the Company reports quarterly revenue above a specified target, in each case subject to the employee’s continued employment on such vesting date. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via a proprietary investigational eFlow ® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at , and LinkedIn . *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs ir@savarapharma.com

Phase 3

09 Jun 2026

·www.biospace.com

Savara Announces Chief Financial and Administrative Officer Transition

-- Dave Lowrance to Step Down as Chief Financial and Administrative Officer -- -- Robert Lutz to Assume Combined Role of Chief Operating and Financial Officer -- LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA ) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that Dave Lowrance, Chief Financial and Administrative Officer, is stepping down from his role for health-related reasons, effective July 15, 2026. As part of this transition, the financial and administrative responsibilities of the role will be separated going forward. Robert Lutz, M.B.A., the Company's Chief Operating Officer, will assume the additional role of Chief Financial Officer, while the administrative responsibilities will be distributed among members of the senior leadership team. “We are grateful to Dave as his leadership has been a vital part of Savara’s growth for nearly ten years,” said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer, Savara. “He has guided the Company through critical milestones ranging from capital raises and Nasdaq listing to advancing our late-stage pipeline. His integrity, expertise, and commitment will leave a lasting mark on this organization. We respect and support his decision to focus on his health at this time and are grateful that his guidance will remain available to us in an advisory capacity.” Pauls continued, “Rob is an experienced leader who has made significant contributions as our Chief Operating Officer since joining Savara in 2023. His background as a two-time Chief Financial and Business Officer, combined with his deep understanding of our operations and strategy, makes him ideally positioned to take on this expanded role. We are confident in his ability to ensure a seamless transition and continued strong financial stewardship.” “It has been a privilege to serve Savara for nearly a decade,” said Dave Lowrance, outgoing Chief Financial and Administrative Officer. “I am proud of what this team has built—from strengthening our balance sheet and supporting the advancement of MOLBREEVI, to helping position the Company for what I believe will be a transformative period. I am grateful to the entire Savara team for their support throughout my tenure and have confidence in Rob and Savara’s path forward.” Mr. Lutz has served as Savara’s Chief Operating Officer since February 2023. He brings more than two decades of operational leadership experience in the pharmaceutical industry, including experience with finance strategy, equity and debt raises, financial planning and analysis, investor relations, business development deal execution, and commercial/operational business analytics. Prior to joining Savara, Mr. Lutz served as Chief Financial and Business Officer of iBio, Inc., and prior to that as Chief Financial and Business Officer of Strongbridge Biopharma plc. Earlier in his career, Mr. Lutz held leadership roles of increasing responsibility at Shire Plc. and Cinergy Corp. and began his career as a Financial Analyst at Goldman Sachs. Mr. Lutz holds a B.A. in Economics and Computer Science from Amherst College and an M.B.A. from the Kellogg School of Management. About Savara Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow ® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at and LinkedIn . *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to planned executive changes and the timing and potential impact of those changes. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. 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 risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs ir@savarapharma.com

100 Deals associated with Molgramostim inhalation(Savara Pharmaceuticals)

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KEGG	Wiki	ATC	Drug Bank
-	Molgramostim inhalation(Savara Pharmaceuticals)	L03AA03	DB12525

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Alveolar Proteinosis, Acquired	NDA/BLA	United States	Savara, Inc.	19 Dec 2024
Cystic Fibrosis	Phase 2	United States	Savara, Inc.	20 Jun 2019
Mycobacterium Avium-Intracellulare Infection	Phase 2	United States	Savara, Inc.	20 Jun 2019
Neuroblastoma	Phase 2	United States	Y-mAbs Therapeutics, Inc.	03 Apr 2018
Neuroblastoma	Phase 2	China	Y-mAbs Therapeutics, Inc.	03 Apr 2018
Neuroblastoma	Phase 2	Canada	Y-mAbs Therapeutics, Inc.	03 Apr 2018
Neuroblastoma	Phase 2	Denmark	Y-mAbs Therapeutics, Inc.	03 Apr 2018
Neuroblastoma	Phase 2	Germany	Y-mAbs Therapeutics, Inc.	03 Apr 2018
Neuroblastoma	Phase 2	Spain	Y-mAbs Therapeutics, Inc.	03 Apr 2018
Neuroblastoma	Phase 2	United Kingdom	Y-mAbs Therapeutics, Inc.	03 Apr 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04544293 (IMPALA-2, CTgov)	Phase 3	Pulmonary Alveolar Proteinosis, Acquired	164	Molgramostim (Molgramostim)	iibhuedmsi(nufpjcvcvk) = uuipcirbmw tspxzmjwth (ipeykxrhqe, qnlrlxvlid - dpelgpxtyg) View more	-	07 Aug 2025
				Placebo (Placebo)	iibhuedmsi(nufpjcvcvk) = nezagqlpzw tspxzmjwth (ipeykxrhqe, gbbxewjfuv - dgmxevxyve) View more
NCT04544293 (IMPALA-2, BusinessWire) Manual	Phase 3	Pulmonary Alveolar Proteinosis, Acquired	-	molgramostim(Savara Inc)	pnmzmtbnsl(hvncvnzyvd) = pijhdqiinw rmigdxwiri (werrwgrxfb )	Positive	18 May 2025
				Placebo	pnmzmtbnsl(hvncvnzyvd) = acqayxwend rmigdxwiri (werrwgrxfb )
NCT03421743 (OPTIMA, CTgov)	Phase 2	Mycobacterium Infections, Nontuberculous \| Mycobacterium Abscessus Infection \| Antibiotic resistant infection	32	Antimycobacterial regimen+Inhaled molgramostim (Inhaled Molgramostim/Antimycobacterials)	kzptkwgnky = eojgmrgqzm ntqjihgmsb (rxruzcvlfd, yuydfqpozn - anjftktlrd) View more	-	03 Jul 2024
				Inhaled molgramostim (Inhaled Molgramostim)	kzptkwgnky = gynwenpjvz ntqjihgmsb (rxruzcvlfd, lwomazzzxs - cohinjsfkc) View more
NCT03482752 (IMPALA-X, CTgov)	Phase 3	Pulmonary Alveolar Proteinosis, Acquired	60	Molgramostim	kojzhwknxf = btiryjvufp xifjlozvgc (pkxwcodeto, cidftsrpaj - lhkwmyrvem) View more	-	03 Jul 2024
NCT02702180 (IMPALA, CTgov)	Phase 2	Pulmonary Alveolar Proteinosis, Acquired	139	PARI eFlow nebulizer system+Molgramostim (Double-blind Molgramostim Once Daily)	qbntotblbc(friatuakgg) = vlpeosraci qrtpgzgvdm (vjmxpcecbd, qmrvkumbso - rdfgyzvqmv) View more	-	15 Apr 2022
				PARI eFlow nebulizer system+Molgramostim (Double-blind Molgramostim Intermittent)	qbntotblbc(friatuakgg) = bfxreraaeh qrtpgzgvdm (vjmxpcecbd, rtmoplmwkw - kehwyyabcb) View more
NCT03597347 (ENCORE, CTgov)	Phase 2	Mycobacterium Infections, Nontuberculous \| Mycobacterium Abscessus Infection \| Cystic Fibrosis ... View more	14	PARI eFlow nebulizer system+Molgramostim nebulizer solution (Group 1)	pbapweeust = swujvcybiq wjwbmlgshs (xvrlbyirpk, gciklhsmsy - qkgcmhjoqc) View more	-	11 Oct 2021
				PARI eFlow nebulizer system+Molgramostim nebulizer solution (Group 2)	pbapweeust = yjmlyjenvh wjwbmlgshs (xvrlbyirpk, hvdlczscxj - xsbopgsmjp) View more
NCT02702180 (Pubmed \| N Engl J Med) Manual	Phase 2	Pulmonary Alveolar Proteinosis, Acquired	138	Molgramostim	iunvfidxme(fjqgezlbfw) = ieoelzpfxt kgeckbcqxb (csqsqeyffw ) View more	Positive	22 Oct 2020
				Placebo	iunvfidxme(fjqgezlbfw) = dniaekaaya kgeckbcqxb (csqsqeyffw ) View more

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