Savara SVRA continues to advance Molbreevi (molgramostim inhalation solution), its lead and only late-stage pipeline candidate, for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), a rare, chronic lung disease with no FDA-approved therapies. Molbreevi is an inhaled recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) designed to restore alveolar macrophage function and improve lung health in patients with aPAP.
Over the past year, shares of SVRA have skyrocketed 134.5% against the industry’s 5.5% fall.
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SVRA’s Strong Clinical Data Support Regulatory Progress
Investor confidence has strengthened following positive phase III data, continued positive long-term clinical results and progress toward regulatory approval. In May, Savara presented updated analyses from the ongoing IMPALA-2 open-label extension study, which demonstrated sustained improvements in pulmonary gas transfer, exercise capacity and respiratory health-related quality of life through 96 weeks.
Patients who switched from placebo to Molbreevi also achieved meaningful clinical benefits after initiating therapy. The long-term safety profile remained favorable, with no new safety signals or treatment-related discontinuations, while biomarker findings further supported Molbreevi's mechanism of action.
Molbreevi’s Regulatory Milestones on Track
In December 2025, Savara resubmitted the biologics license application (BLA) for Molbreevi after addressing the FDA's complete response letter, which was limited to manufacturing and chemistry, manufacturing and controls information and did not require additional clinical efficacy or safety studies. The FDA subsequently accepted the BLA and set a target action date for Nov. 22, 2026. If approved, Molbreevi would become the first FDA-approved therapy for autoimmune PAP.
Beyond the United States, the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) have validated Molbreevi's marketing applications. Regulatory decisions are expected in the fourth quarter of 2026 in the United Kingdom and the first quarter of 2027 in Europe.
Molbreevi received multiple regulatory designations, including Fast Track, Breakthrough Therapy, and Orphan Drug designations from the FDA, Orphan Drug Designation from the EMA, and Innovation Passport and Promising Innovative Medicine designations from the U.K. MHRA, underscoring its potential to address a significant unmet medical need.
SRVA’s Expanded Intellectual Property Protection
Savara has strengthened Molbreevi's long-term commercial outlook through expanded European patent protection. The European Patent Office (EPO) granted a patent covering the combination of Molbreevi with PARI's proprietary eFlow nebulizer system, providing protection through March 2043. In addition, the EPO intends to grant a patent covering Molbreevi's liquid formulation, extending protection through March 2041.
SVRA's Zacks Rank & Estimates
Savara currently carries a Zacks Rank #2 (Buy). Over the past 60 days, estimates for SVRA’s 2026 loss per share have narrowed from 58 cents to 57 cents. Estimates for 2027 loss per share have also improved from 24 cents to 17 cents.
Other Stocks to Consider
Some other better-ranked stocks in the biotech sector are Neurocrine Biosciences NBIX, Amarin Corporation AMRN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 90 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $8.00 to $9.44. Over the same period, EPS estimates for 2027 have increased from $9.48 to $10.79. NBIX shares have gained 26.2% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 90 days, loss per share estimates for Amarin Corporation have narrowed from $6.36 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $4.64 to 51 cents for 2027. AMRN shares have lost 0.1% year to date.
Amarin Corporation’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 90 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.92 from $2.91. LQDA shares have gained 134.6% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
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