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olivLaw · US equity research

Savara Inc SVRA

Pharmaceutical Preparations · SIC 2834 · Vertical: Pharmaceutical Preparations (SIC 2834)

4.66USD−1.89% · 1 dayClose 04 Nov 2026

Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases, whose sole candidate MOLBREEVI targets autoimmune PAP. The FDA review was extended to November 22, 2026, which makes the approval timeline central for the company. The company has no product revenue and relies on equity offerings and loans to fund losses.

At the close of 04 Nov 2026, Savara Inc (SVRA) stock was 4.66 USD (−1.89% on the day), with market capitalisation 957.4 m USD, beta 1.04, 52-week range 3.95–6.94 USD. Latest reported quarter (Q2 2026): net income of -40.2 m USD, diluted EPS -0.16 USD.

Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.

Market cap
957.4 m USD
shares as of 11 Aug 2026
P/E (TTM)
unavailable
Diluted EPS TTM -0.58 · TTM to 30 Jun 2026
E/P (TTM)
-12.54%
TTM to 30 Jun 2026
Dividend yield
unavailable
Beta (2y)
1.04
Volatility (1y) 53%
52-week range
3.956.94

Price history

Loading chart…

Technical reading

RSI (14)
45.3
neutral
Bollinger (20, 2)
4.36 – 5.08
in the lower half of the band · %B 0.41 · band width 15.3%
SMA 50 / 200
5.02 / 5.37
downtrend (price < SMA50 < SMA200)
MACD (12, 26, 9)
-0.07 / -0.10
MACD above signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyS&P 500vs S&P 500Vertical median
1 month−2.5%−1.1%−1.4 pp—
3 months−15.4%−0.5%−15.0 pp—
6 months−11.6%+4.4%−16.0 pp—
Year to date−22.7%+12.3%−35.0 pp—
1 year+12.8%+13.5%−0.7 pp+8.9%
3 years+23.0%+76.4%−53.5 pp+15.7%
5 years+288.3%+63.7%+224.7 pp—
Max drawdown (1y)
−39.2%
11 Dec 2025 → 23 Oct 2026
Max drawdown (5y)
−65.3%
07 Mar 2024 → 27 May 2025
Compound annual growth (5y)
+31.2%
S&P 500 +10.4%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q2 2026 · 30 Jun 2026

Revenue
unavailable USD
unavailable YoY
Net income
-40.2 m USD
unavailable YoY
Diluted EPS
-0.16
unavailable YoY
net / operating
unavailable / unavailable

Quarterly statements · USD

Fiscal yearQ3 '24Q4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26
Operating income-26.4 m-31.2 m-28.4 m-31.4 m-30.3 m-33.4 m-39.0 m-41.0 m
Depreciation & amortisation33.0 k32.0 k30.0 k34.0 k36.0 k-11.0 k24.0 k28.0 k
Pre-tax income——-26.6 m—————
Net income-24.2 m-29.0 m-26.6 m-30.4 m-29.6 m-32.2 m-37.3 m-40.2 m
Diluted EPS-0.11-0.13 ≈-0.12-0.14-0.14-0.13 ≈-0.15-0.16
Operating cash flow-22.7 m ≈-23.3 m-27.2 m-26.3 m ≈-22.5 m ≈-25.1 m-33.0 m-29.7 m ≈
Capex3.0 k ≈-9.0 k3.0 k15.0 k ≈2.0 k ≈2.0 k54.0 k222.0 k ≈

≈ derived quarter (cumulative difference / share-days average)

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Fiscal years

Fiscal year20182019202020212022202320242025
Revenueunavailable0257.0 kunavailableunavailableunavailableunavailableunavailable
Revenue YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
Net income-61.5 m-78.2 m-49.6 m-43.0 m-38.2 m-54.7 m-95.9 m-118.8 m
Net income YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
Diluted EPSunavailableunavailableunavailable-0.32-0.25-0.33-0.48-0.53
Diluted EPS YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
net %unavailableunavailable-19,305.4%unavailableunavailableunavailableunavailableunavailable
Free cash flow-39.4 m-45.3 m-39.9 m-40.1 m-34.6 m-51.4 m-89.1 m-101.1 m

Reported results vs expectations

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Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
33.2 m USD
Financial debt
29.9 m USD
Net debt
-3.3 m USD
Equity
-87.0 k USD
Total assets
253.4 m USD
Debt / equity
unavailable
Current ratio
11.85x
ROE
unavailable
ROA
-51.0%
FCF margin
unavailable

Financial statements (source on every figure)

Revenue and net income (USD)

Income statement · USD

Revenue
2023
—
2024
—
2025
—

SEC (XBRL)· 10 Mar 2021verified

Operating income
2023
-60.0 m
2024
-103.2 m
2025
-123.5 m

SEC (XBRL)· 13 Mar 2026verified

Depreciation & amortisation
2023
77.0 k
2024
130.0 k
2025
87.0 k

SEC (XBRL)· 13 Mar 2026verified

EBITDA
2023
-59.9 m ≈
2024
-103.1 m ≈
2025
-123.5 m ≈

SEC (XBRL)· 13 Mar 2026derived

Pre-tax income
2023
-54.7 m
2024
-95.9 m
2025
-118.8 m

SEC (XBRL)· 13 Mar 2026verified

Income tax
2023
—
2024
9.0 k
2025
0

SEC (XBRL)· 13 Mar 2026verified

Net income
2023
-54.7 m
2024
-95.9 m
2025
-118.8 m

SEC (XBRL)· 13 Mar 2026verified

Diluted EPS
2023
-0.33
2024
-0.48
2025
-0.53

SEC (XBRL)· 13 Mar 2026verified

Weighted average diluted shares
2023
165.2 m
2024
198.2 m
2025
222.4 m

SEC (XBRL)· 13 Mar 2026verified

Balance sheet · USD

Cash
2023
26.6 m
2024
15.1 m
2025
33.2 m

SEC (XBRL)· 13 Mar 2026verified

Current assets
2023
165.9 m
2024
202.1 m
2025
241.6 m

SEC (XBRL)· 13 Mar 2026verified

Property, plant & equipment, net
2023
270.0 k
2024
165.0 k
2025
100.0 k

SEC (XBRL)· 13 Mar 2026verified

Goodwill
2023
—
2024
—
2025
—

SEC (XBRL)· 10 Mar 2021verified

Total assets
2023
177.6 m
2024
212.9 m
2025
253.4 m

SEC (XBRL)· 13 Mar 2026verified

Accounts payable
2023
3.5 m
2024
4.5 m
2025
5.8 m

SEC (XBRL)· 13 Mar 2026verified

Short-term debt
2023
—
2024
0
2025
0

SEC (XBRL)· 13 Mar 2026verified

Long-term debt
2023
26.3 m
2024
26.6 m
2025
29.9 m

SEC (XBRL)· 13 Mar 2026verified

Current liabilities
2023
10.6 m
2024
14.7 m
2025
20.4 m

SEC (XBRL)· 13 Mar 2026verified

Total liabilities
2023
37.2 m
2024
41.4 m
2025
50.3 m

SEC (XBRL)· 13 Mar 2026verified

Equity
2023
-271.0 k
2024
-750.0 k
2025
-87.0 k

SEC (XBRL)· 13 Mar 2026verified

Cash flow · USD

Operating cash flow
2023
-51.1 m
2024
-89.1 m
2025
-101.0 m

SEC (XBRL)· 13 Mar 2026verified

Capex
2023
296.0 k
2024
25.0 k
2025
22.0 k

SEC (XBRL)· 13 Mar 2026verified

Free cash flow
2023
-51.4 m ≈
2024
-89.1 m ≈
2025
-101.1 m ≈

SEC (XBRL)· 13 Mar 2026derived

Investing cash flow
2023
-57.1 m
2024
-39.9 m
2025
-18.4 m

SEC (XBRL)· 13 Mar 2026verified

Financing cash flow
2023
82.8 m
2024
117.6 m
2025
137.8 m

SEC (XBRL)· 13 Mar 2026verified

Computed indicators

Growth

Revenue growth (YoY)
unavailable
the base of the ratio is not positive
Revenue CAGR 3Y
unavailable
the base of the ratio is not positive
Revenue CAGR 5Y
36.6%
computed by olivLawFY 2015 → FY 2020
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
the base of the ratio is not positive
Net income CAGR 5Y
unavailable
the base of the ratio is not positive
EPS growth (YoY)
unavailable
input data missing
EPS CAGR 3Y
unavailable
input data missing
EPS CAGR 5Y
unavailable
input data missing
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
unavailable
input data missing
EBITDA margin
unavailable
input data missing
EBIT margin
unavailable
input data missing
Net margin
unavailable
input data missing
FCF margin
unavailable
input data missing

Returns

ROE
-105.5%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROA
-78.3%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROIC
unavailable
equity is negative: buybacks shrink the invested capital and ROIC would come out large without meaning anything
ROCE
-82.3%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
-11.7 m USD
computed by olivLawbalance sheet at 30 Jun 2026
Net debt / EBITDA
unavailable
insufficient data
Debt / equity
0.2x
computed by olivLawbalance sheet at 30 Jun 2026
Interest coverage
unavailable
the reported interest expense is far older than the latest period (the filer changed its XBRL tag): a stale figure is not used

Liquidity

Current ratio
10.1x
computed by olivLawbalance sheet at 30 Jun 2026
Quick ratio
unavailable
input data missing
Cash ratio
2.4x
computed by olivLawbalance sheet at 30 Jun 2026

Cash

Operating cash flow
-110.4 m USD
computed by olivLawTTM to 30 Jun 2026
Capital expenditure
280.0 k USD
computed by olivLawTTM to 30 Jun 2026
Free cash flow
-110.7 m USD
computed by olivLawTTM to 30 Jun 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
insufficient data

Efficiency

Days sales outstanding
unavailable
input data missing
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
957.4 m USD
computed by olivLawbalance sheet at 30 Jun 2026
Enterprise value
945.8 m USD
computed by olivLawbalance sheet at 30 Jun 2026
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-12.5%
computed by olivLawTTM to 30 Jun 2026
P/B
6.7x
computed by olivLawbalance sheet at 30 Jun 2026
P/S
unavailable
input data missing
EV/EBITDA
unavailable
insufficient data
EV/EBIT
unavailable
insufficient data
EV/Sales
unavailable
input data missing
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-11.6%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 2 of at least 6
  • score weight coverage: 12.5% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

4.66 USD

04 Nov 2026Source: olivLaw, closing series

Market cap: 957.4 m USD

Key indicators

Market capitalisation
957.4 m USD
computed by olivLawbalance sheet at 30 Jun 2026
P/E (TTM)
unavailable
insufficient data
P/B
6.7x
computed by olivLawbalance sheet at 30 Jun 2026
EV/EBITDA
unavailable
insufficient data
ROE
-105.5%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Net margin
unavailable
input data missing
Revenue growth (YoY)
unavailable
the base of the ratio is not positive
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

25/37 reporting lines present
Latest full fiscal year: 2020
Latest reported period: 30 Jun 2026
Latest balance sheet date: 30 Jun 2026
Share count (cover of the latest filing), as of: 11 Aug 2026
Source: SEC (XBRL)published 11 Aug 2026
verified 1566derived 106

Score by group

13% · Insufficient data

Estimated value range

unavailable — no valuation method could be computed

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

  • DCF (discounted cash flow)unavailable · the reported interest expense is far older than the latest period (the filer changed its XBRL tag): a stale figure is not used
  • Peers: EV/EBITDAunavailable · the base of the ratio is not positive
  • Peers: P/Eunavailable · the base of the ratio is not positive
  • Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption

no valuation method could be computed

Multiple comparisons use the SIC vertical: Pharmaceutical Preparations (SIC 2834)

Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.

Assumptions (illustrative, editorial)

Risk-free rate
4.3%
Equity risk premium
5.0%
Beta (default)
1.00
Cost of equity
9.3%
Terminal growth
2.5%

Factor scorecard

Insufficient data

Minimum-evidence gate: indicators available: 2 of at least 6; score weight coverage: 12.5% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Qualityunavailableunavailable—
Net margin · Qualityunavailableunavailable—
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growthunavailableunavailable—
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheetunavailableunavailable—
Current ratio · Balance sheet10.1x100 (on a fixed band)33%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-11.6%0 (on a fixed band)67%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet· partial100/100 · 1/3 factors with a value
  • Growth· partialunavailable · 0/2 factors with a value
  • Quality· partialunavailable · 0/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation· partial0/100 · 1/3 factors with a value

A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

Memo

Savara Inc (SVRA). Latest full fiscal year: 2020; data up to 2026-06-30.

Figures computed from the financial statements: revenue 257.0 k USD in 2020; ROE -105.5%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 2 of at least 6; score weight coverage: 12.5% of at least 60%; valuation methods computed: 0 of at least 1).

Text generated deterministically from the figures shown; no language model. Not investment advice.

What supports the thesis

  • Current ratio: 10.1x

What contradicts it

  • FCF yield: -11.6%

Not assessed (insufficient data or a ratio without meaning): ROIC, Net margin, FCF conversion, Revenue CAGR 3Y, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

Pharmaceutical Preparations (SIC 2834) · same industry (4-digit SIC) · compared with 39 companies

Multiples and returns vs the median

P/E
—
vertical median 38.6x
EV/EBITDA
—
vertical median 20.2x
P/S
—
vertical median 5.5x
P/B
6.7x
vertical median 4.1x
above median (+61.4%)
ROE
-105.5%
vertical median -6.2%
below median
Net margin
—
vertical median 9.7%
EBIT margin
—
vertical median 10.2%
Revenue YoY
—
vertical median 5.4%
Net debt/EBITDA
—
vertical median -0.2x
Dividend yield
—
vertical median 2.2%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
LLYEli Lilly And Company1,334.0 bn46.086.1%31.9%+44.7%+32% / +140%
JNJJohnson & Johnson665.2 bn41.920.0%16.2%+6.0%+34% / +79%
ONCBeone Medicines Ltd.558.4 bn869.914.7%10.7%+40.2%+11% / +102%
ABBVAbbVie Inc.521.1 bn50.7—15.7%+8.6%+29% / +107%
MRKMerck & Co., Inc.370.7 bn154.75.1%3.6%+1.3%+43% / +47%
ABTAbbott Laboratories200.1 bn43.09.2%9.7%+5.7%−10% / +11%
PFEPfizer Inc175.5 bn43.94.4%6.3%−1.6%+20% / +1%
VRTXVertex Pharmaceuticals Inc139.2 bn35.320.8%30.7%+8.9%+27% / +55%
BMYBristol-Myers Squibb Company131.2 bn14.244.1%18.5%−0.2%+30% / +30%
TEVATeva Pharmaceutical Industries Limited48.8 bn97.46.6%3.6%+4.3%+56% / +326%
ZTSZoetis Inc.36.9 bn14.764.4%27.5%+2.3%−30% / −50%
ROIVRoivant Sciences Ltd.27.6 bn—-6.2%-3,535.0%−71.6%+84% / +300%
RPRXRoyalty Pharma plc26.2 bn47.76.9%25.7%+5.1%+69% / +150%
UTHRUnited Therapeutics Corporation25.9 bn23.019.1%38.6%+10.6%+25% / +154%
INSMInsmed Inc24.1 bn—-72.5%-39.9%+66.7%−47% / +340%
VTRSViatris Inc.22.1 bn—-23.6%-23.9%−3.0%+80% / +109%
ALNYAlnylam Pharmaceuticals, Inc.21.6 bn8.1126.6%52.8%+65.2%−64% / −4%
ORKAOruka Therapeutics, Inc.6.7 bn—-18.2%—unavailable+237% / +364%
HRMYHarmony Biosciences Holdings, Inc.2.0 bn11.418.7%18.1%+21.5%−2% / +18%
OMEROmeros Corp1.3 bn10.5——−34.0%+88% / +730%
SVRASavara Inc957.4 m—-105.5%—unavailable+13% / +23%
VSTMVerastem, Inc.892.0 m—-471.2%-231.6%+209.1%−7% / +43%
COLLCollegium Pharmaceutical, Inc.770.6 m19.117.6%5.9%+23.6%−49% / −8%
IBOImpact BioMedical, INC.442.1 m560.3371.3%2,254.3%unavailable−27% / unavailable
KMDAKamada Ltd428.0 m21.27.6%11.2%+12.1%+11% / +57%

1- and 3-year price returns: for SVRA from daily closes (the same as the performance table), for the other companies from month-end closes.

olivLaw engine forecast

The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

The engine has no published run for this company yet.

Valuation scenarios (editable assumptions)

Illustrative scenarios

Scenarios are not available. input data missing

AI analysis

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

In brief

Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases, whose sole candidate MOLBREEVI targets autoimmune PAP. The FDA review was extended to November 22, 2026, which makes the approval timeline central for the company 2. The company has no product revenue and relies on equity offerings and loans to fund losses 12.

SWOT

Strengths

  • The company has a single advanced program with a pivotal Phase 3 study, FDA Fast Track and Breakthrough Therapy designations, and exclusive access to the eFlow device for this indication 1.
  • The application already has Priority Review in the U.S., and marketing applications are validated in Europe and the UK 2.
  • The outsourcing model reduces fixed costs and allows relatively capital-efficient development 1.

Weaknesses

  • The company has no product revenue and records recurring net losses, making it dependent on external funding 12.
  • Cash available is limited relative to planned spending, and the company acknowledges it will need additional capital 2.
  • The application was initially refused for filing, and manufacturing comparability between suppliers required further clarification 12.

Opportunities

  • Approval could open markets in the U.S. and Europe where no approved treatment exists for autoimmune PAP 1.
  • If approval occurs, the royalty payment conditions and loan tranches could ease financing 12.
  • Pediatric development and expanded access programs could create new patient sources 1.

Threats

  • A further FDA information request or rejection could delay launch and reduce the program's value 2.
  • Long-term results are still unknown, and regulators may require additional studies 1.
  • Geopolitical tensions and supply chain disruption risks could affect manufacturing and study timing 2.

Risks

  • Dependence on a single producthigh

    The company depends almost entirely on the clinical and regulatory success of MOLBREEVI, so a failure would affect the entire portfolio 1.

  • Regulatory timelinehigh

    The FDA decision date has been extended and the application was already refused once, showing a further delay is possible 12.

  • Capital requirementshigh

    The company will need additional funds for development and launch, and financing terms may be less favorable 12.

  • Manufacturing and supply chainmedium

    Production depends on external suppliers, and any quality or technology transfer problem could delay supply 1.

  • Litigation and investor attentionlow

    A securities class action and a derivative action were filed in 2025 and later dismissed without prejudice, but could be reopened 1.

Investment thesis

What would need to be true (bull case)

  • If the FDA approves MOLBREEVI, the company could become the first approved treatment for autoimmune PAP, with market exclusivity and a royalty payment linked to approval 1.
  • IMPALA-2 data show significant improvements in DLCO and quality of life scores, with very high trial completion 1.
  • Validation of marketing applications in Europe and the UK could expand commercial potential if regulators confirm clinical benefit 2.

What would break the thesis

  • The autoimmune PAP market is very small, and commercial success could remain limited even after approval 1.
  • The company has no revenue and depends on external capital, which could force dilution or less favorable financing terms 12.
  • The initial refusal and the extended review show regulators can request clarifications, and approval is not assured 12.

What to watch

  • FDA decision on the MOLBREEVI BLANovember 2026
  • CHMP opinion from the EMA on the marketing application2026
  • Cash position and need for additional capitalnext quarterly report
  • Possible Hercules loan tranches after approval2027

Products, market & competition

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

The business

Savara Inc. develops molgramostim inhalation, branded MOLBREEVI, an inhaled form of recombinant human GM-CSF for autoimmune PAP, a rare lung disease 1. The product is a drug-device combination, administered once daily with the eFlow nebulizer from PARI Pharma 1. The company outsources manufacturing and most clinical operations and has no product revenue to date 1.

The main clinical evidence is the Phase 3 IMPALA-2 trial, the largest placebo-controlled study in autoimmune PAP, in which the DLCO improvement versus placebo was statistically significant at Week 24 1. The BLA was submitted in March 2025, received a Refusal to File in May 2025, was resubmitted in December 2025, and was formally filed with Priority Review in February 2026 12.

Segments

MOLBREEVI development in autoimmune PAP

The sole program, MOLBREEVI, is at an advanced stage, with a BLA under FDA review and marketing applications at the EMA and MHRA 2. The decision date now sits at November 22, 2026, after a three-month extension of the PDUFA target 2.

Financing and capital structure

The company has no product revenue and covers net losses through equity offerings, loans and a royalty agreement 12. Available liquidity at June 30, 2026 is modest, so capital needs remain an important condition for continuity 2.

Market context

Autoimmune PAP is the most common form of PAP and a very small market, with a diagnosed prevalence estimated at six to seven cases per million people in the U.S. 1. No treatment is approved in the U.S. or Europe, and the current therapy is whole lung lavage, an invasive procedure 1. This creates an unmet need but a limited patient volume.

If MOLBREEVI is approved, commercial potential will depend on diagnosed patient numbers, reimbursement and adoption of a chronic treatment that the company expects to be long-term 1. Long-term data remain limited, which could influence uptake 1.

Trends

  • U.S. regulatory processmixed

    The initial refusal to file and the subsequent Priority Review show how sensitive the timeline is to FDA requirements on manufacturing comparability 12. If the FDA requests further information, the timeline could again be extended.

  • Expansion into Europe and the UKtailwind

    The EMA and MHRA have validated marketing applications, and the UK accelerated review assumes a 150-day assessment 2. This could open more markets if assessments progress.

  • Dependence on external fundingheadwind

    The company has raised capital through public offerings, private placements and loans, and losses continue 12. Manufacturing and launch preparation costs could rise with commercialization.

  • Patent protection and exclusivitytailwind

    The patent covering the drug-device combination runs through 2043, and a European patent on the liquid formulation protects until 2041 1. Orphan drug designations add market exclusivity after approval 1.

Competitive position

The company presents the absence of approved treatments as an advantage, but this does not rule out other therapies or off-label options 1. Injectable sargramostim is approved in Japan for autoimmune PAP, showing that an alternative already exists in another market 1.

The main competition is whole lung lavage, which remains the current standard, and any new candidates that could enter development 1. The company notes that no other candidate is in clinical development for autoimmune PAP in the U.S. or Europe, apart from MOLBREEVI 1.

  • Whole lung lavage

    Invasive procedure performed under general anesthesia, currently the standard therapy without an approved drug 1.

  • Sargramostim (Leukine)

    Injectable form of GM-CSF, approved in Japan for autoimmune PAP in April 2024 1.

  • Other autoimmune PAP candidates in development

    The company states that no other inhaled therapy is in clinical development for this disease in the U.S. or Europe 1.

  • Investigator-sponsored inhaled GM-CSF studies

    Open-label academic studies have reported promising results, indicating medical interest in the same drug class 1.

News & filings

In the press

No news in our archive over the last 180 days.

SEC filings

Sources

  1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Savara Inc · 13 Mar 2026
  2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Savara Inc · 11 Aug 2026
  3. [3] Form 8-K, results release (exhibit 99.1) · SEC / Savara Inc · 06 Aug 2020

Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.