📊 Backtest📒 Journal Updated 04/08/2026
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FRESHReport written today · at $5.69

SVRA

MoonshotSMALL CAP
Savara Inc. · NASDAQ · Healthcare / Biotechnology
$5.69
▲ 1.40%
MCap $1.17B
Trading near the top of its 52-week range ($1.98-$7.01), above its 200-day average, as buy-side positioning builds into the Nov 22 PDUFA
BusinessRare disease biotech · First-in-class inhaled MOLBREEVI (molgramostim) in Priority Review for autoimmune pulmonary alveolar proteinosis (aPAP) — no FDA-approved therapy exists for this ultra-rare lung disease today
Thesis

Savara's MOLBREEVI has a PDUFA date of Nov 22, 2026 (extended 3 months from Aug 22 after the FDA requested additional information — no safety, efficacy, or manufacturing concerns were cited) to become the first and only approved therapy for autoimmune pulmonary alveolar proteinosis, an ultra-rare lung disease with real unmet need. Cash runway to H2 2027 removes near-term dilution risk, and Street consensus already prices in a meaningful probability of approval (avg target ~$9.20, high $16 vs a $5.69 current price). The binary is real: a clean approval could re-rate this as a first-in-class launch story, while a second delay or CRL — a genuine risk given the review has already slipped once — could cut the stock in half overnight.

📝 Primary Verdict · Core Holding
SPECULATIVEMoonshot

Binary PDUFA play — small starter now, add on dips into Nov 22; size for a CRL that could cut the stock in half

75
score / 100 ⓘ
⚡ Catalyst
💊 PDUFA decision — MOLBREEVI in autoimmune PAPPDUFA

FDA decides by Nov 22, 2026 whether to approve the first and only therapy for autoimmune pulmonary alveolar proteinosis. Priority Review; no safety, efficacy, or manufacturing issues cited in the extension letter.

Nov 22, 2026
🎯 Entry Point
Entry 1
$5.69
Current price, pre-PDUFANow
Entry 2PREFERRED
$4.8–5.2
Dip zone on broad biotech/macro weaknessIf dips
Entry 3
$3.80
Deep dip — near pre-runup baseIf sector selloff
✅ Take Profit
TP1
Base case — approval, partially priced-in re-rate to consensus
$9.39
+65%
TP2
Bull case — clean approval + strong launch narrative, Street high target
$15.93
+180%
TP3 🌙
Moon case · first-in-class monopoly + takeout speculation post-approval
$20.48
+260%
🔴 Stop Loss
Tight Stop
Below near-term support ahead of PDUFA
$5.01
-12%
Hard Stop
Below 200-day MA — pre-catalyst setup in doubt
$4.27
-25%
Risk / Reward
Asymmetric binary — small technical stop vs convex catalyst upside
15 : 1 (vs TP2)
⚠ Binary event — a CRL gaps straight through any technical stop
📅 Estimate Date
PDUFA decision
FDA approval/CRL decision on MOLBREEVI
Nov 22, 2026
Priority Review
📈 Possible Up % — Scenario Spread
Bear
-40%
$3.41
Base
+65%
$9.39
Bull
+180%
$15.93
Moon
+260%
$20.48
← downsideupside →
🏛️ Fed / Macro Risk — MEDIUM

Assesses how Fed policy / interest rates / inflation affect this stock — LOW = minimal risk, HIGH = proceed with caution

Rate Outlook
Fed held at 3.50-3.75% on Jul 29 with 3 hawkish dissents favoring a hike — rate-hike tail risk into year-end hasn't gone away
Inflation
Core PCE still 3.3% YoY, well above the 2% target
Sector Impact
Biotech is rate-sensitive as a long-duration, cash-burning sector, but SVRA's binary FDA catalyst dominates the stock's direction far more than macro does
Summary
Macro risk is secondary here — the Nov 22 FDA decision, not the Fed, is what moves this stock
🎯 Analyst Targets

Wall Street price targets vs the current price — cross-check our TP levels

Street consensus (8 analysts)
Buy$9.2+62%
Street high estimate
Buy$16+181%
current price $5.69
🔍 Similar-Catalyst Comparable Check

Stocks that went through similar catalyst events — calibrate whether the +30%+ target is realistic

RETA✅ GoodFeb 2023
+199%
in 1 day
Skyclarys (Friedreich's ataxia) FDA approval — first-in-class
Underfollowed first-in-class rare-disease approval — the stock nearly tripled overnight as the market re-rated a name few had modeled for a clean approval.
VERA✅ GoodJul 2026
+33%
in 30 days
Trutakna (IgA nephropathy) accelerated approval
Already well-anticipated approval — modest +7% day-of pop, but the stock re-rated +33% over the following month as commercial launch derisked.
CORT❌ BadDec 2025
-50%
in 1 day
Relacorilant Complete Response Letter
A CRL with no cited safety issue still triggered a 50% single-day collapse — shows how violently binary FDA misses can move even a well-covered name.
⚡ Optional Layer · Tactical Overlay
🎯 Catalyst Spot Mode

Short-term play around the catalyst (Sep 2026 earnings) only — an optional overlay, not a verdict that ranks equal to the Core Holding.

⚠️

Use this stop-loss set (-20% / -35%) only when trading the earnings spot — not for the core holding (use the -12% / -25% set above). If you are holding long-term, follow the core set.

📈Pre-Catalyst Run-up Pattern
+10% to +20%2-4 weeks before PDUFA

Rare-disease PDUFA names often drift up into the decision date as options positioning builds and buy-side conviction grows on a clean regulatory record — SVRA's Priority Review has no cited safety signal

🎲Historical Post-Catalyst Move
✅ Catalyst Winavg +40%
range: +15% to +80% same-day/week; already-anticipated approvals can still add another +33% over the following month· Jul 2026 (VERA) / Feb 2023 (RARE)
Vera Therapeutics (Trutakna, Jul 2026) — already well-anticipated approval, +7% day-of but +33% over the next month as launch derisked. Underfollowed first-in-class rare-disease names can move far more explosively: Reata (Skyclarys, Feb 2023) jumped +199% the day after approval.
❌ Catalyst Missavg -35%
range: -21% to -50%· Dec 2025 (CORT)
CRLs in rare-disease/orphan biotech have produced brutal single-day drops even without a cited safety issue — Corcept (CORT) fell -50% on a Dec 2025 CRL, RegenxBio (RGNX) fell -21% on a Feb 2026 CRL
💼Spot Position Sizing
How the recommended % is derived
4%
of portfolio

Binary FDA event with real precedent for -35% to -50% single-day downside on a miss; size small even given the first-in-class upside case

🛑Stop Loss · Spot Trade
Spot cut-loss levels — separate from the core holding
Before Catalyst
-20%($4.55)
Below this, the clean pre-PDUFA setup is in question even before the FDA decision lands
After Catalyst (Bad Result)-35%
If a CRL/delay hits, exit into the gap rather than average down — rare-disease CRLs have historically kept falling for days as the market re-prices the delay
📎 Sources

Generated 2026-08-04 · Not financial advice