📊 Backtest📒 Journal Updated 29/09/2026
← 🔥 Turbo
📐 Simulate Position
STALE?Report written 6 days ago · at $5.07entry levels may be stale — re-check before acting

SVRA

MoonshotSMALL CAP
Savara Inc. · NASDAQ · Healthcare / Biotechnology
$5.07
▲ 1.40%
MCap $1.29B
Down ~11% from the Aug 4 report price ($5.69) despite no negative newsflow — the Nov 22, 2026 PDUFA date has held firm (no second delay), Phase 3 IMPALA-2 data got encore presentations at the European Respiratory Society Congress in late Aug, and consensus target actually rose to $10.94 (8 analysts) from ~$9.20. Shares outstanding rose to 254.14M (from an implied ~206M at the last report) even as cash fell from $203M (Q1) to $173M (Q2) — consistent with steady ATM issuance funding the burn, likely the real driver of the price drift rather than any thesis change.
BusinessRare disease biotech · First-in-class inhaled MOLBREEVI (molgramostim) in Priority Review for autoimmune pulmonary alveolar proteinosis (aPAP) — PDUFA target action date Nov 22, 2026 holds firm, no second delay — no FDA-approved therapy exists for this ultra-rare lung disease today
Thesis

The binary catalyst hasn't fired yet and nothing has changed the setup: MOLBREEVI's PDUFA target action date is still Nov 22, 2026 (54 days out), no second delay, no new safety/efficacy signal, and Phase 3 IMPALA-2 data got a second round of positive conference exposure in late August. What HAS changed since the last report: the stock is down ~11% ($5.69→$5.07) while analyst consensus rose to $10.94 from ~$9.20 (215.6%/115.8% Moon/Bull upside now, both wider than before) — the gap between price and target widened almost entirely on its own, not on new bad news. Likely driver: shares outstanding grew from an implied ~206M to a confirmed 254.14M (+23%) while cash fell from $203M (Q1) to $173M (Q2), pointing to steady ATM-funded dilution ahead of the binary event — a real cost to per-share upside, not a survival risk (runway still ~14 months from today at the current $30M/qtr burn rate, comfortably above the 12-month survival-flag threshold). This remains a real binary: a clean approval re-rates the stock as the first-in-class launch story in an unmet-need disease; a second delay or CRL is a genuine possibility given the review already slipped once, and could cut the stock in half.

📝 Primary Verdict · Core Holding
SPECULATIVEMoonshot

Binary PDUFA play — entry-rule prior (n=19, median -13.7%) argues against chasing Entry 1; wait for the dip (Entry 2) and size for a CRL that could cut the stock in half

75
score / 100 ⓘ
⚡ Catalyst
💊 PDUFA decision — MOLBREEVI in autoimmune PAP54 DAYS

FDA decides by Nov 22, 2026 whether to approve the first and only therapy for autoimmune pulmonary alveolar proteinosis. Date has held firm since the Aug extension (no second delay); Priority Review; no new safety, efficacy, or manufacturing issues since then.

Nov 22, 2026
🎯 Entry Point
Entry 1
$5.07
Current price, pre-PDUFA. NOT preferred: the turbo entry-rule prior (entryGuidance.turbo, n=19) shows a median -13.7% return chasing a name 'now' ahead of a binary eventNow (not preferred)
Entry 2PREFERRED
$4.3–4.6
Dip zone, roughly -9% to -15% off current — matches the -13.7% median the entry-rule prior measures, and where broad biotech/macro weakness would likely push this pre-binaryIf dips
Entry 3
$3.60
Deep dip — near the new 52-week low ($3.34), only on a broad sector selloffIf sector selloff
✅ Take Profit
TP1
Base — assumes a ~7-8 week horizon into the Nov 22 PDUFA: continued pre-catalyst positioning consistent with the +10-20% historical pre-runup range for rare-disease PDUFA setups, not yet the approval outcome itself
$6.19
+22%
TP2
Bull case — clean approval, hits the 8-analyst consensus average, launch narrative intact
$10.94
+115.8%
TP3 🌙
Moon case — first-in-class monopoly + strong launch + takeout speculation post-approval, hits Street high
$16
+215.6%
🔴 Stop Loss
Tight Stop
Below near-term support ahead of PDUFA — wider than the fda_decision-type median MAE (-18.4%, n=10) per the turbo feedback prior
$4.05
-20.1%
Hard Stop
Below the new 52-week low ($3.34) — pre-catalyst setup materially in doubt
$3
-40.8%
Risk / Reward
From Entry 2 ($4.45 mid), tight stop vs TP2
16.2 : 1
⚠ Binary event — a CRL gaps straight through any technical stop, R/R math doesn't protect against overnight gap risk
📅 Estimate Date
PDUFA decision
FDA approval/CRL decision on MOLBREEVI — date has held firm, no second delay
Nov 22, 2026
Priority Review
📈 Possible Up % — Scenario Spread
Bear
-40%
$3.04
Base
+22%
$6.19
Bull
+115.8%
$10.94
Moon
+215.6%
$16
← 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 unexpectedly hiked 25bp to 3.75-4.00% on Sep 16, 2026 (unanimous 12-0), reversing the market's prior read that hike odds were fading after the weak July jobs print — a genuinely hawkish surprise
Inflation
FOMC's own statement cites elevated inflation and a push for 'a timelier return to the 2% goal'
Sector Impact
Biotech is rate-sensitive as a long-duration, cash-burning sector — especially SVRA, which appears to be funding its burn via steady ATM issuance — but SVRA's binary FDA catalyst still 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, though the hawkish surprise raises the broad cost-of-capital backdrop for a name that's actively diluting
🎯 Analyst Targets

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

Street consensus (8 analysts)
Strong Buy$10.94+116%
Street high estimate
Buy$16+216%
current price $5.07
🔍 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. Closest structural precedent to SVRA's own first-in-class aPAP monopoly setup.
VERA✅ GoodJul 7, 2026
+7.05%
in 1 day
TRUTAKNA (IgA nephropathy) accelerated approval
A larger, more-followed biotech name still only re-rated modestly on approval day — shows the range of outcomes even within 'good' approvals depends heavily on how much was already priced in and how well-known the name is.
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; SVRA's review has already slipped once, raising the odds of a repeat.
⚡ 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 -20.1% / -40.8% set above). If you are holding long-term, follow the core set.

📈Pre-Catalyst Run-up Pattern
+10% to +20%, based on comparable rare-disease PDUFA setups2-4 weeks before the Nov 22 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 and the date has held firm without a second delay

🎲Historical Post-Catalyst Move
✅ Catalyst Winavg +40%
range: +15% to +80% same-day/week for underfollowed first-in-class rare-disease approvals· Feb 2023 (RETA) / Jul 2026 (VERA)
Reata (Skyclarys, Feb 2023) jumped +199% the day after an underfollowed first-in-class rare-disease approval — the closest structural comparable to SVRA's monopoly setup. VERA's own Jul 7, 2026 accelerated approval drove a more muted +7.05% day-of gain (a larger, more-followed name with a less clean-cut binary). fda_decision is a Tier-2 LEADER bucket in the turbo feedback prior (n=10, +9.3pp median excess vs SPY, gap +7.3 vs the overall +2pp).
❌ 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
3%
of portfolio

Binary FDA event with real precedent for -35% to -50% single-day downside on a miss, plus an active dilution overhang (shares +23% since the last report) reducing per-share upside — size small even given the first-in-class monopoly upside case

🛑Stop Loss · Spot Trade
Spot cut-loss levels — separate from the core holding
Before Catalyst
-20%($4.05)
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 2026-09-29 · Not financial advice