STALE?Report written 7 days ago · at $49.10entry levels may be stale — re-check before acting
SRRK
SpeculativeMID CAP
Scholar Rock Holding Corporation · NASDAQ · Healthcare / Biotechnology
$49.10
▲ 0.00%
MCap $6.18B
Price self-fetched via search — SRRK is absent from live-prices.json (cache asOf Aug 5, 8 days stale). Intraday change not available, so priceChange is 0 rather than a guess. Context: stock rallied ~17% on Aug 12 as regulatory progress outweighed in-line Q2, and sits below the 52-week high of $56.54.
BusinessSingle-asset biotech · Apitegromab (anti-myostatin) for SMA — PDUFA Sep 30 turns a clinical-stage story into a commercial one, or doesn't
Thesis
Binary PDUFA on Sep 30 for apitegromab in SMA — Scholar Rock has no approved product, so this decision either creates a commercial-stage company or removes the entire thesis. BLA was accepted with two manufacturing sites after the earlier resubmission, and the stock has already run on regulatory progress (+14% on resubmission, +17% post-Q2). Consensus $59.94 across 16 analysts is +22% from here, which clears the dashboard's gate but is not a large cushion for an event with CRL downside of -40% to -80%. Size it as an event trade, not a position.
📝 Primary Verdict · Core Holding
SPECULATIVESpeculative
Event trade, not a position — 3–5% size, prefer the $44–46 dip, and accept that no stop protects you through the decision itself.
64
score / 100 ⓘ
⚡ Catalyst
⚖️ Apitegromab PDUFA Decision (SMA)48 DAYS
FDA target action date for apitegromab in spinal muscular atrophy. BLA accepted with two manufacturing sites following resubmission. Approval would be Scholar Rock's first commercial product; a CRL removes the near-term revenue thesis entirely.
Sep 30, 2026
🏭 Manufacturing Site ReadinessONGOING
The resubmission added a second manufacturing site — the issue that drove the original delay. Any pre-approval inspection finding between now and Sep 30 is the most likely path to another CRL.
Ongoing
🎯 Entry Point
Entry 1
$49.10
Current price — already +17% off the Q2 reactionNow
Entry 2PREFERRED
$44–46
Give back the post-Q2 pop; better risk into a binaryIf dips
Entry 3
$38.00
Deep dip — would imply the market is repricing CRL oddsDeep dip
✅ Take Profit
TP1
Consensus $59.94 — approval largely as expected
$59.9
+22%
TP2
BMO target — approval with a clean, broad label
$70
+42.6%
TP3 🌙
Street high — approval plus launch/uptake credit · 2027
$76
+54.8%
🔴 Stop Loss
Tight Stop
Set deliberately wider than the measured core medianMAE of -14% — a stop inside that range gets hit by ordinary pre-event noise rather than by a broken thesis
$41.2
-16.1%
Hard Stop
Below this the market is pricing a CRL and the pre-event thesis is gone
$36.8
-25.1%
Risk / Reward
Tight stop (-16.1%) vs TP2 (+42.6%)
2.6 : 1
⚠ R/R is only meaningful BEFORE Sep 30 — a CRL gaps through any stop overnight
📅 Estimate Date
Apitegromab PDUFA
Binary — approval vs CRL
Sep 30, 2026
approval = first commercial product
Q3 2026 Earnings
First print after the decision; launch readiness detail if approved
Nov 2026
n/a — pre-revenue
📈 Stock Timeline
1 snapshot · Aug 13
First snapshot — check back next week
Score
66
Aug 13
TP2 Target
$70
Aug 13
Rank
#24
Aug 13
📈 Possible Up % — Scenario Spread
Bear
-45%
$27
Base
+22%
$59.9
Bull
+42.6%
$70
Moon
+54.8%
$76
← downsideupside →
🏛️ Fed / Macro Risk — LOW
Assesses how Fed policy / interest rates / inflation affect this stock — LOW = minimal risk, HIGH = proceed with caution
Rate Outlook
Fed funds held at 3.50–3.75% on Jul 29 — fifth consecutive pause, though three members dissented in favour of a hike. Next FOMC Sep 16, two weeks before the PDUFA.
Inflation
July CPI (released Aug 12) came in at 3.4% headline, down from 3.5%, with core at 2.5% and +0.1% m/m — soft enough to take hike pressure down after July payrolls printed -23k with >100k of downward revisions.
Sector Impact
A binary PDUFA is close to macro-independent: the Sep 30 outcome dominates anything the Sep 16 FOMC does to this name. Rates matter only via the long-duration discount on unprofitable biotech, and the direction of travel there is currently favourable.
Summary
LOW — the event is idiosyncratic. The Sep 16 FOMC is a background variable, not a driver of this thesis.
🎯 Analyst Targets
Wall Street price targets vs the current price — cross-check our TP levels
BMO Capital
Outperform$70+43%
H.C. Wainwright
Buy$65+32%
BofA Securities
Buy$58+18%
Jefferies
Buy$57+16%
Truist Securities
Buy$55+12%
current price $49.10
🔍 Similar-Catalyst Comparable Check
Stocks that went through similar catalyst events — calibrate whether the +30%+ target is realistic
Same ticker, same catalyst family: the market pays SRRK for regulatory de-risking ahead of the decision. Directly relevant because it shows how much is already in the price going into Sep 30.
CHRS❌ BadJun 2017
-24%
in 1 day
FDA rejection (Complete Response Letter)
Milder CRL reaction because Coherus had other programs to fall back on. SRRK has no approved product, so this is closer to a floor on the downside case than a central estimate.
ALIM❌ BadNov 2011
-73%
in 1 day
FDA rejection of lead candidate
Single-asset company rejected on its flagship — the structural analogue to SRRK's position. This is what the bear case actually looks like when there is no second program.
⚡ 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 (-16.1% / -35%) only when trading the earnings spot — not for the core holding (use the -16.1% / -25.1% set above). If you are holding long-term, follow the core set.
📈Pre-Catalyst Run-up Pattern
+14% to +17%2–6 สัปดาห์ก่อน PDUFA
SRRK has repeatedly re-rated on regulatory milestones rather than waiting for the decision itself: +14% on the BLA resubmission and ~+17% on Aug 12 when regulatory progress outweighed an in-line Q2. The pattern is that progress gets paid early, which also means less is left for the approval.
🎲Historical Post-Catalyst Move
✅ Catalyst Winavg +15%
range: +10% to +25%· Aug 2026
Event studies of FDA approvals report mean/median cumulative abnormal returns in the low-single to low-double digits over the 0 to +5 day window. Small single-asset biotechs can double or triple on approval, but that applies to names far smaller than a $6.18B cap that has already run ~17% into the event — hence the +10% to +25% band rather than the headline multiples.
❌ Catalyst Missavg -50%
range: -40% to -80%· Nov 2011
CRL outcomes for single-asset biotechs cluster in the -40% to -80% range. Named cases: Alimera Sciences -73% (Nov 2011) and Coherus -24% (Jun 2017), the latter cushioned by a broader pipeline that SRRK does not have.
💼Spot Position Sizing
How the recommended % is derived
4%
of portfolio
Binary single-asset event with -40% to -80% downside and no pipeline cushion. Conviction is in the setup, not the outcome — 4% keeps a CRL survivable. The feedback prior's fda_decision bucket is n=3, below the n>=5 bar, so it is context only and does not justify sizing up.
🛑Stop Loss · Spot Trade
Spot cut-loss levels — separate from the core holding
Before Catalyst
-16.1%($41.2)
Wider than the measured -14% median MAE; a break here before Sep 30 means the market is repricing approval odds, not just drifting
After Catalyst (Bad Result)-35%
If a CRL lands, exit into the first liquidity rather than waiting for a bounce — the re-filing clock is measured in quarters