PoA = probability-of-approval (0–100), banded below.
This issue: one live binary in the next 7 days, key setups into mid-December, tape context, retail lens, and PoA accountability.
Featured Binary (next 7 days)
Plozasiran — $ARWR ( ▲ 0.29% )
Date: Nov 18 • Event: PDUFA (FCS) • PoA: 85
Skew: Robust Ph3 efficacy (large TG reduction) and clean safety; core debate is label scope and pancreatitis-risk positioning, not approvability.
Why it matters: Potential new standard in FCS with read-through to RNAi lipid franchises; watch label language and early payer framing.
On Deck (Nov 20 – Dec 15)
Events prioritized by impact and proximity; ordered by date.
For non-approval events (e.g., toplines, conference details), PoA reflects our probability of a favorable/meaningful outcome.
Nirsevimab — $AZN ( ▲ 0.55% )
Nov 24 • Ph3 detail • PoA: 60
Large RSV prevention read-through; competitive positioning and guideline implications are the swing factors.
Rocatinlimab (AMG 451) — $AMGN ( ▲ 0.22% )
Nov 27 • Ph3 topline (AD) • PoA: 60
Needs clear differentiation vs dupilumab-class incumbents; durability and safety will drive adoption.
Ziftomenib — $KURA ( ▲ 4.92% )
Nov 30 • PDUFA • PoA: 80
First-in-class menin inhibitor (R/R AML) with Priority Review; efficacy established, safety/tolerability is the gating risk.
Avance® Nerve Graft — $AXGN ( ▼ 2.04% )
Dec 5 • PDUFA • PoA: 72
Tissue allograft under biologics-style scrutiny; data package mature, CMC/manufacturing nuance is key.
Mitapivat (PYRUKYND) — $AGIO ( ▲ 2.61% )
Dec 6 • Ph3 topline • PoA: 98
Validated MoA in hemolytic anemia; main question is breadth/strength across endpoints and commercial expansion, not whether it works.
PRAX-628 — $PRAX ( ▲ 4.68% )
Dec 8 • Ph2 topline (focal seizure) • PoA: 40
True CNS binary; upside if effect size is clearly clinically meaningful with acceptable safety.
Palazestrant (OP-1250) — $OLMA ( ▲ 5.79% )
Dec 12 • Ph3 readout (ER+/HER2−) • PoA: 45
Needs compelling efficacy plus clean safety to secure a role in a crowded oral endocrine landscape.
Resolved This Week (context, not binaries)
These were framed as label/positioning or speculative color, not true approval decisions; outcomes tracked against that context.
$MDGL ( ▲ 2.77% ) — Rezdiffra (AASLD expansion/2-year data)
Largely in line; supports durability/safety. Focus stays on label scope and payer alignment rather than approvability.
$IMNN ( ▲ 1.44% ) — IMNN-001 (SITC translational/early data)
Incremental translational signal; does not reset thesis without powered efficacy. Remains high-volatility, single-asset risk.
$SNY ( ▼ 0.38% ) — Amlitelimab (COAST details)
Consistent with topline; debate remains differentiation vs incumbents and positioning in the inflammatory pipeline.
$GALT ( ▼ 0.36% ) — Belapectin (AASLD biomarker/subgroup)
Subgroup/biomarker cuts did not overturn prior NAVIGATE miss; residual narrative, not true de-risking.
This Week on the Tape — Biotech
Context only; not investment advice.
Flows: Rotation favored cardio-metabolic over speculative IO; breadth improved mid-week, faded into Friday.
Catalyst follow-through: $MDGL ( ▲ 2.77% ) / $SNY ( ▼ 0.38% ) “as expected”; $GALT ( ▼ 0.36% ) incremental only.
Financing/weather: Cash-tight microcaps stayed defensive; expect opportunistic offerings around binaries.
Setups into next week: $ARWR ( ▲ 0.29% ) (11/18) is the live binary; lens is label language and pancreatitis positioning more than approvability.
Retail Lens
Patterns we see around catalyst weeks. This is not investment advice.
High PoA (>70), well-telegraphed: Moves often hinge on label and launch detail; “sell the news” on in-line outcomes is common.
Mid PoA (40–70): Where surprise premium lives; upside usually needs clearly better-than-expected data, not just hitting endpoints.
Low PoA (<40) microcaps: Misses often followed by secondaries; size assuming dilution risk even if day-one drop is modest.
Balance sheet: Short runway + risky binary ⇒ higher chance of post-event financing overhang.
Event type: PDUFAs and pivotal toplines move intrinsic value; conference sub-analyses rarely rewrite the story alone.
PoA Calibration — This Week
Light, accountable, same format every Friday. Small weekly samples; focus is directional sanity, not precision backtests.
All four tracked events this week behaved in line with prior framing:
High/established PoA names translated into label/commercial nuance, not binary surprises.
Sub-40 PoA names functioned as speculative/platform color without true de-risking.No new binary approvals resolved this week. First upcoming binary scorecard: $ARWR (Nov 18).
PoA Framework (Snapshot)
PoA bands: High (>70) | Moderate (40–70) | Speculative (<40)
Construct: Five-factor model (study design, data strength, safety/CMC, regulatory precedent, sponsor execution), calibrated by FDA division and historical base rates. Directional only; based strictly on public information.
Disclaimer
This newsletter is for informational and educational purposes only and does not constitute investment advice, a recommendation to buy or sell any security, or an offer to provide investment advisory services. All views are based solely on publicly available information and historical regulatory behavior. Biotech and pharmaceutical securities involve substantial risk, including the risk of complete loss of capital. Always conduct your own due diligence.