Top 5 for This Week
Rezdiffra — $MDGL ( ▲ 0.62% )
Setup:
Post-approval MASH data at AASLD, including compensated cirrhosis and combo studies, refining Rezdiffra’s long-term and label-expansion narrative.
Our View:
PoA 90 (High) — Efficacy, durability, and safety are largely de-risked; focus now on real-world performance and expansion endpoints.
Key Risk:
Label scope (fibrosis stage, comorbidities) and payer alignment drive upside more than regulatory status.
Implication:
Short-term risk/reward capped; shift from if approved to how broad / how fast. Expect digestion as major holders recalibrate commercial models.
IMNN-001 — $IMNN ( ▼ 5.5% )
Setup:
DNA-IL-12 immunotherapy data in advanced ovarian cancer.
Our View:
PoA 30 (Speculative) — Small, early dataset with limited power; mechanistic interest but high execution and biology risk.
Key Risk:
Fundamental efficacy; single-asset binary.
Implication:
Serves more as a read-through on DNA-delivery and local-cytokine approaches than a durable single-name long; treat as high-volatility event exposure.
Amlitelimab — $SNY ( ▲ 1.17% )
Setup:
Detailed Phase 3 COAST data presentation in atopic dermatitis at upcoming meetings; topline results were positive in September.
Our View:
PoA 60 (Moderate) — Biologic plausibility strong; differentiation vs. existing IL-pathway agents and long-term safety are gating factors.
Key Risk:
Class-wide safety profile and positioning versus $LLY lebrikizumab and other incumbents.
Implication:
Outcome will shape how the market prices next-gen AD franchises, not just $SNY’s own asset.
Belapectin — $GALT ( ▲ 14.23% )
Setup:
Follow-up and subgroup analyses from the NAVIGATE Phase 2b/3 study at AASLD; revisiting longer-term trends after prior negative primary readout.
Our View:
PoA 25 (Speculative) — Historical signals inconsistent; high bar for efficacy in advanced cirrhosis.
Key Risk:
True binary for mechanism validity and remaining equity value.
Implication:
Classic microcap event. If positive, re-rates fibrosis-adjacent programs; if flat, limited residual narrative. Strict position-sizing required.
Plozasiran — $ARWR ( ▲ 1.7% )
Setup:
Imminent PDUFA (Nov 18) for plozasiran in familial chylomicronemia syndrome (FCS).
Our View:
PoA 85 (High) — Strong data package with clear efficacy and clean safety; likely approval barring label nuance.
Key Risk:
Label scope and post-approval commercial execution.
Implication:
High-confidence binary with read-through to the broader RNAi lipid pipeline. Definitive catalyst for mid-cap RNA names into Q4.
Second Tier — Additional Events to Watch
Lower-conviction or narrower-scope events with optionality, read-through, or platform-signal value.
$MIST ( ▲ 7.9% ) — Etripamil: Phase 3 data (Nov 10); nasal CCB for PSVT. PoA 75 (High) — Prior data supportive; key variable is real-world adoption.
$MBX ( ▼ 5.48% ) — Canvuparatide: Phase 2 Avail™ data in hypoparathyroidism; company guiding to Phase 3 initiation in 2026. PoA 55 (Moderate).
$CMMB ( ▲ 3.03% ) — Nebokitug: Phase 2 PSC data. PoA 30 (Speculative) — High unmet need; small, noisy dataset risk.
$KMDA ( ▲ 6.01% ) — Inhaled AAT: Phase 3 readout. PoA 20 (Speculative) — Mixed history and inhaled-route complexity keep bar high.
$RNXT ( ▲ 7.12% ) — RenovoCath: Phase 3 pancreatic cancer device. PoA 60 (Moderate) — Procedure execution key.
$IMMP ( ▲ 2.96% ) — Eftilagimod: Phase 2 STS data. PoA 30 (Speculative) — IO combo differentiation remains tough.
Market Context
MASH / AASLD Cycle — $MDGL ( ▲ 0.62% ) and $GALT ( ▲ 14.23% ) anchor the meeting; clean MASH data still commands a premium. Label language and fibrosis-stage scope now drive valuation.
Cardio-Metabolic Leadership — Names like $CYTK ( ▲ 2.83% ) and $AMGN ( ▲ 0.35% ) remain bid as GLP-1 dominance persists; oncology flows lighten post-SITC.
Microcap Stress — Cash-tight sub-$50 M caps face financing risk through year-end; CRL-style or marginal readouts often translate to immediate dilution.
PoA Framework (Snapshot)
PoA bands: High (> 70) | Moderate (40–70) | Speculative (< 40)
Construct: Weighted five-factor model integrating study design, data strength, safety/CMC, regulatory precedent, and execution quality. Calibrated by FDA division and historical base rates.
Directional only; derived strictly from 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.
PDUFA Pulse is independent and unaffiliated with any issuer mentioned.