PDUFA Pulse Monday Edition Nov 17

Date: Nov 18

Event: PDUFA (FCS)

PoA: 85

Setup: NDA accepted; Phase 3 PALISADE showed large TG reduction and pancreatitis-risk signal improvement in FCS. The FDA has granted Breakthrough Therapy, Orphan Drug, and Fast Track status.

Our View: Approval odds high; the debate is label scope (e.g., pancreatitis risk language, monitoring) and early payer stance rather than approvability. No AdCom was planned, suggesting a streamlined review.

Trade (quick): Binary skew favors label read-through vs downside surprise; watch wording for early access hurdles.

Tape context: Mkt cap $5.70B

Date: Nov 21

Event: Earnings call 21 Nov; pivotal safety data previously released 09 Sept.

PoA: 60

Setup: Pivotal STRIVE-ON safety study; injectable nimodipine aiming to address administration/PK limitations vs oral in aSAH.

Our View: Moderate PoA; signal is safety/operational. Results showed more consistent PK, fewer hypotensive events, and shorter ICU stays vs oral nimodipine.

Trade (quick): Small-cap volatility; liquidity and financing overhang matter more than marginal deltas on “safe/operationally cleaner.”

Tape context: Mkt cap $43.23M

Date: Nov 18

Event: Pre-clinical data webcast

PoA: 4

Note: Scientific color only; not a trading-grade catalyst. Preclinical data showed compelling efficacy in murine models , but there is no human efficacy or safety data.

Date: November 2025

Event: Phase 2a data readout (obesity)

PoA: 15

Setup: Phase 2a study of a CB1 antibody (NCT06577090).

Our View: Low PoA. Initial data showed monotherapy at 200mg missed its primary endpoint (p=0.2699). The bull case relies on combination data with a GLP-1 agonist, which showed "clinically meaningful" weight loss, but the small sample size and monotherapy failure create high uncertainty.

Date: Nov 30

Event: PDUFA (Achondroplasia)

PoA: 80

Setup: NDA accepted for Priority Review. The pivotal ApproaCH Trial demonstrated a superior annualized growth velocity (AGV) of 1.78 cm/year at Week 52 compared to placebo.

Our View: High PoA. The drug has a favorable safety profile (akin to placebo) and robust, double-blind, placebo-controlled data. High likelihood of approval.

Rotation: Flows favor cardio-metabolic over speculative IO; breadth improved mid-week, faded into Friday.

Financing: Cash-tight microcaps remain defensive; expect opportunistic offerings around binaries.

Accountability: $KURA ( ▲ 1.38% ) approval came early (Nov 14); a positive catalyst resolution.

Ziftomenib — $KURA ( ▲ 1.38% ) A: (Early Approval) Was on our watchlist for a Nov 30 PDUFA. The FDA granted an early approval on Friday, Nov 14. This resolves the binary event as a clear win.

Rezdiffra — $MDGL ( ▲ 1.92% ) : (AASLD Data) Post-approval MASH data at AASLD, including compensated cirrhosis data, was presented. This was largely in line with expectations and supported the long-term narrative.

Amlitelimab — $SNY ( ▼ 0.19% ) : (COAST Details) Detailed Phase 3 COAST data for atopic dermatitis was presented , following the positive topline in September. Debate remains on differentiation vs. incumbents.

Belapectin — $GALT ( ▲ 8.35% ) : (AASLD Data) Follow-up and subgroup analyses from the NAVIGATE study were presented after the prior negative primary readout. The data was incremental and did not appear to reset the thesis.

IMNN-001 — $IMNN ( ▼ 3.08% ) : (Early Data) Early data for the DNA-IL-12 immunotherapy was presented. As expected, this was a speculative, early dataset with high risk.

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.