PoA = probability-of-approval band (directional only; not FDA guidance).
This issue covers
The Weekend Warrior: $ATRA ( ▲ 0.24% ) (tab-cel) faces a rare Saturday PDUFA (Jan 10).
JPM Week Volatility: J.P. Morgan Healthcare Conference runs Jan 12–15 (San Francisco).
The Tuesday Gate: $TVTX ( ▲ 0.49% ) (Filspari, FSGS full approval) is the next major binary on Jan 13—this week’s pre-mortem preview below.
Off-calendar signals: Parabilis reopens the financing window with an oversubscribed $305M Series F; MoonLake gets FDA alignment for an HS BLA strategy (H2 2026).
Market outlook
With desks fully online and JPM Week acting as a volatility amplifier, the highest-signal events are the ones tied to hard FDA dates (not podium narratives). Into that backdrop, we have a genuine operational edge case: a Saturday PDUFA.
The weekend warrior: $ATRA ( ▲ 0.24% ) — tab-cel (EBV+ PTLD)
Date: Jan 10 (Saturday) | Event: PDUFA | PoA: 77 (High)
What matters this weekend
Timing risk: Saturday PDUFAs often resolve Friday after the close or Monday pre-market—plan for both windows.
Clinical floor: Pivotal data showed 50.7% ORR with 18.4 months median overall survival.
Commercial kicker: A positive decision triggers a reported $40M milestone payment from partner Pierre Fabre.
This quarter we’re piloting Pre-Mortem Desk: one FDA decision per week, mapped for failure modes and decision language. Today’s $TVTX section is a preview. Paid issues will include the full failure-mode table, 3–5 label watch-phrases, and a decision-day playbook.
$TVTX ( ▲ 0.49% ) — Filspari (FSGS full approval)
Date: Jan 13 (Tuesday) | Event: sNDA for traditional approval in FSGS | PoA: 70 (High)
Pre-mortem preview: what can derail conversion even when proteinuria moved?
Verification gate: DUPLEX missed the 108-week eGFR slope endpoint but showed a meaningful proteinuria effect; the conversion decision hinges on whether proteinuria is treated as a validated surrogate without slope confirmation.
Total-slope math: label language flags an acute early eGFR dip; chronic benefit must be large enough to overcome that in total-slope analyses.
Benefit-risk compression: boxed warning + REMS (hepatotoxicity/embryo-fetal risk) raises the evidence bar; without clear functional benefit, tolerance for risk narrows.
Decision-Day Checklist (Preview) — $TVTX ( ▲ 0.49% ) FILSPARI | Jan 13
Decision type: conversion vs CRL vs restrictions
FDA framing of the slope miss (verification language)
Surrogate stance: proteinuria sufficient or not
Label watch: acute eGFR dip / total-slope wording
Safety: REMS/boxed warning unchanged vs tightened
Indication scope: narrowing/guardrails
PMRs: functional-outcome obligations
Bottom line: none of these determine outcome alone, but together they define a narrow corridor in which approval has to occur.
Next up: $FBIO ( ▲ 2.61% ) — CUTX-101 (Menkes disease)
Date: Jan 14 (Wednesday) | Event: NDA (Class 1 resubmission) | PoA: 80 (High)
Class 1 resubmission typically signals an administrative/CMC-focused repair rather than a full clinical re-litigation.
Why “Class 1” matters: timeline is typically 2 months (vs 6 months for Class 2).
Watch manufacturing language and any inspection-related updates into the decision window.
January PDUFA calendar
Ticker | Date | PoA | Summary |
|---|---|---|---|
Jan 10 | 77 | Tab-cel (EBV+ PTLD) — first-in-class allogeneic T-cell therapy | |
Jan 13 | 70 | Filspari (FSGS) — full approval decision (DUPLEX/DUET) | |
Jan 14 | 80 | CUTX-101 (Menkes) — Class 1 resubmission | |
Jan 31* | 80 | Anaphylm (Epi Film) — first oral epinephrine film | |
Jan 31* | 85 | Leniolisib pediatric sNDA (APDS) — Priority Review; label expansion |
* Jan 31 falls on a Saturday; FDA action may post Friday after the close or Monday pre-market.
Off-calendar signals (desk notes)
Parabilis financing window reopens: Parabilis (formerly FogPharma) announced an oversubscribed $305M financing to advance zolucatetide and support broader pipeline development.
MoonLake FDA alignment: MoonLake reported a positive Type B FDA meeting outcome indicating a path to HS BLA in H2 2026 without additional HS trials (strategy uses existing datasets).
Deal tape: after a prior AbbVie denial, fresh reporting now points to Merck–Revolution talks; still worth tracking as a JPM-week sentiment barometer.
Disclaimer
This newsletter is for informational purposes only. Biotech securities involve substantial risk, including total loss of capital. Always conduct your own due diligence.