PoA = probability-of-approval band (directional only; not FDA guidance).
A QUICK FRAME FOR THE WEEK
This is a quiet PDUFA tape (Jan 19–23): no clean midweek FDA binaries. The week is about positioning into the Jan 31 weekend cluster and monitoring late-cycle disclosure risk.
Treat most headlines as optional unless they change FDA timelines, endpoints, or CMC / label risk. Operating posture: trade the tape if you must; anchor positions to decision language and manufacturing readiness.
WEEKEND PDUFA OVERHANG (JAN 31)
Jan 31 lands on a Saturday. Expect outcomes to compress into Fri after close (Jan 30) and/or Mon morning (Feb 2) depending on issuer disclosure cadence.
THE PDUFA DECK (NO MIDWEEK BINARIES)
No date-certain FDA decision events this week. Use the gap to tighten the late-month playbook: what you will do based on (a) approval with clean label, (b) approval with restrictive label / PMR load, (c) delay, (d) CRL.
RISK UPDATE: AQUESTIVE — $AQST ( 0.0% ) | ANAPHYLM (EPINEPHRINE) | JAN 31 PDUFA
Date: Jan 31 | Event: PDUFA
PoA: 30 — Low / high execution risk
Update: FDA notified the company of NDA deficiencies that currently preclude labeling discussions. Review is ongoing, but this is a late-cycle red flag.
Gmail - PDUFA Pulse_ Monday (Ja…
Watch for: specificity of deficiencies (clinical vs CMC vs application integrity) and whether timing realistically allows closure by the action date.
LATE-MONTH PDUFA (STABLE / HIGH-PROBABILITY)
Pharming — $PHAR ( ▲ 1.68% ) | leniolisib (Joenja) pediatric sNDA (ages 4–11)
Date: Jan 31 | Event: PDUFA, Priority Review
PoA: 85 — High
Setup: age-expansion of an approved agent (12+).
Gmail - PDUFA Pulse_ Monday (Ja…
Watch for: pediatric safety/dosing language and any label caveats that change uptake assumptions.
OFF-CALENDAR / FORWARD SIGNALS
Kodiak — $KOD ( ▼ 0.33% ) | tarcocimab (GLOW2) Phase 3
Timing: “On track for 1Q 2026” is the correct framing — rolling window, not a hard-dated Jan 31 binary.
Gmail - PDUFA Pulse_ Monday (Ja…
OS Therapies — $OSTX ( ▲ 1.44% ) | OST-HER2
Update: released positive Phase 2b biomarker data (Jan 15) that functions as the “fundamental floor” for the BLA submission watch you’re tracking.
Watch for: confirmation of BLA submission timing and any FDA filing posture / accelerated-approval packaging language.
Axsome — $AXSM ( ▲ 0.79% ) | AXS-12
Timing: NDA submission remains a January-window watch (company-timing driven; not a date-certain catalyst).
Forward calendar: AXS-05 (Alzheimer’s agitation) has an FDA action goal date of Apr 30, 2026 (Priority Review).
CLOSING NOTE
This is a low-catalyst week, but not a low-volatility week: the forcing functions remain late-cycle disclosure risk into $AQST ( 0.0% ) , and decision-language / label caveat risk into the Jan 31 cluster. Keep the plan simple: pre-commit to action based on the written outcome, not the intraday tape.
Tools we use: Affiliate disclosure: Market Chameleon (options/IV + unusual activity). We may earn a commission at no extra cost to you: [Market Chameleon]
Disclaimer
This newsletter is for informational purposes only. Biotech securities involve substantial risk, including total loss of capital. Always conduct your own due diligence.