PoA = probability-of-approval band (directional only; not FDA guidance).
A QUICK FRAME FOR THE WEEK
JPM Week (Jan 12–15, San Francisco): High PR density, financings, and narrative-driven volatility. Treat most headlines as optional unless they change FDA timelines, endpoints, or CMC risk.
This is a regulatory week: Two clean midweek binaries—$TVTX ( ▲ 0.49% ) (Tue) and $FBIO ( ▲ 2.61% ) (Wed)—plus a late-month setup where risk just worsened $AQST ( ▲ 3.02% ) .
Weekend PDUFA overhang: $ATRA ( ▲ 0.24% ) had a rare Saturday action date (Jan 10). Monday morning becomes the de-facto tape.
JPM WEEK LENS (JAN 12–15)
Expect three categories of “conference tape”:
Regulatory framing: Type B language, filing timing, “no AdComm,” surrogate talk.
Capital structure news: financings/partnerships packaged as momentum.
Bar shifts: competitive comps tightening what qualifies as “good enough,” especially in oncology.
Operating posture: trade the headlines if you must; anchor positions to label language + manufacturing readiness.
STATUS WATCH: ATARA — $ATRA ( ▲ 0.24% ) | TAB-CEL (EBV+ PTLD)
Event: PDUFA target action date was Saturday, Jan 10.
What matters Monday: decision disclosure timing (pre-market vs open) and any “limbo” effect if the company doesn’t communicate quickly.
Economics note: Pierre Fabre agreement economics have been amended; do not rely on the older “$40M milestone” shorthand.
THE PDUFA DECK (JAN 13–14)
Travere — $TVTX ( ▲ 0.49% ) | FILSPARI (sparsentan) | FSGS full approval conversion
Date: Jan 13 (Tuesday) | Event: sNDA (accelerated → traditional)
PoA: 70 (High)
Setup: Conversion mechanics and decision language matter as much as yes/no.
Watch for (decision-language):
Surrogate stance: how FDA frames proteinuria in the conversion logic.
Weak-win risk: full approval with restrictive label language (population constraints, baseline proteinuria thresholds, or heavier PMR burden) that the market discounts.
Framing watch: any language that implicitly shifts emphasis from proteinuria toward kidney function preservation (and how that affects perceived de-risking).
Fortress — $FBIO ( ▲ 2.61% ) | CUTX-101 | Menkes disease
Date: Jan 14 (Wednesday) | Event: PDUFA
PoA: 80 (High)
Setup: Class 1 resubmission after CRL; reads as late-cycle readiness rather than new efficacy debate.
Watch for: any “site readiness / availability / manufacturing” language that impacts launchability even on approval.
RISK UPDATE: AQUESTIVE — $AQST ( ▲ 3.02% ) T | 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.
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 ( ▲ 0.24% ) | 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+).
Watch for: pediatric safety/dosing language and any label caveats that change uptake assumptions.
OFF-CALENDAR / FORWARD SIGNALS
Immuneering — $IMRX ( ▲ 2.82% ) | atebimetinib + mGnP (1L pancreatic cancer)
Validator: 12-month OS durability remains the headline anchor (64% at 12 months; N=34).
Next gate (real timeline): the company has guided to a Phase 3 start in mid-2026—this is now the key “what happens next” timeline the market will price.
Tape read: market reaction suggests the competitive “bar” is tightening; expanded cohorts and durability context matter more than a single headline.
Kodiak — $KOD ( ▲ 4.87% ) | tarcocimab (GLOW2) Phase 3
Timing: “On track for 1Q 2026” is the correct framing—rolling window, not a hard-dated Jan 31 binary.
PRE-MORTEM (LIGHT): $TVTX FAILURE MODES THAT ACTUALLY MATTER
If $TVTX disappoints, the most plausible breakpoints are:
Surrogate interpretation and how the decision logic is written.
Restrictive label language that compresses the “full approval” upside.
PMR/PMC burden that reframes conversion as “not fully de-risked.”
CLOSING NOTE
This is a narrative-heavy week (JPM), but the actual forcing functions are still FDA decision language on $TVTX and $FBIO, plus the late-month $AQST risk reset.
— PDUFA Pulse