PoA = directional probability band (not FDA guidance).
Rule: FDA decision events get a %; data/webinars/conferences get N/A.
THE FRAME (FEB 23–28): “DATA WEEK + TWO WEEKEND PDUFAs”
This is a stacked tape:
Front-half = data + microcaps (FULC, OCUL detail into Macula, INMB webinar).
Back-half = two real PDUFAs (Sat Feb 28): $REGN (Dupixent/AFRS) and $ASND ( ▲ 4.42% ) (TransCon CNP).
WEEKEND WALL: WHAT CHANGED
VNDA — $VNDA ( ▲ 41.49% ) | BYSANTI (milsaperidone) | Approved Fri Feb 20 | PoA: N/A (resolved)
Approval removes the “Saturday PDUFA overhang”; positioning shifts to launch timing + differentiation.
THIS WEEK’S HARD EVENTS (IN ORDER)
Tue Feb 24 — FULC — $FULC ( ▼ 1.0% ) | Pociredir (FTX-6058) (SCD) | 12-week data call (8:00am ET) | PoA: N/A
What to listen for:
Durability of HbF induction
Safety/tolerability at 20 mg
How they frame the next trial’s “reg path” (VOC endpoints eventually matter)
Wed Feb 25 — ETON — $ETON ( ▲ 1.95% ) | ET-600 (desmopressin oral solution) | PDUFA | PoA: 85
Clean approval-style setup; mostly label/CMC execution risk.
Feb 25–28 — OCUL — $OCUL ( ▲ 8.1% ) | AXPAXLI (wet AMD) | Macula Society detail window | PoA: N/A
Topline already printed; the stock now trades dataset shape:
Durability / interval flexibility
Vision vs anatomy split
Safety narrative vs anti-VEGF standard
Subgroups that change addressable population
Thu Feb 26 — INMB — $INMB ( ▼ 3.82% ) | CORDStrom (RDEB) | MissionEB webinar (1:00pm ET) | PoA: N/A
Expect headline risk if they show new deltas (or if framing shifts from “symptom relief” → “systemic disease modifying”).
Fri Feb 27 — TARA — $TARA ( ▲ 8.63% ) | TARA-002 (NMIBC) | ASCO GU Poster Session B | PoA: N/A
What matters:
Patient evaluable set cleanliness
CR/durability language (especially BCG-unresponsive)
Safety narrative consistency
SATURDAY PDUFAs (EFFECTIVELY FRIDAY-CLOSE TRADE)
Sat Feb 28 — REGN — $REGN ( ▲ 0.8% ) | Dupixent (AFRS) | PDUFA | PoA: 87
Mostly a label scope event. (Watch for any unexpectedly narrow population wording.)
Sat Feb 28 — ASND — $ASND ( ▲ 4.42% ) | TransCon CNP (achondroplasia) | PDUFA | PoA: 85
Trades as label + launch posture plus any post-marketing terms.
Trade note: even though the dates are Saturday, the market typically treats these as Friday-close outcomes (rare weekend exceptions).
ANY-DAY-NOW WILDCARDS (FEB TIMING, NOT DAY-CERTAIN)
GOSS / XOMA — $GOSS ( ▼ 80.13% ) / $XOMA ( ▼ 1.9% ) | Seralutinib (PROSERA) | Phase 3 topline expected in Feb | PoA: N/A
Headline risk any day until month-end.
CAPR — $CAPR ( ▼ 2.25% ) | Deramiocel (DMD) | BLA update/submission window (Feb) | PoA: N/A
Not an approval event yet—this is process/clock setup for a future FDA action date.
WEEKLY CALENDAR (ONE SCREEN, WITH PoA)
Date | Ticker | Catalyst | PoA |
|---|---|---|---|
Tue Feb 24 | 12-week data call — Pociredir (FTX-6058) | N/A | |
Wed Feb 25 | PDUFA — ET-600 desmopressin oral solution | 85 | |
Feb 25–28 | Macula Society detail window (SOL-1) | N/A | |
Thu Feb 26 | MissionEB webinar (CORDStrom/RDEB) | N/A | |
Fri Feb 27 | ASCO GU Poster Session B | N/A | |
Sat Feb 28 | PDUFA — Dupixent (AFRS) | 87 | |
Sat Feb 28 | PDUFA — TransCon CNP | 85 | |
Feb (TBD) | PROSERA Phase 3 topline expected | N/A | |
Feb (TBD) | BLA update/submission window | N/A |
WEEKLY POSTURE (ONE PARAGRAPH)
Highest volatility sits Tue (FULC) and conference narrative into Macula (OCUL); the cleanest binary clock is ETON Wed, and the week resolves with the REGN + ASND Saturday PDUFAs (effectively Friday-close).
Tools we use: Market Chameleon (options/IV + unusual activity). We may earn a commission at no extra cost to you.
Disclaimer: informational only; not investment advice; biotech carries risk of total loss.