PoA = probability-of-approval band (directional only; not FDA guidance).
THE FRAME (FEB 27–MAR 2): “CLOCKS COLLAPSE → EXECUTION TAPE + CONFERENCE NOISE”
Last Friday’s “weekend clock risk” is gone — the market got three early-week FDA prints and now shifts to launch posture + conference framing:
$VNDA ( ▲ 2.56% ) : BYSANTI (milsaperidone) approved Feb 20 (ahead of the Sat Feb 21 PDUFA).
$REGN ( ▲ 1.34% ) / Sanofi: Dupixent approved Feb 24 for AFRS (ahead of Feb 28).
$ETON ( ▼ 0.81% ) : ET-600 now branded Desmoda — approved Feb 25; launch target Mar 9.
So the tape splits:
Tape A (now): ASCO GU + AAAAI data cadence (headline risk is dataset shape, not binary approvals).
Tape B (next week): the next clean regulatory clock ($LNTH ( ▲ 1.22% ) Mar 6) plus March label/CMC events.
THIS WEEK’S BIG REGULATORY PRINTS (DONE)
VNDA — $VNDA ( ▲ 2.56% ) | BYSANTI (milsaperidone) | FDA APPROVAL (Feb 20)
What matters now: label breadth + payer friction + “next indication” optionality (adjunct MDD remains the longer-dated narrative).
REGN/SNY — $REGN ( ▲ 1.34% ) | Dupixent (AFRS) | FDA APPROVAL (Feb 24)
What matters now: uptake pace in a surgery-linked, high-burden niche; how quickly ENT/allergy practice patterns absorb it.
(Keep claims tight: “approved for AFRS” is enough — avoid “only therapy” language.)
ETON — $ETON ( ▼ 0.81% ) | Desmoda (desmopressin oral solution) | FDA APPROVAL (Feb 25)
Trade lens: clean “approval → launch execution” tape; early scripts + coverage decisions matter more than science now.
AFTERSHOCKS (POST-APPROVAL TAPE)
$ETON ( ▼ 0.81% ) : launch target Mar 9 → watch early access/coverage and initial traction.
$VNDA ( ▲ 2.56% ) : NCE glow fades fast → the market pivots to commercial reality and psych channel dynamics.
$REGN ( ▲ 1.34% ) : adoption curve will be driven by prescriber behavior + pathway placement, not a debate over biology.
IMMEDIATE VISIBILITY / TRADEABLE WINDOWS (NEXT ~7 DAYS)
ASND — $ASND ( ▼ 0.67% ) | TransCon CNP (achondroplasia) | PDUFA: Sat Feb 28
Only remaining “real” FDA clock in this window.
Watch: label language vs Voxzogo, any post-approval commitments, and manufacturing/CMC tone.
TARA — $TARA ( ▲ 6.07% ) | TARA-002 (NMIBC) | ASCO GU poster: Fri Feb 27
This is the event. Updated interim dataset for BCG-unresponsive cohort hits Friday.
Watch the tape-movers:
CR with maturity (6-mo vs 12-mo durability)
any-time CR vs durable CR (front-loaded responses get punished)
safety/discontinuations + “registrational cohort” messaging (clear path vs hand-waving)
CLDX — $CLDX ( ▼ 2.29% ) | barzolvolimab (CSU/ColdU/SD) | AAAAI: Feb 27–Mar 2
Multiple Phase 2 datasets at AAAAI; allergy/immunology room narrative can move this quickly.
Watch: durability + re-treatment behavior and whether “disease modification” framing holds up.
QUICK CALENDAR (FEB 27–MAR 6)
Day | Ticker | Event | Why it matters |
|---|---|---|---|
Fri Feb 27 | $TARA | ASCO GU poster | Dataset durability + registrational clarity |
Feb 27–Mar 2 | $CLDX | AAAAI readouts | “Room narrative” catalyst |
Sat Feb 28 | $ASND | PDUFA | Remaining binary clock in-window |
Fri Mar 6 | $LNTH | PDUFA | Clean CMC/formulation clock |
(Longer-dated March clocks remain on deck: $ALDX Mar 16, $RLAY Mar 16, $RYTM Mar 20, $RCKT Mar 28, etc.)
WHAT WE MISSED / WHAT CHANGED SINCE LAST FRIDAY
$REGN ( ▲ 1.34% ) Dupixent AFRS was a Feb 28 PDUFA, but approved early (Feb 24) → treat as “DONE,” not upcoming.
$VNDA ( ▲ 2.56% ) BYSANTI approved Feb 20 → “weekend gap risk” no longer relevant.
$ETON ( ▼ 0.81% ) Desmoda approved Feb 25 → forward-looking hook is launch execution (Mar 9 target).
Pipeline radar (new Priority Review acceptances):
$RARE ( ▲ 1.0% ) (Ultragenyx) DTX401 — BLA accepted w/ Priority Review; PDUFA Aug 23, 2026.
$IONS ( ▲ 1.47% ) olezarsen (sHTG) — sNDA accepted w/ Priority Review; PDUFA Jun 30, 2026.
CLOSING NOTE
Treat this as two tapes:
Tape A (now → Mar 2): conference-driven price discovery ($TARA/$CLDX) + one remaining FDA clock ($ASND).
Tape B (Mar): cleaner calendar trades where positioning is about label/CMC language + execution, not storytime.
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.