PoA = probability-of-approval band (directional only; not FDA guidance).
THE FRAME (FEB 20–23): “WEEKEND CLOCKS + CONFERENCE GRAVITY”
This tape is deadline-driven (a Saturday PDUFA), then immediately conference-shaped (Macula + ASCO GU) where detail, not headlines, moves positioning.
Two forces into Monday:
Weekend PDUFA risk ($VNDA) + “Sunday-night repricing” setup into the open.
CRL regime stays dominant: FDA is policing endpoint logic + benefit–risk linkage (Disc is the cleanest recent example).
THIS WEEK’S BIG REGULATORY PRINTS (DONE)
IRON — $IRON ( ▼ 3.14% ) | Bitopertin (EPP) | CRL (Feb 13)
What happened: FDA issued a CRL; the core issue is surrogate-to-benefit linkage (i.e., whether biomarker change convincingly maps to meaningful clinical benefit).
Pulse take: This is not “fast track” getting pulled. It’s the agency saying the accelerated-approval-style surrogate package isn’t enough, pushing the path toward traditional approval anchored in clinical outcomes.
OCUL: POST-PRINT SETUP (NOW A MACULA TRADE)
OCULAR THERAPEUTIX — $OCUL ( ▲ 10.67% ) | AXPAXLI (OTX-TKI) wet AMD
Topline SOL-1 superiority result (Feb 17) → detail at Macula Society (Feb 25–28)
Company reported positive SOL-1 superiority results; detailed data is slated for Macula Society.
Note: OCUL sold off sharply (~25–27%) on the print despite superiority — Macula is now a recovery/confirmation setup (dataset shape + narrative repair), not a fresh catalyst.
Reg clock: company has stated it intends to pursue an NDA submission off SOL-1 (subject to FDA discussions).
What Macula will actually trade:
Durability / dosing interval flexibility
Vision vs anatomy split (and how “superiority” is framed in the details)
Safety/tolerability narrative vs standard anti-VEGF
Any subgroup story that changes the addressable population
IMMEDIATE VISIBILITY / TRADEABLE WINDOWS (NEXT ~10 DAYS)
VNDA — $VNDA ( ▼ 5.57% ) | Bysanti (milsaperidone) | PDUFA: Sat Feb 21
Classic weekend binary; expect gap risk at the Monday open.
FULC — $FULC ( ▼ 6.22% ) | Pociredir (SCD) | 12-week data call: Tue Feb 24 (8:00am ET)
Watch dose-response clarity + tolerability at 20mg; listen for “next-trial shape” language.
ETON — $ETON ( ▼ 1.59% ) | ET-600 (desmopressin oral solution) | PDUFA: Feb 25 (confirmed)
This date is verifiable: Eton’s NDA acceptance release states PDUFA target action date = Feb 25, 2026.
MACULA SOCIETY — Feb 25–28
Conference gravity: this is where OCUL’s SOL-1 detail package is expected to surface. (maculasociety.org)
INMB — $INMB ( ▼ 0.76% ) | CORDStrom (RDEB) | Webinar: Thu Feb 26 (1:00pm ET)
Ticker attribution is correct: INmune Bio (INMB) is presenting new MissionEB Phase III clinical data/insights for CORDStrom in RDEB.
Optional flag (hedged): some market calendars also tag this date as near expected earnings timing → compounded event-risk (treat as “double headline” risk, but not confirmed by the company in the webinar PR).
ASCO GU — Feb 26–28 (San Francisco)
High-attention window; posters can move small/midcaps if the “room narrative” flips. (asco.org)
TARA — $TARA ( ▼ 4.34% ) | TARA-002 (NMIBC) | Poster Session B: Fri Feb 27
Poster Session B timing is confirmable from Protara’s release.
ASND — $ASND ( ▼ 2.26% ) | TransCon CNP (achondroplasia) | PDUFA: Feb 28
Label + launch posture print; clock confirmed after extension.
REGN — $REGN ( ▼ 0.23% ) | Dupixent (AFRS) | PDUFA: Feb 28
Priority-review sBLA; approval is primarily a scope expansion catalyst.
THE LONG GAME (MARCH CATALYSTS TO PRE-POSITION)
LNTH — $LNTH ( ▲ 0.94% ) | Pylarify (new formulation) | PDUFA: Mar 6
Clean regulatory clock; commercial/workflow upside.
RLAY — $RLAY ( ▼ 1.81% ) | Zovegalisib | ESMO Targeted Anticancer Therapies Congress 2026: Mon Mar 16
Correct full name: ESMO Targeted Anticancer Therapies Congress (TAT).
RYTM — $RYTM ( ▼ 3.28% ) | IMCIVREE (acquired hypothalamic obesity) | PDUFA: Mar 20
Label breadth is the trade.
RCKT — $RCKT ( ▲ 1.07% ) | KRESLADI (LAD-I) | PDUFA: Mar 28
Gene therapy approval event; language/CMC posture matters.
QUICK CALENDAR (FEB 20–MAR 1)
Day | Ticker | Event | Why it matters |
|---|---|---|---|
Sat Feb 21 | PDUFA | Weekend binary / Monday gap risk | |
Tue Feb 24 | 12-week data call | Dataset quality + next-trial framing | |
Wed Feb 25 | PDUFA (confirmed) | Clean approval print potential | |
Feb 25–28 | $OCUL ( ▲ 10.67% ) (indirect) | Macula Society | Dataset “shape” trades after selloff |
Thu Feb 26 | CORDStrom MissionEB webinar | Data + narrative risk (possible “double headline” day) | |
Fri Feb 27 | ASCO GU Poster Session B | Update density / room narrative | |
Sat Feb 28 | PDUFAs | Two real “print” events |
CLOSING NOTE
Treat this as two tapes:
Tape A (now → Feb 28): weekend clocks + deadline mechanics.
Tape B (March): conference framing + label language + commercial execution.
Trade the documented clock and the next explicit step—not the story you want.
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.