PoA = probability-of-approval band (directional only; not FDA guidance).
A QUICK FRAME FOR THE WEEK (FEB 9–13)
This remains a process-first tape:
Weekend wall digestion: $KOD ( ▲ 5.38% ) (Saturday data visibility) + $RGNX ( ▼ 0.48% ) (Sunday PDUFA date vs clinical hold) are the only “Monday open” forcing functions.
Visibility events > hard binaries this week (MAZE / INAB), but they can still move names via regulatory-alignment tone, trial design specificity, and timeline discipline.
WEEKEND WALL FALLOUT (WHAT MATTERS MONDAY)
REGENXBIO — $RGNX ( ▼ 0.48% ) | RGX-121 (MPS II) | PDUFA: Feb 8 (Sun)
Status: Program remains under FDA clinical hold (announced Jan 28) following a CNS tumor in the RGX-111 sister program; FDA cited a potentially shared risk and REGENXBIO noted it had not yet received the full hold letter at the time of the announcement.
PoA: 5 (functionally impaired while the hold is active)
Desk note: REGENXBIO disclosed preliminary evidence consistent with AAV vector genome integration associated with PLAG1 overexpression—why this trades as platform/class risk, not a single-asset issue.
What to watch today: any formal FDA action/process update mechanics (delay language vs CRL language) and whether the company has now received details from the FDA on the hold.
Kodiak — $KOD ( ▲ 5.38% ) | KSI-101 (MESI) | Angiogenesis 2026: Feb 7 (Sat)
Status: Final APEX Phase 1b Week 24 results were scheduled for presentation Saturday (classic weekend disclosure bias).
PoA: n/a (data visibility)
What to watch in the read-through:
5mg/10mg safety profile clarity (what changes confidence into PEAK/PINNACLE Phase 3).
Durability at Week 24 + any safety/tolerability language that changes the “extended interval” framing.
HARD EVENTS (FEB 9–13)
MAZE Therapeutics — $MAZE ( ▲ 6.22% ) | Feb 11 (Wed), 3:00 PM ET
Event: Guggenheim Emerging Outlook: Biotech Summit webcast.
Focus (company pipeline framing): watch for execution/timeline updates around MZE829 (APOL1) and MZE782 (SLC6A19).
IN8bio — $INAB ( ▼ 1.51% ) | Feb 12 (Thu), 1:20–1:40 PM ET
Event: IO360° Conference presentation (William Ho).
Topic: “DeltEx DRI approach… results from Phase 1/2 study in newly diagnosed GBM” (agenda language).
Listen for: trial design specificity, durability, and any “FDA alignment” cues in the forward path.
LATE-FEB FDA BINARIES (DATES UNCHANGED)
Date | Ticker | Asset | Event | PoA |
|---|---|---|---|---|
Feb 25 | ET-600 (desmopressin oral solution) | PDUFA | 70 | |
Feb 27 | TARA-002 (ADVANCED-2) | ASCO GU poster (Poster Session B) | n/a | |
Feb 28 | Dupixent (AFRS) | PDUFA | 80 | |
Feb 28 | TransCon CNP | PDUFA | 65 |
Calendar hygiene: ASCO GU runs Feb 26–28, 2026; Protara’s TARA-002 visibility is Friday, Feb 27 (Poster Session B).
QUICK RECAP (PROCESS RISK STILL RELEVANT)
AQST — $AQST ( ▼ 4.38% ) | ANAPHYLM | CRL issued Feb 2
CRL centered on human factors / administration under stress plus a supportive PK study requirement (after packaging / usability work).
PHAR — $PHAR ( ▲ 1.93% ) | JOENJA peds sNDA | CRL issued Feb 1
CRL driven by pediatric PK/underexposure in lower-weight groups plus analytical method / batch testing issues; base label remains intact.
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Disclaimer: Informational only, not investment advice. Biotech securities are highly speculative and can result in total loss of capital.