PoA = probability-of-approval band (directional only; not FDA guidance).
A QUICK FRAME FOR THE WEEK (Jan 26–30)
This is a quiet midweek FDA binary tape, but it is not a quiet timing-risk tape. The week is primarily about positioning into the Jan 31 weekend cluster and monitoring late-cycle signals that can force process extensions and paperwork risk (deficiency letters, CSR requests, CMC cleanup, major amendments).
Operating posture:
Treat most headlines as optional unless they change FDA timing, file status, endpoint package, or CMC and label risk.
Pre-commit decisions for the Jan 31 weekend wall outcomes: approval clean, label restrictive, delay, CRL.
WEEKEND PDUFA OVERHANG (JAN 31)
Jan 31 lands on a Saturday. Expect outcomes to compress into Fri after close (Jan 30) or Mon pre-market (Feb 2) depending on issuer disclosure cadence.
The Jan 31 cluster
Aquestive — $AQST ( 0.0% ) | ANAPHYLM (epinephrine) | PDUFA: Jan 31
Pharming — $PHAR ( ▲ 1.68% ) | Joenja leniolisib pediatric sNDA (ages 4–11) | PDUFA: Jan 31
RISK UPDATE: AQUESTIVE — $AQST ( 0.0% ) | ANAPHYLM | JAN 31 PDUFA
Date: Jan 31 | Event: PDUFA
PoA: 30 — Low / high execution risk (our band; directional)
Update: FDA notified the company of NDA deficiencies that currently preclude labeling discussions. Review is ongoing, but this is a late-cycle red flag and keeps “process risk” live into the weekend. Practically, this increases the probability of a CRL or a timeline extension versus a clean approval.
Watch for:
Whether the deficiency language points to CMC, device, packaging versus clinical or application integrity issues.
Any hint that closure by the action date is realistic versus drifting into a delay or extension.
LATE-MONTH PDUFA (STABLE / HIGH-PROBABILITY): $PHAR ( ▲ 1.68% )
Pharming — $PHAR ( ▲ 1.68% ) | Joenja leniolisib pediatric sNDA (ages 4–11)
Date: Jan 31 | Event: PDUFA, Priority Review
PoA: 85 — High (our band; directional)
Setup:
Pediatric age-expansion of an already approved drug (12+). Statistically higher-probability than most new approvals, but still binary on label specifics.
Watch for:
Pediatric safety and dosing language and any label caveats that change uptake assumptions.
DESK NOTE: CAPRICOR — $CAPR ( ▲ 7.75% ) | DERAMIOCEL BLA TIMELINE UPDATE
$CAPR ( ▲ 7.75% ) (Deramiocel / CAP-1002, DMD): On Jan 20, 2026, Capricor disclosed FDA requested the full HOPE-3 Clinical Study Report (CSR). Company expects to submit in February 2026, after which a new PDUFA target date should be assigned.
Interpretation:
Reinforces that the tape is currently sensitive to process extensions even in programs that appear clinically coherent.
OFF-CALENDAR / FORWARD SIGNALS (NEXT 2–4 WEEKS)
Early February
Exicure — $XCUR ( ▼ 1.43% ) | Burixafor (GPC-100) | Feb 5, 6:30 PM | Tandem Meetings (SLC)
Poster session timing is confirmed; monitor for incremental efficacy and safety detail.REGENXBIO — $RGNX ( ▲ 0.74% ) | RGX-121 (MPS II) | PDUFA: Feb 8 (Sunday)
Note: Feb 8 is the extended goal date (shifted from a prior 2025 timing). Another weekend wall dynamic: disclosure bias toward Fri after close or Mon pre-market.
Late February (hard-dated)
Eton — $ETON ( ▲ 1.45% ) | ET-600 (desmopressin oral solution) | PDUFA: Feb 25
Protara — $TARA ( ▼ 4.12% ) | TARA-002 | Feb 27 visibility (ASCO GU poster session timing)
Regeneron — $REGN ( ▲ 0.55% ) | Dupixent (AFRS) sBLA | PDUFA: Feb 28
Ascendis — $ASND ( ▲ 0.48% ) | TransCon CNP | PDUFA: Feb 28
Extended roughly 3 months after a major amendment (Nov 2025) — consistent with the broader “process risk” tape.
“Any day” signal (into month-end)
Kazia — $KZIA ( ▼ 2.26% ) | Paxalisib (TNBC) | update expected before month-end
Treat as high-alert headline risk over the next few sessions.
Rolling (not hard-dated)
Kodiak — $KOD ( ▼ 0.33% ) | tarcocimab (GLOW2) Phase 3 | topline guided for 1Q 2026
Keep expectations anchored to 1Q topline rather than date-pin.
Quick carryover desk note (optional context)
OS Therapies — $OSTX ( ▲ 1.44% ) | Jan 15 biomarker update
Company reported interferon-gamma pathway activation biomarker findings and claims correlation with overall survival; useful “floor” context into its forward regulatory path.
CLOSING NOTE
This is a low-catalyst week, but not a low-volatility week: the forcing function remains late-cycle disclosure risk into $AQST ( 0.0% ) and decision-language / label caveat risk into the Jan 31 cluster. Keep it simple: anchor to the written outcome, not the intraday tape.
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Disclaimer: This newsletter is for informational purposes only. Biotech securities involve substantial risk including total loss of capital. Always conduct your own due diligence.