PoA = probability-of-approval band (directional only; not FDA guidance)
THIS ISSUE COVERS
The Week That Was: Holiday approvals for $CYTK ( ▼ 1.67% ) and $OMER ( ▲ 2.28% )
The Dead Zone: Navigating the liquidity vacuum through Jan 2 (with thin desks lingering into Jan 5)
Year-End Binary Stack: Final 2025 catalysts $CORT ( ▼ 1.13% ) , $OTLK ( ▼ 0.55% )
The Placeholder Minefield: Real events vs. Dec 31 calendar errors
January 2026 Outlook: Data Week (Jan 6–10) + January PDUFA heavy-hitters
THE WEEK THAT WAS (Recap)
The FDA cleared the two largest remaining binaries of the year just before the holiday break.
$CYTK ( ▼ 1.67% ) — Aficamten (MYQORZO)
Status: APPROVED (Dec 19)
Context: Approved for adults with symptomatic obstructive HCM. The early approval (vs. Dec 26 PDUFA) is consistent with REMS clearance not being a late-cycle gating issue. Focus now shifts to early 2026 launch dynamics and competitive positioning vs. Camzyos.
$OMER ( ▲ 2.28% ) — Narsoplimab (YARTEMLEA)
Status: APPROVED (Dec 24)
Context: First approved therapy for TA-TMA. This resolves a multi-year regulatory saga; commercial launch is expected in January.
$GSK ( ▲ 0.25% ) — Depemokimab (Exdensur)
Status: APPROVED (Dec 16)
Context: Approved for severe eosinophilic asthma. The CRSwNP indication remains under FDA review.
$ALDX ( ▲ 0.57% ) — Reproxalap
Status: DELAYED (New Target Date: March 16, 2026)
Context: Delay follows a “Major Amendment” related to failed field-trial data; the review clock has been formally extended.
THE DEAD ZONE: Liquidity Warning
We are now in the deepest part of the holiday liquidity vacuum (Dec 26–Jan 2), with many desks remaining thin until Jan 5.
Spreads are wide and depth is shallow, particularly in microcaps
Avoid market orders; small prints can move the tape disproportionately
Volatility around news can be exaggerated and misleading during this window
YEAR-END BINARY STACK (Dec 30–Dec 31)
Liquidity is at its annual low—price reactions may be outsized.
$CORT ( ▼ 1.13% ) — Relacorilant (Hypercortisolism)
Date: Dec 30 (Tuesday) | PDUFA
PoA: 70 (High)
Our View: A cleaner successor to Korlym without the QT-prolongation baggage. The lack of an AdCom remains a constructive signal for a safety-focused approval.
$OTLK ( ▼ 0.55% ) — ONS-5010 (Wet AMD)
Date: Dec 31 (Wednesday) | PDUFA
PoA: 40 (Speculative)
Our View: This Class 1 resubmission is an anomaly. Resolving an efficacy-based CRL in 60 days is a high bar. Expect extreme volatility given year-end timing and thin liquidity.
THE PLACEHOLDER MINEFIELD (Dec 31)
Do not trade these names expecting actionable news on New Year’s Eve.
Likely placeholders: $IBRX ( 0.0% ) (BLA filing), $FOLD ( 0.0% ) (Phase 3 data), $ALT ( ▼ 3.02% ) (Phase 2b data), $CAPR ( ▲ 0.03% ) (Phase 3 data)
Incorrect listing: $HUMA ( ▼ 0.93% ) — any “Dec 31 PDUFA” is incorrect; their regulatory window is in 2026
JANUARY 2026 OUTLOOK
Data Week (Jan 6–Jan 10)
A cluster of meaningful data readouts as desks return.
$GANX ( ▼ 2.17% ) (GT-02287): Jan 6 — Phase 1b data in Parkinson’s disease
$IMRX ( ▼ 1.18% ) (Atebimetinib): Jan 7 — Phase 2a data in first-line pancreatic cancer
$RNXT ( ▼ 4.56% ) (RenovoCath): Jan 9 — Phase 3 TIGER-PaC interim data (likely ASCO GI)
$ACTU ( 0.0% ) (Elraglusib / 9-ING-41): Jan 9 — Data update in metastatic pancreatic cancer
January PDUFA Calendar
Ticker | Date | Event | PoA |
|---|---|---|---|
Jan 10 | Tab-cel (EBV+ PTLD) | 77 | |
Jan 13 | Filspari — Full approval (FSGS) | 70 | |
Jan 14 | CUTX-101 (Menkes disease) | 80 | |
Jan 31 | Anaphylm (oral epinephrine film) | 80 | |
Jan 31 | Leniolisib — sNDA (pediatric APDS) | 85 |
Note: PoA for data readouts reflects the historical probability of positive topline outcomes, not regulatory approval.
PoA Framework
High: >70
Moderate: 40–70
Speculative: <40
Directional only; not investment advice.
Disclaimer: This newsletter is for informational purposes only. Biotech securities involve substantial risk, including total loss of capital. Always conduct your own due diligence.