PDUFA Pulse: Friday Edition (Dec 19)

PoA = probability-of-approval band (directional only; not FDA guidance)

The FDA cleared a significant portion of the December deck this week, with mixed results.

Status: APPROVED (Dec 16)
Context: Approved for severe eosinophilic asthma in patients 12+.
Impact: First ultra-long-acting biologic in class (q6-month dosing), positioning it as a convenience play versus Fasenra and Nucala. The CRSwNP indication remains under review.

Status: DELAYED
New Date: March 16, 2026
Context: This was not a routine clock extension. The FDA requested a Clinical Study Report from a failed field trial that the agency had previously agreed in writing did not need to be submitted. That reversal triggered a major amendment and materially increases regulatory uncertainty into the March review.

Status: DATA READOUT (Dec 15)
Context: Phase 2 TOIVA data was positive (73% improvement on the primary endpoint).
The Trade: Classic sell-the-news. Shares fell despite positive data, reflecting long timelines to Phase 3 and thin mid-December liquidity in microcaps.

The calendar is effectively empty for the holiday week. Expect low volume and drift.

Liquidity Warning: We are now in the deepest part of the holiday liquidity gap. Spreads widen quickly and small orders can move tape significantly. Avoid market orders in thin names during this window.

These are the currently communicated target action dates; timing can still move into year-end.

Date: Dec 26 (Friday)
Event: PDUFA
PoA: 85

Our View:
The Big One. The most significant binary of Q4. The PDUFA was extended by three months to review REMS, suggesting the FDA is focused on how to approve the drug safely rather than whether it works.
Setup: Commercial preparations are underway. Approval directly challenges Camzyos (BMS).

Date: Dec 26 (Friday)
Event: PDUFA target action date
PoA: 50 (High Risk)

Our View:
Reports of a “Dec 10 CRL” appear to be mis-indexed references to the 2021 CRL. The current target action date remains Dec 26 per prior FDA updates.
Risk: Approval risk remains elevated given the review history and lack of recent FDA commentary. Expect high volatility.

Date: Dec 30 (Tuesday)
Event: PDUFA
PoA: 70

Our View:
Positioning: A cleaner, safer successor to Korlym without QT prolongation or hypokalemia.
Signal: No AdCom was held, which is generally constructive for a safety-focused improvement. On track.

Date: Dec 31 (Wednesday)
Event: PDUFA (Class 1 resubmission)
PoA: 40 (Speculative)

Our View:
The Anomaly. A Class 1 (2-month) resubmission following an efficacy-based CRL in August. Fixing a “lack of substantial evidence” CRL in 60 days is highly unusual.
Risk: The FDA accepted the timeline procedurally, but whether the re-analysis supports approval is a coin flip. Expect extreme volatility.

Status: DELAYED to Q1 2026
Update: Sanofi announced on Dec 15 that the FDA review will extend beyond the Dec 28 target action date, with further FDA guidance expected by end of Q1 2026. This is no longer a year-end binary.

Many data aggregators default “Q4 2025” guidance to Dec 31. Most of these are not real FDA events and will likely slip to 2026 without a press release.

Directional only; not investment advice.

Disclaimer: This newsletter is for informational purposes only and does not constitute investment advice. Biotech securities involve substantial risk, including total loss of capital. Always conduct your own due diligence.