A QUICK FRAME FOR THE WEEK
PDUFA activity continues to thin into the final trading days of the year. That does not mean regulatory signal disappears, it changes form.
In quieter weeks like this, useful information rarely comes from calendar density. It shows up instead in:
what doesn’t extend,
what resolves cleanly,
and how year-end timing itself distorts risk.
This edition focuses on:
FDA signal,
what has already resolved,
what remains live into year-end,
and a short format addition testing a deeper way to frame downside risk.
QUIET FDA SIGNALS (YEAR-END MODE)
There were no new procedural extensions, late-cycle amendments, or safety disclosures across the remaining active year-end stack since last Monday.
In late December, this kind of silence is itself informative. When outcomes are going to slip, narrow materially, or fail on procedural grounds, those signals usually surface earlier in the month. Their absence does not guarantee approval, but it narrows the range of outcomes.
RESOLVED: WHAT JUST CAME OFF THE BOARD
Omeros $OMER ( ▲ 5.47% ) — Narsoplimab (YARTEMLEA)
APPROVED (Dec 24)
The FDA issued approval on Christmas Eve for TA-TMA, the first approved therapy for this indication. The timing muted the signal, but regulatory risk is now removed. Focus shifts immediately to launch execution into Q1 2026.
GlaxoSmithKline $GSK ( ▲ 0.06% ) — Depemokimab (Exdensur)
Approved for asthma, but not for CRSwNP. A reminder that indication-specific precedent still matters, even within the same molecule and review cycle.
Cytokinetics $CYTK ( ▼ 2.16% ) — Aficamten (Myqorzo)
Approved ahead of the formal PDUFA. With regulatory risk removed, focus shifts fully to post-approval execution.
THE YEAR-END STACK (WHAT’S STILL LIVE)
Liquidity will be thin. Reactions may be exaggerated. Position sizing matters.
Corcept Therapeutics $CORT ( ▼ 3.42% ) — Relacorilant
PDUFA: Dec 30
PoA (directional): ~80–85%
Late-December timing introduces execution and liquidity risk despite clearer regulatory precedent.
Outlook Therapeutics $OTLK ( ▲ 8.79% ) — ONS-5010
PDUFA goal date: Dec 31
PoA (directional): ~35–40%
Resubmission with well-understood risk factors. Year-end timing amplifies volatility more than clarity.
FORMAT NOTE — A SMALL ADDITION THIS WEEK
As calendars wind down, this week adds a short-format piece to Monday's usual scan.
The section below tests a compact pre-mortem deep dive: how a regulatory decision could realistically fail, what that failure would look like, and whether it is survivable.
This is not a recommendation. It is an exercise in risk framing.
PRE-MORTEM DEEP DIVE
Corcept Therapeutics $CORT ( ▼ 3.42% )
Asset: Relacorilant
Event: PDUFA — Dec 30, 2025
Indication: Endogenous hypercortisolism (Cushing’s syndrome)
Clinical Snapshot (What Matters)
Relacorilant is a selective glucocorticoid receptor modulator for endogenous Cushing’s syndrome.
Phase 3 GRACE met primary metabolic endpoints (hypertension, glucose control).
Safety profile appears cleaner than first-generation GR antagonists, particularly mifepristone.
The indication is rare, serious, and historically tolerant of modest efficacy if safety is acceptable.
Translation:
This is not a marginal dataset in an unforgiving category. FDA precedent in Cushing’s has favored approval when benefit is shown and safety concerns are manageable.
The Bear Cave (How This Fails)
If relacorilant fails, the failure mode is unlikely to be dramatic. The more realistic risks are interpretive, not scientific.
Primary downside paths:
Label Scope Risk
Approval with a narrower-than-expected label, materially altering commercial assumptions without a CRL.Endpoint Framing Risk
FDA disagreement over how metabolic improvements translate into durable clinical benefit.Residual Class Sensitivity
Cortisol modulation remains a cautious area for regulators, even with a cleaner molecule.
Notably absent so far:
no late-cycle safety signal,
no disclosed CMC deficiencies,
no advisory committee,
no language suggesting a punitive extension.
A negative outcome here would most likely reflect how benefit is framed, not whether benefit exists.
Cash & Survival (If This Breaks)
Corcept is not a single-asset, binary-dependent microcap.
Cash position is substantial relative to burn.
Runway is measured in years, not quarters.
If the FDA issues a CRL or materially constrains the label:
the stock likely resets,
solvency is not immediately threatened,
refiling or lifecycle management remains viable.
This is repricing risk, not existential risk.
Pre-Mortem Summary
If relacorilant fails, it is most likely due to label interpretation, endpoint framing, or residual class caution, not lack of activity. Downside is meaningful but non-terminal. This is a regulatory outcome risk, not a balance-sheet risk.
CLOSING NOTE
Year-end weeks are often where mispricing quietly builds, not because of new information, but because of timing, liquidity, and attention gaps.
We will continue prioritizing regulatory signal over calendar noise, and shift back to denser coverage as activity picks up in January.
-PDUFA Pulse