PDUFA Pulse: Monday Edition (Dec 15)

The FDA cleared the deck late last week, resolving the primary mid-December binaries and pushing remaining risk into a thin, back-loaded year-end calendar. With liquidity deteriorating into the holidays, label nuance and surprise extensions matter more than headline approvals.

Status: APPROVED (Dec 12)
Indication: PSVT
Context: First self-administered nasal spray rescue therapy for paroxysmal supraventricular tachycardia.

Our View:
Regulatory risk is now off the table. Focus shifts to commercial execution, payer access, and milestone timing. Management has guided to an early-2026 launch. This is now a rollout and adoption story, not a binary trade.

Status: APPROVED (Dec 12)
Indication: Uncomplicated urogenital gonorrhea

Our View:
A public-health win and a genuine first-in-class mechanism. Commercial upside will be capped by stewardship and guideline-driven use, but approval removes a major overhang and de-risks the platform.

Status: APPROVED (Dec 11)
Indication: Uncomplicated urogenital gonorrhea

Our View:
Two novel oral antibiotics cleared in the same week for a resistant pathogen is rare. GSK’s commercial infrastructure likely gives it an advantage in formulary negotiations and guideline positioning versus smaller competitors.

Status: APPROVED (Dec 12)
Indication: Pediatric HAE (ages 2 to <12)

Our View:
A straightforward label-expansion win that strengthens franchise durability. Commercial impact outweighs binary risk here.

Event: PDUFA (Dec 16 – Tuesday)
Indication: Dry Eye Disease
PoA: ~40 (Speculative)

Setup:
This is Aldeyra’s third regulatory attempt following a CRL in Nov 2023 and another setback in April 2025. The NDA was resubmitted in June based on new chamber trial data.

Our View:
The FDA has been unusually strict on symptom endpoints in Dry Eye. While the resubmitted data technically cleared prior deficiencies, regulatory fatigue and precedent make this a high-risk binary. Treat as a volatility trade, not a conviction long.

Event: PDUFA (Dec 16 – Tuesday)
Indication: Severe Asthma / CRSwNP
PoA: ~85 (High Confidence)

Setup:
Ultra-long-acting IL-5 biologic dosed every six months.

Our View:
A likely approval and a clean lifecycle-management win for GSK’s respiratory franchise. Convenience and adherence are the value proposition. Expect internal cannibalization of Nucala, but stronger long-term franchise lock-in.

Expect very thin liquidity and exaggerated gaps.

Event: PDUFA (Dec 26)
Indication: Obstructive HCM
PoA: ~85

Update:
Positive CHMP opinion (Dec 12) materially de-risks the clinical package.

Our View:
US approval is widely expected. Labeling and any REMS requirements remain the key swing factors. Commercial comparisons to Camzyos will dominate post-approval debate.

Event: PDUFA (Dec 26)
Indication: TA-TMA
PoA: ~50

Setup:
Resubmission following a 2021 CRL; current action date reflects a 3-month extension from September.

Our View:
A true “show-me” story. A surprise approval would likely trigger a sharp short squeeze; another rejection would reinforce long-standing skepticism.

Event: PDUFA (Dec 28)
Indication: Multiple Sclerosis
PoA: ~50

Setup:
Review extended in September following prior clinical holds for liver injury.

Our View:
Approval, if granted, is likely to come with restrictive labeling and monitoring requirements tied to hepatotoxicity risk. Commercial positioning versus safer BTK inhibitors remains challenging.

Event: PDUFA (Dec 30)
Indication: Hypercortisolism (Cushing’s)
PoA: ~70

Our View:
No AdCom and a relatively clean safety narrative keep this on track. Focus post-decision will be differentiation versus Korlym and physician adoption.

Event: PDUFA Goal Date (Dec 31)
Indication: Wet AMD
PoA: Very Low

Caution:
The August 2025 CRL cited insufficient evidence of efficacy. While the FDA accepted the resubmission with a short review clock, efficacy deficiencies historically carry a low probability of reversal. Treat this as a high-uncertainty event, not an approval trade.

Liquidity drops sharply after Dec 15.
Late-December FDA actions often resolve into thin order books, producing exaggerated gaps—both up and down. Position sizing and exit planning matter more than conviction.

The mid-December catalyst cluster has resolved. What remains is a back-loaded, low-liquidity tape where year-end FDA decisions will be driven less by surprise efficacy and more by label language, extensions, and regulatory caution. Trade carefully.