Event: PDUFA (Dec 15) — Priority Review
PoA: 85
Rating: High Confidence

Setup: Innoviva approaches a critical decision for zoliflodacin, a first-in-class oral antibiotic for uncomplicated urogenital gonorrhea. The NDA is backed by a global randomized Phase 3 non-inferiority trial showing single-dose oral zoliflodacin matched the current standard regimen (ceftriaxone injection plus oral azithromycin), with a clean safety profile.

Our View: The combination of Priority Review, QIDP designation, and urgent public health demand supports a high-probability approval. Commercial upside will depend on how aggressively stewardship and use-restriction language constrain real-world utilization, but mechanistically this is a step-change asset in resistant STI management.

Event: PDUFA (Dec 13) — Class 2 Resubmission
PoA: 65
Rating: Mixed Risk

Setup: Milestone faces an FDA decision for self-administered PSVT rescue therapy. The original NDA received a CRL in March 2025 over chemistry, manufacturing, and controls. The FDA accepted a Class 2 resubmission in July 2025, setting a new PDUFA target of December 13.

Our View: The clinical program (NODE-303 and related studies) supports efficacy, but regulatory friction history justifies a discount vs a “clean” file. The key value driver is how prescriptive the label becomes around self-administration and setting of use. This is a label-risk trade more than a pure efficacy bet.

Event: PDUFA (Dec 11) — Gonorrhea sNDA
PoA: 68
Rating: Moderate Confidence

Setup: Gepotidacin, already approved for uUTI, is under FDA review for uncomplicated urogenital gonorrhea in patients ≥12. The pivotal EAGLE-1 trial showed non-inferiority versus ceftriaxone plus azithromycin, with meaningful activity against resistant strains and a manageable safety profile.

Our View: Mechanistically differentiated and well-positioned as an oral alternative. We expect stewardship language and patient-selection constraints to temper early adoption. Approval is more likely than not; the market reaction will hinge on the degree of restriction embedded in the label.

Event: Phase 3 Data Presentation (Dec 11, SABCS)
PoA: 78
Rating: High Confidence

Setup: Celcuity will present comprehensive data from VIKTORIA-1, with particular focus on the PIK3CA wild-type HR+/HER2- cohort. Topline readout previously showed an approximate 7.3-month PFS improvement versus control.

Our View: This is not a binary event; topline de-risks efficacy. The focus now is on durability, safety nuance, and positioning vs CDK4/6 inhibitors and PI3K/AKT agents. Expect management to lean into a late-2025 NDA timing narrative and potential combinations.

Event: PDUFA (Dec 12) — Pediatric HAE
PoA: 86
Rating: High Confidence

This is primarily a label-expansion narrative. Key watch items:

Commercial impact > binary risk.

Event: HFpEF Data (Dec 8, CVCT)

Incremental HFpEF positioning rather than a binary catalyst. The angle here is cardiometabolic phenotyping and the extent to which new data support use in obesity-linked HFpEF subgroups. Treat as background thesis-building, not as near-term P&L disruption.

Earlier raw feeds framed TIGeR-PaC as a potential interim data “event”. Management has since stated:

Net: We do not expect a public data release this week. Keep TIGeR-PaC on the background risk radar for pancreatic cancer, but do not trade it as a dated catalyst.

Raw Signal: Phase 3 readout flagged for Dec 12.
Reality: SABCS schedules indicate an OPERA-02 Trial-in-Progress (TiP) poster, not a Phase 3 topline disclosure.

Action:
We do not expect a binary efficacy readout this week. Treat any price volatility around the SABCS slot as noise, not as data-driven repricing.

Event: BLA PDUFA (Dec 5)
Status: Approved (Dec 3)

The FDA granted:

We will dig into biologic exclusivity, label nuances, and reimbursement trajectory in the next issue.

Event: SUO 2025 Data (Dec 2)

Updated data showed that TLX250-CDx imaging would have altered clinical management in a substantial fraction of patients with indeterminate renal masses versus standard imaging alone. This reinforces its positioning as a high-specificity PET adjunct in the small-renal-mass workup.

This week’s anti-infective stack (gepotidacin + zoliflodacin) creates a rare dual binary window in resistant gonorrhea:

At the same time, Cardio + HAE catalysts (Cardamyst, Orladeyo granules, Inpefa data) keep a floor of non-oncology activity in a tape that’s been heavily oncology-weighted.

High: >70
Moderate: 40–70
Speculative: <40

We assign PoA using a five-factor model

These are directional probability estimates, not guarantees. Pair them with:

Liquidity drops sharply after Dec 15.

Binary prints in thin conditions can produce exaggerated gaps in:

Position sizing and post-event liquidity planning matter more than usual.

This is the densest non-oncology catalyst week of Q4, anchored by:

Expect labels and stewardship frameworks, not just efficacy, to drive how these trades resolve.