PoA = probability-of-approval band (directional only; not FDA guidance)
This issue covers:
The immediate PDUFA deck: BMY, AGIO, GSK, BCRX, MIST, AMGN, INVA
December respiratory + anti-infective cluster (Dec 11–16)
Late-month binaries: CYTK, CORT, OTLK
The “Placeholder Effect”: How to treat Dec 31 guidance
This Week on the Tape: Thin liquidity and binary volatility
CRITICAL UPDATE
Avance® Nerve Graft $AXGN ( ▲ 1.98% ) was approved by the FDA on Dec 3, two days ahead of the originally posted Dec 5 PDUFA date.
Indicated for sensory, mixed, and motor peripheral nerve discontinuities in adults and pediatric patients (≥1 month)
First-in-class nerve allograft transitioned from Section 361 tissue product to licensed biologic
Commercial launch expected Q2 2026; market access and pricing dynamics meaningfully improve under biologic regulation
This removes one of the larger “structural overhangs” in the December calendar.
No new PDUFA delays or CRLs announced overnight.
RESOLVED / RECENTLY COMPLETED
$AXGN ( ▲ 1.98% ) – Avance® (BLA)
Outcome: Approved (Dec 3)
Implication: Material structural upgrade to reimbursement, exclusivity, and physician confidence
This is a business model unlock, not just a label milestone
ON DECK: Dec 5 – Dec 16
Prioritized by date and regulatory materiality.
PoA = directional only; not investment advice.
$BMY ( ▼ 0.97% ) – Breyanzi® (lisocabtagene maraleucel, sBLA; MZL)
Date: Dec 5
Event: PDUFA – label expansion (relapsed/refractory marginal zone lymphoma; Priority Review)
PoA: 78%
Our View:
Breyanzi’s Priority Review acceptance in August set the action date for Dec 5. The timeline looks fast, but fits within the fifth indication playbook, not a first-principles re-evaluation.
Risk lies in:
Label scope
REMS / post-marketing requirements
Base case: approval with guardrails.
$AGIO ( ▼ 3.07% ) – Pyrukynd® (mitapivat, sNDA; α/β-thalassemia)
Date: Dec 7
Event: PDUFA – label expansion
PoA: 70%
Our View:
Mitapivat is clinically validated in PK deficiency, but thalassemia has a different risk/benefit profile.
If approved, it meaningfully broadens the hematology franchise, but commercial execution remains uncertain.
$GSK ( ▲ 0.06% ) – Blujepa™ (gepotidacin; sNDA)
Date: Dec 11
Event: PDUFA – uncomplicated urogenital gonorrhea
PoA: 68%
Our View:
Gepotidacin is a first-in-class oral antimicrobial with strong AMR policy tailwinds.
Expect:
Stewardship language
Surveillance requirements
Restricted indications
Good public-health probability, messy commercial path.
$BCRX ( ▲ 1.05% ) – ORLADEYO® (oral granules; pediatric HAE)
Date: Dec 12
Event: PDUFA – pediatric formulation + age expansion
PoA: 86%
Our View:
Adult version is established; FDA extended review to process additional data, not due to new safety concerns.
This is a de-risked regulatory event with manufacturing/formulation caveats.
$MIST ( ▼ 1.92% ) – CARDAMYST™ (etripamil; resubmitted NDA)
Date: Dec 13
Event: PDUFA – PSVT (resubmission post-CRL)
PoA: 65%
Our View:
High practical utility story: self-administered nasal spray to terminate PSVT.
Binary risk rests on:
Real-world capture
Safety at home
Reasonable probability of approval, but label constraints likely.
$AMGN ( ▼ 0.99% ) – Uplizna® (inebilizumab; sBLA for gMG)
Date: Dec 14 (Sunday PDUFA – expect action Dec 12–15)
Event: PDUFA – generalized myasthenia gravis
PoA: 80%
Our View:
FDA calendars assign the nominal date, but real-world execution is driven by weekday operations.
Mechanism familiar; Phase 3 data supportive.
This is a regulatory path of least resistance, but commercial battle will occur in a crowded MG market (Soliris, Vyvgart, Ultomiris, Rystiggo).
$INVA ( ▼ 0.4% ) – Zoliflodacin
Date: Dec 15
Event: PDUFA – first-in-class oral antibiotic for gonorrhea
PoA: 85%
Our View:
One of the cleanest December binaries.
Global AMR urgency tilts probability materially upward.
$GSK ( ▲ 0.06% ) – Depemokimab (BLA; asthma / CRSwNP)
Date: Dec 16
Event: PDUFA – dual indications
PoA: 82%
Our View:
Solid data and familiar regulatory pathway.
Real question is whether GSK can carve durable share in a market defined by frequency, convenience, and payer dynamics.
YEAR-END BINARY STACK: Dec 26 – Dec 31
$CYTK ( ▼ 2.16% ) – Aficamten (BLA; obstructive HCM)
Date: Dec 26
Event: PDUFA – BLA for oHCM
PoA: 72%
Our View:
One of the highest-stakes 2H25 cardio binaries.
Regulatory risk is class-level (safety/monitoring), not efficacy.
$CORT ( ▼ 3.42% ) – Relacorilant (NDA; Cushing’s)
Date: Dec 30
Event: PDUFA – NDA for endogenous Cushing’s
PoA: 68%
Our View:
Small indication, messy endpoints.
If approved, becomes a specialty endocrine asset, not a blockbuster.
$OTLK ( ▲ 8.79% ) – ONS-5010 / bevacizumab-vikg (LYTENAVA™; wet AMD)
Date: Dec 31
Event: PDUFA – Class 1 BLA resubmission after August CRL
PoA: 55%
Our View:
This is a 60-day review following a CRL in August.
Binary risk is almost entirely:
CMC adequacy
Evidence sufficiency vs. incumbents
Coin-flip outcome with asymmetric downside.
WHAT’S NO LONGER DECEMBER
$RYTM ( ▲ 2.32% ) – IMCIVREE: Moved to March 20, 2026
$ANVS ( ▼ 2.78% ) – buntanetap: No December readout; existing Phase 3 data largely digested
Travere FILSPARI, Talphera Niyad, IBRX BCG alternative:
Regulatory timelines now 2026+
Treat as pipeline, not calendar catalysts
THIS WEEK ON THE TAPE
The December Liquidity Trap
We’re entering the last liquid week of the year.
Beyond Dec 15, institutional risk books shut down.
Approvals:
Upside often fails to sustain due to absent follow-through capital
Failures:
Downside is amplified by vanishing bids and forced liquidity
Think air-pocket risk, not orderly repricing.
Retail Lens: The “Quiet Period” Tell
Companies that guided to “by year-end” and have not PR’d a date by mid-December are signaling:
Delay,
Data weakness, or
Intent to bury bad news on Dec 31 after hours.
The absence of a date is itself information.
PoA FRAMEWORK
Directional only; not investment advice.
High: >70%
Moderate: 40–70%
Speculative: <40%
PoA reflects regulatory precedent, data strength, and sponsor execution—not stock price reaction.
Disclaimer
This newsletter is for informational and educational purposes only and does not constitute investment advice, a recommendation to buy or sell any security, or an offer to provide investment advisory services. All views are based on publicly available information and historical regulatory behavior. Biotech securities involve substantial risk, including the potential for total loss of capital. Always conduct your own due diligence.