PoA = probability-of-approval band; directional only

This issue covers:
• Weekend PDUFA Cluster: BCRX, MIST, AMGN, INVA
• SABCS Reality Check: OLMA & BBOT
• Year-End Binary Stack: CYTK, CORT, OTLK
• January 2026 Outlook: ATRA, TVTX, AQST
• This Week on the Tape

As the San Antonio Breast Cancer Symposium (Dec 9–12) concludes, investors must separate trial updates from true efficacy readouts.

$OLMA ( ▼ 4.44% ) (Olema)
• The OPERA-02 presentation today (Dec 12) is a Phase 3 Trial-in-Progress poster — a study design update, not a pivotal data release.
• The palazestrant + ribociclib efficacy dataset remains pending.

$BBOT ( ▲ 1.07% ) (BridgeBio Oncology)
• SABCS features preclinical data for BBO-10203 and a TiP poster for the Phase 1 BREAKER-101 trial.
• Initial Phase 1 clinical data are guided for 1H 2026.
• No clinical efficacy readout should be expected this week.

Prioritized by date and regulatory materiality.

Date: Dec 12
Event: PDUFA – Label expansion (ages 2–<12)
PoA: 90%

Our View:
Low-risk expansion. The pediatric sNDA locks in younger hereditary angioedema patients before they migrate to injectable prophylaxis. Franchise-durability catalyst.

Date: Dec 13 (Saturday)
Event: PDUFA – PSVT
PoA: 65%

Our View:
FDA assigned a new PDUFA goal date of Dec 13, 2025. Expect a Monday (Dec 15) press release if approved. Etripamil offers a major quality-of-life upgrade over ER-administered adenosine.

Date: Dec 14 (Sunday)
Event: PDUFA – Generalized Myasthenia Gravis
PoA: 75%

Our View:
The generalized MG market is crowded (Vyvgart, Soliris, Ultomiris). Uplizna differentiates through q6-month maintenance dosing. Expect a Monday announcement.

Date: Dec 15
Event: PDUFA – First-in-class oral antibiotic
PoA: 85%

Our View:
Priority Review with strong public-health momentum. High approval probability, though commercial upside is capped by antibiotic economics.

Date: Dec 26
PoA: 85%

Our View:
The FDA extended the PDUFA to Dec 26, 2025. No AdCom suggests the debate centers on labeling and REMS, not efficacy. The key Q4 catalyst across biotech.

Date: Dec 30
PoA: 70%

Our View:
Targets a safer replacement for Korlym. PDUFA confirmed for Dec 30, 2025. Watch for tax-loss pressure regardless of outcome.

Date: Dec 31
Event: PDUFA – Class 1 Resubmission
PoA: 55%

Our View:
Following the August CRL, the resubmission yielded a 60-day review and Dec 31 PDUFA. Entirely a CMC/manufacturing resolution story.

Date: Jan 9 (ASCO GI)
Event: Poster presentation
Note: This is a PK/PD sub-study update, not topline Phase 3 TIGeR-PaC survival data.

Date: Jan 10
Event: PDUFA – Priority Review
Would be the first off-the-shelf allogeneic T-cell therapy.

Date: Jan 13
Event: sNDA PDUFA
Decision for traditional approval in FSGS.

Date: Jan 31
Event: PDUFA
A device-free epinephrine delivery competitor.

$RYTM ( ▼ 2.02% ) : Setmelanotide PDUFA moved to March 20, 2026.
$MURA ( 0.0% ) : Q4 IND guidance likely slips to early 2026 absent a press release.
$SAGE ( ▼ 0.23% ) : SAGE-319 Phase 1 data now likely a 2026 event.

Conference Hangover: With ASH and SABCS concluding, the sector typically enters a “sell the news” rotation.

Liquidity Warning: Dec 15–Jan 2 is the dead zone — trading desks thin out, volume fades.

Binary Impact:
• Positive news (CYTK, CORT) may face muted upside.
• Negative news (e.g., OTLK CRL) can be exaggerated by air pockets in the bid stack.

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

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