BioMed Nexus Daily Updates

Your essential biotech, medtech, and pharma recap — no noise, just what matters.

🔮 The Pre-Market Download

The "SABCS" Shift & The Aldeyra Delay:

The market returns from the San Antonio Breast Cancer Symposium (SABCS) with a new hierarchy in oncology. Roche and AstraZeneca have established new Standards of Care, forcing a capital rotation out of competitors like Lilly. Meanwhile, the binary event of the day—Aldeyra (ALDX)—has been canceled: the FDA extended the review late yesterday, sending the stock lower.

Market Mood: Selective. The XBI is flat, but "Clinical Winners" (Immunome, Roche) are seeing heavy accumulation while "Misses" (Sanofi) are being punished.
Top Mover: Immunome (IMNM) is surging (+18%) on Phase 3 success.
Top Loser: Sanofi (SNY) is down on a Phase 3 MS failure; Aldeyra (ALDX) is down -12% pre-market on the regulatory delay.
👉 Read the Full SABCS 2025 Debrief

🎗️ Special Report: SABCS 2025 Debrief

The data that changed clinical practice over the weekend.

1. The New Standard of Care: Roche (RHHBY) 🏆

The Data: Phase 3 lidERA trial for giredestrant (oral SERD) showed a 30% reduction in invasive disease recurrence in the adjuvant setting.
The Impact: This effectively wins the first leg of the "SERD Wars." It likely replaces standard endocrine therapy for early-stage ER+/HER2- patients. Lilly (LLY) is now under immense pressure; their competing asset (imlunestrant) must match this high bar in 2026 to remain relevant in the adjuvant setting.
👉 Read the Full SABCS 2025 Debrief

2. The "HER2" King: AstraZeneca/Daiichi (AZN) 👑

The News: Validating the SABCS hype, the FDA approved Enhertu + pertuzumab for 1st-line metastatic HER2+ breast cancer yesterday (Dec 15).
The Impact: Dominance Cemented. By moving into the 1st-line setting (replacing the classic "CLEOPATRA" regimen), Enhertu expands its reach to virtually all HER2+ metastatic patients. AZN will pay a $150M milestone to Daiichi on this win.
👉 Read the Full SABCS 2025 Debrief

💉 Top Stories

Aldeyra PDUFA Delayed to March 2026: Late yesterday, the FDA extended the review period for Aldeyra's reproxalap (Dry Eye) by three months to March 16, 2026. The agency requested a "Clinical Study Report" as a major amendment. The stock sold off -12% in reaction to the uncertainty.
👉 Read more
Immunome (IMNM) Hits Phase 3 Home Run: Immunome reported that varegacestat met its primary endpoint in the Phase 3 RINGSIDE trial for desmoid tumors, reducing the risk of progression by 84% (HR=0.16). The company plans to file an NDA in Q2 2026.
👉 Read more
J&J Wins "Proactive" Priority Voucher: In a rare move, the FDA "proactively" awarded Johnson & Johnson a Priority Review Voucher (PRV) for its Tecvayli/Darzalex myeloma combo, citing "unprecedented" efficacy. This PRV is a tradable asset worth ~$100M+.
👉 Read more

🤝 M&A & Funding Room

Sobi Buys Arthrosi for $1.5B: Sobi (Swedish Orphan Biovitrum) has agreed to acquire Arthrosi Therapeutics for $950M upfront (plus $550M milestones). The deal secures pozdeutinurad, a Phase 3-ready asset for gout, continuing the trend of premiums paid for de-risked late-stage assets.
👉 Read more

🔬 Clinical Pulse

Failure: Sanofi (SNY) tolebrutinib (BTK inhibitor) missed primary endpoints in the Phase 3 PERSEUS trial for primary progressive MS. The company is abandoning this indication.
Success: Immunome (IMNM) confirms desmoid tumor dominance with Phase 3 data.
👉 Read more

📊 Market Snapshot (Monday Close)

Index/Ticker	Change	Note
XBI (Biotech)	+0.8%	Buoyed by M&A (Sobi) and SABCS wins.
RHHBY (Roche)	+2.1%	lidERA data reaction.
ALDX (Aldeyra)	-12.1%	Review delayed to March 2026.
SNY (Sanofi)	-5.0%	Phase 3 Failure.

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🟢 Enhertu Approved. 🔴 Aldeyra Delayed. 🏆 Roche Wins.