2025-05-19-Jefferies-未来一周美国临床肿瘤学会（ASCO）摘要（MRUS_IDYA_ORIC_CELC）；URGN咨询委员会（与TYRA相关）_15页_693kb

Summary of Equity Research Report (USA Biotechnology - May 18, 2025)

Key Highlights

• ASCO 2025 Conference:

  • May 30-June 2: Registration and late-breaking abstracts will post on May 22. The report highlights several companies and data points:
    • MRUS: Posters on 1L HNSCC Phase II data and BCAX in 1L HPV⁻ HNSCC. Conference call on May 22 to discuss Phase II data with 12mos OS, 6mos PFS, and ORR.
    • IDYA-related: ZLAB's DLL3 ADC update and CELC's 3L+ HER2+ data.
    • ORIC/CELC updates on mCRPC and oral SERDs.
    • ERAS and BCRX updates.
  • URGN ODAC on May 21 will vote on therapies for NMIBC and potential approval of UGN-102, with PDUFA approval expected by June 13.

• Clinical Trial Updates:

  • MRUS: Phase III LiGeR-HN1 trial recruiting rapidly; Phase II BCAX data due June 1 at ASCO.
  • ALNY: Recruitment status for ALN-BCAT and ALN-APP.
  • NTLA: NTLA-2001 in ATTR-CM continues recruitment.
  • Other trials (e.g., RARE, SLDB, ELVN) have updated designs or ongoing enrollment.

• Regulatory Updates:

  • BCRX and NTLA-related IONS drug under review.
  • TVTX to change REMS monitoring from QM to Q3M.
  • KALV's Sebetralstat PDUFA clock extends to June 17, 2025.

• Upcoming Events:

  • Medical Conferences: June 4-7 (ERN/DNF), June 11-14 (EULAR), June 12-15 (EHA), etc. (See full list).
  • Company Catalysts: Mid-2025 interim data releases from CRSP, MRUS, CELCO, RARE, among others.

• Valuation & Analyst Recommendations:

  • Covers companies like MRUS, IDYA, TYRA, CELC, TSHA, URGN, etc.
  • Ratings include Buy, Hold, Underperform with price targets (e.g., BUY recommendations for ALNY, NTLA, MRUS).

• Company Specifics:

  • MRUS: Focus on HNSCC and combo trials with Peto/Pembro.
  • TYRA: URGN ODAC decision upcoming for NMIBC therapy.
  • IDYA: Phase II data expected in mid-2025 for neoadjuvant therapy.

Analyst Certifications

The equity analysts (Raycroft, Qian, Stamos, Haque, Makarem) certify that all views reflect personal opinions and that compensation is not tied to recommendations, though internal firm performance may influence incentives.

Key takeaways:

• High-frequency focus: Data releases tied to ASCO 2025, involving multiple companies like MRUS, IDYA, AYX, ORIC, and CELC.
• Risk-reward analysis: Many firms have Biotech’s HOLD BUY/UNDP, with strong catalysts expected in H1 2025.
• Valuation: Emphasis on accelerated clinical progress, regulatory pathways, and market potential—especially in oncology, gene therapy, and novel targets.