The US FDA approves an in vivo CRISPR gene editing therapy before January 1, 2028.

• G
  GPTOpenAI

  The key variable is whether late-stage safety and durability data let FDA accept the first systemic editing risk-benefit case.

  • FDA approved ex vivo CRISPR therapy Casgevy in 2023, while in vivo candidates already have human proof-of-concept.
  • Verve, Intellia, Beam and CRISPR Therapeutics must complete pivotal-quality follow-up and submit a BLA by 2027.
  • The main downside is an editing-related safety signal or durable off-target concern; a successful Phase 3 readout would raise odds sharply.

  openai/gpt-5.6-terra · asked 19 Sept 2026
  78%
• G
  GrokxAI

  Intellia NTLA-2001 Phase 3 readout-to-BLA timing vs 15-month window.

  • MAGNITUDE must finish, read out, and support a BLA by mid-2027 for 6-month priority review to hit 2027.
  • First-in-class in-vivo CRISPR has no prior FDA precedent; ex-vivo Casgevy took ~18 months post-pivotal.
  • A clean 2026 data cut or breakthrough designation would raise odds; a hold or extra trial would kill them.

  x-ai/grok-4.6 · asked 19 Sept 2026
  38%
• C
  ClaudeAnthropic

  Turns on whether NTLA-2002/Intellia's ATTR trials or similar in vivo CRISPR programs hit pivotal readouts and file in time.

  • Intellia's NTLA-2002 (HAE) is in Phase 3 with data expected ~2026-2027, making it the leading in vivo CRISPR candidate for a possible BLA by 2028.
  • FDA review typically takes 10-12 months post-filing, so a 2027 filing could plausibly yield approval before Jan 2028, but pivotal trial completion, safety follow-up, and…
  • Verve Therapeutics, Beam, and others are earlier stage; base rate for first-in-class gene therapy approvals slipping past initial timelines is high, favoring a…

  anthropic/claude-sonnet-5 · asked 19 Sept 2026
  32%
• G
  GeminiGoogle

  Turns on whether late-stage in vivo trials like NTLA-2001 or VERVE-101 clear Phase 3 and FDA review before the 2028 cutoff.

  • Intellia's NTLA-2001 for ATTR amyloidosis entered Phase 3 in early 2024, but readout, BLA submission, and review rarely take under 40 months.
  • Off-target cutting and liver delivery safety remain heightened scrutiny points for the FDA's cellular and gene therapy division.
  • Accelerated approval based on intermediate biomarkers would bump odds, but standard complete response requirements push approval to 2028-2029.

  google/gemini-3.8-flash · asked 19 Sept 2026
  27%
• D
  DeepSeekDeepSeek

  Whether Intellia's lonvo-z or a rival in vivo editor clears FDA before 2028, not whether the science works.

  • Intellia's lonvo-z for ATTR amyloidosis is the front-runner, with Phase 3 HAELO data expected 2026 and a possible 2027 filing.
  • Regeneron/Intellia's NTLA-2001 already showed >90% TTR knockdown; the gating issue is durability and off-target data, not efficacy.
  • Base rate for a first-in-class modality from Phase 3 readout to FDA approval is roughly 2-3 years; a 2026 readout makes a 2027 approval tight but plausible.

  deepseek/deepseek-v4.1-flash · asked 19 Sept 2026
  22%
• Q
  QwenAlibaba

  Intellia's NTLA-2001 (ATTR amyloidosis) is the frontrunner but faces a 2027 BLA filing at best, leaving tight FDA review timelines.

  • Intellia's NTLA-2001 for ATTR is furthest along; Phase 3 MAGNITUDE trial data expected ~2026-27, but BLA filing and standard 10-12 month review makes approval before Jan…
  • Verve Therapeutics' VERVE-101 (PCSK9) is earlier-stage and unlikely to reach approval by 2028; no other in vivo CRISPR candidate is in late-stage trials with a clear…
  • FDA has never approved an in vivo gene editing therapy; even with priority review (~6 months), the candidate would need BLA acceptance by mid-2027, which is optimistic…

  qwen/qwen3.8-max-0902 · asked 19 Sept 2026
  22%

6 of 6 models answered · 56 points between the highest and lowest. None was shown the market price.