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reni-cel RUBY Phase 1/2 SCD Update at ASH 2026

EDIT·reni-cel·Sickle Cell Disease··NCT05444894
current best date
DEC
2026
MONTH7 months
Takeaway

Updated Phase 1/2 reni-cel data in sickle cell disease at ASH 2026. Approved benchmark in the same indication: CASGEVY (CRSP/Vertex). Watch: VOC reduction, fetal hemoglobin %, time to engraftment, safety.

What’s at stake

market · comparables · base rate · prior moves
Market opportunity
company filings
Peer comparables
1 readout
ClinicalTrials.gov
Stage base rate
~58%
BIO Industry Analysis 2023 (2011–2020)
Avg prior-readout move
historical price reactions
Drug
cell therapy
reni-cel
INN
MoACRISPR/Cas12a HBG1/2 promoter edit

Reni-cel is Editas Medicine's ex vivo gene-editing therapy for sickle cell disease and beta thalassemia that uses CRISPR/Cas12a — rather than the more common Cas9 — to edit patient-derived blood stem cells and reactivate fetal hemoglobin production. After the edited cells are reinfused following conditioning chemotherapy, elevated fetal hemoglobin compensates for defective adult globin, preventing red blood cell sickling and reducing transfusion dependence. Editas positions reni-cel as a next-generation alternative to CASGEVY, with the hypothesis that Cas12a provides a distinct precision profile at the BCL11A enhancer locus.

Indication
Oncology - Heme
Sickle Cell Disease
MeSH · D000755

No primer in glossary yet.

Trial
active
NCT05444894
RUBY Phase 1/2 Reni-cel in SCD
Phase
Ph 3
N
30
Primary completion
Mar 30, 2027
Glossary · what this readout is measuring
1 term detected in the takeaway
  • ASHconference
    American Society of Hematology Annual Meeting

    The major heme/onc meeting (~30,000 attendees). Early-December; key venue for blood cancer and rare hematology readouts.

Sector base rates · reference data
historical record · not prediction

of 1 historical Phase 3 readouts in Oncology - Heme: 1 positive, 0 mixed, 0 negative.

Positive
1/ 1
100%
Mixed
0/ 1
0%
Negative
0/ 1
0%
positive rate 100% · primary endpoint hit rate 100%
Reference data · comparable readouts

How Ph3 readouts in Oncology - Heme have landed.

Reference, not prediction. We surface the historical record so you can read it yourself. We never extrapolate to the upcoming event.

Positive
1/1
100% in record
Primary endpoint hit
100%
across 1 readouts
Drug · sponsorPhase · yearOutcomeKey metricSource
pirtobrutinib (BRUIN-321)
LLY · CLL
Ph3 · Dec 2024positivePFS HR 0.54PR
mosunetuzumab
RHHBY · r/r FL
Ph2 · Jun 2022positiveCR rate 60%conference
sorted by phase match, then recency · sources span PR wires, CT.gov, FDA notices, and conference presentations · we never editorialize the outcome label

Competitive landscape

4 peers in Oncology - Heme · ranked by indication + modality match
DrugCompanyModalityMechanismPhaseNext catalyst
BEAM-101BEAMcell therapybase editing of HBG1/2 to reactivate fetal hemoglobinREADOUT · Dec 26
CASGEVYexagamglogene autotemcelCRSPcell therapyCRISPR/Cas9 BCL11A enhancer editCONFERENCE · Dec 26
CB-010CRBUcell therapyallogeneic CRISPR-edited anti-CD19 CAR-TCONFERENCE · May 26
JAKAFIruxolitinibINCYsmall moleculeJAK1/JAK2 inhibitorREADOUT · Sep 26

Prior EDIT reactions to Readout events

1 historical event · base rate, not prediction
Median 1W move
-27.2%
Median 1M move
-16.6%
Positive outcomes
0/ 1
0%
Negative outcomes
1/ 1
100%
DateHeadlineOutcome1W1M6M
Oct 2023reni-cel — Phase 3 Topline — Mixed Resultnegative-27.2%-16.6%-34.8%

Historical EDIT stock reaction to past Readout catalysts. Past performance is not a forecast — base rates anchor expectations, not outcomes. Positive rate 0%.

Disclosure trail

1 observation · sorted by confidence
  1. Apr 12, 2026·18d agopinned · highest confidence
    MED confPR
    top claim
    DEC2026
    MONTH
    Editas plans to present an updated dataset from the RUBY Phase 1/2 study of reni-cel in sickle cell disease at ASH 2026 in December.
    conf 84%via llm

MethodologyEvery catalyst date is anchored to a primary source. Disclosures with confidence ≥ 0.85 auto-publish; the rest are reviewed by a human within 24 hours. We never interpret data — we organize public information.

Disclaimer·BioSight aggregates publicly available data (SEC EDGAR, ClinicalTrials.gov, FDA, company press releases) and is provided as is for informational purposes only. Nothing here is investment, financial, legal, tax, or medical advice, or an offer to buy or sell any security. We make no warranty as to accuracy, completeness, or timeliness; dates and filings may contain errors or be superseded without notice; past events do not predict future outcomes. To the maximum extent permitted by law, BioSight, its operators, contributors, and affiliates disclaim all liability for any loss or damage arising from use of or reliance on this site. You are solely responsible for your own investment decisions — consult a licensed professional before acting on any information.

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