FDA approves CASGEVY for sickle cell and beta thalassemia patients ages 2+
The FDA approved CRISPR’s CASGEVY (exagamglogene autotemcel) for Sickle cell disease and transfusion-dependent beta thalassemia on Jul 2, 2026. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- CRISPR Therapeutics AG CRSP
- Drug
- CASGEVY (exagamglogene autotemcel)
- For
- Sickle cell disease and transfusion-dependent beta thalassemia
- Stage
- Regulatory (sBLA label expansion)
- When
- Jul 2, 2026
- Source note
- FDA approved expanded use of the Vertex/CRISPR-partnered CASGEVY (exagamglogene autotemcel) for people ages 2 and older with sickle cell disease with recurrent VOCs or transfusion-dependent beta thalassemia, the first genetic therapy indicated for children as young as 2 in both diseases. CRSP shares rose on the news.
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- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
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- CRSP headlines on this site
CRISPR expects to report results from its Phase 1 study of CTX320 / CTX321 for Elevated lipoprotein(a) / ASCVD during 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.
More details
- Entry
- Lp(a) program (CTX320/CTX321) update expected in 2026 · Clinical trial results (readout / topline data)
- Drug
- CTX320 / CTX321
- For
- Elevated lipoprotein(a) / ASCVD
- Stage
- Phase 1 · an early safety study in a small group of people
- When
- 2026 · the company gave a window, not a day
- Source note
- Q2 2026 release (Aug 3, 2026) reiterates JPM 2026 guidance. CTX320 showed up to 73% Lp(a) reduction in dose escalation; next-gen CTX321 (~2x potency guide RNA) is advancing.
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- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- CRSP headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
CRISPR expects to report results from its Phase 1 study of Zugocabtagene geleucel (zugo-cel, formerly CTX112) for Autoimmune (SLE, SSc, myositis, ITP, wAIHA) and B-cell malignancies in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.
More details
- Entry
- Zugo-cel (CTX112) updates across autoimmune disease and immuno-oncology · Clinical trial results (readout / topline data)
- Drug
- Zugocabtagene geleucel (zugo-cel, formerly CTX112)
- For
- Autoimmune (SLE, SSc, myositis, ITP, wAIHA) and B-cell malignancies
- Stage
- Phase 1 · an early safety study in a small group of people
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Jan 12, 2026 milestones PR: 'Updates across autoimmune disease and immuno-oncology for zugocabtagene geleucel... are expected in the second half of 2026.'
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- Source: crisprtx.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- CRSP headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
CRISPR expects to report results from its Phase 2 study of CTX611 (siRNA) for Thromboembolism prevention in total knee arthroplasty in the second half of 2026 (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.
More details
- Entry
- CTX611 Phase 2 topline in total knee arthroplasty (VTE prevention) · Clinical trial results (readout / topline data)
- Drug
- CTX611 (siRNA)
- For
- Thromboembolism prevention in total knee arthroplasty
- Stage
- Phase 2 · the stage that tests whether the drug actually works
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Jan 12, 2026 milestones PR: 'Top-line Phase 2 clinical data from CTX611 in patients undergoing total knee arthroplasty (TKA) are expected in the second half of 2026.'
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- Source: crisprtx.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- CRSP headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
CRISPR expects to report results from its Phase 1b study of CTX310 for Severe hypertriglyceridemia / refractory hypercholesterolemia in the second half of 2026 (no exact date yet). This is the first look at whether the drug did what the company hoped.
More details
- Entry
- CTX310 ANGPTL3 Ph1b clinical update (sHTG/refractory hypercholesterolemia) · Clinical trial results (readout / topline data)
- Drug
- CTX310
- For
- Severe hypertriglyceridemia / refractory hypercholesterolemia
- Stage
- Phase 1b
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Q2 2026 release (Aug 3, 2026). Separate from the already-listed ESC Aug 28 durability late-breaker; Phase 1b prioritizes sHTG and refractory hypercholesterolemia.
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- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- CRSP headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page