CRISPR Therapeutics (NASDAQ: CRSP) details broad gene-editing trial updates

Rhea-AI Filing Summary

CRISPR Therapeutics AG filed an update on multiple gene-editing programs across cardiovascular, autoimmune, oncology and regenerative medicine. The company highlighted continued progress with its in vivo programs using a proprietary lipid nanoparticle delivery platform, including CTX310, which in 2025 showed deep and durable reductions in triglycerides and LDL after a single intravenous dose with a well‑tolerated safety profile and has moved into Phase 1b trials.

CTX320, targeting LPA, has shown reductions of up to 73% in a dose‑escalation trial, while next‑generation candidate CTX321 with about two‑fold greater preclinical potency is in IND/CTA‑enabling studies. Additional preclinical assets include CTX460 for alpha‑1 antitrypsin deficiency and CTX340 for refractory hypertension. Zugocabtagene geleucel (zugo‑cel) is in Phase 1 autoimmune trials where early systemic lupus erythematosus patients achieved drug‑free remission or full score improvement, and an oncology trial is ongoing alongside a new collaboration with Eli Lilly. In regenerative medicine for diabetes, CTX211 data with detectable C‑peptide at 12 months support a move to next‑generation candidate CTX213.

Insights

Biotech pipelines and clinical development analyst

Filing outlines broad clinical progress but remains early-stage.

CRISPR Therapeutics describes advancement across several gene-editing programs rather than a single pivotal event. Key points include Phase 1 data for CTX310 showing deep, durable triglyceride and LDL reductions after one infusion, allowing progression into Phase 1b, and up to 73% reductions with CTX320 in a dose-escalation trial. These are early clinical signals and do not yet reflect late-stage efficacy outcomes.

In autoimmune disease, early systemic lupus erythematosus patients treated with zugo-cel achieved drug-free remission or sustained B-cell depletion with improved SLEDAI-2K scores through months 2–9, while oncology trials continue and now include a collaboration with Eli Lilly. Regenerative efforts show CTX211 generating detectable C-peptide 12 months post-implant, informing a transition to next-generation CTX213. Overall, the content expands visibility into the pipeline but does not provide registrational data or commercial metrics, so the impact leans more informational than thesis-changing.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Understanding 8-K Material Events →

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 12, 2026

CRISPR THERAPEUTICS AG

(Exact name of Registrant as Specified in Its Charter)

Switzerland			001-37923	Not Applicable
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
Baarerstrasse 14
6300 Zug, Switzerland				Not Applicable
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: 41 (0)41 561 32 77

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Shares, nominal value CHF 0.03		CRSP		The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

☐

Item 8.01 Other Events.

On January 12, 2026, CRISPR Therapeutics AG (the “Company”) issued a press release highlighting, among other things, selected updates related to its wholly-owned cardiovascular, autoimmune, immuno-oncology and regenerative medicine programs:

•The Company continues to advance a diversified portfolio of in vivo gene editing programs leveraging its proprietary lipid nanoparticle (“LNP”) delivery platform.

oIn 2025, the Company presented data for CTX310, demonstrating deep and durable reductions of triglycerides and low-density lipoprotein following a single-course intravenous infusion, with a well-tolerated safety profile. Based on the positive Phase 1 results, the Company has advanced CTX310, targeting angiopoietin-related protein 3 (ANGPTL3), into Phase 1b clinical trials, prioritizing development in severe hypertriglyceridemia and refractory hypercholesterolemia.

oCTX320, targeting LPA, has demonstrated reductions of up to 73% in the dose escalation phase of the clinical trial. In parallel, the Company is advancing a next-generation LPA program, CTX321, incorporating an updated guide RNA that demonstrates approximately two-fold greater potency in preclinical testing, while utilizing the same LNP delivery system. CTX321 is currently in IND/CTA-enabling studies.

oIn addition to its clinical-stage programs, the Company continues to advance several preclinical in vivo gene editing candidates, including:

▪CTX460, targeting SERPINA1 for the treatment of alpha-1 antitrypsin deficiency (AATD), the first investigational candidate to emerge from the Company’s SyNTase editing platform; and

▪CTX340, targeting angiotensinogen (AGT) for refractory hypertension, which is currently in IND/CTA-enabling studies.

•Zugocabtagene geleucel (zugo-cel; formerly CTX112) continues to advance in both autoimmune disease and hematologic malignancies.

oIn autoimmune disease, Phase 1 clinical trials are ongoing across multiple indications, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and inflammatory myositis and a second Phase 1 trial in immune thrombocytopenia purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA). The first patient with SLE, refractory to 9 prior therapies with a baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 8, has maintained drug-free DORIS clinical remission through month 9 following CAR-T therapy. The second SLE patient with a baseline SLEDAI-2K score of 8, has sustained B cell depletion with SLEDAI-2K score of 0 through month 2 following CAR-T therapy.

oThe Phase 1/2 clinical trial of zugo-cel in B-cell malignancies is ongoing.

oThe Company has established a collaboration and clinical supply agreement with Eli Lilly to evaluate zugo-cel together with pirtobrutinib in aggressive B-cell lymphomas, further expanding the program’s development in oncology.

•The Company continues to advance its regenerative medicine portfolio, including its efforts in diabetes. Clinical data generated from CTX211 were promising, demonstrating detectable C-peptide levels 12 months after implantation. These data have informed the Company’s approach to hypoimmune cell engineering, supporting a transition to a next-generation candidate, CTX213. CTX213 has demonstrated compelling preclinical efficacy and is progressing towards the clinic.

Forward-Looking Statements

Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in the Company's most recent annual report on Form 10-K and in any other subsequent filings made by the Company with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

CRISPR THERAPEUTICS® standard character mark and design logo, SyNTase™, CTX112™, CTX211™, CTX213™, CTX310®, CTX320™, CTX321™, CTX340™ and CTX460™ are trademarks and registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

			CRISPR Therapeutics AG
Date:	January 12, 2026	By:	/s/ Samarth Kulkarni
			Samarth Kulkarni, Ph.D. Chief Executive Officer

FAQ

What did CRISPR Therapeutics (CRSP) disclose in this 8-K filing?

The company provided updates on several wholly owned programs in cardiovascular, autoimmune, immuno-oncology and regenerative medicine, highlighting new clinical and preclinical data and program progress.

What were the key results for CTX310 in CRISPR Therapeutics' pipeline update?

CTX310 showed deep and durable reductions of triglycerides and low-density lipoprotein after a single intravenous infusion in Phase 1, with a well-tolerated safety profile, enabling advancement into Phase 1b trials in severe hypertriglyceridemia and refractory hypercholesterolemia.

How did CTX320 and CTX321 perform in CRISPR Therapeutics' cardiovascular programs?

CTX320, targeting LPA, achieved reductions of up to 73% in a dose-escalation trial, while next-generation CTX321 showed about two-fold greater potency in preclinical testing and is in IND/CTA-enabling studies using the same lipid nanoparticle delivery system.

What autoimmune disease data were reported for zugo-cel by CRISPR Therapeutics (CRSP)?

In Phase 1 autoimmune trials, one systemic lupus erythematosus patient refractory to nine prior therapies maintained drug-free DORIS clinical remission through month 9, and a second patient had sustained B-cell depletion with a SLEDAI-2K score of 0 through month 2 after zugo-cel CAR-T therapy.

What oncology collaboration involving zugo-cel did CRISPR Therapeutics announce?

CRISPR Therapeutics established a collaboration and clinical supply agreement with Eli Lilly to evaluate zugo-cel together with pirtobrutinib in aggressive B-cell lymphomas, expanding development of the program in oncology.

How is CRISPR Therapeutics progressing its regenerative medicine and diabetes programs?

Clinical data from CTX211 showed detectable C-peptide levels 12 months after implantation, and these results are guiding a transition to next-generation candidate CTX213, which has demonstrated compelling preclinical efficacy and is moving toward clinical testing.