StreetInsider.com News Articles

Fractyl Health names Mike Zumdahl senior VP of market access

Mon, 01 Jun 2026 07:00:24 -0400

Fractyl Health, Inc. (NASDAQ: GUTS) appointed Mike Zumdahl as Senior Vice President, Market Access and Commercial Strategy, the company announced June 1.

Zumdahl previously served as Vice President of Global Health Economics, Market Access, and Government Affairs at Inari Medical, leading the function through the company's growth and its acquisition by Stryker for approximately $4.9 billion in February 2025. Most recently, he was President of Commercial Access Partners, advising medical technology companies on go-to-market strategy and reimbursement.

The appointment comes as Fractyl prepares for anticipated REMAIN-1 Pivotal Cohort topline data in early Q4 2026 and a potential De Novo marketing application submission

Fractyl Health Appoints Mike Zumdahl as Senior Vice President, Market Access and Commercial Strategy

Mon, 01 Jun 2026 07:00:00 -0400

Experienced market access leader joins to build reimbursement and health economic infrastructure for Revita® ahead of anticipated REMAIN-1 Pivotal Cohort topline data in early Q4 2026

BURLINGTON, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced the appointment of Mike Zumdahl as Senior Vice President, Market Access and Commercial Strategy. Mr. Zumdahl served as Vice President of Global Health Economics, Market Access, and Government Affairs at Inari Medical, where he led

Fractyl Health Appoints Mike Zumdahl as Senior Vice President, Market Access and Commercial Strategy

Mon, 01 Jun 2026 07:00:00 -0400

Experienced market access leader joins to build reimbursement and health economic infrastructure for Revita® ahead of anticipated REMAIN-1 Pivotal Cohort topline data in early Q4 2026

Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: Nantahala Capital Management, LLC

Fri, 15 May 2026 16:44:00 -0400

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Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: Nantahala Capital Management, LLC

Fri, 15 May 2026 16:44:00 -0400

si-local-file:///var/storage/secattach/20260515/26507029.html

Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: 683 Capital Management, LLC

Fri, 15 May 2026 10:25:00 -0400

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Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: 683 Capital Management, LLC

Fri, 15 May 2026 10:25:00 -0400

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Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: SILVERARC CAPITAL MANAGEMENT, LLC

Wed, 13 May 2026 16:21:00 -0400

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Form SCHEDULE 13G/A FRACTYL HEALTH, INC. Filed by: SILVERARC CAPITAL MANAGEMENT, LLC

Wed, 13 May 2026 16:21:00 -0400

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Fractyl Health, Inc. (GUTS) Tops Q1 EPS by 19c

Tue, 12 May 2026 17:11:40 -0400

Fractyl Health, Inc. (NASDAQ: GUTS) reported Q1 EPS of ($0.06), $0.19 better than the analyst estimate of ($0.25).

For earnings history and earnings-related data on Fractyl Health, Inc. (GUTS) click here.

Form 10-Q FRACTYL HEALTH, INC. For: Mar 31

Tue, 12 May 2026 16:06:00 -0400

si-local-file:///var/storage/secattach/20260512/26477747.html

Form 10-Q FRACTYL HEALTH, INC. For: Mar 31

Tue, 12 May 2026 16:06:00 -0400

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Fractyl Health Reports First Quarter 2026 Financial Results and Business Updates

Tue, 12 May 2026 16:05:00 -0400

Next anticipated Revita^® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026

Early Q4 2026 timing for topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and late Q4 2026 timing for potential FDA De Novo marketing application submission in post-GLP-1 weight maintenance reaffirmed

Clinical Trial Application authorization of RJVA-001 first-in-human study in the Netherlands for T2D; first-in-human dosing anticipated in second half of 2026 reiterated

Cash runway guidance into early 2027, beyond anticipated Pivotal data readout

Fractyl Health Reports First Quarter 2026 Financial Results and Business Updates

Tue, 12 May 2026 16:05:00 -0400

Next anticipated Revita^® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026

Early Q4 2026 timing for topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and late Q4 2026 timing for potential FDA De Novo marketing application submission in post-GLP-1 weight maintenance reaffirmed

Clinical Trial Application authorization of RJVA-001 first-in-human study in the Netherlands for T2D; first-in-human dosing anticipated in second half of 2026 reiterated

Cash runway guidance into early 2027, beyond anticipated Pivotal data readout

Form 8-K FRACTYL HEALTH, INC. For: May 12

Tue, 12 May 2026 16:05:00 -0400
si-local-file:///var/storage/secattach/20260512/26477681.html

Form 8-K FRACTYL HEALTH, INC. For: May 12

Tue, 12 May 2026 16:05:00 -0400
si-local-file:///var/storage/secattach/20260512/26477681.html

Fractyl Health gets approval for first gene therapy trial in type 2 diabetes

Mon, 11 May 2026 07:00:50 -0400

Fractyl Health Inc. (NASDAQ: GUTS) received authorization from Dutch regulators to begin the first human trial of RJVA-001, a gene therapy for type 2 diabetes. The company states this marks the first adeno-associated virus-based gene therapy candidate to enter clinical development for the condition.
The Phase 1/2 trial will evaluate RJVA-001 in adults with inadequately controlled type 2 diabetes despite using multiple glucose-lowering medications, including GLP-1 receptor agonists. The open-label study will test three escalating dose levels with three participants each, followed by an optional expansion cohort of up to 20 additional participants.
RJVA-001 is designed as a one-time treatment delivered directly

Fractyl Health gets approval for first gene therapy trial in type 2 diabetes

Mon, 11 May 2026 07:00:50 -0400

Fractyl Health Inc. (NASDAQ: GUTS) received authorization from Dutch regulators to begin the first human trial of RJVA-001, a gene therapy for type 2 diabetes. The company states this marks the first adeno-associated virus-based gene therapy candidate to enter clinical development for the condition.
The Phase 1/2 trial will evaluate RJVA-001 in adults with inadequately controlled type 2 diabetes despite using multiple glucose-lowering medications, including GLP-1 receptor agonists. The open-label study will test three escalating dose levels with three participants each, followed by an optional expansion cohort of up to 20 additional participants.
RJVA-001 is designed as a one-time treatment delivered directly

Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes

Mon, 11 May 2026 07:00:00 -0400

Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes

First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation

Rejuva® clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans

BURLINGTON, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches

Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes

Mon, 11 May 2026 07:00:00 -0400

Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes

First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation

Rejuva® clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans

BURLINGTON, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches

Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes

Mon, 11 May 2026 07:00:00 -0400

Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes

First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation

Rejuva® clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans

BURLINGTON, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches

Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes

Mon, 11 May 2026 07:00:00 -0400

Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes

First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation

Rejuva® clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans

BURLINGTON, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches

Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes

Mon, 11 May 2026 07:00:00 -0400

Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes

First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation

Rejuva® clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans

BURLINGTON, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches

Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes

Mon, 11 May 2026 07:00:00 -0400

Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes

First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation

Rejuva® clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans

BURLINGTON, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches

Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes

Mon, 11 May 2026 07:00:00 -0400

Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes

First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation

Rejuva® clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans

BURLINGTON, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches