# Pegozafermin by Roche

Canonical page: https://technooptimist.io/biotech/pegozafermin
Frontier: [Biotech](https://technooptimist.io/biotech.md) · Field: Fatty liver (MASH) · Company: [Roche](https://technooptimist.io/companies/roche.md)
Stage: Pilot (3 of 5: Research → Proto → Pilot → Deploy → Scaling)
Updated: last update 2025-10-30, facts checked 2026-10-11
Goal: Reverse liver scarring in MASH, including in cirrhosis where no drug is approved, by restoring the hormone signal FGF21 that tells the liver to burn fat and stop laying down scar tissue.
Status: Phase 3 in MASH fibrosis (data H1 2027) and cirrhosis (2028); Roche bought 89bio for up to $3.5B.
Next milestone: ENLIGHTEN-Fibrosis (F2–F3) first topline results, target 2027

## Milestones

| Status | Milestone | Date | Slip |
| --- | --- | --- | --- |
| Done | Phase 2b ENLIVEN (219 patients): fibrosis and MASH gains at 24 weeks |   |   |
| Done | EMA PRIME priority designation | 2024 |   |
| Done | Roche agrees to buy 89bio (up to $3.5B) | 18 Sep 2025 |   |
| Done | Roche completes tender offer | 29 Oct 2025 |   |
| Current | ENLIGHTEN-Fibrosis (F2–F3) first topline results | 2027 |   |
| Planned | ENLIGHTEN-Cirrhosis (F4) first results | 2028 |   |

## Upcoming events

- **2027**: ENLIGHTEN-Fibrosis (F2–F3) first topline results
- **2028**: ENLIGHTEN-Cirrhosis (F4) first results

## Most important updates

- **30 Oct 2025**: Roche completes tender offer for 89bio, taking control of pegozafermin. Roche's subsidiary accepted all 89bio shares tendered by the 29 October 2025 deadline, about 60.5% of the company, at $14.50 in cash plus the contingent value right. ([our story](https://technooptimist.io/stories/roche-completes-tender-offer-for-89bio-taking-control-of-pegozafermin-377e997e.md) · [original source](https://chemxplore.com/news/roche-purchases-shares-in-tender-offer-for-89bio-inc))
- **18 Sep 2025**: Roche agrees to buy 89bio for up to $3.5B to gain pegozafermin, a phase 3 MASH drug. Roche agreed to acquire 89bio for $14.50 per share in cash (about $2.4B) plus a contingent value right of up to $6 per share, for up to $3.5B in total. ([our story](https://technooptimist.io/stories/roche-agrees-to-buy-89bio-for-up-to-3-5b-to-gain-pegozafermin-a-phase-3-5a3068b0.md) · [original source](https://www.roche.com/media/releases/med-cor-2025-09-18))

## Current obstacles

- **Cirrhosis is the hard target**: Most MASH drugs fail in F4 cirrhosis; one deal milestone requires a cirrhosis launch by March 2030.
- **Same-class rival ahead**: Novo Nordisk's efruxifermin (from Akero) is another FGF21 drug in phase 3 for MASH and cirrhosis.

## Physics limits

- **Proteins need injections**: FGF21 is a protein digested in the gut, so it must be injected; even with shielding, dosing stays weekly or twice-monthly rather than a pill.
- **Scar reversal is slow**: Collagen scars remodel over years, so trials of a year or two catch only early regression, and proof of fewer liver failures needs long outcome trials.

## How it works

### Hormone: FGF21 copy

FGF21 is a hormone the liver makes under stress; it boosts fat burning, insulin sensitivity and calms scar-forming cells.

### Glyco-PEG: Lasts days, not hours

Natural FGF21 is cleared in hours; a sugar-linked polymer chain shields it, allowing weekly or twice-monthly shots.

### Two effects: Less fat, less scarring

Lowers liver fat and triglycerides and directly dampens inflammation and fibrosis, not just weight.

### Combination: Pairs with incretins

Roche plans combinations with GLP-1-type obesity drugs, which cut weight but act on scarring less directly.

## Spec sheet

| Spec | Pegozafermin | Provenance |
| --- | --- | --- |
| ENLIGHTEN-Fibrosis enrollment | ~1,050 adults (F2–F3) | reported |
| ENLIGHTEN-Cirrhosis enrollment | ~760 adults (F4) | reported |
| Doses in phase 3 | 30 mg weekly or 44 mg every two weeks | reported |
| Acquisition value | Up to $3.5B ($2.4B upfront) | reported |
| Phase 2b ENLIVEN | 219 patients | reported |

Provenance: reported = stated by the company; estimated = our estimate; sample = a sample figure.

## About Roche

Swiss pharma giant (Basel, 1896) developing obesity drugs and sequencing systems. Acquired Carmot Therapeutics (2024) and partnered with Zealand Pharma for obesity treatments. Launched Axelios 1 (June 2026), a next-gen sequencing platform with same-day whole-genome analysis.

- Obesity portfolio: CT-388 (once-weekly), CT-996 (daily oral), and petrelintide combo (Phase 3 by 2026).
- Axelios 1 (June 2026): same-day whole genomes via SBX chemistry; first pharma sequencer vs Illumina.
- SIX-listed, ~112,000 employees, established diagnostics and medicines across pharma.

- Founded: 1896
- Headquarters: CH
- Status: public
- Staff: ~112,000
- Website: https://www.roche.com
- People: Thomas Schinecker (Chief Executive Officer)
- Partners, customers, investors: Zealand Pharma (partner); 10x Genomics (partner)

Company page: https://technooptimist.io/companies/roche.md

## Related programs

More from Roche:

- [Axelios 1](https://technooptimist.io/biotech/axelios-1.md) (Deploy)
- [CT-388 + Petrelintide](https://technooptimist.io/biotech/ct-388-petrelintide.md) (Pilot)

Everything in Biotech: https://technooptimist.io/biotech.md

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