Pfizer’s Exit from Akero: A Strategic Retreat or a Green Light for NASH’s Next Breakthrough?

Pfizer’s decision to exit its partnership with Akero Therapeutics in Q2 2024 has sparked debate about the viability of efruxifermin (EFX), Akero’s lead candidate for metabolic dysfunction-associated steatohepatitis (MASH). While some investors view Pfizer’s departure as a red flag, the strategic calculus may instead reveal a calculated move that positions Akero to capitalize on its self-funded momentum. With a robust cash runway, transformative Phase 2 data, and a Phase 3 program targeting a $40 billion+ market, Akero could be primed for a breakout—if investors look past the headlines.

The Exit: A Strategic Divorce or a Loss of Faith?

Pfizer’s $25 million equity stake in Akero, acquired in 2022, was part of its broader focus on NASH therapies. However, by Q2 2024, Pfizer ended its involvement in the partnership, citing unspecified strategic shifts. Critics argue this signals doubt in EFX’s Phase 3 prospects, but the reality is more nuanced.

Pfizer’s exit may reflect its decision to prioritize assets further along in development or consolidate its NASH pipeline. Meanwhile, Akero retains full control of EFX—a FGF21 fusion protein with a unique dual focus on reversing fibrosis and addressing cardiometabolic risks. With Pfizer’s stake no longer tied to Akero’s operational decisions, the company can now pursue its own trajectory, unburdened by external priorities.

Akero’s Post-Exit Strength: Cash, Clinical Progress, and Independence

Akero’s financial health has never been stronger. In January 2025, the company raised $402.5 million in a public offering, boosting its cash reserves to $1.128 billion—a four-year runway to execute its Phase 3 program. This contrasts sharply with the pre-Pfizer era, when Akero’s cash was projected to last only through Q3 2023.

Clinically, Akero has three Phase 3 trials underway in its SYNCHRONY program:
1. Histology: Targets pre-cirrhotic MASH (F2-F3 fibrosis).
2. Real-World: Assesses safety in broader patient populations.
3. Outcomes: Measures mortality and liver-related events in compensated cirrhosis (F4).

The SYMMETRY Phase 2b study’s Week 96 results, due in Q1 2025, are a critical near-term catalyst. Early data showed EFX’s ability to reduce liver fat, reverse fibrosis, and improve insulin sensitivity—a profile that could distinguish it from competing NASH therapies like Madrigal’s resmetirom or Intercept’s obeticholic acid (OCA).

The NASH Market: A $40 Billion Prize, But Who Wins?

The MASH/NASH market is a $40 billion+ opportunity by 2030, with over 17 million Americans alone suffering from advanced liver disease. Current treatments like OCA focus on slowing fibrosis, but none fully address the multi-organ systemic nature of MASH.

EFX’s FGF21 mechanism targets not just the liver but also metabolic pathways tied to insulin resistance, dyslipidemia, and cardiovascular risk—the leading cause of death in MASH patients. This broader profile could position EFX as a best-in-class therapy, especially if Phase 3 outcomes align with Phase 2 results.

Risks: The Elephant in the Room

No investment is without risk. Akero faces hurdles:
- Competitor pressure: Madrigal, Intercept, and others are racing to FDA approval.
- Regulatory hurdles: The FDA’s demand for outcomes data (not just histology) complicates the path to approval.
- Market adoption: Even with efficacy, EFX’s success depends on insurers and clinicians embracing a once-weekly injectable.

But Akero’s Phase 3 design—the first program to include an outcomes trial—directly addresses these concerns. If EFX can demonstrate mortality and complication reductions in cirrhotic patients, it could leapfrog competitors.

Investment Thesis: Buy the Dip on Catalyst-Driven Value

Akero’s stock has underperformed since Pfizer’s exit, trading at a 25% discount to its 2022 highs. Yet this is precisely the moment to consider buying:

1. Catalyst-rich timeline: Q1 2025 SYMMETRY data, followed by Phase 3 readouts in 2025–2026.
2. Self-sufficiency: No need for dilutive financing until 2028.
3. First-mover advantage: EFX’s mechanism and outcomes focus could carve out a leadership position.

Conclusion: Pfizer’s Exit is a False Signal—Akero’s Future is Bright

Pfizer’s departure was likely a strategic realignment, not a vote of no confidence. With a four-year cash runway, industry-leading Phase 3 design, and a mechanism that targets the full spectrum of MASH’s devastation, Akero is positioned to deliver a breakthrough. Investors who ignore the noise and focus on the science and the numbers could find themselves on the ground floor of a major biotech success story.

Act now—before the catalysts hit.

Note: This analysis assumes the completion of ongoing clinical trials and positive data reads. Always consult a financial advisor before making investment decisions.