AnaCardio, a private, Karolinska Institutet-spun-out biotech in Solna, Sweden, has raised an over-subscribed €62.5 million Series B financing, announced 30 September 2026, to fully fund a Phase 2b trial of its oral heart-failure drug AC01. The round, co-led by Novo Holdings and the Ljungström family office, comes three months after the company published favorable early safety data in The Lancet — data that showed none of the tachycardia or arrhythmia signals that have kept earlier contractility-boosting drugs out of routine chronic use.
From a Karolinska lab to a 12-country trial
AC01's road to Phase 2b
- 2017
AnaCardio founded
Incorporated in Sweden on heart-failure research by Professor Lars H. Lund of the Karolinska Institutet.
- 2021
Operational launch
A seed round and a licensing agreement with Helsinn bring AC01 into AnaCardio's pipeline.
- September 2022 – January 2024
SEK 150 million Series A
Led by Flerie Invest and Industrifonden, closed in two tranches.
- 9 January 2025
Series A extension, $19 million
Co-led by Novo Holdings, Pureos Bioventures and Sound Bioventures, to complete the Phase 1b/2a GOAL-HF1 study.
- 2025
FDA and EMA scientific advice
Positive FDA Type B and EMA CHMP scientific advice align on the design of the planned Phase 2b trial.
- 25 June 2026
GOAL-HF1 published in The Lancet
Phase 1b/2a results show favorable safety and sustained increases in cardiac output and ejection fraction.
- 30 September 2026
€62.5 million Series B
Co-led by Novo Holdings and the Ljungström family office, fully funding the GOAL-HF2 Phase 2b trial.
- 2028
Phase 3-ready targeted
AnaCardio's stated goal for AC01 following GOAL-HF2.
What €62.5 million actually buys
The Series B is earmarked for one purpose: fully funding GOAL-HF2, a randomized, double-blind, placebo-controlled Phase 2b trial of AC01 in roughly 400 patients with chronic heart failure with reduced ejection fraction, enrolling across 12 countries. Patients will receive 3 mg or 1 mg of AC01, or placebo, twice daily for 12 weeks, with the trial's primary objective assessing the drug's effect on cardiac structure and function by echocardiography. First-patient enrollment is targeted for the fourth quarter of 2026.
AnaCardio says the trial's design reflects scientific advice from both FDA, through a Type B meeting, and EMA's Committee for Medicinal Products for Human Use, received in 2025 — a step that, if accurately characterized, reduces the regulatory risk of GOAL-HF2's design being rejected later as a basis for a Phase 3 program. Chief Executive Officer Patrik Strömberg tied the financing directly to that trial in the company's own announcement.
“This €62.5 million Series B, co-led by Novo Holdings and the Ljungström family office, fully funds GOAL-HF2, AC01’s 400-patient Phase 2b trial across 12 countries, with a design agreed with the FDA and EMA.” Patrik Strömberg, Chief Executive Officer, AnaCardio AB — 30 September 2026 announcement
AC01's Series B in four numbers
Figures from AnaCardio’s 30 September 2026 financing announcement and its GOAL-HF1 results disclosures.
An inotrope built to avoid the arrhythmia trap
Drugs that boost the heart's pumping strength — inotropes — have a long history of working in the short term and causing harm over months: by raising intracellular calcium or cyclic AMP, most classic inotropes also raise the heart's electrical excitability, driving the tachycardia and arrhythmia risk that has confined them to intravenous, in-hospital use for acute decompensated heart failure. AC01 takes a different route: it is an oral, selective agonist of the ghrelin receptor GHSR1a, which AnaCardio describes as working through a calcium-sensitizing mechanism rather than raising calcium or cyclic AMP directly.
In the Phase 1b/2a GOAL-HF1 study, the company reported no serious adverse events, no treatment discontinuations, and no tachycardia, arrhythmia or ischemia signals, alongside dose-proportional pharmacokinetics. At the highest dose tested, 3 mg, cardiac output rose 29.5% by Day 1 and remained elevated 22.0% at Day 28, with left ventricular ejection fraction improving by an average of 4.8 percentage points over 28 days — figures AnaCardio reported from the trial and that this article has not independently re-verified against the published paper's exact tables.
Three things AnaCardio is betting on
No arrhythmia signal
GOAL-HF1 reported none of the tachycardia, arrhythmia or ischemia findings that have confined conventional inotropes to short, monitored, in-hospital use — the central safety question GOAL-HF2 is designed to test at scale.
An oral pill, not an infusion
AC01 is dosed as an oral tablet twice daily, a dosing form aimed at chronic outpatient heart-failure management rather than the intravenous infusions conventional inotropes require.
A regulator-aligned trial design
AnaCardio says both FDA and EMA gave positive scientific advice on the GOAL-HF2 design in 2025, a step intended to reduce the risk that Phase 2b results are later judged insufficient to support a Phase 3 program.
Heart failure’s crowded, still-growing drug aisle
AC01 enters a heart-failure drug market already reshaped twice in the past decade: first by ARNIs like Novartis's Entresto, then by SGLT2 inhibitors such as AstraZeneca's Farxiga and Boehringer Ingelheim/Lilly's Jardiance, both now standard of care regardless of diabetes status. The contractility-focused approach AC01 represents has a cautionary precedent: Cytokinetics' omecamtiv mecarbil, a cardiac myosin activator, showed a statistically significant reduction in heart-failure events in its Phase 3 GALACTIC-HF trial but not in cardiovascular death alone, and FDA issued a Complete Response Letter in March 2023 that the agency has not reversed as of this writing.
What the heart-failure drug market is worth
$13.5B → $33.7B
Global heart failure drug market, 2022 to 2032, as forecast by GlobalData (published January 2025); Lucintel's narrower methodology puts 2030 at just $17.1 billion.
Sources: GlobalData, heart failure drug market report, via EMJ Reviews · Lucintel, Heart Failure Drug Market report
Regulatory News outlook
We expect oral, non-catecholamine contractility agents like AC01 to capture a growing share of the heart-failure drug market only if Phase 2b safety data continues to show no tachyarrhythmia signal — the safety problem that has blocked prior inotropes from chronic, outpatient use.
How we got here: GlobalData's published 9.6% compound annual growth rate on its $13.5 billion 2022 base reaches roughly $33.7 billion by 2032; we treat that trajectory as more likely than Lucintel's lower $17.1 billion 2030 estimate, given how quickly SGLT2 inhibitors and ARNIs have already expanded the treated population a drug like AC01 would be added on top of, pending GOAL-HF2 confirming GOAL-HF1's safety signal at scale.
AC01 against heart failure’s standard of care
| Product | Mechanism | Stage | Dosing |
|---|---|---|---|
| AC01 (AnaCardio) | Oral GHSR1a agonist, calcium-sensitizing | Phase 2b (GOAL-HF2) starting Q4 2026 | Oral, twice daily |
| Entresto (Novartis) | Neprilysin inhibitor + angiotensin-receptor blocker | FDA approved, standard of care | Oral, twice daily |
| Farxiga / Jardiance (AstraZeneca / Boehringer Ingelheim-Lilly) | SGLT2 inhibitor | FDA approved, standard of care | Oral, once daily |
| Omecamtiv mecarbil (Cytokinetics/Amgen) | Cardiac myosin activator | Phase 3 complete; FDA Complete Response Letter, 2023 | Oral, twice daily |
From each company’s own trial disclosures and labelling; not a clinical comparison.
What GOAL-HF2 has to prove by 2028
The significance of this round is less the dollar figure than what it removes from the calendar: AnaCardio says the €62.5 million fully funds GOAL-HF2 end to end, meaning the company is not depending on a future raise to complete the trial that will decide whether AC01 advances to Phase 3. What the record does not yet show is independent, non-company verification of GOAL-HF1's specific efficacy figures, or a total-funding-to-date figure that reconciles cleanly across AnaCardio's successive Series A, Series A extension and Series B rounds — third-party trackers cite inconsistent totals predating this close.
- Trial: GOAL-HF2, Phase 2b, ~400 patients, 12 countries, 3mg/1mg AC01 vs. placebo twice daily for 12 weeks; first patient targeted Q4 2026.
- Regulatory alignment: positive FDA Type B and EMA CHMP scientific advice on the trial design, received in 2025.
- Target: a Phase 3-ready asset by 2028, on the company's own timeline.
- Not yet independently confirmed: GOAL-HF1's exact efficacy figures against the published Lancet paper's own tables, and a single authoritative total-funds-raised figure across all of AnaCardio's financing rounds to date.
Sources & further reading
- AnaCardio, “AnaCardio Raises €62.5 Million Series B Financing to Advance Transformational Novel Therapy in Heart Failure Towards Phase 3 Readiness,” press release via GlobeNewswire, 30 September 2026. globenewswire.com
- Endpoints News, “Swedish biotech AnaCardio raises $70.9M to advance safer heart failure drug,” 30 September 2026. endpoints.news
- European Biotechnology Magazine, “AnaCardio raises €62.5m to test heart failure drug,” 2026. european-biotechnology.com
- ClinicalTrials.gov, “A Study to Evaluate the Safety and Efficacy of AC01 Compared to Placebo in Participants With Chronic Heart Failure (GOAL-HF2),” NCT07584967. clinicaltrials.gov
- Karolinska Institutet, “New drug for chronic heart failure tested in early study,” 25 June 2026. news.ki.se
- Biostock, “AnaCardio raises EUR 62.5 million for heart failure treatment,” 30 September 2026. biostock.se
- Industrifonden, “AnaCardio raises USD 19 million to advance first-in-class drug candidate AC01 for heart failure,” 9 January 2025. industrifonden.com
- BioSpace, “FDA Rejects Cytokinetics' Heart Failure Drug,” coverage of omecamtiv mecarbil's Complete Response Letter, 2023. biospace.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What does AnaCardio's Series B fund?
The €62.5 million round, announced 30 September 2026, fully funds GOAL-HF2, a planned Phase 2b trial of AC01 in roughly 400 patients with chronic heart failure with reduced ejection fraction (HFrEF) across 12 countries, with first-patient enrollment targeted for the fourth quarter of 2026.
What is AC01 and how is it different from other heart-failure drugs?
AC01 is an oral, first-in-class, selective ghrelin-receptor (GHSR1a) agonist designed to improve cardiac contractility. In its Phase 1b/2a trial, the company reported no serious adverse events, discontinuations, tachycardia, arrhythmia or ischemia signals — the safety problems that have limited conventional inotropes to short-term, in-hospital use.
Is AC01 FDA approved?
No. AC01 has completed only Phase 1b/2a testing, published in The Lancet in June 2026. FDA and EMA have given positive scientific advice on the design of the planned Phase 2b trial, but the drug itself has not been reviewed for approval.
Is AnaCardio a public company?
No. AnaCardio AB is privately held, backed by investors including Novo Holdings, Flerie, Karolinska Development, Industrifonden and the Ljungström family office. There is no stock ticker to follow.
