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Can Novo Nordisk's Aggressive Deal-Making Offset Semaglutide Reliance?
ZACKS· 2025-10-10 14:55
Key Takeaways Novo Nordisk will acquire Akero Therapeutics for $4.7B plus a contingent $6 per share payment.The deal gives NVO access to Akero's EFX, a late-stage FGF21 analog for MASH with fibrosis regression data.The acquisition advances NVO's goal to broaden its cardiometabolic portfolio beyond semaglutide therapies.Novo Nordisk (NVO) continues to derive the bulk of its revenue from its blockbuster semaglutide (GLP-1 RA) therapies, Wegovy for obesity and Ozempic for type II diabetes (T2D). Together, the ...
Novo Nordisk To Acquire Liver Disease Focused Akero Therapeutics For Around $5 Billion
Benzinga· 2025-10-09 13:10
Novo Nordisk A/S (NYSE:NVO) agreed on Thursday to acquire Akero Therapeutics, Inc. (NASDAQ:AKRO) focused on metabolic diseases.Transaction termsNovo Nordisk will pay $54 per share in cash (or an aggregated value of $4.7 billion) at closing.In addition, Akero shareholders will receive a non-transferable CVR entitling holders to a potential additional payment of $6 per share in cash (or an aggregated value of $0.5 billion) upon U.S. regulatory approval of EFX for the treatment of compensated cirrhosis due to ...
Novo Nordisk (NYSE:NVO) M&A Announcement Transcript
2025-10-09 13:02
Summary of Novo Nordisk's Acquisition of Akero Therapeutics Conference Call Company and Industry - **Company**: Novo Nordisk (NYSE: NVO) - **Acquisition Target**: Akero Therapeutics, Inc. - **Industry**: Pharmaceutical, specifically focusing on diabetes, obesity, and metabolic diseases such as MASH (Metabolic Associated Steatotic Liver Disease) Core Points and Arguments 1. **Acquisition Announcement**: Novo Nordisk announced the acquisition of Akero Therapeutics, marking the largest R&D-related acquisition in its history, aimed at enhancing its portfolio in diabetes and obesity treatments [4][2][5] 2. **Strategic Fit**: The acquisition is strategically aligned with Novo Nordisk's focus on diabetes, obesity, and related comorbidities, particularly through Akero's late-stage asset, efruxifermin (EFX), which targets MASH [4][5][10] 3. **Market Need**: Over 250 million people globally are affected by MASH, indicating a significant unmet medical need and commercial opportunity for innovative treatments [5][6] 4. **Efruxifermin's Potential**: Efruxifermin is positioned as a leading treatment option for MASH, with promising Phase II data showing efficacy in fibrosis regression, particularly in late-stage F4 patients [8][10][11] 5. **Clinical Trial Results**: In the HARMONY Phase II trial, 49% of F2-F3 patients achieved fibrosis improvement, while 29% of F4 patients showed similar results in the SYMMETRY Phase IIb trial [11][12] 6. **Future Development Plans**: The ongoing SYNCHRONY Phase III program will further evaluate efruxifermin across all MASH stages, with initial results expected next year [12][11] 7. **Integration with Existing Portfolio**: Efruxifermin complements Novo Nordisk's existing GLP-1 portfolio, with potential for combination therapies to enhance treatment efficacy [26][27] 8. **Financial Impact**: The acquisition is expected to have a low single-digit dilutive impact on earnings, with a projected 3% impact on operating profit for the following year due to increased R&D costs [56][58] Additional Important Points 1. **Regulatory Considerations**: The FDA's requirements for accelerated approval in MASH will be critical for the success of efruxifermin, particularly in the F2 and F3 stages [50][48] 2. **Competitive Landscape**: The acquisition positions Novo Nordisk favorably against competitors in the FGF21 space, with expectations of superior efficacy and safety profiles for efruxifermin compared to other assets [20][41] 3. **CEO's Vision**: The acquisition aligns with the new CEO's strategy to enhance Novo Nordisk's leadership in diabetes and obesity treatments, emphasizing innovation and patient impact [14][62] This summary encapsulates the key points discussed during the conference call regarding Novo Nordisk's acquisition of Akero Therapeutics, highlighting the strategic importance, market potential, and future plans associated with this significant move in the pharmaceutical industry.
Akero Therapeutics to be Acquired by Novo Nordisk for up to $5.2 Billion
Globenewswire· 2025-10-09 10:01
Shareholders to Receive $54 Per Share in Cash and CVR of $6 Per Share Advances Akero’s Mission of Bringing Novel Therapies to Patients with High Unmet Medical Needs SOUTH SAN FRANCISCO, Calif., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (“Akero”) (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that it has entered into a definitive agreement to be acquired by Novo N ...
Novo Nordisk to acquire Akero Therapeutics and its promising phase 3 FGF21 analogue to expand MASH portfolio
Globenewswire· 2025-10-09 10:00
Acquisition adds potential first- and best-in-class asset, enhancing Novo Nordisk’s portfolio for treatment of MASH, one of the most prevalent obesity related comorbiditiesAkero Therapeutics’s FGF21 analogue efruxifermin is the only treatment to show significant fibrosis regression in phase 2 in patients with compensated cirrhosis (F4)Novo Nordisk to acquire Akero Therapeutics for 54 USD per share (4.7 billion USD) in cash at closing with a contingent value right (CVR) of 6 USD per share (0.5 billion USD) ...
Akero Therapeutics to Present New Data from the Phase 2b SYMMETRY and HARMONY Studies of Efruxifermin at the 76th Annual AASLD The Liver Meeting® 2025
Globenewswire· 2025-10-07 11:00
SOUTH SAN FRANCISCO, Calif., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced two upcoming oral presentations and a poster presentation at the 76th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 taking place November 7-11, 2025, in Washington, DC. The presentations will highlight ...
5 Biotech Stocks Worth Adding to Your Portfolio Now
ZACKS· 2025-09-23 14:25
The volatile biotech industry has done reasonably well so far in 2025 amid the ongoing tariff saga. Most pharma/biotech bigwigs are now investing heavily in manufacturing plants/operations in the United States as the Trump administration threatened of levying heavy tariffs on pharmaceutical imports (upto 250%) in a bid to boost domestic production. While the ongoing geopolitical tensions continue to be a headwind, given the continuous need for innovative medical treatments (regardless of the state of the ec ...
Akero Therapeutics to Present at the Morgan Stanley 23rd Annual Global Healthcare Conference
Globenewswire· 2025-08-28 11:00
Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical needs, including metabolic dysfunction-associated steatohepatitis (MASH) [3] Upcoming Events - Management will present at the Morgan Stanley 23 Annual Global Healthcare Conference on September 8, 2025, at 10:45 a.m. E.T. in New York, NY [1] Product Development - Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies targeting different patient populations with MASH [3] - The Phase 3 SYNCHRONY program builds on results from two Phase 2b clinical trials: the HARMONY study for pre-cirrhotic MASH and the SYMMETRY study for compensated cirrhosis due to MASH [3]
Akero Therapeutics Announces Lancet Publication of the Phase 2b HARMONY Clinical Trial Demonstrating 96 Weeks Treatment with EFX Reduced Liver Fibrosis in Patients with Pre-cirrhotic MASH
Globenewswire· 2025-08-14 22:30
Core Insights - The publication of the 96-week results from the Phase 2b HARMONY trial indicates the potential of efruxifermin (EFX) to significantly reduce the risk of fibrosis progression in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1][2][3] Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing treatments for serious metabolic diseases, particularly MASH, which has a high unmet medical need [1][12] - Efruxifermin (EFX) is Akero's lead product candidate, currently being evaluated in three ongoing Phase 3 studies targeting different stages of MASH [9][12] Trial Results - The HARMONY trial was a 96-week multicenter, randomized, double-blind, placebo-controlled study involving 128 adult participants with biopsy-confirmed MASH and moderate to advanced fibrosis [2][11] - In the mITT population at week 96, 49% of participants receiving 50mg EFX achieved at least one stage of fibrosis improvement without worsening of MASH, compared to 19% for placebo (p=0.0030) [3][4] - Improvements in fibrosis were also noted in patients with more advanced disease, indicating EFX's potential effectiveness across different stages of MASH [3][4] Secondary Endpoints - The secondary endpoint of MASH resolution without fibrosis worsening was achieved by 40% of participants receiving 28mg EFX and 37% receiving 50mg EFX, compared to 19% for placebo [4] - A composite endpoint of both MASH resolution and at least one stage of fibrosis improvement was met by 35% and 28% of participants in the 50mg and 28mg EFX groups, respectively, versus 7% for placebo [4] Safety and Tolerability - EFX was generally well tolerated, with a safety profile consistent with previous trials; the most common adverse events were mild to moderate gastrointestinal issues [6] - A small reduction in bone mineral density was observed after 96 weeks of EFX treatment, although the clinical significance of this finding remains to be determined [6] Overall Impact - The sustained reductions in fibrosis and MASH observed in the trial reflect an overall improvement in whole-body metabolic health, including reduced dyslipidemia and increased insulin sensitivity [7] - The results from the HARMONY trial, along with data from the SYMMETRY trial, suggest that EFX has the potential to transform patient outcomes, particularly for those with a high fibrosis burden [3][7]
Akero Therapeutics to Present at the Goldman Sachs 46th Annual Global Healthcare Conference
Globenewswire· 2025-06-03 11:00
Company Overview - Akero Therapeutics is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical needs, including metabolic dysfunction-associated steatohepatitis (MASH) [3] Upcoming Events - Management will present at the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, at 2:40 p.m. E.T. [1] - A live webcast of the presentation will be available on the company's investor relations website, with an archived replay to follow [2] Clinical Development - Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World, targeting different patient populations with MASH [3] - The Phase 3 SYNCHRONY program builds on results from two Phase 2b clinical trials: the HARMONY study and the SYMMETRY study [3]