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Novo Nordisk has completed its acquisition of Akero Therapeutics
Globenewswire· 2025-12-09 13:51
Core Points - Novo Nordisk has completed the acquisition of Akero Therapeutics, announced on October 9, 2025, for $54 per share in cash, totaling an aggregated value of $4.7 billion, along with a Contingent Value Right (CVR) that could provide an additional $6 per share upon regulatory approval of Akero's lead candidate EFX [1][2]. Company Overview - Akero Therapeutics is a clinical-stage company focused on developing treatments for serious metabolic diseases, particularly metabolic dysfunction-associated steatohepatitis (MASH). Its lead product candidate, efruxifermin (EFX), is currently undergoing three Phase 3 clinical studies [5]. - Novo Nordisk is a global healthcare leader founded in 1923, with a mission to combat chronic diseases, particularly diabetes. The company operates in 80 countries and markets its products in around 170 countries [6].
Akero Therapeutics (NasdaqGS:AKRO) 2025 Extraordinary General Meeting Transcript
2025-12-02 17:02
Summary of Akero Therapeutics Special Meeting Company Overview - **Company**: Akero Therapeutics (NasdaqGS:AKRO) - **Event**: Special Meeting of Stockholders - **Date**: December 2, 2025 Key Points Industry and Company Context - Akero Therapeutics is involved in the biotechnology sector, focusing on developing therapies for liver diseases, particularly non-alcoholic steatohepatitis (NASH) [6][10]. Core Proposals Discussed 1. **Merger Proposal**: - The primary business discussed was the adoption of the Agreement and Plan of Merger dated October 9, 2025, involving Akero, Novo Nordisk A/S, and NN Invest Sub Incorporated [6]. - The merger will result in Akero becoming a wholly owned subsidiary of Novo Nordisk [6]. 2. **Compensation Proposal**: - Approval of certain compensation that may be paid to Akero's named executive officers in connection with the merger was also presented [7]. - This proposal was advisory and non-binding [7]. Voting Outcomes - The merger proposal was approved by a majority of the outstanding shares of Akero common stock [9]. - The compensation proposal was also approved by a majority of the outstanding shares [10]. - Due to the approval of the merger proposal, the third proposal regarding the adjournment of the meeting to solicit additional proxies was not presented [10]. Meeting Logistics - The meeting was conducted virtually, allowing stockholders to vote in real-time [4]. - A quorum was established, confirming that the number of shares present constituted a majority of the outstanding shares entitled to vote [5]. Additional Notes - The Inspector of Election was responsible for canvassing the votes and reporting results [3]. - The meeting concluded without any further matters to discuss, and the final report of the Inspector of Election was to be filed with the meeting minutes [10][11].
Akero(AKRO) - 2025 Q3 - Quarterly Report
2025-11-07 22:10
Financial Performance - The company reported net losses of $81.6 million and $72.7 million for the three months ended September 30, 2025 and 2024, respectively, and net losses of $252.1 million and $151.8 million for the years ended December 31, 2024 and 2023, respectively[142]. - As of September 30, 2025, the company had an accumulated deficit of $1,049.0 million[142]. - The company has not generated any revenue since inception and does not expect to do so in the near future[153]. - Net loss for the three months ended September 30, 2025, was $81.6 million, a 12% increase from a net loss of $72.7 million in 2024[163]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $183.1 million, compared to $163.0 million for the same period in 2024, reflecting a 12.9% increase in cash outflow[180][181]. - Cash provided by financing activities was $364.9 million for the nine months ended September 30, 2025, slightly down from $369.9 million in 2024, indicating a 1.4% decrease[184][185]. Research and Development - The ongoing Phase 3 SYNCHRONY program includes three trials with an expected total enrollment of about 3,500 patients, aimed at supporting marketing approval for patients with pre-cirrhotic MASH and compensated cirrhosis[135]. - In the SYMMETRY Phase 2b trial, 39% of patients treated with 50mg EFX experienced reversal of cirrhosis at week 96, compared to 15% for placebo[137]. - The HARMONY Phase 2b trial showed that at week 96, 75% of patients treated with 50mg EFX achieved ≥1 stage improvement in fibrosis, compared to 24% for placebo[138]. - Research and development expenses are expected to increase substantially due to planned clinical development activities for EFX[156]. - Research and development expenses increased to $78.9 million for the three months ended September 30, 2025, up from $72.2 million in 2024, representing a 9% increase[164]. - Research and development expenses for the nine months ended September 30, 2025, totaled $217.7 million, up from $178.2 million in 2024, reflecting a 22% increase[171]. Expenses and Cash Flow - General and administrative expenses rose to $11.4 million for the three months ended September 30, 2025, compared to $9.5 million in 2024, marking a 20% increase[165]. - General and administrative expenses for the nine months ended September 30, 2025, were $34.3 million, compared to $29.2 million in 2024, an increase of 17%[172]. - Total operating expenses for the three months ended September 30, 2025, were $90.2 million, an increase of 10% from $81.7 million in 2024[163]. - Cash used in investing activities increased significantly to $346.1 million for the nine months ended September 30, 2025, from $125.0 million in 2024, representing a 176.8% increase[182][183]. - The company incurred a loss on extinguishment of loan payable of $1.6 million related to the repayment of the Hercules term loan on September 23, 2025[167][174]. Merger and Funding - The merger with Novo is expected to close around year-end 2025, with each share of common stock converting to $54.00 in cash and a contingent value right[149][151]. - If the proposed merger with Novo is not consummated, the company expects to require additional funding to complete clinical development and commercialization of EFX[188][189]. - A termination fee of $165.0 million may be required if certain closing conditions under the Merger Agreement with Novo are not satisfied[190]. - The company raised $402.5 million from a follow-on public offering in January 2025, contributing to a total of $1,910.4 million in gross proceeds since inception[177][178]. Risks and Future Outlook - The company anticipates significant expenses and operating losses for the foreseeable future, primarily due to ongoing research and development activities[187]. - The company is exposed to interest rate risk, with a portfolio primarily consisting of U.S. Treasury-backed securities and corporate debt securities[196][197]. - Inflation may impact operational costs, including clinical trials and labor costs, although it has not materially affected the company to date[200]. - Non-cancelable purchase and other arrangements increased to $90.7 million as of September 30, 2025, compared to $25.6 million as of December 31, 2024, marking a 254.7% increase[192].
Akero Therapeutics Presents New Analyses from Phase 2b SYMMETRY and HARMONY Trials of Efruxifermin at 76th Annual AASLD The Liver Meeting® 2025
Globenewswire· 2025-11-07 12:00
Core Insights - Akero Therapeutics announced new findings from the SYMMETRY and HARMONY Phase 2b trials of efruxifermin, indicating its potential to reduce disease progression risk in compensated cirrhosis (F4c) due to metabolic dysfunction-associated steatohepatitis (MASH) [1][2][5] - The results will be presented at the 76th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 [1] Trial Findings - Post-hoc analyses from the 96-week SYMMETRY trial reinforce the antifibrotic activity of efruxifermin in patients with F4c MASH [2][5] - AI-powered digital pathology analysis corroborated fibrosis improvements observed in the HARMONY trial, supporting the efficacy of efruxifermin [3][5] Presentation Details - Oral presentations will include findings on improvements in non-invasive tests indicative of fibrosis regression and markers of portal hypertension in compensated cirrhosis due to MASH [3][6] - Poster presentations will focus on quantitative digital pathology results and AI-driven changes in liver microarchitecture in participants with F2/F3 MASH [6] Company Overview - Akero Therapeutics is a clinical-stage company focused on developing treatments for serious metabolic diseases, including MASH [7] - Efruxifermin is currently being evaluated in three ongoing Phase 3 clinical trials, building on the results from the SYMMETRY and HARMONY Phase 2b trials [7]
Berger Montague PC Investigates Akero Therapeutics, Inc. and Its Board of Directors for Breach of Fiduciary Duties and Violations of Federal Securities Laws (NASDAQ: AKRO)
Prnewswire· 2025-10-29 22:06
Core Points - An investigation is underway regarding Akero Therapeutics, Inc. and its Board of Directors for potential breaches of fiduciary duties and violations of federal securities laws [1] - The investigation is linked to a proposed merger with Novo Nordisk A/S, where Akero shareholders would receive $54.00 per share in cash and a Contingent Value Right worth an additional $6.00 per share if Akero's lead product candidate, efruxifermin, receives regulatory approval by June 30, 2031 [2] Company Overview - Akero Therapeutics, Inc. is a clinical stage biopharmaceutical company based in San Francisco, focusing on developing efruxifermin for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) [2]
My Top 3 Pharma Stocks
Seeking Alpha· 2025-10-20 15:38
Group 1 - "Big Pharma" has significantly underperformed compared to the S&P 500 and AI stocks this year [1] Group 2 - Allka Research has over two decades of experience in investment, focusing on uncovering undervalued assets in various sectors including pharmaceuticals [2] - The firm emphasizes a conservative investment approach, aiming to deliver substantial returns and strategic insights to clients [2] - Allka Research seeks to simplify investment strategies for both seasoned and novice investors, fostering a community of informed investors [2]
Novo Nordisk Stock Seen Undervalued Despite Pullback and 2026 Growth Focus
Investing· 2025-10-16 15:13
Core Insights - The article provides a market analysis focusing on Eli Lilly and Company, Novo Nordisk A/S, and Akero Therapeutics Inc, highlighting their performance and market trends [1] Company Analysis - Eli Lilly and Company has shown significant growth in its diabetes and obesity treatment segments, contributing to its overall revenue increase [1] - Novo Nordisk A/S continues to dominate the diabetes care market, with strong sales figures and a robust pipeline of new products [1] - Akero Therapeutics Inc is emerging in the liver disease treatment space, with promising clinical trial results that could enhance its market position [1] Industry Trends - The diabetes and obesity treatment market is experiencing rapid growth, driven by increasing prevalence rates and rising healthcare expenditures [1] - There is a growing focus on innovative therapies and personalized medicine within the pharmaceutical industry, particularly in the treatment of chronic diseases [1] - Regulatory changes and advancements in technology are shaping the competitive landscape, providing both opportunities and challenges for companies in the sector [1]
医药生物行业周报:2025ESMO大会将召开,关注三季报业绩情况-20251013
Donghai Securities· 2025-10-13 11:10
Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [1][33]. Core Insights - The pharmaceutical and biotechnology sector experienced an overall decline of 1.20% from October 6 to October 10, 2025, ranking 25th among 31 industries in the Shenwan index, underperforming the CSI 300 index by 0.69 percentage points. Year-to-date, the sector has risen by 21.87%, ranking 12th among the 31 industries and outperforming the CSI 300 index by 4.54 percentage points [3][14]. - The current PE valuation for the pharmaceutical and biotechnology sector stands at 30.87 times, which is at the historical median level, with a valuation premium of 129% compared to the CSI 300 index [22][14]. - Notable stock movements include a 21.00% increase in Zhendemedical, a 12.01% rise in Wanbangde, and a 1.51% increase in the Traditional Chinese Medicine II sub-sector [27][3]. Market Performance - The pharmaceutical and biotechnology sector's performance for the week of October 6 to October 10, 2025, showed a decline of 1.20%, with Traditional Chinese Medicine II and pharmaceutical commerce sub-sectors increasing by 1.51% and 0.64%, respectively [13][3]. - Year-to-date, the sector has increased by 21.87%, with the top-performing sub-sectors being medical services (41.37%), chemical pharmaceuticals (36.28%), and biological products (16.22%) [14][3]. Industry News - On October 10, 2025, the State Council released regulations for the management of clinical research and application of new biomedical technologies, effective from May 1, 2026, establishing a clear framework for the sector's development [4][29]. - The National Medical Products Administration announced on October 9, 2025, that companies with Traditional Chinese Medicine injections approved before 2019 must accelerate post-marketing research and evaluation [4][30]. - Novo Nordisk announced on October 9, 2025, a $47 billion acquisition of Akero Therapeutics, gaining access to a potential best-in-class therapy for metabolic dysfunction-related fatty liver disease [5][30]. Investment Recommendations - The report suggests that the pharmaceutical and biotechnology sector has been underperforming recently, but the acquisition by Novo Nordisk indicates a long-term trend of multinational corporations enriching their R&D pipelines through mergers and acquisitions. The upcoming ESMO conference is anticipated to provide new data on domestic innovative drugs and potential business development opportunities [6][31]. - The report emphasizes that domestic innovative drug companies are rapidly gaining global competitiveness, and innovative drugs remain a key investment theme in the medium to long term. The innovative drug sector is expected to continue showing high revenue growth and reducing losses [6][31]. - Recommended stocks include Teabo Bio, Betta Pharmaceuticals, Kelun Pharmaceutical, KAILI Medical, Pumen Technology, and Huaxia Eye Hospital, with a watchlist including Zhongsheng Pharmaceutical, Rongchang Bio, Qianhong Pharmaceutical, Yifeng Pharmacy, Baipusais, and Lingrui Pharmaceutical [6][31].
医药健康行业周报:BD预期回归理性,关注ESMO大会及三季报-20251011
SINOLINK SECURITIES· 2025-10-11 12:52
Investment Rating - The report maintains a strong confidence in the pharmaceutical sector's potential for a reversal in 2025, particularly focusing on innovative drugs and the recovery of left-side sectors as the biggest investment opportunities for the year [5][14]. Core Insights - The innovative drug sector is expected to continue its upward trend, with BD (business development) activities anticipated to catalyze market movements. The upcoming ESMO conference (October 17-21) is highlighted as a key event for clinical data disclosures from domestic innovative drug companies [2][13]. - The report emphasizes the importance of recent Nobel Prize discoveries related to peripheral immune tolerance, which are relevant to the development of new therapies in oncology and autoimmune diseases. This underscores the significance of innovation in these fields [40][50]. - The report notes that the CXO industry in China is entering a recovery phase, with improvements expected in industry orders, capacity utilization, and performance metrics due to enhanced domestic investment and financing data [2][5]. Summary by Sections Innovative Drugs - The innovative drug sector has seen a recent pullback, but the long-term upward trend remains intact. The report suggests that the market is awaiting further BD catalysts and highlights the importance of upcoming clinical data from the ESMO conference [2][13]. - The report indicates that the overall sentiment in the innovative drug sector is still positive, with a focus on potential breakthroughs in cancer and autoimmune therapies following the recent Nobel Prize discoveries [40][50]. Biologics - Novo Nordisk announced an agreement to acquire Akero for $4.7 billion, with Akero's FGF21 analog EFX showing promise as a leading therapy for metabolic dysfunction-related fatty liver disease (MASH) [3][51]. - The report suggests that EFX is the only drug in Phase 2 trials demonstrating significant fibrosis regression in F4 patients, highlighting the need for continued attention to developments in this area [51][57]. Medical Devices - The commercialization of innovative products is accelerating, with domestic replacements making significant progress. For instance, MicroPort's Tumi laparoscopic surgical robot has surpassed 100 global orders and is leading the domestic market share [4][58]. - The report notes that the Tumi robot has received market access in over 60 countries and regions, with a strong presence in high-end markets such as Europe [60][62]. Traditional Chinese Medicine - There has been a continuous increase in new drug IND and NDA applications for traditional Chinese medicine, with 92 new IND applications and 42 NDA applications reported in the first nine months of 2025 [3][64]. - The report highlights ongoing policy support for traditional Chinese medicine, which is expected to drive further innovation and development in this sector [64][65].
$HAREHOLDER ALERT: The M&A Class Action Firm Announces An Investigation of Akero Therapeutics, Inc. (NASDAQ: AKRO)
Globenewswire· 2025-10-10 21:30
Core Insights - Class Action Attorney Juan Monteverde's firm, Monteverde & Associates PC, is investigating Akero Therapeutics, Inc. regarding its proposed sale to Novo Nordisk A/S, which offers Akero shareholders $54.00 per share in cash and a contingent value right of $6.00 per share upon regulatory approval of efruxifermin by June 30, 2031 [1] Company Overview - Monteverde & Associates PC is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report and has successfully recovered millions for shareholders [1] - The firm is located in the Empire State Building, New York City, and specializes in national class action securities litigation [2] Transaction Details - The proposed transaction involves Akero shareholders receiving a total of $60.00 per share, contingent upon regulatory approval, raising questions about the fairness of the deal [1]