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Globenewswire· 2025-12-16 16:47
Core Viewpoint - EUROAPI's main shareholders, Sanofi and EPIC Bpifrance, have agreed to extend their lock-up period until December 18, 2026, enhancing the stability of EUROAPI's shareholding structure during the execution of its FOCUS-27 plan [1] Business Update - The execution of the FOCUS-27 plan is progressing well, with ongoing improvements in cost efficiency across the organization [1] - EUROAPI anticipates a mid-single digit decrease in Full Year 2025 Net Sales on a comparable basis, a revision from the previously communicated low-single digit decline [5] - The Core EBITDA margin objective for Full Year 2025 remains within the 7% to 9% range due to effective cost reduction measures [5] - A further update will be provided on March 3, 2026, alongside the Full Year 2025 Results [1][5] Company Overview - EUROAPI focuses on reinventing active ingredient solutions to meet global customer and patient needs, with approximately 200 products in its portfolio [2] - The company operates five manufacturing sites in Europe and serves customers in over 80 countries [3] - EUROAPI is listed on Euronext Paris under the ticker EAPI [3]
AZN, Daiichi's Enhertu Gets FDA Nod for First-Line Breast Cancer
ZACKS· 2025-12-16 16:46
Core Insights - AstraZeneca and Daiichi Sankyo received FDA approval for Enhertu as a first-line treatment for HER2-positive breast cancer, in combination with Roche's Perjeta [2][7] - The approval is based on the DESTINY-Breast09 study, which showed a significant improvement in progression-free survival [5][7] - AstraZeneca will pay Daiichi Sankyo a $150 million milestone payment following this approval [3][7] Regulatory and Clinical Data - Enhertu was reviewed under the FDA's real-time oncology review program and is already approved in over 85 countries for second-line treatment of HER2-positive breast cancer [3] - The DESTINY-Breast09 study demonstrated a median progression-free survival of 40.7 months for the Enhertu-Perjeta combination, compared to 26.7 months for the standard regimen, reducing the risk of progression by 44% [5][7] Financial Performance - Over the past year, AstraZeneca's shares increased by 36.3%, outperforming the industry average rise of 12.1% [4] - AstraZeneca and Daiichi Sankyo have a collaboration agreement initiated in March 2019, with an expansion in July 2020 to include Datroway [8]
FOLD Shares Hit 52-Week High: Time to Buy, Sell or Hold the Stock?
ZACKS· 2025-12-16 16:31
Key Takeaways FOLD touched a 52-week high as shares rally 87.6% in six months, beating the industry, sector and S&P 500.Galafold is the key revenue driver, generating $371.5M in the first nine months of 2025, up 12% Y/Y.Pombiliti Opfolda sales reached $77.5M in the first nine months of 2025, reflecting 61.5% y/y growth.Shares of Amicus Therapeutics (FOLD) touched a 52-week high of $11.14 on Dec. 15. The stock is currently trading at $10.88.Shares of Amicus have surged 87.6% in the past six months compared w ...
Is Eli Lilly a Buy Before 2026?
The Motley Fool· 2025-12-16 16:30
Core Viewpoint - Eli Lilly's stock is positioned as a strong candidate for a diversified long-term investment portfolio, bolstered by promising results from the Triumph-4 clinical trial for its anti-obesity drug retatrutide [1] Clinical Trial Results - The Triumph-4 trial demonstrated that a 12 mg weekly injection of retatrutide resulted in an average body weight reduction of 28.7% over 68 weeks, alongside a decrease in knee arthritis pain [2] - Retatrutide, a "triple G" medication, outperformed the leading anti-obesity drug tirzepatide, which reported an average weight loss of approximately 20.9% in late-stage trials [4] Market Potential - The global weight-loss medication market is projected to reach $150 billion by 2035, with retatrutide expected to generate annual revenue of around $5 billion by 2030 [8] - Eli Lilly currently holds a 57.9% share of the U.S. market for incretin-mimicking drugs, with its products tirzepatide and Mounjaro demonstrating strong demand [9] Product Pipeline and Future Growth - Eli Lilly anticipates additional phase 3 trial results for retatrutide in obesity and type 2 diabetes by 2026, which could enhance its market segmentation strategy [6] - The company is also seeking FDA approval for orforglipron, a once-daily oral medication for obesity, with expected annual revenue of $8.3 billion by 2030 [10] - Eli Lilly's Alzheimer's medication Kisunla is projected to achieve nearly $5 billion in annual sales at peak, further diversifying its growth engines [11] Financial Performance - Eli Lilly has raised its full-year revenue guidance for 2025 to a range of $63 billion to $63.5 billion, with earnings per share (EPS) estimates adjusted to $21.80 to $22.50 [13] Valuation Considerations - The stock trades at nearly 32 times forward earnings, which may seem high, but is justified by the company's leadership in the obesity treatment market and its robust late-stage research pipeline [14]
KYTX Stock Rallies 23% on Upbeat Stiff Person Syndrome Study Data
ZACKS· 2025-12-16 16:11
Key Takeaways KYTX surged 23% after its registrational phase II KYSA-8 study met the primary endpoint in SPS.Kyverna Therapeutics reported a 46% median T25FW improvement, with 81% of patients exceeding a 20% gain.KYTX showed broad functional gains, 67% shed walking aids by Week 16 with a manageable safety profile.Shares of Kyverna Therapeutics (KYTX) surged 23.2% on Monday after the company reported positive top-line data from a registrational mid-stage study of its investigational candidate, mivocabtagene ...
CHMP Backs EU Approval of MRNA's New COVID-19 Vaccine mNexspike
ZACKS· 2025-12-16 15:56
Key Takeaways CHMP issued a positive opinion recommending EU approval of Moderna's new COVID-19 vaccine mNexspike.Per phase III data, MRNA's mNexspike was non-inferior to Spikevax, with 9.3% higher rVE overall.mNexspike showed safety comparable to Spikevax, fewer local reactions, and similar systemic adverse events.Moderna (MRNA) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the EU approval of mNexspike ( ...
X @Bloomberg
Bloomberg· 2025-12-16 15:32
US-listed biotech and pharma company share sales are staging a late-year revival, with M&A in the industry boosting valuations and stoking additional demand https://t.co/M7fHJQVbeL ...
Pfizer's modest 2026 outlook shows its big investments will take time to pay off
CNBC· 2025-12-16 15:12
Core Viewpoint - Pfizer is forecasting modest guidance for 2026 as it focuses on long-term investments in its pipeline to mitigate declining sales from Covid products and older drugs [1] Group 1: Financial Outlook - Pfizer expects adjusted profit for 2026 to be between $2.80 and $3 per share, slightly below analysts' consensus estimate of $3.05 per share [3] - Revenue is projected to be between $59.5 billion and $62.5 billion, which is largely flat compared to the 2025 sales guidance of $62 billion [4] - The company anticipates a decline of approximately $1.5 billion in sales from Covid vaccine and antiviral pill Paxlovid, projecting 2026 sales from these products to be around $5 billion [4] Group 2: Market Challenges - Pfizer is facing a projected $1.5 billion year-over-year drop in sales due to certain products losing market exclusivity, with increased competition impacting blockbuster drugs like Prevnar [5] - Patent expirations are expected to significantly affect revenues, with an estimated $17 billion impacted by expirations occurring primarily in 2026 and 2028 [6] Group 3: Strategic Investments - The company has made significant acquisitions, including a $10 billion deal for Metsera and a $43 billion acquisition of Seagen, to build new revenue streams [2] - However, the benefits from these investments are still distant, as Metsera's pipeline consists of drugs in early-stage development [3] Group 4: Cost Management - Pfizer has exceeded its cost-saving goals for 2025 and is targeting over $7 billion in cost cuts by 2027, expecting to deliver most of these savings by next year [8] - The guidance reflects costs associated with recent acquisitions, including Metsera [7] Group 5: Regulatory Environment - The company is navigating changes in U.S. vaccine policy, which has introduced uncertainty, particularly under Health and Human Services Secretary Robert F. Kennedy Jr. [9] - Pfizer's CEO stated that comments from the FDA regarding vaccines do not merit concern and will not alter the company's long-term investment strategy [10] Group 6: Pricing Strategy - Pfizer has entered a drug pricing deal that includes selling existing drugs to Medicaid patients at the lowest price offered in other developed nations, which will lead to price and margin compression in 2026 [11]
Milestone Pharmaceuticals upgraded to Buy at TD Cowen after Cardamyst approval
Yahoo Finance· 2025-12-16 15:10
As previously reported, TD Cowen upgraded Milestone Pharmaceuticals (MIST) to Buy from Hold with an $8 price target after Cardamyst nasal spray was approved by the FDA for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults. The label is clean with no market-limiting warnings or monitoring requirements, notes the analyst, who also points out that Cardamyst will be available in retail pharmacies in Q1 of 2026 with a wholesale acquisition cost of ...
How AbbVie's Pipeline Is Lining Up Key Product Launches
ZACKS· 2025-12-16 15:02
Core Insights - AbbVie is increasing its R&D investments to support long-term growth across various therapeutic areas, including immunology, oncology, and neuroscience [1] Pipeline Developments - Key pipeline assets include label expansion studies for Rinvoq and new candidates like tavapadon and pivekimab sunirine (PVEK), with several candidates in late-stage development or under FDA review [2] - Rinvoq is undergoing label expansions for five additional indications, which could add approximately $2 billion to its peak-year sales, with regulatory submissions expected soon [3] - Tavapadon has been submitted for FDA approval as a treatment for Parkinson's disease, supported by positive data from late-stage studies [4] - PVEK is under FDA review for a rare blood cancer and is also being developed for acute myeloid leukemia [5][6] Acquisition Strategy - AbbVie has executed over 30 M&A transactions since early 2024 to enhance its early-stage pipeline, including the acquisition of Gilgamesh Pharmaceuticals for a drug targeting major depressive disorder [7][8] Competitive Landscape - AbbVie remains a dominant player in the immunology market with blockbuster drugs like Skyrizi, Rinvoq, and Humira, despite facing challenges from competitors like Johnson & Johnson and Eli Lilly [9][11][12] Financial Performance - AbbVie shares have outperformed the industry year-to-date and are trading at a slight discount to the industry average based on the P/E ratio [13][14] - EPS estimates for 2025 and 2026 have shown mixed movements, with some revisions indicating slight increases and others showing declines [16]