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AbbVie to Acquire Gilgamesh Pharmaceuticals' Bretisilocin, a Novel, Investigational Therapy for Major Depressive Disorder, Expanding Psychiatry Pipeline
Prnewswire· 2025-08-25 12:59
Core Viewpoint - AbbVie has announced a definitive agreement to acquire Gilgamesh Pharmaceuticals' lead investigational candidate, bretisilocin, which is in clinical development for treating moderate-to-severe major depressive disorder (MDD) [1][6]. Company Overview - AbbVie is focused on discovering and delivering innovative medicines across key therapeutic areas, including neuroscience, and aims to enhance psychiatric care through novel treatment approaches [5][9]. - Gilgamesh Pharmaceuticals is a clinical-stage biotech company developing new chemical entities for psychiatric diseases, emphasizing rapid-acting and durable therapies [11]. Product Development - Bretisilocin is a next-generation psychedelic compound designed to provide a shorter duration of psychoactive experience while maintaining extended therapeutic benefits [3][10]. - Recent Phase 2a study results for bretisilocin showed a statistically significant reduction in depressive symptoms, with a -21.6 point change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 14 for a 10mg dose compared to a -12.1 point change for a low dose comparator [4][10]. Financial Terms - The acquisition deal is valued at up to $1.2 billion, which includes an upfront payment and development milestones [6]. - Gilgamesh will create a new entity, Gilgamesh Pharma Inc., to manage its remaining programs and employees as part of the transaction [6][7]. Strategic Importance - The acquisition reflects AbbVie's commitment to advancing innovative treatments in psychiatry, addressing the significant need for effective solutions in this challenging medical field [5][6]. - The collaboration between AbbVie and Gilgamesh builds on their previous agreement to develop next-generation therapies for psychiatric disorders [7].
CollPlant to Participate in the Upcoming 27th Annual H.C. Wainwright Global Investment Conference
Prnewswire· 2025-08-25 11:00
Company Overview - CollPlant Biotechnologies is a regenerative and aesthetics medicine company focused on developing technologies and products based on non-animal-derived recombinant human collagen (rhCollagen) [1][3] - The company specializes in 3D bioprinting of tissues and organs, tissue repair, and medical aesthetics [3] Recent Developments - CollPlant will participate in the 27th Annual H.C. Wainwright Global Investment Conference on September 8th and 9th, 2025, at the Lotte New York Palace Hotel [1] - Investors can request one-on-one meetings with CollPlant representatives during the conference [2] Strategic Partnerships - In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, a subsidiary of AbbVie, which is a leader in the dermal filler market [4]
Best Dividend Kings: August 2025
Seeking Alpha· 2025-08-25 02:13
Group 1 - The Dividend Kings experienced a modest gain of 0.64% in July, underperforming compared to the SPDR S&P 500 ETF (SPY), which gained 2.30% [1]
3 Top Stocks to Build Your Portfolio Around
The Motley Fool· 2025-08-24 13:15
Group 1: Investment Principles - Building a strong portfolio requires starting with well-established companies that have robust operations [1] - Diversification is essential; relying on stocks from a single industry is not advisable [2] Group 2: Berkshire Hathaway - Berkshire Hathaway, led by Warren Buffett, is a diversified conglomerate with subsidiaries across various industries, including railroads, energy, insurance, and apparel [4][5] - The company has consistently produced impressive long-term returns, and its diversified operations allow it to navigate economic downturns effectively [5][6] - Greg Abel is set to succeed Buffett as CEO, and the company's philosophy is expected to endure beyond Buffett's tenure [5][6] Group 3: Shopify - Shopify is a leader in e-commerce, providing a platform for merchants to create online storefronts and market their products [8] - The company is experiencing rapid growth in gross merchandise volume and revenue, with significant potential for future growth in the e-commerce sector [9][10] - Despite not being profitable yet, Shopify's market position and growth opportunities make it a strong candidate for a core portfolio holding [10] Group 4: AbbVie - AbbVie is a pharmaceutical leader with a strong lineup of immunology products, including Skyrizi and Rinvoq, which are projected to reach combined sales of $31 billion by 2027 [11][12] - The company has a robust pipeline to mitigate the impact of patent expirations, having returned to top-line growth after losing exclusivity for Humira in 2023 [13] - AbbVie offers a forward dividend yield of 3.2% and has a history of 53 consecutive years of dividend increases, making it a reliable income stock [14]
AbbVie Investors Beware: Strong Growth Potential, Rising Risks
Seeking Alpha· 2025-08-23 14:31
Group 1 - Samuel Smith has extensive experience in dividend stock research and investment, having served as lead analyst and Vice President at notable firms [1] - He is a Professional Engineer and Project Management Professional, holding degrees in Civil Engineering & Mathematics and a Masters in Engineering with a focus on applied mathematics and machine learning [1] - Samuel leads the High Yield Investor investing group, collaborating with Jussi Askola and Paul R. Drake to balance safety, growth, yield, and value in investment strategies [2] Group 2 - High Yield Investor provides real-money core, retirement, and international portfolios, along with regular trade alerts and educational content [2] - The service includes an active chat room for investors to share insights and strategies [2]
AbbVie Pins Hopes on Rinvoq to Drive Next Phase of Growth
ZACKS· 2025-08-22 14:41
Core Insights - AbbVie (ABBV) maintains a strong position in the immunology market, bolstered by robust sales of its new drugs, Rinvoq and Skyrizi, which are compensating for the decline in Humira's sales due to patent expiration and biosimilar competition [1][5] Group 1: Product Performance - Rinvoq has shown impressive sales across all approved indications, particularly in inflammatory bowel diseases like ulcerative colitis and Crohn's disease, with potential approvals for five new indications expected to enhance sales further [2][5] - In the first half of 2025, Rinvoq generated sales of $3.7 billion, marking a 49% year-over-year increase, and is projected to reach approximately $8 billion for the full year [5][9] - Positive results from the pivotal phase III UP-AA clinical program for Rinvoq in treating severe alopecia areata were reported, with 45.2% and 55% of patients achieving significant hair coverage at different dosages, compared to only 1.5% with placebo [3][9] Group 2: Regulatory and Future Prospects - AbbVie plans to submit a regulatory application for Rinvoq for alopecia areata in late 2025, with additional phase III data for vitiligo expected in the same year [4] - The anticipated approvals for Rinvoq in new indications could potentially add around $2 billion to peak-year sales [5] Group 3: Competitive Landscape - The market for alopecia areata treatments is highly competitive, with established players like Eli Lilly and Incyte's Olumiant, which generated $475.2 million in sales in the first half of 2025 [6] - Pfizer's Litfulo, approved for alopecia areata, is also in late-stage development for vitiligo, indicating increasing competition in the market [7] Group 4: Financial Performance and Valuation - AbbVie shares have increased by 17.9% year-to-date, contrasting with a 1.6% decline in the industry [8] - AbbVie is trading at a premium valuation, with a price/earnings (P/E) ratio of 15.54, above the industry average of 14.64 and its five-year mean of 12.69 [10] - The Zacks Consensus Estimate for AbbVie's 2025 earnings has slightly decreased from $12.03 to $12.02 per share, while the estimate for 2026 has risen from $14.08 to $14.31 [11]
ABBV's Improving Oncology Sales Poise It Well for Long-Term Growth
ZACKS· 2025-08-22 13:46
Core Insights - AbbVie has a strong immunology franchise with blockbuster drugs and has also developed a substantial oncology franchise with key products like Imbruvica and Venclexta [1] Oncology Franchise Development - AbbVie and Genmab's Epkinly was approved for relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma, while Emrelis was approved for non-squamous non-small cell lung cancer [2] - The acquisition of Immunogen added Elahere to AbbVie's oncology portfolio, contributing to double-digit revenue growth for Elahere and Epkinly in the first half of 2025 [2] - AbbVie's oncology segment generated $3.3 billion in revenue in the first half of 2025, a 4.2% increase year over year, driven by Venclexta and new drugs [3] Innovation in Oncology - AbbVie is enhancing its oncology portfolio with antibody-drug conjugates (ADCs), which are seen as a disruptive innovation in cancer treatment [4] - The company has two ADCs in its commercial portfolio and two additional next-generation ADCs in late-stage development, along with others in early-stage development [4] Pipeline and Growth Potential - A key candidate in AbbVie's oncology pipeline is etentamig/ABBV-383, targeting relapsed/refractory multiple myeloma [5] - Despite competitive pressure on Imbruvica, AbbVie's oncology business is well-positioned for growth in the coming years [5] Competitive Landscape - Major competitors in the oncology space include AstraZeneca, Merck, Bristol-Myers, and Pfizer, with AstraZeneca's oncology sales comprising around 43% of total revenues and growing 16% in the first half of 2025 [6] - Merck's Keytruda accounts for about 50% of its pharmaceutical sales, with a 6.6% sales increase to $15.1 billion in the first half of 2025 [7] - Pfizer's oncology revenues grew 9% in the first half of 2025, driven by various drugs, while AbbVie's oncology revenues rose 4.2% to $3.3 billion [8] Financial Performance and Valuation - AbbVie's stock has increased by 21.2% this year, outperforming the industry [10] - The company's shares trade at a price/earnings ratio of 15.54, higher than the industry average of 14.64 [13] - The Zacks Consensus Estimate for 2025 earnings has slightly decreased to $12.02 per share, while the estimate for 2026 has increased to $14.31 per share [16]
AbbVie Announces Positive Topline Results from Second Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata
Prnewswire· 2025-08-21 12:30
Core Insights - AbbVie announced positive topline results from the Phase 3 UP-AA clinical program for upadacitinib (RINVOQ) in treating severe alopecia areata, showing significant hair regrowth in patients [1][4][34] Study Results - In Study 1, 45.2% of patients on 15 mg and 55.0% on 30 mg of upadacitinib achieved 80% or more scalp hair coverage at week 24, compared to only 1.5% in the placebo group (p<0.001) [1][4] - Additionally, 35.2% and 45.8% of patients on 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage at week 24, compared to 0.7% in the placebo group (p<0.001) [2][4] - Key secondary endpoints were also met, including improvements in eyebrows and eyelashes, and complete scalp hair coverage (SALT=0) [2][4] Safety Profile - The safety profile of upadacitinib was consistent with previous studies, with treatment-emergent serious adverse events occurring in 1.9% and 1.8% of patients in the 15 mg and 30 mg groups, respectively, compared to 0.7% in the placebo group [2][4] - Common treatment-emergent adverse events included upper respiratory tract infections, acne, and increased blood creatine phosphokinase levels [2][4] Clinical Trial Design - The UP-AA clinical trial included two pivotal studies (Study 1 and Study 2) with a total of 1,399 participants aged 12 to 64 across 248 sites globally [5][34] - The studies were randomized, placebo-controlled, and double-blind, evaluating the efficacy and safety of upadacitinib over a total duration of 52 weeks [5][34]
AbbVie Rises 11.5% in a Month: Buy, Hold or Sell the Stock?
ZACKS· 2025-08-20 14:42
Core Insights - AbbVie's stock has increased by 11.5% in the past month due to strong second-quarter performance, beating earnings and sales estimates with earnings of $2.97 per share, a 12.1% year-over-year increase [1][2] Financial Performance - Revenues reached $15.42 billion, reflecting a 6.6% year-over-year increase, driven by strong sales of key drugs such as Rinvoq and Skyrizi, alongside contributions from newer drugs like Ubrelvy and Elahere [2][3] - AbbVie raised its revenue and EPS guidance for 2025, expecting adjusted EPS between $11.88-$12.08 and total revenues around $60.5 billion, up from previous estimates [3] Product Performance - AbbVie has successfully launched new immunology drugs, Skyrizi and Rinvoq, which are expected to replace declining sales from Humira, generating combined sales of $11.6 billion in the first half of 2025 [5][7] - Skyrizi and Rinvoq are projected to achieve combined sales exceeding $25 billion in 2025 and over $31 billion by 2027, with Skyrizi annualizing at nearly $18 billion and Rinvoq at over $8 billion [8][9] Oncology and Neuroscience Growth - The oncology segment generated $3.3 billion in the first half of 2025, a 4.2% year-over-year increase, supported by new drug launches and the addition of antibody-drug conjugates [11][13] - Sales in the neuroscience portfolio increased by 20.3% to nearly $5 billion, driven by products like Botox Therapeutic and newer migraine treatments [14] Acquisition Strategy - AbbVie has engaged in over 30 M&A transactions since early 2024, focusing on immunology, oncology, and neuroscience to enhance its early-stage pipeline [15][16] - Recent acquisitions include Capstan Therapeutics, adding a potential first-in-class CAR-T therapy to its immunology pipeline [16] Challenges and Market Dynamics - Humira's sales have declined over 50% in the first half of 2025 due to biosimilar erosion, with expectations of continued decline as more plans adopt exclusionary formularies [17] - Sales of Juvederm fillers have also decreased by 22.2% in the first half of 2025, impacted by macroeconomic challenges and weakened consumer sentiment [18] Stock Performance and Valuation - AbbVie's stock has gained 19.3% year-to-date, outperforming the industry and S&P 500 [19] - The stock trades at a price/earnings ratio of 15.31, higher than the industry average of 14.46, indicating a relatively high valuation compared to some peers [22] Future Outlook - AbbVie anticipates returning to mid-single-digit revenue growth in 2025, driven by the performance of Skyrizi and Rinvoq, with no significant loss of exclusivity events expected for the remainder of the decade [28][29]
AbbVie Completes Acquisition of Capstan Therapeutics
Prnewswire· 2025-08-19 12:55
Core Insights - AbbVie has completed the acquisition of Capstan Therapeutics, enhancing its capabilities in developing innovative therapies for B cell-mediated autoimmune diseases [1][3] Company Overview - AbbVie aims to discover and deliver innovative medicines addressing serious health issues across key therapeutic areas including immunology, oncology, neuroscience, and eye care [4] Acquisition Details - Capstan's lead asset, CPTX2309, is currently in Phase 1 trials and utilizes a targeted lipid nanoparticle (tLNP) platform to generate CD19-specific, CD8+ in vivo CAR-T cells, which are designed for rapid and deep B cell depletion [2][3] - The acquisition strengthens AbbVie's ability to deliver new treatments that can reset the immune system and allows broader application of Capstan's proprietary technology for in vivo cell programming [3]