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RARE INVESTOR ALERT: Faruqi & Faruqi, LLP Reminds Ultragenyx Pharmaceutical (RARE) Investors of Securities Class Action Deadline on April 6, 2026
TMX Newsfile· 2026-03-27 14:19
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Ultragenyx Pharmaceutical Inc due to alleged violations of federal securities laws related to misleading statements about the efficacy of its drug setrusumab in treating Osteogenesis Imperfecta [2][5]. Group 1: Legal Investigation - The law firm is encouraging investors who suffered losses in Ultragenyx between August 3, 2023, and December 26, 2025, to discuss their legal rights [1]. - There is an April 6, 2026, deadline for investors to seek the role of lead plaintiff in a federal securities class action against Ultragenyx [2]. Group 2: Allegations Against Ultragenyx - The complaint alleges that Ultragenyx and its executives created a false impression regarding the reliability of information on setrusumab's effects, while downplaying the risks of the Phase III Orbit study failing to achieve statistically significant results [5]. - On July 9, 2025, Ultragenyx disclosed that the Phase III Orbit study did not achieve statistical significance for its second interim analysis, leading to a stock price drop of over 25% [6]. - On December 29, 2025, Ultragenyx announced that both the Phase III Orbit and Cosmic Studies failed to meet primary endpoints, resulting in a further stock price decline of more than 42% [7][8].
Can New Drugs Drive J&J's Innovative Medicine Despite Stelara LOE?
ZACKS· 2026-03-27 14:16
Core Viewpoint - Johnson & Johnson's Innovative Medicine segment is expected to show growth in Q1 2026, driven by key product sales despite challenges from the loss of exclusivity of Stelara and competitive pressures from biosimilars [1][10]. Sales Performance - The Innovative Medicine unit's sales increased by 4.1% on an organic basis in 2025, even with the loss of exclusivity for Stelara and the negative impact of the Part D redesign [2]. - The segment achieved over $15 billion in sales for three consecutive quarters in 2025, a trend anticipated to continue into Q1 2026 [2]. Key Product Contributions - Growth in Q1 2026 is expected to be supported by increased sales of Darzalex, Tremfya, and Erleada, along with market share gains and expansion [3]. - Newer therapies such as Carvykti, Tecvayli, Talvey, Rybrevant, Lazcluze, Caplyta, and Spravato are also projected to contribute to overall growth [3]. Competitive Landscape - The launch of several biosimilar versions of Stelara in 2025 negatively impacted the Innovative Medicines segment's growth by 10.4% [5]. - Imbruvica sales are expected to decline due to rising competition, and the Part D redesign is anticipated to further affect sales of Stelara, Imbruvica, and Erleada [6]. New Product Developments - Investors are keen on commercialization plans and initial sales figures for newly approved products like Inlexzoh/TAR-200 and Imaavy [7]. - The FDA recently approved Icotyde for treating moderate-to-severe plaque psoriasis, although it will not contribute to Q1 2026 sales [8]. Market Position and Valuation - J&J's shares have outperformed the industry, rising 46.2% over the past year compared to the industry's 10.6% increase [11]. - The company's shares are trading at a forward price/earnings ratio of 20.36, higher than the industry average of 16.99 and above its five-year mean of 15.65 [13]. Earnings Estimates - The Zacks Consensus Estimate for 2026 earnings remains stable at $11.54 per share, while the estimate for 2027 has increased from $12.33 to $12.44 [15]. - Current estimates for Q1 and Q2 2026 are $2.69 and $2.93 per share, respectively [16].
Vector Institute Extends Collaboration With Roche
Globenewswire· 2026-03-27 14:06
Core Insights - The Vector Institute has renewed its collaboration with Roche until 2030, enhancing AI research and application in health since 2020 [1] Group 1: Collaboration and Research Initiatives - The collaborative model of Vector has facilitated joint research projects with Roche and other industry partners, including an initiative that uses AI to analyze social media posts for patterns in long COVID symptoms [2] - The partnership provides Roche with access to AI talent, recruitment support, engineering capabilities, and specialized training programs to accelerate AI adoption [2] Group 2: Impact and Vision - Cameron Schuler, Chief Commercialization Officer at Vector, emphasizes that effective collaboration between industry partners and researchers leads to significant healthcare breakthroughs [3] - The Vector Institute, established in 2017, aims to build AI talent and drive research excellence to foster economic growth and improve the lives of Canadians [3][4] - Vector's programs are designed to advance AI research and its adoption in industry and health, offering training for professionals and connections to workforce-ready talent [4]
Merck Stock Soars 50% in 6 Months: Buy, Hold, or Take Profits?
ZACKS· 2026-03-27 14:02
Core Insights - Merck's stock has increased by 51.4% over the past six months, driven by an optimistic outlook for long-term growth following the patent expiration of its key drug, Keytruda, in 2028 [1][9] - The company is enhancing its pipeline through recent M&A activities and new product launches, which bolsters confidence in its growth prospects post-Keytruda [2][6] Group 1: Keytruda's Impact - Keytruda is Merck's most significant product, accounting for approximately 55% of pharmaceutical sales, with sales reaching $31.7 billion in 2025, a 7% increase year-over-year [3][5] - The drug's sales are expected to peak at $35 billion by 2028, with continued growth anticipated until patent expiration [5][16] - Merck is exploring innovative strategies to sustain Keytruda's growth, including new immuno-oncology combinations and a personalized mRNA therapeutic cancer vaccine in collaboration with Moderna [4][11] Group 2: Pipeline and M&A Activities - Merck's drug pipeline has nearly tripled since 2021, supported by both internal development and acquisitions, with promising candidates like Capvaxive and Winrevair showing strong market potential [7][10] - Recent acquisitions, including Verona and Cidara Therapeutics, have added valuable products to Merck's portfolio, enhancing its long-term growth outlook [11][12] - The company has announced a definitive agreement to acquire Terns Pharmaceuticals for $6.7 billion, which will add a candidate for chronic myeloid leukemia to its pipeline [13] Group 3: Challenges and Market Dynamics - Sales of Gardasil, Merck's second-largest product, have declined significantly, with a 39% drop in 2025 due to weak demand in China and Japan [14][16] - The company faces potential revenue losses from generic competition for several products, including Januvia and Bridion, with an estimated impact of approximately $2.5 billion in 2026 [18][19] - Despite the challenges, Merck anticipates over $70 billion in potential commercial opportunities from its current pipeline by the mid-2030s, which is significantly higher than the peak sales estimate for Keytruda [29][30]
AbbVie to Highlight New Clinical and Real-World Evidence Advancing Standards of Care in Immune-Mediated Skin Diseases at the 2026 AAD Annual Meeting
Prnewswire· 2026-03-27 14:00
Core Insights - AbbVie is set to present new research at the 2026 American Academy of Dermatology (AAD) Annual Meeting, showcasing advancements in standards of care for immune-mediated skin diseases [1][2] Group 1: Research Highlights - AbbVie will present 24 abstracts, including a late-breaking presentation, emphasizing its leadership in immune-mediated skin diseases [2] - The clinical evidence demonstrates durable treatment responses, long-term safety, and quality of life improvements across various dermatologic diseases [2][3] - Key findings include the long-term efficacy of risankizumab in maintaining radiographic non-progression in psoriatic arthritis, with 88% of patients showing no progression over five years [5] Group 2: Quality of Life Improvements - Data indicates significant quality of life improvements for patients with atopic dermatitis and psoriasis, with risankizumab showing high efficacy in treating these conditions [4][6] - In the UnlIMMited trial, 72% to 88.9% of patients with genital psoriasis achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1 after 16 weeks of treatment [6] - Real-world evidence from the AD-VISE study shows that 72.3% of patients achieved minimal disease activity with upadacitinib treatment [5][9] Group 3: Investigational Data - Phase 3 data for upadacitinib in treating non-segmental vitiligo and severe alopecia areata will be presented, highlighting its potential efficacy [8][9] - The investigational studies show a greater proportion of patients achieving significant improvements in disease severity compared to placebo [8][9] - Upadacitinib is currently not FDA approved for vitiligo and alopecia areata, indicating ongoing research and development in these areas [8][9]
Lilly's eczema drug shows durable long-term response in late-stage study
Reuters· 2026-03-27 13:56
Core Insights - Eli Lilly's eczema drug, Ebglyss, demonstrates durable long-term efficacy, providing relief from persistent itch for up to four years in patients with moderate-to-severe atopic dermatitis [1][2]. Group 1: Drug Efficacy and Approval - Ebglyss, a once-monthly injectable treatment, is approved for adults and children aged 12 and older who cannot use topical therapies [2]. - The majority of patients in the study achieved near-complete skin clearance and itch relief with up to four years of continuous treatment [3]. Group 2: Safety Profile - The safety profile of Ebglyss during the first year of the study remained consistent with known data, with no new safety issues reported [3]. Group 3: Regulatory Developments - Eli Lilly has submitted data from another trial to the U.S. Food and Drug Administration for a potential label update, indicating the drug's durable response when dosed every four or eight weeks [4].
AQST INVESTOR ALERT: Faruqi & Faruqi, LLP Reminds Aquestive Therapeutics (AQST) Investors of Securities Class Action Deadline on May 4, 2026
TMX Newsfile· 2026-03-27 13:40
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. due to alleged violations of federal securities laws related to misleading statements about the company's NDA for Anaphylm [2][5]. Group 1: Legal Investigation and Claims - The law firm is encouraging investors who suffered losses in Aquestive between June 16, 2025, and January 8, 2026, to discuss their legal rights [1]. - A federal securities class action has been filed against Aquestive, with a deadline of May 4, 2026, for investors to seek the role of lead plaintiff [2]. - The complaint alleges that Aquestive and its executives failed to disclose significant deficiencies in the NDA for Anaphylm, particularly regarding human factors in the use of its sublingual film [5]. Group 2: Stock Price Impact - Following the announcement of deficiencies in the NDA by the FDA on January 9, 2026, Aquestive's stock price dropped by $2.30 per share, representing a 37.04% decline, closing at $3.91 per share [6]. Group 3: Firm Background and Outreach - Faruqi & Faruqi, LLP has recovered hundreds of millions of dollars for investors since its founding in 1995 and has offices in multiple states [4]. - The firm is also seeking information from whistleblowers, former employees, and shareholders regarding Aquestive's conduct [8].
EU regulator backs Sanofi's injectable version of blood cancer drug
Reuters· 2026-03-27 13:36
Core Viewpoint - The European Medicines Agency has recommended the approval of a subcutaneous version of Sanofi's blood cancer drug, which will be administered through an on-body injector [1] Group 1 - Sanofi is a French drugmaker [1] - The recommended approval pertains to a new formulation of a blood cancer drug [1] - The drug will be delivered using an innovative on-body injector [1]
INO INVESTOR ALERT: Faruqi & Faruqi, LLP Reminds Inovio Pharmaceuticals (INO) Investors of Securities Class Action Deadline on April 7, 2026
TMX Newsfile· 2026-03-27 13:34
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Inovio Pharmaceuticals, Inc. regarding alleged violations of federal securities laws related to misleading statements about the company's product development and regulatory prospects [2][5]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi is encouraging investors who suffered losses in Inovio to contact them to discuss legal options, particularly for those who purchased securities between October 10, 2023, and December 26, 2025 [1]. - There is an April 7, 2026 deadline for investors to seek the role of lead plaintiff in a federal securities class action against Inovio [2]. - The complaint alleges that Inovio and its executives made false statements regarding the manufacturing of the CELLECTRA device and the likelihood of submitting the INO-3107 Biologics License Application (BLA) to the FDA by the second half of 2024 [5]. Group 2: Regulatory Developments - On December 29, 2025, the FDA accepted Inovio's BLA for INO-3107 for standard review but noted that the company did not provide sufficient information for accelerated approval [6]. - Inovio's stock price fell by $0.56, or 24.45%, closing at $1.73 per share following the FDA's announcement [7]. - Inovio plans to request a meeting with the FDA to discuss potential pathways for pursuing accelerated approval despite the current setback [6].
Iterum Therapeutics Announces Filing of Winding Up Petition
Globenewswire· 2026-03-27 13:25
Core Viewpoint - Iterum Therapeutics plc has filed a petition for winding up the company due to financial difficulties and inability to comply with Nasdaq listing requirements, leading to the appointment of Joint Provisional Liquidators [1][2][3] Financial Situation - The company cited limited cash resources and restrictions on raising additional capital as primary reasons for pursuing liquidation [3] - The inability to regain compliance with Nasdaq listing requirements was a significant factor in the decision [3] - The company has incurred significant expenses related to the commercialization of its product ORLYNVAH™ amidst modest sales [3] Strategic Alternatives - Iterum engaged in discussions with two potential counterparties regarding the acquisition of sulopenem but could not finalize any agreements due to time constraints and limited cash runway [3] - The Board concluded that there were no reasonable avenues for alternative strategic transactions outside of liquidation [3] Liquidation Process - The High Court in Ireland will hear the winding up petition on April 13, 2026, which, if approved, will lead to the dissolution of the company [2] - Joint Provisional Liquidators will oversee the wind down of Iterum's subsidiaries [4] Product Information - Iterum's primary product, ORLYNVAH™, is an oral antibiotic aimed at treating uncomplicated urinary tract infections caused by specific bacteria [7][9] - The product has received FDA approval and designations for its formulations, indicating its potential in addressing multi-drug resistant infections [7]