Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against REGENXBIO Inc. due to allegations of violations of federal securities laws related to misleading statements about the efficacy and safety of its RGX-111 trial study [4][5]. Group 1: Legal Investigation - The firm is reminding investors of the April 14, 2026 deadline to seek the role of lead plaintiff in a federal securities class action against REGENXBIO [4]. - The investigation follows a press release from REGENXBIO on January 28, 2026, announcing a clinical hold by the FDA on its RGX-111 investigational gene therapy due to a case of neoplasm in a trial participant [6]. - Following the announcement, REGENXBIO's stock price dropped by $2.40 per share, or 17.9%, closing at $11.01 per share [6]. Group 2: Company Background - REGENXBIO is involved in gene therapy, specifically targeting conditions such as MPS I (Hurler syndrome) and MPS II (Hunter syndrome) [6]. - The firm has recovered hundreds of millions of dollars for investors since its founding in 1995, indicating a strong track record in securities law [5].

NMRA-511 demonstrated a clinically meaningful effect size in people with AD agitation.Alzheimer's Disease Agitation DataIn the Phase 1b study, NMRA-511 showed a favorable safety profile with no somnolence or sedation, and meaningful improvements in agitation. Patients saw placebo-adjusted CMAI total score changes of -2.6 and -2.1 at Weeks 6 and 8, while those with elevated anxiety improved by -7.6 and -5.6, respectively.William Blair projects peak U.S. sales of $1.8 billion for NMRA-511 and called the early ...

NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of securities of REGENXBIO, Inc. (NASDAQ: RGNX) between February 9, 2022 and January 27, 2026, inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than April 14, 2026. SO WHAT: If you purchased REGENXBIO securities during the Class Period you may be enti ...

Core Viewpoint - Quantum Biopharma, Ltd. is facing a class action lawsuit for allegedly misleading investors during the Class Period from January 6, 2021, to October 15, 2025, with claims of stock price manipulation [1][2]. Group 1: Class Action Details - Investors who purchased Quantum securities during the specified Class Period have until February 23, 2026, to file a lead plaintiff motion [1]. - The lawsuit is being led by the Portnoy Law Firm, which offers complimentary case evaluations for affected investors [2]. Group 2: Allegations Against Defendants - The Complaint alleges that Defendants engaged in thousands of spoofed sell orders to create a false impression of a declining stock price for Quantum [2]. - These manipulative orders were intended to deceive investors into selling their shares at artificially low prices [2]. - Following the price decline, Defendants allegedly bought Quantum shares at these depressed levels, allowing them to profit from the scheme [2]. - As a result of these actions, investors were improperly induced to sell their shares at artificially depressed prices [2].

Financial Data and Key Metrics Changes - Total revenue increased by 19% to $3.7 billion in 2025, driven by strong execution across the royalty portfolio and commercialized medicines [25][26] - Operating profit expanded to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales [26][30] - Sales of proprietary medicines totaled $632 million, up 54% year-over-year, accounting for approximately 28% of total revenue growth [16][25] Business Line Data and Key Metrics Changes - Epkinly achieved $468 million in sales for 2025, representing a 67% year-over-year increase, driven by its dual indication in diffuse large B-cell lymphoma and follicular lymphoma [17][19] - Tivdak generated $164 million in sales, a 26% year-over-year increase, maintaining market leadership in recurrent or metastatic cervical cancer [20][21] Market Data and Key Metrics Changes - Epkinly closed 2025 with regulatory approvals in over 65 countries, nearly all featuring the dual indication [17] - The U.S. market saw increased uptake for Epkinly, particularly in community settings, with a majority of health systems ordering from multiple sites [18] Company Strategy and Development Direction - The company aims to accelerate the development of its late-stage pipeline and maximize the potential of its commercialized medicines, with a focus on sustainable growth into the 2030s [5][6] - The acquisition of Merus is expected to enhance the late-stage portfolio with petosemtamab, providing multiple value-creating catalysts in 2026 and beyond [8][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute on key data readouts in 2026 and subsequent high-impact launches in 2027, emphasizing a disciplined approach to capital allocation [31] - The company anticipates continued momentum in Epkinly and its royalty portfolio, with a revenue growth guidance of 14% for 2026 [27][30] Other Important Information - The company has five combined breakthrough therapy designations for its late-stage programs, which have multi-billion dollar potential [9] - The company is committed to deleveraging, targeting gross leverage below 3x by the end of 2027 [30] Q&A Session Summary Question: Next steps for Epkinly following EPCORE DLBCL-1 study results? - Management confirmed that the study showed positive progression-free survival but missed overall survival, and discussions with regulatory agencies are ongoing regarding the next steps [34][36] Question: Update on outpatient data for Epkinly? - Management indicated that the outpatient study is crucial for modifying the label and facilitating administration in the community [43][46] Question: Expectations for Rina-S pivotal phase two readout? - Management stated that the study is designed to support accelerated approval based on overall response rate and duration of response [51][54] Question: Expectations for EPCORE DLBCL 4 trial? - Management expressed optimism that the trial will lead to registration in second-line and third-line settings, differentiating it from other studies [58][60] Question: Thoughts on pembro approval in PROC and implications for Rina-S? - Management acknowledged the approval as a good option for patients but believes Rina-S can be more transformative for a broader population [62][64] Question: Confirmation on interim results for Epkinly frontline DLBCL trial? - Management reiterated that the readout for the study is expected to happen in 2026 [55][68]

Genmab (NasdaqGS:GMAB) Q4 2025 Earnings call February 17, 2026 12:00 PM ET Company ParticipantsAnthony Pagano - CFOBenjamin Jackson - VP of Equity ResearchBrad Bailey - CCOJames Gordon - Director and Head of European Pharma and Biotech & Life Sciences Equity ResearchJan van de Winkel - CEOJudith Klimovsky - Chief Development OfficerMatthew Phipps - Group Head–BiotechnologyTahamtan Ahmadi - CMOVictor Floc'h - Equity Research of PharmaceuticalsXian Deng - Executive Director and Pharma and Biotech Equity Resea ...

Immunocore Holdings PLC Sponsored ADR (IMCR) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tra ...

Financial Data and Key Metrics Changes - Total revenue increased by 19% to $3.7 billion in 2025, driven by strong execution across the royalty portfolio and commercialized medicines [24][25] - Operating profit expanded to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales [25][27] - Sales of proprietary medicines totaled $632 million, up 54% year over year, accounting for approximately 28% of total revenue growth [14][24] Business Line Data and Key Metrics Changes - Epkinly achieved $468 million in sales for the year, representing a 67% year-over-year increase, driven by its dual indication in diffuse large B-cell lymphoma and follicular lymphoma [15][24] - Tivdak generated $164 million in sales, representing a 26% year-over-year increase, maintaining market leadership in recurrent or metastatic cervical cancer [19][20] Market Data and Key Metrics Changes - Epkinly closed 2025 with regulatory approvals in more than 65 countries, nearly all featuring the dual indication [15] - The U.S. market saw increased uptake for Epkinly, particularly following its approval in second-line follicular lymphoma [17][18] - Tivdak's launch in Germany showed strong uptake, with positive physician feedback [20] Company Strategy and Development Direction - The company aims to accelerate the development of its late-stage pipeline and maximize the potential of its commercialized medicines [5][24] - The acquisition of Merus is expected to enhance the late-stage portfolio with petosemtamab, contributing to sustainable growth [6][25] - The focus for 2026 includes advancing proprietary portfolio impact, expanding market footprint, and preparing for multiple product launches [22][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute on key data readouts in 2026 and subsequent high-impact launches in 2027 [29] - The company anticipates continued revenue growth driven by Epkinly and its royalty portfolio, with a guidance of 14% total revenue growth for 2026 [26][28] - Management highlighted the importance of maintaining substantial profitability while investing in growth opportunities [27][28] Other Important Information - The company has five combined breakthrough therapy designations for its late-stage programs, indicating multi-billion dollar potential [7] - The anticipated data readouts in 2026 are expected to set the stage for multiple important product launches and line extensions in 2027 [8][10] Q&A Session Summary Question: Next steps for Epkinly following EPCORE DLBCL-1 study results - Management confirmed that the study showed positive progression-free survival but missed overall survival, with ongoing discussions with regulatory agencies about the data [31][33] Question: Update on outpatient data for Epkinly - Management indicated that the outpatient study is crucial for modifying the label and facilitating administration in the community [40][42] Question: Expectations for Rina-S pivotal phase two readout - Management stated that the study is designed to support accelerated approval based on overall response rate and duration of response [47][49] Question: Expectations for EPCORE DLBCL-4 trial outcomes - Management expressed optimism that the trial will lead to registration in second-line and third-line settings, differentiating it from other studies [53][55] Question: Thoughts on pembro approval in PROC and implications for Rina-S - Management acknowledged the approval as a good option for patients but believes Rina-S can be more transformative for a broader population [57][59] Question: Clarification on phase 3 for petosemtamab - Management confirmed that the phase 3 studies have dual endpoints of overall response rate and overall survival, which are standard in areas of unmet medical need [75]

ATLANTA, Feb. 17, 2026 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against REGENXBIO Inc. (NASDAQ: RGNX). The lawsuit alleges that Defendants issued false and misleading statements and/or failed to disclose material adverse facts concerning the efficacy and safety of its RGX-111 trial study, causing Plaintiff and other shareholders to purchase REGENXBIO’s securities at artificially inflated prices. If you purchased REGENXBIO shares between February 9, 2022 and January 27, 2026, an ...

Management attributed Q4 performance to successful US sales force expansion and initial revenue contributions from early launches in Germany, France, and Japan. The US market is evolving toward a 'start-stop' regime where longer-tenured patients transition to intermittent treatment as disease management stabilizes. International expansion is identified as the primary revenue growth driver for 2026, leveraging a larger patient pool outside the US and favorable product labels. The company is maintaini ...