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 ...

Core Insights - The company's Q4 performance is attributed to successful expansion of the US sales force and initial revenue contributions from early launches in Germany, France, and Japan [1] - The US market is shifting towards a 'start-stop' treatment regime for longer-tenured patients as disease management stabilizes [1] - International expansion is identified as the primary revenue growth driver for 2026, leveraging a larger patient pool outside the US and favorable product labels [1] - The company is maintaining a disciplined capital allocation strategy, aiming to compound value through operating profitability without relying on equity dilution [1] - High gross margins of 94% were achieved through efficient manufacturing, though slightly offset by higher unit costs for initial international volumes ahead of planned optimizations [1] - Strategic positioning focuses on self-launching four potential upcoming indications and building a specialized commercial infrastructure for rare genetic medicines [1]

Financial Data and Key Metrics Changes - Revenue for the second quarter was $116,000, compared to $0 in the same period last year, primarily from cost reimbursements under a collaboration agreement with Boehringer Ingelheim [6] - Total operating expenses increased to $7.4 million from $2.6 million in the prior year, driven by higher investments in obesity development programs and increased compensation costs [6][7] - Net loss for the quarter was $7.3 million, or $2.86 per share, compared to a net loss of $2.4 million, or $5.92 per share in the comparable period last year [8] - Cash and cash equivalents as of December 31, 2025, were $14.5 million, up from $1.3 million at September 30, 2025 [9] Business Line Data and Key Metrics Changes - The company is advancing its melanocortin-4 receptor-based obesity pipeline, focusing on rare syndromic and genetic obesity disorders [10] - The lead oral small molecule MC4R agonist, PL7737, is progressing through IND-enabling toxicology studies, with an IND submission planned for the first half of 2026 [11] - Next-generation selective melanocortin-4 receptor peptide agonists are also being developed, with an IND submission planned for the second half of 2026 [11] Market Data and Key Metrics Changes - The company regained compliance with NYSE American listing standards, and its common stock resumed trading under the symbol PTN [5][13] - The focus remains on rare neuroendocrine obesity disorders, including hypothalamic obesity and Prader-Willi syndrome, which represent significant unmet medical needs [10][12] Company Strategy and Development Direction - The company aims to deliver differentiated product profiles with a focus on enhancing patient tolerability and minimizing off-target effects [11] - A sub-licensing transaction for PL9643 provided approximately $3.8 million in upfront consideration, allowing the company to sharpen its focus on core obesity programs [12][13] - The company is positioned to pursue substantial long-term value creation through multiple partnerships and near-term milestones [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiation of their products, particularly regarding tolerability and safety profiles compared to existing treatments [17][34] - The company anticipates moving forward into phase II studies for both oral small molecules and long-acting peptides targeting hypothalamic obesity and Prader-Willi syndrome patients by mid-2027 [43] Other Important Information - The company completed an $18.2 million public offering, which significantly strengthened its balance sheet and provided capital for advancing its obesity pipeline [5][10] - The company expects its cash runway to extend beyond the quarter ending March 31, 2027 [9] Q&A Session Summary Question: What preclinical or translational signals give confidence in differentiation for PL7737? - Management highlighted the design of the compound to be more selective for the melanocortin-4 receptor, which should reduce hyperpigmentation and control GI side effects [17] Question: How will patient selection and endpoints be approached in the phase one study? - The focus will be on safety and confirming oral absorption, with weight reduction and control of hyperphagia as key parameters in the multiple-ascending dose study [19][20] Question: Is there an increased emphasis on Prader-Willi syndrome? - Management confirmed that while Prader-Willi has always been in the background, they are focusing on indications with substantial patient populations [21][22] Question: How will the oral small molecule and weekly injection be positioned? - Both products are seen as complementary, with each suited for different patient populations [24][25] Question: What is the anticipated cash flow and resource allocation for PWS studies? - Management indicated sufficient cash to move forward with both oral and peptide studies, with plans to initiate studies in PWS patients by mid-2027 [43] Question: How will GLP-1 therapies be integrated into product development? - Management anticipates that combination therapies will be necessary for optimizing treatment, particularly for patients with severe hyperphagia [48]

Financial Data and Key Metrics Changes - Revenue for the second quarter was $116,000, compared to $0 in the same period last year, primarily from cost reimbursements under a collaboration agreement with Boehringer Ingelheim [6] - Total operating expenses increased to $7.4 million from $2.6 million in the prior year, driven by higher investments in obesity development programs and increased compensation costs [6][7] - Net loss for the quarter was $7.3 million, or $2.86 per share, compared to a net loss of $2.4 million, or $5.92 per share in the comparable period last year [8] - Cash and cash equivalents as of December 31, 2025, were $14.5 million, up from $1.3 million at September 30, 2025 [9] Business Line Data and Key Metrics Changes - The company is advancing its melanocortin-4 receptor-based obesity pipeline, focusing on rare syndromic and genetic obesity disorders [10] - The lead oral small molecule MC4R agonist, PL7737, is progressing through IND-enabling toxicology studies, with an IND submission planned for the first half of 2026 [11] - The next generation selective melanocortin-4 receptor peptide agonists are also being developed, with an IND submission planned for the second half of 2026 [11] Market Data and Key Metrics Changes - The company has regained compliance with NYSE American listing standards, and its common stock resumed trading under the symbol PTN [5][13] - The focus remains on rare neuroendocrine obesity disorders, including hypothalamic obesity and Prader-Willi syndrome, which represent significant unmet medical needs [10][12] Company Strategy and Development Direction - The company aims to deliver differentiated product profiles with a focus on enhancing patient tolerability and minimizing off-target effects [11] - A strategic shift was made by sub-licensing the dry eye disease clinical candidate, PL9643, to focus more on core obesity programs [12][13] - The company is positioned to pursue long-term value creation through multiple partnerships and a focused pipeline [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiation of their products, particularly regarding tolerability and safety profiles compared to current treatments [17][34] - The company anticipates moving into phase II studies for Prader-Willi syndrome and hypothalamic obesity patients by mid-2027 [43] - Management highlighted the importance of combination therapies with GLP-1 based treatments as the market evolves [48] Other Important Information - The company completed a public offering of $18.2 million, strengthening its balance sheet and providing capital for advancing obesity programs [5][10] - The company expects its cash runway to extend beyond March 31, 2027, based on current operating plans [9] Q&A Session Summary Question: What preclinical signals give confidence in differentiation for PL7737? - Management highlighted the design of the compound to be more selective for the melanocortin-4 receptor, which should reduce hyperpigmentation and control GI side effects [17] Question: How will patient selection and endpoints be defined for phase one studies? - The focus will be on safety and confirming oral absorption, with weight reduction and control of hyperphagia as key metrics in the multiple-ascending dose study [19][20] Question: Is there an increased emphasis on Prader-Willi syndrome? - Management confirmed that while it has always been in the background, there is a focus on larger indications like hypothalamic obesity and Prader-Willi syndrome due to the number of patients [22] Question: How will the oral small molecule and weekly injection be positioned? - Both products are seen as complementary, with each suited for different patient populations [24][25] Question: What is the anticipated cash flow for the next quarters? - Management indicated that there were one-time extraordinary expenses in the previous quarter, and they expect operating expenses to decrease in the upcoming quarters [27][28]

Financial Data and Key Metrics Changes - Revenue for Q2 2026 was $116,000, compared to $0 in the same period last year, attributed to cost reimbursements from a collaboration with Boehringer Ingelheim [7] - Total operating expenses increased to $7.4 million from $2.6 million in the prior year, primarily due to higher investments in obesity development programs and increased compensation costs [7] - Net loss for the quarter was $7.3 million, or $2.86 per share, compared to a net loss of $2.4 million, or $5.92 per share in the prior year [8] - Cash and cash equivalents as of December 31, 2025, were $14.5 million, up from $1.3 million at September 30, 2025 [10] Business Line Data and Key Metrics Changes - The company is advancing its melanocortin-4 receptor-based obesity pipeline, focusing on rare syndromic and genetic obesity disorders [11] - The lead oral small molecule MC4R agonist, PL7737, is progressing through IND-enabling toxicology studies, with plans to submit an IND in the first half of 2026 [12] - A next-generation selective melanocortin-4 receptor peptide agonist is also in development, with an IND submission planned for the second half of 2026 [12] Market Data and Key Metrics Changes - The company regained compliance with NYSE American listing standards, allowing its common stock to resume trading under the symbol PTN [6][14] - The focus remains on rare neuroendocrine obesity disorders, including hypothalamic obesity and Prader-Willi syndrome, which represent significant unmet medical needs [12] Company Strategy and Development Direction - The company aims to deliver differentiated product profiles with a focus on enhancing patient tolerability and minimizing side effects [12] - A strategic sub-licensing of PL9643 for dry eye disease has allowed the company to sharpen its focus on core obesity programs while retaining potential future financial participation [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and pipeline, indicating that the successful public offering has provided the necessary capital to advance obesity programs [11][14] - The company anticipates a cash runway extending beyond March 31, 2027, based on current operating plans [10] Other Important Information - The company received approximately $3.8 million in upfront consideration from the sublicensing transaction, which will be recognized as licensed revenue in the quarter ending March 31, 2026 [10] Q&A Session Summary Question: What preclinical or translational signals give confidence in differentiation for PL7737? - The compound is designed to be more selective for the melanocortin-4 receptor, which should reduce hyperpigmentation and control GI side effects through its administration [17][18] Question: How will patient selection and endpoints be approached in the phase one study? - The phase one studies will primarily focus on safety, with the multiple-ascending dose study looking for reductions in body weight and control of hyperphagia [19][20] Question: Is there an increased emphasis on Prader-Willi syndrome? - Prader-Willi syndrome has always been in the background, but the company is focusing on larger indications with substantial patient populations [22] Question: How will the oral small molecule and weekly injection be positioned? - Both products are seen as complementary, with each suited for different patient populations [24][26] Question: What is the anticipated impact of GLP-1 therapies on product development? - The company is exploring combination therapies with GLP-1s to optimize treatment for patients with severe hyperphagia [49]

Core Insights - Compass Pathways has made significant progress in its psilocybin therapy for treatment-resistant depression (TRD), achieving positive results in two Phase 3 trials and planning to submit a New Drug Application (NDA) to the FDA [2][5][6] Group 1: Clinical Trial Results - The second Phase 3 trial met its primary endpoint, demonstrating statistically significant results for the proprietary formulation COMP360 [5] - The trials involved over 1,000 participants, showcasing consistent and clinically meaningful effects, which is a notable achievement in the challenging field of TRD treatment [5] Group 2: Market Reaction - Following the announcement of the trial results, Compass Pathways' stock surged by over 50%, with a trading increase of 42.3% noted shortly after the news [3][6] - The positive trial outcomes have prompted investor interest, indicating a potential for continued stock growth pending FDA feedback [6] Group 3: Regulatory Steps - Compass has requested a meeting with the FDA and aims to submit the NDA for full approval by the end of the year, marking a critical step in the drug approval process [6]

New York, New York--(Newsfile Corp. - February 17, 2026) - WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of American Depositary Shares ("ADS") of Mereo BioPharma Group plc (NASDAQ: MREO) between June 5, 2023 and December 26, 2025, inclusive (the "Class Period"), of the important April 6, 2026 lead plaintiff deadline.SO WHAT: If you purchased Mereo ADSs during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contin ...

Core Viewpoint - The Meridian Hedged Equity Fund's fourth-quarter 2025 performance was influenced by optimism regarding monetary easing and concerns about economic growth and valuations, with a modest gain of 0.08% compared to the S&P 500 Index's 2.66% return and the CBOE S&P 500 BuyWrite Index's 6.53% return [1] Group 1: Fund Performance - In Q4 2025, the Fund gained 0.08%, while the S&P 500 Index returned 2.66% and the CBOE S&P 500 BuyWrite Index returned 6.53% [1] - The Fund's performance contributed positively to robust annual results despite a cooling market sentiment later in the quarter [1] Group 2: Danaher Corporation (NYSE:DHR) - Danaher Corporation was highlighted as a key contributor to the portfolio performance, with a market capitalization of $150.16 billion [2][4] - The stock closed at $212.58 per share on February 13, 2026, with a one-month return of -9.92% and a twelve-month return of 3.04% [2] - Danaher is recognized for its strong presence in life sciences and diagnostics, particularly in bioprocessing, medical research, and clinical diagnostics [3] Group 3: Investment Insights - The Fund holds Danaher for its competitive positioning in growing end-markets and consistent free cash flow generation, with management reaffirming forward guidance [3] - In 2025, Danaher reported sales of $24.6 billion and core revenue growth of 2% [4] - Despite recognizing Danaher's potential, the Fund suggests that certain AI stocks may offer greater upside potential and less downside risk [4]

Core Insights - Genmab A/S published its Annual Report for 2025, highlighting significant business progress, financial performance, and outlook for 2026 [1] Business Progress - Epcoritamab (EPKINLY®) received FDA approval for earlier lines of therapy in follicular lymphoma, based on successful Phase 3 EPCORE® FL-1 trial results [6] - Acquisition of Merus N.V. adds a late-stage breakthrough therapy asset, petosemtamab, enhancing growth opportunities [6] - Tivdak® was approved in Europe and Japan for recurrent or metastatic cervical cancer, marking Genmab's first independent product launch [6] - Rina-S® expanded its Phase 3 development into endometrial cancer and platinum-sensitive ovarian cancer, receiving Breakthrough Therapy Designation from the FDA [6] - Continued development of organizational infrastructure with over 300 new hires [6] Financial Performance - Net sales of DARZALEX® reached $14,351 million in 2025, a 23% increase from $11,670 million in 2024 [6] - Global net sales of EPKINLY/TEPKINLY were $468 million in 2025, up 67% from $281 million in 2024, driven by growth in diffuse large B-cell lymphoma and follicular lymphoma [6] - Genmab's total revenue for 2025 was $3,720 million, a 19% increase from $3,121 million in 2024, primarily due to higher royalties from DARZALEX and Kesimpta [6] 2026 Outlook - Genmab projects 2026 revenue between $4,065 million and $4,395 million, with a midpoint guidance of $4,230 million [7] - Expected royalty revenue for 2026 is projected to be between $3,440 million and $3,685 million, with a midpoint of $3,563 million [7] - Anticipated operating expenses for 2026 are expected to range from $2,710 million to $2,910 million, reflecting investments in late-stage programs [13] - Projected operating profit for 2026 is estimated to be between $900 million and $1,400 million [14]

Core Insights - Krystal Biotech reported strong revenue growth for Q4 2025 and full-year 2025, with net revenue from VYJUVEK reaching $107.1 million in Q4 and $389.1 million for the year, representing approximately 34% year-over-year growth [3][4][6] Financial Performance - R&D expenses for Q4 2025 were $14.8 million, up from $13.5 million a year earlier, while SG&A expenses increased to $41.4 million from $31.3 million, primarily due to higher headcount and costs associated with global launches [1] - Gross margin remained strong at 94% for both the quarter and the full year, with expectations to maintain margins in the 90% to 95% range for the foreseeable future [2] Market Expansion - The company is experiencing momentum in international markets, particularly in Europe and Japan, with over 90 DEB patients prescribed VYJUVEK across these regions [13] - U.S. commercial momentum is also strong, with more than 660 reimbursement approvals and over 500 unique prescribers since launch [6][9] Pipeline Developments - Krystal is advancing multiple programs, including KB407 for cystic fibrosis, with expected registrational readouts before year-end [5][18] - Protocol changes for KB801 and KB803 aim to facilitate at-home dosing, with data expected before year-end [19][20] Cash Position - The company ended 2025 with $955.9 million in cash and investments, providing a strong financial foundation for future growth [8]