Core Insights - TuHURA Biosciences has filed an Investigational New Drug Application (IND) for TBS-2025, a novel VISTA inhibiting antibody, aimed at treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia (AML) in combination with a menin inhibitor [1] - The company plans to initiate a Phase 2 study in early Q2 2026, targeting menin inhibitor naïve patients, with preliminary results expected in Q3 2026 [1] - TBS-2025 is expected to address the unmet medical need in AML treatment, as current therapies have low complete response rates of less than 25% [1] Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to overcome resistance to cancer immunotherapy [1] - The company’s lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 trial for advanced Merkel Cell Carcinoma [1] - TBS-2025 was acquired through the merger with Kineta Inc. and is moving into Phase 2 development for mutNPM1 r/r AML [1] Scientific Rationale - Scientific evidence indicates that mutations like mutNPM1 drive VISTA expression on leukemic cells, contributing to poor therapy responses and high relapse rates in AML [1] - The removal of the VSIR gene, which encodes for VISTA, in murine models has shown enhanced immune response and improved survival rates [1] - TBS-2025 demonstrated a favorable safety profile in a Phase 1 trial, with an optimal Phase 2 dose anticipated to be 750mg every three weeks [1]

Core Viewpoint - Helus Pharma announced positive results from a Phase 2a clinical trial of SPL026, a novel serotonergic agonist for treating major depressive disorder, demonstrating significant reductions in depressive symptoms compared to placebo [2][3][7]. Study Results - The Phase 2a trial met its primary endpoint, showing a mean difference of -7.35 in MADRS scores at two weeks for SPL026 compared to placebo, with a p-value of 0.023 [3][7]. - Significant reductions in depressive symptoms were observed as early as one week post-dosing, with effects lasting up to six months in some participants [3][4]. - Response rates for SPL026 were 35% at Week 2, compared to 12% for placebo, while remission rates were 29% for SPL026 versus 12% for placebo [4][7]. Treatment Safety and Efficacy - SPL026 was generally well tolerated, with no serious treatment-related adverse events reported [3][4]. - The study involved 34 participants with a mean age of 32.8 years, predominantly white, who had experienced depression for an average of 10.5 years [8]. Future Developments - Helus Pharma plans to advance HLP004, another proprietary NSA, for generalized anxiety disorder, with topline data expected in Q1 2026 [5][11]. - The findings from the SPL026 trial support the potential of short-acting serotonergic agonists in mental health treatments, reinforcing the company's strategy for developing novel serotonergic agonist molecules [5][7]. Company Overview - Helus Pharma is a clinical-stage pharmaceutical company focused on developing proprietary NSAs aimed at addressing mental health conditions such as depression and anxiety [10][11]. - The company operates in multiple regions, including Canada, the United States, the United Kingdom, and Ireland [12].

Core Insights - Helus Pharma announced positive results from a Phase 2a clinical trial of SPL026 for major depressive disorder, showing significant reductions in depressive symptoms compared to placebo [2][3][7] Study Results - The study met its primary endpoint with a mean difference in MADRS score of -7.35 at two weeks, indicating a statistically significant reduction in depressive symptoms [3][7] - Participants treated with SPL026 showed reductions in symptoms as early as one week, with effects lasting up to six months in some cases [3][4] - Response rates for SPL026 were 35% compared to 12% for placebo, and remission rates were 29% versus 12% [4][7] Treatment Efficacy - A single 21.5 mg dose of SPL026 was well tolerated, with no serious adverse events reported [3][4] - The treatment effects were comparable to other longer-duration interventions, suggesting potential cost-effectiveness [4][5] Future Developments - Helus Pharma is advancing HLP004, another proprietary serotonergic agonist, with topline data expected from its Phase 2 study in generalized anxiety disorder in Q1 2026 [5][11] - Insights from the SPL026 trial are informing the development of HLP004, which aims to optimize pharmacology and scalability [5][11] Company Overview - Helus Pharma is focused on developing novel serotonergic agonists to address unmet needs in mental health, including depression and anxiety [10][11] - The company operates in multiple regions, including Canada, the United States, the United Kingdom, and Ireland [12]

Pharma giant Novo Nordisk is investing more in Ireland hoping to capitalize on the obesity-drug boom https://t.co/XcHe48qkw7 ...

Core Insights - Ocular Therapeutix's experimental eye drug, Axpaxli, has demonstrated superior efficacy in maintaining vision compared to Regeneron's Eylea in a late-stage trial, marking a significant advancement in treatment for wet age-related macular degeneration (AMD) [1] Company Summary - Ocular Therapeutix reported that Axpaxli outperformed Eylea, with 74% of patients maintaining vision at 36 weeks after a single 0.45 mg dose, compared to nearly 56% for Eylea's 2 mg dose [1] - After one year, approximately 66% of Axpaxli patients maintained their vision, while less than 50% of Eylea patients did [1] - The drug also showed better fluid control in the eye, indicating improved disease management, and many Axpaxli patients did not require additional "rescue" injections for almost a year, potentially reducing clinic visits [1] Industry Summary - Wet AMD affects around 1.7 million Americans, leading to vision loss due to abnormal blood vessel growth in the retina [1] - Ocular Therapeutix plans to discuss the trial data with the U.S. Food and Drug Administration and anticipates submitting a marketing application based on these results [1] - Following the announcement, Ocular's shares experienced a significant decline of about 30% in premarket trading, despite a previous gain of nearly 39% in 2025 [1]

Core Insights - Teva and Sanofi announced positive results from the RELIEVE UCCD long-term extension study of duvakitug, showing durable clinical efficacy in ulcerative colitis and Crohn's disease patients over 44 weeks [1] Study Results - The study involved 130 patients who initially responded to duvakitug, with both doses (450 mg and 900 mg) being well tolerated [2] - In ulcerative colitis, 58% of patients on the 900 mg dose and 47% on the 450 mg dose achieved clinical remission [2] - In Crohn's disease, 55% of patients on the 900 mg dose and 41% on the 450 mg dose achieved endoscopic response [3] - Consistent benefits were observed across additional efficacy endpoints in both patient groups [3] Technical Analysis - The stock is currently trading 6.3% below its 20-day simple moving average and 10.5% below its 100-day simple moving average, indicating short-term weakness [4] - Over the past 12 months, shares have increased by 105.07% and are closer to their 52-week highs than lows [4] - The RSI is at 50.00, indicating neutral territory, while MACD is below its signal line, suggesting bearish pressure [4] Analyst Consensus & Recent Actions - The stock carries a Buy Rating with an average price target of $31.75 [5] - Recent analyst actions include Goldman Sachs raising the target to $45, Barclays raising the target to $38, and Scotiabank raising the target to $40 [5] - Teva shares are up 2.85% at $34.94 during premarket trading, while Sanofi shares are up 0.26% at $46.13 [5]

Toronto, Ontario--(Newsfile Corp. - February 17, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses, is pleased to announce that its interim clinical data has been selected for presentation at the 2026 European Association of Urology Congress ("EAU26").The EAU has accepted Th ...

Core Insights - Harrow has launched a new Direct-to-Prescriber (DTP) cash-pay offering called PharmaPack, aimed at providing affordable FDA-approved ophthalmic products as alternatives to off-label compounded formulations [1][2]. Product Offering - PharmaPack kits are designed to enhance access to FDA-approved ophthalmic products for millions of Americans needing infection control and treatment of pain and inflammation related to cataract surgery [2]. - The kits simplify the prescribing process by eliminating insurance-related administrative complexities and reducing regulatory and medical-legal risks associated with off-label compounded products [2]. Market Demand - The PharmaPack program addresses a significant challenge in ophthalmology by providing reliable and affordable FDA-approved therapies, which has been a request from optometrists [4]. - The offering is expected to foster greater confidence among prescribers when considering FDA-approved branded alternatives to compounded products [4]. Availability and Expansion - Initially, PharmaPack kits will be available in California, Mississippi, Arkansas, Connecticut, and Alabama, with plans for nationwide expansion in the coming weeks [6].

Bausch Health to Participate in the J.P. Morgan Global Leveraged Finance Conference [Accessibility Statement] Skip NavigationLAVAL, QC, Feb. 17, 2026 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) today announced that Executive Vice President and CFO Jean-Jacques (JJ) Charhon, along with other management team members, will attend the J.P. Morgan Global Leveraged Finance Conference in Miami Beach, Florida, from March 2–4, 2026, to meet with investors.About Bausch HealthBausch Health Compan ...

ORLANDO, Fla., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Nutriband Inc. today announced that it has signed an exclusive distribution agreement with Costa Rica Based Innomedica for AVERSA Fentanyl upon approval and all sports tape products manufactured at its Pocono Pharmaceutical / Active Intell subsidiary. Innomedica will also be overseeing and financing all regulatory approvals for the above mentioned products as they ramp up for launch. About AVERSA™ Abuse-Deterrent Transdermal Technology Nutriband's AVERSA™ abu ...