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InMed Provides Update on Pharmaceutical Development Programs - Advancing Lead Drug Candidates Towards IND and Clinical Trial
TMX Newsfile· 2026-03-09 11:30
Core Insights - InMed Pharmaceuticals is advancing its Alzheimer's disease program, particularly focusing on the INM-901 drug candidate, with plans to initiate a Phase 1 clinical trial in 2027 [1][3][10] INM-901 Program Outlook - INM-901 is a proprietary, orally bioavailable small molecule drug candidate that targets neuroinflammation in Alzheimer's disease by acting as a CB1/CB2 signaling agonist [3][4] - The company has generated preclinical evidence showing that INM-901 reduces inflammatory biomarkers and neurodegenerative markers, indicating its potential therapeutic effects [4][9] - The program aims to clarify its focus on neuroinflammation, which is believed to be a primary driver of Alzheimer's progression, rather than a secondary effect [4][5] Development Plans for 2026 - The company plans to conduct a pre-IND meeting with the FDA in Q3 2026 to discuss the INM-901 program, which is seen as a critical milestone [3][10] - Continued development of INM-089, a candidate for dry age-related macular degeneration, is also planned, with a pre-IND meeting targeted for Q4 2026 [6][10] - The company is executing IND-enabling pharmacology and toxicology studies, with a focus on advancing drug substance and product development [9][10] Scientific and Operational Progress - Significant progress has been made in understanding the anti-neuroinflammatory effects of INM-901, with data supporting its multifactorial mechanism of action [2][5] - Preclinical studies have shown improvements in cognitive function and neuronal regeneration, reinforcing the drug's potential efficacy [9][10] - The company is also working on optimizing drug formulation and scaling up manufacturing processes to support future studies [9][10]
Corbus Pharmaceuticals Reports Q4 and 2025 Financial Results and Provides a Corporate Update
Globenewswire· 2026-03-09 11:30
Core Insights - Corbus Pharmaceuticals is focused on developing new therapies in oncology and obesity, with promising data for CRB-701 and CRB-913 expected to drive significant developments in 2026 [2][11]. Corporate and Program Updates - CRB-701 is a next-generation antibody-drug conjugate targeting Nectin-4, with Fast Track designations from the FDA for treating head and neck squamous cell carcinoma (HNSCC) and cervical cancer [3]. - CRB-913 is an oral CB1 inverse agonist aimed at obesity treatment, showing rapid weight loss and favorable gastrointestinal tolerability [4]. - Data presented at ESMO 2025 indicated an unconfirmed objective response rate for CRB-701 of 47.6% in HNSCC, 37.5% in cervical cancer, and 55.6% in bladder cancer, with no severe treatment-related adverse events reported [5][6]. Financial Results - For Q4 2025, the company reported a net loss of approximately $20.6 million, compared to a net loss of $9.5 million in Q4 2024, reflecting an increase in operating expenses primarily due to clinical development [8][9]. - Operating expenses rose to approximately $22.0 million in Q4 2025 from $12.6 million in Q4 2024 [9]. - The company had $163.3 million in cash and equivalents as of December 31, 2025, following a public offering that raised $75 million, which is expected to fund operations into 2028 [10].
Medicus Pharma Provides Interpretation of Positive Phase 2 SkinJect™ Dataset
Globenewswire· 2026-03-09 11:30
Core Insights - Medicus Pharma Ltd. reported a 73% clinical clearance in the 200-µg cohort at Day 57 of the Phase 2 SKNJCT-003 study evaluating SkinJect® for basal cell carcinoma (BCC) [1][2][3] Clinical Efficacy - The 200-µg treatment cohort achieved 73% clinical clearance and 40% histological clearance, indicating a strong treatment response [2][5] - The clinical response showed a clear separation between the D-MNA treatment arm (73%) and the P-MNA treatment arm (38%) [3][10] - The results suggest that a significant proportion of treated lesions achieved both visual and histological clearance, supporting the therapeutic potential of the SkinJect platform [5][10] Biological Mechanism - The biological activity observed in the P-MNA cohort aligns with known mechanisms in intratumoral device therapies, indicating that microneedle delivery can produce localized biological responses contributing to tumor regression [6][7] - Microneedle insertion creates localized micro-injury, activating wound-healing pathways and immune signaling, which may enhance treatment efficacy [7][9] Strategic Development - The dataset is considered decision-grade evidence, supporting advancement toward regulatory discussions and potential strategic partnerships [4][14] - The company plans to engage in an End-of-Phase-2 meeting with the FDA to determine the optimal registrational development pathway [15][16] Clinical Impact - The 73% clinical clearance suggests that approximately three out of four treated lesions may achieve visual tumor clearance, potentially reducing the need for surgical intervention [11][12] - This treatment approach may be particularly beneficial for patients with Gorlin Syndrome, who often face multiple surgical procedures due to recurrent basal cell carcinomas [13] Future Directions - The company aims to continue evaluating the 200-µg dose, optimize patch application duration, and refine treatment intervals as part of its development strategy [16][17] - Medicus is focused on assembling decision-grade clinical and regulatory data to support a partnering-focused model for late-stage development and commercialization [18]
Pfizer's eczema drug meets main goal in mid-stage trial, plans late-stage study
Reuters· 2026-03-09 11:27
Core Viewpoint - U.S. drugmaker Pfizer announced that its experimental drug for a chronic skin disease successfully met the primary endpoint in a mid-stage clinical trial [1] Group 1 - Pfizer's experimental drug targets a chronic skin disease [1] - The mid-stage study results indicate positive efficacy for the drug [1]
Xenon Pharma's epilepsy drug meets main goal in late-stage trial
Reuters· 2026-03-09 11:26
Core Viewpoint - Xenon Pharmaceuticals' experimental epilepsy drug azetukalner has successfully met its primary endpoint by demonstrating a statistically significant reduction in focal onset seizures during a late-stage trial [1] Company Summary - Xenon Pharmaceuticals plans to submit a marketing application for azetukalner to the U.S. Food and Drug Administration in the third quarter [1] - Following the announcement, shares of Xenon Pharmaceuticals increased by 16.5% in premarket trading [1] Industry Summary - The drug is aimed at treating focal onset seizures, a specific type of epilepsy that originates in one area of the brain [1]
ARS Pharmaceuticals (NasdaqGM:SPRY) Earnings Call Presentation
2026-03-09 11:00
NASDAQ: SPRY neffy – the transformative needle -free solution for severe allergic reactions March 2026 Corporate Presentation Forward-looking statements Statements in this presentation that are not purely historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this presentation include, without limitation, statements regarding: the potential market, demand and expansion opportunities for neffy; the belief ...
Olatorepatide Obesity Treatment Licensed by Regeneron Demonstrates Positive Phase 3 Results in Chinese Patients
Globenewswire· 2026-03-09 11:00
Core Insights - Regeneron Pharmaceuticals announced positive topline data from a Phase 3 trial of olatorepatide, a dual GLP-1/GIP receptor agonist, showing up to 19% body-weight loss in patients at week 48 [1][2] - The trial, conducted by Hansoh Pharmaceutical, involved 604 adults in China and met its co-primary endpoints, demonstrating significant weight loss compared to placebo [2][6] - Olatorepatide exhibited favorable gastrointestinal tolerability, with low rates of nausea and vomiting [3] Group 1: Trial Details - The Phase 3 trial was randomized, double-blind, and placebo-controlled, conducted across 33 clinical sites in mainland China [2][6] - Participants were randomized into four cohorts receiving either 5 mg, 10 mg, or 15 mg of olatorepatide or placebo, evaluated over 48 weeks [2][6] - Up to 97% of participants treated with olatorepatide achieved at least 5% weight loss at week 48 [2] Group 2: Company Strategy and Pipeline - Regeneron holds exclusive rights for clinical development and commercialization of olatorepatide outside Greater China, while Hansoh retains rights within Greater China [1][5] - The company is advancing into a global Phase 3 registrational program later this year, with detailed trial data expected to be presented at an upcoming medical meeting [1][4] - Regeneron is focused on developing a pipeline that addresses obesity and related metabolic diseases, aiming to enhance the quality of weight reduction [7]
Pfizer's Phase 2 Study of Trispecific Antibody Positive in Moderate to Severe Atopic Dermatitis
Businesswire· 2026-03-09 10:45
Core Insights - Pfizer Inc. announced positive topline results from a Phase 2 study of tilrekimig (PF-07275315) for adults with moderate to severe atopic dermatitis [1] - The study achieved its primary efficacy endpoint, showing a statistically significant increase in the percentage of participants reaching EASI-75 at Week 16 compared to placebo [1] Study Details - The Phase 2 study evaluated the efficacy of tilrekimig in adults suffering from moderate to severe atopic dermatitis [1] - In Stage 2 of the study, the focus was on assessing the effects of monthly dosing [1]
Hims & Hers Stock Soars 54%. It's Struck a Truce With Novo Nordisk, Report Says.
Barrons· 2026-03-09 10:33
Core Viewpoint - Hims & Hers Health stock experienced a significant increase of 54% following reports of a truce with Novo Nordisk, a major player in the pharmaceutical industry known for its anti-diabetic medications Ozempic and Wegovy [1]. Company Summary - Hims & Hers Health is a telehealth platform that has recently resolved its ongoing dispute with Novo Nordisk, which is expected to positively impact its stock performance [1]. - The resolution of the conflict with Novo Nordisk is a pivotal development for Hims & Hers, potentially enhancing its market position and investor confidence [1]. Industry Summary - Novo Nordisk is recognized for its leading anti-diabetic medications, including Ozempic and Wegovy, which are significant products in the healthcare market [1]. - The agreement between Hims & Hers and Novo Nordisk may indicate a trend towards collaboration in the healthcare sector, particularly among telehealth platforms and traditional pharmaceutical companies [1].
Hims & Hers stock rockets on reported end to Novo Nordisk weight-loss drug dispute
MarketWatch· 2026-03-09 09:45
Core Insights - Hims & Hers shares experienced a nearly 50% increase in premarket trading following the announcement of a partnership with Novo Nordisk, resolving a prior dispute [1] Company Summary - Hims & Hers has successfully ended a dispute with Novo Nordisk by forming a partnership with the Danish pharmaceutical company [1] - The partnership is expected to enhance Hims & Hers' market position and potentially drive future growth [1] Industry Context - The collaboration between Hims & Hers and Novo Nordisk highlights the increasing trend of partnerships in the pharmaceutical and health sectors to leverage strengths and expand market reach [1]