Happy Thanksgiving Week!   It’s Turkey of the Year time again!One of our grand traditions here at Stock Gumshoe is the awarding of the annual Turkey of the Year trophy — this prize goes to the teaser pitch that provided us with the worst-performing, most-overhyped, or otherwise just the goofiest gobbler of the past twelve months.  We try to avoid those that were just bad luck or bad timing, like maybe a hotel or travel stock that was recommended a month before COVID hit, but, like creating a great Thanksgiv ...

Core Insights - Oryzon Genomics, a clinical-stage biopharmaceutical company, is a leader in epigenetics and focuses on personalized medicine for CNS disorders and oncology [3]. Upcoming Events - Oryzon management will participate in BIO-EUROPE from November 3-5 in Vienna, Austria, and the LSX Investival Showcase Europe 2025 on November 17 in London, UK [1][2]. - One-on-one meetings will be available during these conferences [2]. Company Overview - Founded in 2000 in Barcelona, Spain, Oryzon specializes in epigenetics and has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready for CNS) and iadademstat (Phase II for oncology) [3]. - The company is also developing ORY-4001, targeting HDAC-6 for potential applications in CMT and ALS [3]. - Oryzon has a robust platform for biomarker identification and target validation across various malignant and neurological diseases [3].

How much does it cost. >> It is a six-f figureure program. >> Like 100,000 or 500,000 or 800,000 cuz there's a big range.>> Much closer to 100,000 than 500,000. >> That's a lot of money. I mean, what do you get for that. You don't get I mean, you don't live forever.>> Nope. You're getting access to me, a team of a couple other physicians, a strength and conditioning team, a nutrition team, and what you're really getting is a path to help you achieve your goal of living longer and living Better. ...

[Music] [Applause] [Music] I'd like you to picture Thomas Edison tinkering away by himself. self inventing the modern light bulb or Jonas Sulk working tirelessly alone in his laboratory creating the polio vaccine or even Albert Einstein sitting in a secluded basement patent office quietly theorizing about special relativity. It's a romantic notion, right.Well, I'm here to tell you that that is the old paradigm. You see, science and especially biomedical science has grown so vast and complex that it can no l ...

Core Insights - Biodesix has signed an expanded partnership agreement with Bio-Rad to develop and clinically validate the ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer testing [1][2][4] - The assay will enable highly sensitive detection and quantification of multiple ESR1 mutations from ctDNA samples, which is critical for HR+/HER2- advanced breast cancer treatment [2][3] - Biodesix plans to offer the validated assay as a test service at its accredited CLIA-CAP laboratory and will seek reimbursement through the Centers for Medicare & Medicaid Services (CMS) [3] Company Developments - The first assay to be validated under the agreement is Bio-Rad's ddPLEX ESR1 Mutation Detection Assay, which is essential for the new generation of therapies known as oral selective estrogen receptor degraders (SERDs) [2] - Biodesix aims to improve clinical care and outcomes for patients through its diagnostic solutions, including the Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance [5] Market Impact - The emergence of ESR1 mutations as biomarkers for breast cancer has significantly increased global demand for rapid and sensitive assays in the oncology market [4] - The collaboration between Biodesix and Bio-Rad is expected to enhance access to sensitive biomarker detection for advanced breast cancer, addressing clinical needs with speed and precision [4] Upcoming Events - Both companies will present more details on their R&D visions, partnerships, and commercial roadmaps at the upcoming AMP conference scheduled for November 11-15 in Boston, MA [4]

Company Overview - Eagle Pharmaceuticals, Inc. is a fully integrated pharmaceutical company with expertise in research and development, clinical, manufacturing, and commercial sectors [2] - The company is dedicated to developing innovative medicines that significantly improve patients' lives [2] Product Portfolio - Eagle's commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), BYFAVO®, and BARHEMSYS® through its subsidiary Acacia Pharma Inc. [2] - The company has a pipeline focused on oncology and CNS/metabolic critical care, targeting underserved therapeutic areas across multiple disease states [2] Strategic Focus - Eagle is committed to developing medicines that have the potential to be integrated into the personalized medicine paradigm in cancer care [2]

Core Insights - Oculis Holding AG is showcasing its innovative late-stage pipeline at Eyecelerator and the American Academy of Ophthalmology (AAO) Annual Meeting, highlighting significant advancements in treatments for ophthalmic diseases [1][2]. Company Developments - The CEO of Oculis, Riad Sherif, will present updates on the late-stage pipeline, including the acceleration of Privosegtor into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy after a positive FDA meeting [2]. - The Phase 3 DIAMOND program for OCS-01 eye drops targeting diabetic macular edema is expected to provide topline readouts in Q2 2026 [2]. - A registrational trial for Licaminlimab in dry eye disease is anticipated to start in Q4 2025, utilizing a genotype-based approach [2]. Industry Context - Oculis is actively participating in multiple events at the AAO, including discussions on the role of eye drops like OCS-01 in treating diabetic macular edema, indicating a shift towards non-invasive treatment options [3][4]. - The company’s pipeline includes Privosegtor, which has shown neuroprotective effects in acute optic neuritis, and OCS-01, which aims to transform treatment paradigms for diabetic macular edema [6][10]. Product Information - Privosegtor is a novel peptoid small molecule candidate with potential applications in neuro-ophthalmic diseases, having received Orphan Drug designation from both the FDA and EMA [6]. - OCS-01 is an investigational high-concentration dexamethasone eye drop designed to treat diabetic macular edema non-invasively, addressing limitations of current treatments that require invasive delivery methods [10][12]. Market Need - There is a significant unmet medical need for effective treatments for conditions like acute optic neuritis and diabetic macular edema, with millions affected globally [8][12].

Core Insights - Oculis Holding AG is showcasing its innovative late-stage pipeline at Eyecelerator and the American Academy of Ophthalmology (AAO) Annual Meeting, highlighting significant advancements in treatments for ophthalmic diseases [1][2]. Company Developments - The CEO of Oculis, Riad Sherif, will present updates on the late-stage pipeline, including the acceleration of Privosegtor into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy after a positive FDA meeting [2]. - The Phase 3 DIAMOND program for OCS-01 eye drops targeting diabetic macular edema is expected to provide topline readouts in Q2 2026 [2]. - A registrational trial for Licaminlimab in dry eye disease is anticipated to start in Q4 2025, utilizing a genotype-based approach [2]. Industry Participation - Oculis will participate in multiple events at the AAO, including Innovate Retina and the Society for Artificial Intelligence in Vision and Ophthalmology (SAIVO), discussing the future of eye drop treatments for diabetic macular edema [3][4]. - The company will also support the COPhy Satellite Symposium during the AAO Annual Meeting [5]. Product Pipeline - Privosegtor is a novel peptoid small molecule candidate showing potential as the first neuroprotective therapy for acute optic neuritis, with positive results from the ACUITY Phase 2 trial indicating neuroprotective effects [7]. - OCS-01 is an investigational high-concentration dexamethasone eye drop designed to treat diabetic macular edema non-invasively, aiming to transform treatment paradigms in this area [11][12]. - Licaminlimab is being developed as a topical anti-TNFα treatment for dry eye disease, currently in Phase 2 trials [14]. Market Context - Diabetic macular edema affects approximately 37 million people globally, with projections indicating an increase to 53 million by 2040, highlighting the urgent need for effective treatments [13]. - Acute optic neuritis and non-arteritic anterior ischemic optic neuropathy represent significant unmet medical needs, with no approved therapies currently available [9][10].

Healthcare Industry Challenges - The current healthcare system often prioritizes efficiency over human connection, leading to patients feeling unseen during consultations, with an average consultation time of approximately 7 minutes [1][2] - Traditional medicine relies on averages, neglecting the unique biological, genomic, lifestyle, and environmental factors of each individual [12][13] Personalized Medicine & Technology - PMX Health utilizes technology to collect and interpret patient health data, identify early risk markers, and provide doctors with a more complete understanding of the patient's story before the consultation begins [6] - Personalized medicine focuses on individual data, health goals, and stories to design customized treatment plans, moving away from a one-size-fits-all approach [13] - Technology can facilitate a healthcare system that benefits both patients and doctors, enabling doctors to practice medicine with a focus on what matters most: patient care and understanding [15][16] Patient Outcomes & Benefits - Personalized medicine leads to improved patient outcomes, including lifestyle and nutrition plans tailored to individual needs, better management of chronic conditions, and early identification of potential health risks [8][9][11] - Patients feel more understood and in control of their health when healthcare is personalized, leading to increased confidence and improved healing [7][10][14][17]

Core Insights - VolitionRx Limited has signed a co-marketing agreement with Hologic Diagenode to promote its Nu.Q Discover service, which focuses on epigenetic profiling for drug developers and scientists [1][3][4] Company Overview - VolitionRx is a multi-national epigenetics company dedicated to advancing the science of epigenetics, aiming to improve outcomes for patients through earlier detection and monitoring of diseases [12][13] - Hologic, a company with over $4 billion in revenue for 2024, specializes in medical technologies and has extensive experience in various disease areas, including oncology and immunology [5][10] Product and Market Potential - The Nu.Q Discover service offers state-of-the-art assays for rapid epigenetic profiling, with an estimated total addressable market of $200 million annually [4][7] - The partnership aims to expand customer access to Nu.Q Discover assays, potentially leading to Hologic becoming an exclusive provider of these services [3][4] Strategic Goals - The collaboration is expected to enhance the reach of Nu.Q Discover services, leveraging Hologic's established client base and international presence [5][6] - Both companies aim to create value for clients by identifying specific epigenetic signatures that can inform personalized medicine approaches [6]