MADRID and CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, today announced that Maxim LLC, a U.S.-based investment bank, has initiated research coverage of the company, effective July 18, 2025. This milestone reflects Oryzon's ongoing commitment to transparency and proactive communication with the investment community. Over the years, the company has consistently ...

Core Viewpoint - Biomerica, Inc. has received a Current Procedural Terminology (CPT) code for its inFoods IBS test, which will facilitate insurance reimbursement and expand patient access starting October 1, 2025 [1][2][10]. Group 1: Commercialization and Patient Access - The issuance of the PLA code is a significant milestone in Biomerica's strategy to commercialize the inFoods IBS test, enhancing transparency in claims submission and adjudication [3][4]. - The PLA code will streamline the claims process, supporting the goal of increasing adoption of the inFoods technology among patients and physicians [4][9]. - The inFoods IBS test is designed to identify food triggers for IBS symptoms, providing a personalized dietary therapy alternative to traditional medications [5][13]. Group 2: Market Need and Financial Implications - IBS affects approximately 10% to 15% of adults in the U.S., leading to up to $10 billion in direct annual medical costs, highlighting a substantial unmet need in the market [6]. - The inFoods IBS test offers a scientifically validated, non-invasive solution aimed at improving symptom control and quality of life for patients [6][9]. Group 3: Clinical Validation and Effectiveness - Results from a randomized, controlled clinical trial published in June 2025 demonstrated that patients following a diet based on inFoods test results experienced significantly greater symptom reduction compared to those on a placebo diet [7][14]. - The study showed that 59.6% of patients in the treatment group achieved the FDA's endpoint for abdominal pain reduction, compared to 42.2% in the control group [17]. Group 4: Long-Term Value Creation - The PLA code issuance enhances reimbursement transparency for the inFoods IBS test, aligning with the company's mission to provide personalized, non-drug solutions for chronic conditions [9][11]. - As insurance coverage expands and clinical evidence accumulates, the inFoods IBS test is positioned to become a key tool in managing IBS and related gastrointestinal disorders [9].

Core Insights - Oryzon Genomics is hosting a virtual KOL event to discuss the unmet medical needs in Borderline Personality Disorder (BPD) and the design of vafidemstat's Phase III PORTICO-2 trial [1] - The event will address the lack of approved pharmacological treatments for BPD and the limitations of off-label medications, emphasizing the importance of addressing agitation and aggression in BPD and other psychiatric conditions [1] - Vafidemstat is highlighted as a promising treatment option due to its novel epigenetic mechanism of action, with ongoing discussions about its potential applications in BPD, schizophrenia, and autism spectrum disorder (ASD) [1] Company Overview - Oryzon Genomics, founded in 2000 in Barcelona, Spain, is a clinical-stage biopharmaceutical company specializing in epigenetics and personalized medicine for CNS disorders and oncology [9] - The company has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [9] - Oryzon is also focused on biomarker identification and target validation for various malignant and neurological diseases [9] Vafidemstat Details - Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor that has shown efficacy in reducing cognitive impairment and neuroinflammation, as well as having neuroprotective effects [10] - The drug has demonstrated positive results in multiple Phase IIa clinical trials, including studies on aggression in psychiatric disorders and Alzheimer's disease [10] - Vafidemstat is advancing towards a Phase III trial in BPD following the completion of the Phase IIb PORTICO trial, with plans to investigate its effects on agitation and aggression [10]

Core Insights - Smith+Nephew has introduced a new medial stabilized insert for its LEGION Total Knee System, reflecting a significant trend in knee arthroplasty procedures, with medial stabilized inserts increasing from 4% in 2018 to 32% in 2023 [1][4] Product Development - The new medial stabilized design allows for use with or without the Posterior Cruciate Ligament (PCL), indicating a shift from Posterior Stabilized (PS) designs to more bone-conservative Cruciate Retaining (CR) femoral designs [2] - The medial stabilized design features a larger anterior medial lip and medial pivot kinematics that mimic the natural knee [3] Market Trends - US registry data shows that one in three total knee replacements now utilize a medial stabilized design, highlighting a growing preference among surgeons for solutions that provide natural kinematics and improved patient satisfaction [4] - The LEGION TKS has over 20 years of clinical success, and the new insert aligns with rapidly growing market trends for advanced knee solutions [6] Strategic Positioning - The LEGION Medial Stabilized TKS is positioned as a leading option in the market, combining advanced kinematics, porous fixation, and integration with technologies like the CORI Surgical System [4][7] - The medial stabilized insert will be available in the US on a limited basis, with a full commercial release planned for 2025 and an introduction in Canada in 2026 [7]

Core Insights - Hydreight Technologies Inc. has launched a direct-to-consumer genetic testing and personalized wellness solution through its VSDHOne platform, expanding access to precision-based care [1][2][8] Group 1: Product Offering - The new offering allows patients to access at-home DNA testing kits and receive personalized health plans based on their genetic profiles, including insights on nutrition, fitness, supplementation, and medication compatibility [2][5] - Key features of the offering include at-home DNA swab kits, lab-based genetic sequencing, personalized health recommendations, and consultations with licensed prescribers [11][12] Group 2: Market Positioning - The launch positions Hydreight's extensive network of over 3,000 nurses, 200 physicians, and 400 direct-to-consumer brands to provide this service, enhancing revenue and patient retention through personalized care [4][7] - The global consumer genomics market is projected to exceed $50 billion by 2030, with the at-home testing market expected to surpass $15 billion by 2028, indicating strong growth potential for Hydreight's new offering [6] Group 3: Business Model - The offering is structured around a subscription-based model, generating upfront revenue from testing and recurring monthly revenue from tailored health regimens and supplement delivery [9] - The integration into the VSDHOne platform allows for immediate embedding of genetic testing into existing offerings, driving higher customer retention and lifetime value [9] Group 4: Strategic Goals - Hydreight's genetic testing initiative aligns with its 2025 priorities, which include expanding high-margin white-label services, scaling onboarding of licensed direct-to-consumer brands, and launching new wellness categories [10][16]

Core Viewpoint - PacBio has entered a strategic distribution agreement with Haorui Gene to enhance the adoption of its HiFi sequencing technology in China, particularly in clinical diagnostics and precision medicine [1][2][4]. Company Summary - The partnership with Haorui Gene allows PacBio to access a broader clinical laboratory network in China, which is expected to accelerate the adoption of its long-read sequencing platforms [1][4]. - PacBio's market capitalization is currently $294.4 million, with an anticipated earnings growth of 16.8% by 2025 [5]. - Following the announcement of the distribution agreement, PacBio's shares closed at $1.12, reflecting a year-to-date decline of 48.6% compared to the industry’s 9.7% decline [3]. Industry Summary - The global long-read sequencing market is projected to grow from an estimated size of $538.9 million in 2024, with a compound annual growth rate (CAGR) of 20.12% from 2025 to 2030 [12]. - Key drivers of market growth include the increasing prevalence of genetic diseases, the rise of personalized medicine, and advancements in technology leading to new sequencing methods [13].

Financial Data and Key Metrics Changes - The company reported USD 206 million in cash on hand as of March, with no debt, providing a runway into early 2028 [4] - The company aims to file for NDA in the second half of next year if Phase III trial results are positive [15] Business Line Data and Key Metrics Changes - OCS-one, targeting diabetic macular edema (DME), showed a 7.2 letter gain in BCVA at week six, increasing to 7.6 at week twelve, with 25.3% of patients gaining 15 letters or more at week six, improving to 27.4% at week twelve [10] - Privel Sector for acute optic neuritis achieved a 43% reduction in retinal ganglion cell thickness at month three, maintained to month six, and an 18 letters improvement in low contrast visual acuity compared to placebo [21] - Lickminumab for dry eye disease demonstrated a negative 0.12 in inferior corneal staining, outperforming Xiidra, with six times better results for patients with TNFR1 genotype [32] Market Data and Key Metrics Changes - The addressable market for DME in the U.S. is estimated at 1.3 million patients, with only 0.5 million currently treated [14] - The market for acute optic neuritis has no approved neuroprotective therapies, indicating a significant opportunity for Privel Sector [18] - The potential market for multiple sclerosis is large, with 2.8 million affected worldwide and 170,000 estimated relapses per year in the U.S. [24] Company Strategy and Development Direction - The company is expanding its pipeline beyond ophthalmology into neuro ophthalmology, targeting large unmet needs with innovative products [33] - The strategy includes being the first-line treatment for early intervention in DME and addressing inadequacies in current treatments [13][15] - Plans to meet with the FDA to discuss registrational studies for acute optic neuritis and to advance investigational trials for new indications [28] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant unmet needs in the ophthalmic and neuro-ophthalmic markets, emphasizing the potential for their innovative treatments to fill these gaps [33] - The company is well-positioned to generate multiple value catalysts in the coming quarters, with ongoing trials and expected results [33] Other Important Information - The company has completed patient enrollment for its Phase III trials for OCS-one, with results expected in Q2 of 2026 [12] - The management team is experienced and supported by leading international healthcare investors [4] Q&A Session All Questions and Answers Question: What are the next steps for the Privel Sector? - The company is moving full steam ahead on the investigational program for acute optic neuritis and adding two new indications: acute relapses in multiple sclerosis and NAION [23][28]

Core Insights - Oculis Holding AG reported significant advancements in its clinical portfolio, including the completion of patient randomization in Phase 3 trials and the initiation of a genotype-based development program in ophthalmology [2][5][6] - The company is well-positioned for future growth with a strengthened financial position and several upcoming value inflection points [2][5] Clinical Developments - Oculis completed randomization of over 800 patients in the Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01, with topline results expected in Q2 2026 [5][7] - Licaminlimab (OCS-02) is set to initiate its first registrational trial in the second half of 2025, focusing on a personalized medicine approach for dry eye disease [5][12] - Privosegtor (OCS-05) demonstrated promising neuroprotective effects in the ACUITY trial for acute optic neuritis, with plans for a global registration program [5][6][12] Financial Overview - As of March 31, 2025, Oculis reported cash, cash equivalents, and short-term investments totaling $206.3 million, bolstered by a $100 million financing in February 2025 [5][12] - Research and development expenses for Q1 2025 were $16.4 million, an increase from $12.4 million in Q1 2024, primarily due to active clinical trials [12][16] - The net loss for Q1 2025 was $36.9 million, compared to $18.4 million in the same period in 2024, driven by clinical development advancements and increased general and administrative expenses [12][16] Market Opportunity - Diabetic macular edema (DME) currently affects approximately 37 million people globally, representing a market opportunity of around $5 billion [6]

Core Insights - Oculis Holding AG is presenting its innovative late-stage pipeline at major ophthalmology conferences, including Eyecelerator 2025, ARVO Annual Meeting, and Retina World Congress [1][2][3] Pipeline Developments - The DME AWARE Delphi Study interim results will focus on unmet needs in diabetic macular edema (DME) patient management, with insights from the Phase 3 DIAMOND program on OCS-01 eye drops [2][7] - OCS-01 is being developed as the first non-invasive treatment for DME, addressing the need for earlier intervention and for patients who do not respond adequately to current treatments [2][13] - Licaminlimab (OCS-02) is being investigated for dry eye disease (DED) and has shown positive results in Phase 2 trials, with a genetic biomarker identified to predict patient response [3][16] Conference Presentations - Oculis will showcase its developments at the following events: - Eyecelerator 2025 on May 2, 2025, featuring TKI and Drug Delivery [4] - ARVO Annual Meeting on May 5, 2025, presenting interim results of the DME AWARE Delphi Study [7] - Retina World Congress on May 8, 2025, discussing Licaminlimab in DED treatment [7] Market Context - DME currently affects approximately 37 million people globally, with projections to rise to 53 million by 2040 due to increasing diabetes prevalence [15] - DED impacts over 110 million people in G7 countries, with a significant portion of patients remaining unsatisfied with current treatment options [18][19] Company Overview - Oculis is a biopharmaceutical company focused on addressing significant unmet medical needs in ophthalmic and neuro-ophthalmic diseases, with a pipeline that includes OCS-01 for DME and Licaminlimab for DED [20]

Core Viewpoint - Interpace Diagnostics will cease offering the PancraGEN test due to the end of Medicare reimbursement, but the company expects to remain profitable through its thyroid-focused testing services [1][3]. Group 1: Company Overview - Interpace Diagnostics is a subsidiary of Interpace Biosciences, focusing on personalized medicine and molecular diagnostic tests [4]. - The company has three commercialized molecular tests: ThyGeNEXT, ThyraMIRv2, and RespriDX, along with BarreGEN currently in clinical evaluation [5]. Group 2: Impact of Reimbursement Changes - The Genetic Testing for Oncology Local Coverage Determination (LCD) by Novitas Solutions will end reimbursement for the PancraGEN test, effective May 2, 2025 [1][2]. - PancraGEN has been utilized for over a decade to assess the risk of pancreatic cyst progression to cancer, primarily for Medicare patients [2][3]. - The loss of reimbursement will require Interpace to restructure its operations, although the company believes it can sustain profitability without PancraGEN [3]. Group 3: Future Outlook - The company anticipates that its testing franchise for indeterminate thyroid nodules, specifically ThyGeNEXT and ThyraMIRv2, will support continued profitability in 2025 and beyond [3].