William Stilley

Decentralized (virtual) clinical trials and remote patient monitoring are powerful, innovative pharma tools. But they are not simple for pharma to use. Adoption is slow for a myriad of reasons! #DCT #RPM #virtualtrials #remotepatientmonitoring

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The pharmaceutical industry is abuzz with Acadia Pharmaceuticals Inc. Pharmaceuticals' recent licensing of SAN711, a groundbreaking first-in-class drug developed by Saniona. This innovative medication is poised to revolutionize the treatment of essential tremor, a challenging neurological movement disorder. The strategic move includes a robust Phase 2 study set to commence in 2026, indicating a significant step towards addressing a longstanding gap in essential tremor therapy. Acadia's acquisition of SAN711 not only broadens its product portfolio but also underscores its dedication to advancing solutions for central nervous system ailments. This collaboration holds promise for patients grappling with essential tremor, a condition that has seen minimal therapeutic advancements over the years, emphasizing the urgent need for effective treatments in this area. Financially, the agreement involves a substantial $28 million upfront payment to Saniona, with the potential for milestone payments totaling up to $582 million contingent on developmental achievements and commercial success. Saniona stands to benefit from tiered royalties based on future net sales of SAN711, ranging from mid-single to low double-digits. Acadia's commitment extends beyond financial transactions, encompassing clinical development, regulatory procedures, and global marketing efforts, highlighting their confidence in SAN711's market potential. This collaboration propels Acadia towards exploring uncharted therapeutic territories and addressing a critical medical necessity. The success of SAN711 could herald significant growth and revenue for Acadia while offering a ray of hope for individuals battling essential tremor. The upcoming Phase 2 study in 2026 holds immense importance, serving as a pivotal juncture to evaluate SAN711's efficacy and chart its regulatory journey towards potential commercialization. The results of this study carry profound implications for the future landscape of essential tremor management, potentially enhancing the quality of life for numerous affected individuals. Acadia's substantial investment underscores their belief in SAN711's transformative capabilities and the lucrative market prospects it presents. 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞: https://lnkd.in/df3ajqu7 Jennifer Fiorenza Diane Harvey

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Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (NASDAQ: EPRX) (TSX: EPRX), a clinical-stage biotechnology company, today unveiled new pharmacokinetic ("PK") data from its Phase 2a Eosinophilic Esophagitis ("#EoE") program. Management believes these data underscore the unique capabilities of Eupraxia's proprietary DiffuSphere™ platform technology, which aims to provide precise, localized, safe, and effective long-lasting drug delivery. Most conventional drugs release in a pattern characterized by steep peaks and rapid declines in drug concentration, where peaks often lead to negative side effects, and troughs result in reduced efficacy. In contrast, #DiffuSphere™ is a unique microsphere that is designed to enable #precisedrugrelease into target tissues with a flat, stable, and long-lasting profile, minimizing potential adverse events associated with high-dose systemic delivery. What sets DiffuSphere™ apart is its composition: a pure drug crystal encased in a microns-thick polymer shell. Eupraxia's #proprietary #technology uses this polymer to precisely control a drug's release, ensuring high drug concentrations in the target tissues while minimizing exposure to the rest of the body. This #innovative approach has been observed in Eupraxia's clinical programs, demonstrating precision, tolerability, and extended duration of delivering fluticasone propionate ("FP") directly to the intended tissues for EoE and knee osteoarthritis ("OA") patients. #biotech #pharma #investing #mergers https://lnkd.in/gX8fii4X

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Eupraxia Pharmaciticals (NASDAQ: EPRX) One of three patients in Cohort 5 achieved complete histological remission at 12 weeks. Consistent improvement in patient-reported outcomes with six of six evaluable patients in the fourth and fifth cohorts experiencing a reduction in symptom (SDI1) scores at 12 weeks. At 24 weeks, the fourth cohort experienced the largest average reduction in SDI scores of all cohorts to date. The fifth cohort continued to show improved patient outcomes with the greatest percentage change in histology (EoEHSS2) scores of any cohort to date. Both the mean reduction in Peak Eosinophil Counts (PEC3)at four biopsy sites and the percent change in histology (EoEHSS2) scores showed a clear dose response across Cohorts 3 to 5, with Cohort 5 showing the greatest response. No serious adverse events reported in any of the five cohorts to date. Cohort 6 is now fully enrolled and dosed, with 12-week data anticipated in Q1 2025.

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Cell Life products derived from porcine sources offer several distinct advantages over stem cell therapies. European "Cell Therapy" is widely used in Europe today with amazing success. As the sole importer of these products into the USA we offer a great alternative to anti-aging and holistic approaches. Targeted Specificity Unlike stem cells, which have the potential to differentiate into various cell types, Cell Life products are organ-specific. This means they are designed to interact exclusively with the receptor sites of their corresponding organs. For example: -Hypothalamus extracts target the hypothalamus -Adrenal extracts target the adrenal glands This targeted approach ensures a more precise and controlled therapeutic effect. Practical Benefits Cost-Effectiveness: Porcine extracts are generally more affordable than stem cell therapies, making them accessible to a broader range of patients. Availability: Sourced from various porcine tissues and organs, these extracts are readily available and do not face the same supply constraints as stem cells. Ethical Considerations: The use of porcine extracts avoids the ethical debates surrounding certain stem cell sources. Consistency and Administration Standardized Composition: Porcine extracts offer a consistent formulation, ensuring reliable therapeutic effects across batches. Non-Invasive Delivery: These products can be administered orally, eliminating the need for invasive procedures often associated with stem cell treatments. By combining targeted action with practical advantages, porcine tissue extracts present a compelling alternative for regenerative and anti-aging therapies. Visit us at CellLifeUSA.com to find out more.

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Our portfolio company NurExone Biologic (TSXV: NRX)(OTCQB:NRXBF)(FSE: J90) is picked as onne of the top biotech stock to watch on 10x Research The hub for stocks with 10x potential, small market caps, visionary leadership whose interests are aligned with shareholders and above all, see massive opportunities to grow into. NurExone Biologic (TSXV: NRX)(OTCQB:NRXBF)(FSE: J90) is advancing regenerative medicine with its innovative, non-invasive therapies for Central Nervous System (CNS) injuries. Their lead product, ExoPTEN, has shown promising results in preclinical studies, restoring motor function in 75% of rats with acute spinal cord injuries. What makes ExoPTEN unique is its intranasal delivery, offering a less invasive option than traditional treatments. A key finding is that ExoPTEN remains effective up to a week after injury, extending the treatment window and giving more patients a chance to recover. Dr. Lior Shaltiel, CEO of NurExone, highlights how this could expand patient eligibility, improve outcomes, and ease clinical trial recruitment. With 500,000 new spinal cord injuries reported globally each year, this approach has significant potential to change lives. Lior Shaltiel, PhD https://lnkd.in/deMACKN2

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Bob Nelsen, co-founder of ARCH Venture Partners, emphasizes the firm's pursuit of home runs in drug development.... ...ARCH's recent $3 billion fund, slightly larger than the previous $2.97 billion fund, reflects the firm's focus on groundbreaking ventures like AI bio Xaira Therapeutics. This spring, Xaira Therapeutics raised $1 billion, marking one of biotech's largest company launches... ...Nelsen highlighted the thorough diligence process by LPs, despite the challenging investment landscape. Noteworthy developments coincide with ARCH's fund announcement, including a potential FDA approval for a schizophrenia treatment from one of its neuroscience bets. The firm's strategic approach continues to draw attention in the venture capital landscape, alongside recent fund announcements by other industry players. ARCH Venture Partners #advancedtherapies #funding #financing #biotech #biotechnology #regenerativemedicine #lifesciences #lifescience #celltherapy #genetherapy #geneticmedicine Bain Capital Flagship Pioneering #venturecapital #duediligence

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Epoch 48: Regulatory & Geopolitical Forces Shaping Biotech 👉 Bio-politics 👉 New drug approvals 👉 New potential blockbusters 👉 Modality trends 👉 BioSecure Act https://lnkd.in/dEkBy2bY

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🔥 Some very exciting investments over the last week or so! 🧬 Some really innovative companies and advancements! City Therapeutics ($135M): A Cambridge, MA-based biopharmaceutical company, raised $135 million in Series A funding to advance its RNAi-based medicine. Maven Clinic ($125M): A New York-based virtual clinic for women's and family health, Maven Clinic raised $125 million in Series F funding to enhance its partnerships in maternity care. Purespring Therapeutics ($105M): A London-based gene therapy company, they raised $105 million in Series B funding to support its pipeline, including initiating a Phase I/II clinical trial for IgAN. Glooko ($100M): Digital health company, Glooko raised $100 million in Series F funding to accelerate the global expansion of its digital healthcare platform for diabetes management. Cytovale ($100M): A SF-based company founded secured a $100 million Series D funding to develop rapid tests for early detection of sepsis. This accelerate bringing their innovative tools to market. Orasis Pharmaceuticals: Raised $78 million to launch Qlosi™, a new eye drop for the treatment of presbyopia. ShiraTronics, Inc.: Raised $66 million to support its FDA-approved pivotal trial, RELIEV-CM2, and seek premarket approval for its migraine therapy system. Basecamp Research: Raised $60 million to expand its data collection, strengthen its AI capabilities, and invest in computing to tackle more complex tasks in the life sciences. Arda Therapeutics Raised $43 million to expand its operations and development efforts in targeted cell depletion therapies for chronic diseases. Eleanor Health: Raised $30 million to expand its outpatient addiction treatment services. MARAbio Raised $19 million to support the commercial launch of its autism test in 2025 and the development of therapeutic interventions. Lymphatica Medtech: Raised €17.9 million to accelerate the clinical development and validation of LymphoDrain, an implantable device designed to treat lymphedema. Centaur Labs: Raised over $16 million to expand its operations and development efforts in health data annotation. Somagenetix: Raised CHF10 million to advance its leading gene therapy candidate, SGX-001, for phagocyte disorders. MiLaboratories: Raised an undisclosed amount to create software solutions that enhance biological research and development. Amprion Raised $6 million to expand its commercial reach and invest in research and development to improve brain disease diagnosis. Booster Therapeutics: Raised $15 million in seed funding. clock.bio: Raised $5.3 million to build its "Atlas of Rejuvenation Factors" by identifying genes influencing aging. LEVY Health Raised $4.5 million to integrate its virtual care pathways with electronic medical record software and expand its offerings to women's health and reproductive care. ALPHA FUSION INC. Raised ¥1.02 billion to expand its research and development efforts in targeted alpha therapy using Astatine-211 for cancer treatment.

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Wondering how you will navigate the new FDA stance on LDTs? We are here to discuss strategies and paths to success. Contact i5 BioPartners to learn more.

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RApport's twice yearly analysis of biotech sector trends published today, with author Peter Kolchinsky noting that the first half of 2024 was a relatively quiet one for the public development-stage biotech universe, which has been gradually recovering from the last downturn. Do you know your Core from your Peripheral? How 2024 stacks up, M&A-wise, to prior years? How many years of free cash flow it would take the industry's strategic buyers to acquire the entire biotech universe for a 100% premium? Jump in to our Semper Maior report to find out. #biotech #M&A #financing #fixinsurance https://lnkd.in/ePywBE9C

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How do we minimize the number of protocol amendments and increase the operational feasibility of our clinical trials? This article below points out the benefits of using data, conversations and real world data to enhance the feasibility of the protocol design and inclusion/exclusion criteria: 1) Are we being too strict on our criteria in order to "control" for data variability? 2) Do are criteria allow for the intended patient population in the real world (if not, they need to) 3) How realistic is your design in how the study sites actually work? How they see and treat patients? How is your company ensuring the design meets these requirements? https://lnkd.in/gzJzFd-3

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🚀 $MIRA MIRA Pharmaceuticals Announces Key Milestone in Ketamir-2 Clinical Development! We're thrilled to share an exciting update as MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) accelerates its journey toward becoming a clinical-stage company! 🔬 Clinical Trial Site Selected: We've chosen The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for our Phase I/IIa trial for Ketamir-2, our novel oral ketamine analog. Recruitment begins in Q1 2025, and initial safety and efficacy data is expected in the second half of 2025. 💡 Why CHDR? Their cutting-edge PainCart® technology will allow us to assess early signs of Ketamir-2’s efficacy in healthy subjects during Phase I—a groundbreaking approach to pain management. 📋 Innovative Study Design: Our trial will include: Phase I: Focused on safety, tolerability, and early efficacy in healthy subjects. Phase IIa: Targeting diabetic neuropathy patients, with initial efficacy data anticipated in the first half of 2026. 🏆 Advancing Breakthroughs: Ketamir-2 has shown superior efficacy compared to existing drugs like pregabalin and gabapentin, offering a potential non-addictive, safe, and effective solution for pain and depression. 💪 Strong Financial Position: With a healthy balance sheet, MIRA is well-equipped to achieve these milestones without unfavorable financing deals. 📈 Looking Ahead: As we transition into a clinical-stage company, we remain dedicated to building strategic partnerships, advancing Ketamir-2, and exploring its potential across additional indications. 🔗 Visit our website to learn more: https://lnkd.in/eZNZzHR7 Together, we're redefining possibilities in pain and depression treatment. 🚀 #Pharmaceuticals #ClinicalTrials #Innovation #PainManagement #DepressionTreatment #Biotech #FDA

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Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) Announces $2.5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules   Acurx Pharmaceuticals, Inc. (#NASDAQ: #ACXP), a late-stage #biopharmaceutical company developing a new class of #antibiotics for difficult-to-treat #bacterial #infections, announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 2,463,058 shares of its common stock at a purchase price of $1.015 per share in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 2,463,058 shares of common stock. The warrants will have an exercise price of $0.90 per share, will be exercisable upon issuance and expire five years following the date of issuance. The closing of the offering is expected to occur on or about January 7, 2025, subject to the satisfaction of customary closing conditions.   https://lnkd.in/eAKy4iSM #nasdaq #acxp #antibiotics #acurx

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