Jason Campagna, MD, PhD, joins Inventiva as President of R&D and Chief Medical Officer, succeeding Pierre Broqua, PhD, and Michael Cooreman, MDMartine Zimmermann, PharmD, joins as Executive Vice President of Regulatory Affairs and Quality AssuranceThese key leadership appointments underscore Inventiva’s commitment to long-term growth and operational excellence, with topline results from NATiV3 on track for the second half of 2026 Daix (France), New York City (New York, United States), July 9, 2025 – Invent ...

Core Insights - The Phase 3 Orbit study for UX143 (setrusumab) in pediatric and young adult patients with osteogenesis imperfecta (OI) is on track for final analysis by the end of the year [1][3] - The Data Monitoring Committee has confirmed an acceptable safety profile for UX143, allowing the study to proceed [2] - Ultragenyx and Mereo BioPharma are collaborating on the development of setrusumab, targeting OI sub-types I, III, and IV [5][12] Study Details - The Phase 3 Orbit study has enrolled 159 patients across 45 sites in 11 countries, with a primary efficacy endpoint focused on annualized clinical fracture rate [7] - The Cosmic study, which is also in Phase 3, has enrolled 69 patients aged 2 to <7 years, comparing setrusumab to intravenous bisphosphonates [8] - Both studies will conduct final analyses after patients have been on therapy for at least 18 months, with specific statistical thresholds set for each study [4] Background on Osteogenesis Imperfecta - OI is a genetic disorder affecting bone metabolism, primarily caused by mutations in the COL1A1 or COL1A2 genes, leading to increased bone brittleness and a high rate of fractures [9] - Approximately 60,000 individuals are affected by OI in commercially accessible regions, with no globally approved treatments available [9] Mechanism of Setrusumab - Setrusumab is a fully human monoclonal antibody that inhibits sclerostin, which negatively regulates bone formation, potentially increasing bone mass and strength [10] - Previous studies have shown that anti-sclerostin antibodies can significantly improve bone formation and density in OI models [11] Company Profiles - Ultragenyx is focused on developing therapies for rare genetic diseases, with a portfolio aimed at addressing high unmet medical needs [13] - Mereo BioPharma is also dedicated to innovative therapeutics for rare diseases, with setrusumab as one of its key candidates [15]

Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist healthcare investors [2] Group 2 - The service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, representing a 33.50% discount [1] - The analyst has no current stock or derivative positions in any mentioned companies and does not plan to initiate any within the next 72 hours [3]

Presented updated data for bexobrutideg (NX-5948) at EHA2025 and ICML-18, demonstrating a favorable safety profile and deepening responses in patients with r/r chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia (WM) Secured $15M license fee as Sanofi extends STAT6 collaboration to target type 2 inflammatory diseases Announced FDA clearance of IND application for novel IRAK4 degrader GS-6791/NX-0479, enabling collaboration partner Gilead to initiate Phase 1 trial Well capitalized with cash ...

Conference Call and Webcast Scheduled for Wednesday, July 30SAN DIEGO, July 9, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its second quarter 2025 financial results conference call and webcast for 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) on July 30, 2025.The schedule for the press release and conference call / webcast is as follows: Q2 2025 Press Release: July 30, 2025 at 1:00 p.m. PT / 4:00 p.m. ET Q2 2025 Conference Call: July 30, 2025 at 1 ...

Core Insights - The RESILIENT trial data demonstrates that TNX-102 SL significantly reduces fibromyalgia pain compared to placebo, confirming previous findings from the RELIEF trial [1][2] - If approved, TNX-102 SL will be the first new drug for fibromyalgia in over 15 years, with a PDUFA target date set for August 15, 2025 [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company focused on developing therapies for pain management and central nervous system disorders [8] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on two statistically significant Phase 3 studies [2][8] Study Details - The RESILIENT study was a randomized, double-blind, placebo-controlled trial involving 457 adults with fibromyalgia across 33 sites in the U.S. [2][7] - Participants received TNX-102 SL in two dosage phases: 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, with a primary endpoint of pain reduction assessed over fourteen weeks [2][7] Efficacy Results - TNX-102 SL achieved a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale, compared to a 1.2-point reduction for placebo, indicating high statistical significance [2][7] - Statistically significant improvements were also noted across all six prespecified key secondary endpoints, including various patient-reported outcomes [2][3] Safety Profile - TNX-102 SL was generally well tolerated, with the most common adverse events being mild and transient, such as oral tingling/numbness and a bitter aftertaste [3] - No serious drug-related adverse events or deaths were reported, highlighting a favorable risk-benefit profile [3] Fibromyalgia Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., predominantly women, and is characterized by chronic pain, fatigue, and sleep disturbances [4] - Current treatment options are often met with dissatisfaction from both physicians and patients, indicating a significant unmet need in the market [4] Product Information - TNX-102 SL is a patented sublingual formulation of cyclobenzaprine hydrochloride designed for rapid absorption and reduced side effects [5][6] - The drug is also being explored for other indications, including acute stress reaction, Long COVID, and alcohol use disorder [5][8]

Eli Lilly and Co. LLY is set to release its second-quarter earnings on August 7. According to Benzinga Pro data, analysts are anticipating adjusted earnings of $5.56 per share and sales of $14.4 billion.Expectations are slightly higher for the quarter, primarily driven by the strong performance of its obesity drug, Zepbound. The pharmaceutical giant, a dominant player in the incretin/GLP-1 drug market for obesity and diabetes, continues to draw investor attention with its robust pipeline and long-term growt ...

Group 1 - Johnson & Johnson is set to release its second-quarter earnings on July 16, with analysts estimating adjusted earnings of $2.68 per share and sales of $22.85 billion [1] - Investor focus will be on the updated 2025 guidance, the impact of tariffs and biosimilars, and the progress of the company's pipeline and recent product launches [1][3] - Bank of America Securities has updated its revenue estimates for Johnson & Johnson for 2025 and beyond ahead of the earnings release [2] Group 2 - Bank of America slightly increased its second-quarter 2025 revenue and EPS estimates by 1% due to improved foreign exchange rates, with similar modest increases projected for the later 2020s [4] - Despite the upward revisions, Bank of America maintains a Neutral rating and a price forecast of $61, considering the stock fairly valued [5] - Johnson & Johnson anticipates a $2 billion net headwind in 2025, affecting various assets while Xarelto is expected to benefit [6] Group 3 - CFO Joseph Wolk revised the estimated 2025 tariff impact down to $200 million from $400 million, with the majority expected in the second half of the year [7] - A federal court sided with the U.S. Department of Health and Human Services, rejecting Johnson & Johnson's attempt to alter its participation in the 340B Drug Pricing Program [7][8]

Key Takeaways PROK surged 515% on positive Phase II data for rilparencel in diabetic chronic kidney disease patients. Group 1 showed a 78% improvement in kidney decline rate, meeting statistical and clinical benchmarks. ProKidney will seek FDA confirmation of eGFR slope as a surrogate endpoint in its ongoing Phase III trial.Shares of ProKidney Corp. (PROK) skyrocketed 515% yesterday after the company reported encouraging top-line data from the phase II REGEN-007 study evaluating its lead pipeline drug, ri ...

Core Insights - Recursion Pharmaceuticals (RXRX) shares increased by 8.7% following the announcement of acquiring Rallybio's (RLYB) full interest in their joint venture for developing REV102, a treatment for hypophosphatasia (HPP) [2][4] Company Developments - The acquisition allows Recursion Pharmaceuticals to independently accelerate the development of REV102, potentially the first oral, disease-modifying therapy for HPP [4][6] - RXRX will pay $7.5 million upfront and an additional $12.5 million contingent upon further preclinical studies, along with a $5 million milestone payment upon the initiation of dosing in an early-stage clinical study [7][8] - The REV102 program is expected to begin phase I studies in late 2026, with initial preclinical data showing a favorable safety profile [6][10] Market Context - Year-to-date, RXRX shares have declined by 20.7%, contrasting with a 2.9% decline in the industry [5] - The acquisition has strengthened Rallybio's balance sheet, extending its cash runway into mid-2027, leading to a 50.2% increase in Rallybio's shares [8] Treatment Potential - REV102 targets ENPP1, aiming to restore the balance of PPi for proper bone mineralization, addressing the underlying cause of HPP [9][11] - The treatment could provide a more accessible and cost-effective long-term option for over 7,800 diagnosed patients in the U.S. and EU, improving patient convenience and quality of life compared to current enzyme replacement therapies [11][13]