Core Viewpoint - Pharvaris is advancing its late-stage development of deucrictibant, an oral bradykinin B2 receptor antagonist, targeting unmet needs in bradykinin-mediated diseases, with topline data from the RAPIDe-3 Phase 3 study expected in Q4 2025 and a potential NDA submission in H1 2026 [1][2][4] Group 1: Study and Data - The RAPIDe-3 study has achieved target enrollment, and the topline data announcement is now anticipated in the fourth quarter of 2025 [2] - The study evaluates deucrictibant immediate-release capsules (20 mg) for on-demand treatment of angioedema attacks in approximately 120 participants aged 12 and older, including those with C1 inhibitor deficiency [2][3] - Primary endpoints include time to onset of symptom relief and other measures of symptom resolution and safety [2][3] Group 2: Drug Development - Deucrictibant is being developed in two formulations: an extended-release tablet for prophylactic treatment and an immediate-release capsule for rapid treatment [3][4] - The drug has received orphan drug designation from the FDA and the European Commission for treating bradykinin-mediated angioedema [3] Group 3: Company Overview - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability through oral therapies for bradykinin-mediated angioedema [4] - The company is conducting multiple pivotal Phase 3 studies, including CHAPTER-3 for prevention and RAPIDe-3 for on-demand treatment of HAE attacks [4]

Group 1 - Rhythm Pharmaceuticals, Inc. announced the pricing of its upsized public offering of 2,058,824 shares at a price of $85.00 per share, with expected gross proceeds of approximately $175 million [1] - The offering includes a 30-day option for underwriters to purchase an additional 308,823 shares at the same public offering price [1] - The offering is expected to close on or about July 11, 2025, subject to customary closing conditions [1] Group 2 - Morgan Stanley, BofA Securities, Stifel, and Wells Fargo Securities are acting as joint book-running managers for the offering, with Canaccord Genuity and Citizens Capital Markets as lead managers [2] - The offering is made pursuant to a shelf registration statement on Form S-3 filed with the SEC, which became effective on March 2, 2023 [3] - A preliminary prospectus supplement and accompanying prospectus have been filed with the SEC and are available on the SEC's website [3]

Core Viewpoint - Soleno Therapeutics, Inc. plans to offer and sell $200 million of its common stock in an underwritten public offering, with an additional option for underwriters to purchase up to $30 million more [1][2]. Group 1: Offering Details - The public offering is subject to market conditions, and there is no assurance regarding the completion or terms of the offering [1]. - Goldman Sachs & Co. LLC and Guggenheim Securities are acting as the joint book-running managers for the offering [2]. - The shares will be offered under a registration statement previously filed with the SEC, and a preliminary prospectus will be made available [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund the commercialization of VYKAT™ XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, which received FDA approval on March 26, 2025 [3]. - Proceeds will also support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3][6].

Core Insights - Soleno Therapeutics, Inc. announced preliminary unaudited financial and operational results for the three months ended June 30, 2025, indicating ongoing financial review processes that may alter the reported figures [1][5] Financial Performance - Estimated net revenue from sales of VYKATTM XR for the three months ended June 30, 2025, is projected to be between $31.0 million and $33.0 million, based on specific assumptions regarding Medicare/Medicaid rebates and other factors [5] - As of June 30, 2025, Soleno reported approximately $293.8 million in cash, cash equivalents, and marketable securities [5] - The company had approximately $50.0 million of debt outstanding under its loan and security agreement with Oxford Financing LLC and its affiliates as of June 30, 2025 [5] Product Development - Soleno's first commercial product, VYKATTM XR, is a once-daily oral treatment for hyperphagia in individuals with Prader-Willi syndrome, approved on March 26, 2025 [2] - The company received approximately 646 patient start forms from about 295 unique prescribers between the product's approval date and June 30, 2025 [5]

Core Insights - Telix Pharmaceuticals has received a permanent HCPCS code for its next-generation PSMA PET imaging agent, Gozellix, which will enhance billing and reimbursement processes in the U.S. healthcare system [1][2][4] Group 1: Product Development and Approval - Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer, particularly those with suspected metastasis or biochemical recurrence [3] - The product features an extended shelf-life and flexible production options, addressing logistical barriers to PSMA-PET imaging access [3][4] - Gozellix has been approved by the U.S. FDA, following the success of Telix's first-generation PSMA-PET imaging agent, Illuccix [5] Group 2: Market Impact and Future Prospects - The HCPCS code assignment is a significant milestone that supports clinical adoption and reimbursement for Gozellix, facilitating its commercial scale-up in the U.S. [2][4] - The CEO of Telix emphasized that this development is crucial for improving access to precision medicine imaging for prostate cancer patients across the U.S. [4] Group 3: Company Overview - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals [4] - The company operates internationally, with a presence in the U.S., Brazil, Canada, Europe, and Japan, aiming to address unmet medical needs in oncology and rare diseases [4]

Company Overview - Rhythm Pharmaceuticals, Inc. is a global, commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases [1] Proposed Offering - Rhythm announced a proposed public offering of $150 million of its common stock, with an additional option for underwriters to purchase up to $22.5 million of shares [1][2] - The offering is subject to market conditions and customary closing conditions, with no assurance on completion or terms [2] Regulatory Compliance - The offering is made under a shelf registration statement on Form S-3, which became effective on March 2, 2023 [3] - A preliminary prospectus supplement will be filed with the SEC and available on their website [3] Contact Information - Investor relations contact is David Connolly, Head of Investor Relations and Corporate Communications, reachable at 857-264-4280 [6]

Core Viewpoint - Certara, Inc. will release its financial results for Q2 2025 on August 6, 2025, after market close, followed by a conference call at 5:00 PM ET to discuss the results [1]. Company Overview - Certara is a global leader in model-informed drug development, utilizing biosimulation software, technology, and services to enhance traditional drug discovery and development [3]. - The company serves over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [3]. Investor Information - Investors interested in the conference call must register online, with a recommendation to do so at least one day in advance [1]. - A live and archived webcast of the conference call will be available on the "Investors" section of Certara's website [2]. Contact Information - Investor Relations contact is David Deuchler from Gilmartin Group [4]. - Media contact is Alyssa Horowitz [4].

Leadership Transition - Inventiva announced a leadership transition with the appointment of Jason Campagna, MD, PhD, as President of Research and Development and Chief Medical Officer, and Martine Zimmermann, PharmD, as Executive Vice President of Regulatory Affairs and Quality Assurance [1][2][4] - Dr. Campagna succeeds Pierre Broqua, PhD, who will transition to a consulting role as Scientific Advisor, and Michael Cooreman, MD, who is departing as CMO [2][4] Executive Experience - Dr. Campagna brings extensive expertise in the MASH field, having previously served as CMO at Q32 Bio and MASH Global Program Lead at Intercept Pharmaceuticals [2] - Dr. Zimmermann was most recently Senior Vice President, Head of Regulatory Affairs at Ipsen, where she led the approval of two liver disease drugs [3] Company Focus and Goals - Inventiva is focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and is currently evaluating lanifibranor in the NATiV3 pivotal Phase 3 clinical trial [5][6] - The company is preparing for the readout of the NATiV3 Phase 3 study next year, with potential regulatory approval and commercialization of lanifibranor [4][6]

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]

Core Insights - Nurix Therapeutics reported significant advancements in its clinical programs, including the presentation of updated data for bexobrutideg and the extension of collaborations with Sanofi and Gilead [1][2][3] Clinical Developments - Updated Phase 1 clinical data for bexobrutideg (NX-5948) showed an objective response rate (ORR) of 80.9% in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), with durable responses and a favorable safety profile [3][4] - The FDA cleared the IND application for GS-6791/NX-0479, a novel IRAK4 degrader, allowing Gilead to initiate Phase 1 trials [1][3] - The European Medicines Agency granted Orphan Drug Designation to bexobrutideg for lymphoplasmacytic lymphoma, providing incentives for its development [5] Financial Performance - Revenue for the fiscal quarter ended May 31, 2025, was $44.1 million, a significant increase from $12.1 million in the same quarter of 2024, primarily due to a $30 million license revenue from bexobrutideg [6][9] - Research and development expenses rose to $78.1 million from $48.9 million year-over-year, reflecting increased clinical and manufacturing costs [8][9] - The net loss for the quarter was $43.5 million, or $0.52 per share, compared to a net loss of $44.5 million, or $0.71 per share, in the prior year [9][10] Strategic Collaborations - Sanofi extended its license for Nurix's STAT6 program, resulting in a $15 million payment, with potential for an additional $465 million in future milestones [3][6] - Nurix continues to advance its collaborations with Gilead and Pfizer, expecting to achieve further research milestones [6][7] Cash Position - As of May 31, 2025, Nurix had cash and marketable securities totaling $485.8 million, down from $609.6 million as of November 30, 2024 [10][15]