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Rapport Therapeutics to Present New Phase 2a Data Analysis Further Characterizing RAP-219 in Focal Onset Seizures at 2025 American Epilepsy Society Annual Meeting
Globenewswire· 2025-11-25 12:00
New analysis examines RAP-219’s effect during the first month of treatment and consistency of efficacy over the treatment period, effectiveness across baseline disease severities, and impact on seizure severityBOSTON and SAN DIEGO, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Rapport Therapeutics, Inc. (Nasdaq: RAPP) (“Rapport” or the “Company”), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological or psychiatric disorder ...
Moderna Secures $1.5 Billion Five-Year Credit Facility from Ares Management
Accessnewswire· 2025-11-20 12:00
Non-dilutive financing from premier lender bolsters strong balance sheet and provides increased flexibility Company reiterates 2025 financial guidance provided on 3Q25 earnings call and targets cash breakeven by 2028 CAMBRIDGE, MA / ACCESS Newswire / November 20, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced it has closed a five-year term loan facility for up to $1.5 billion of capital from Ares Management Credit Funds (Ares), a leading global alternative investment manager, to increase flexibility. Th ...
Silence Therapeutics: Divesiran Targets High-Burden PV (NASDAQ:SLN)
Seeking Alpha· 2025-11-18 11:03
Core Insights - Silence Therapeutics (SLN) is positioned as a focused, clinical-stage RNAi drug development company, but its valuation is impacted by historical execution concerns and the general fatigue in the small-cap biotech sector [1] Company Analysis - The company is seen as having high growth potential, particularly in sectors that are expected to experience exponential expansion [1] - There is a strong emphasis on the importance of innovation in generating substantial returns, indicating a forward-looking approach to investment in disruptive technologies [1] Market Context - The current market sentiment reflects a broader exhaustion in the small-cap biotech space, which may affect investor confidence and company valuations [1]
Baron International Growth Fund Q3 2025 Contributors And Detractors
Seeking Alpha· 2025-11-06 10:40
Core Insights - The Baron International Growth Fund gained 6.04% in Q3 2025, slightly underperforming the MSCI ACWI ex USA Index which appreciated 6.89% [3][4] - The performance was influenced by the Federal Reserve's easing cycle and significant investments in AI data center capacity and GPU commitments [4] Top Contributors to Performance - Lynas Rare Earths Limited contributed 1.25% to returns, with shares nearly doubling due to geopolitical tensions highlighting the importance of non-China supply sources [5] - Argenx SE added 0.79%, driven by strong sales of its drug Vyvgart, which exceeded expectations and showed potential for growth in autoimmune conditions [6] - Lundin Mining Corporation contributed 0.66%, benefiting from solid financial results and a tightening copper supply due to competitor production suspension [7] - Taiwan Semiconductor Manufacturing Company Limited and Contemporary Amperex Technology Co., Limited also contributed positively to the Fund's performance [5] Top Detractors from Performance - Constellation Software Inc. detracted 0.70% due to uncertainty around AI's impact on software and the announcement of leadership changes [8] - InPost S.A. contributed a negative return of 0.39% as concerns arose over its largest customer Allegro exploring alternative logistics solutions [9] - ODDITY Tech Ltd. saw a decline of 0.37% despite exceeding expectations, as investors were concerned about the magnitude of the earnings beat and future cost pressures [10]
MLTX INVESTOR ALERT: RGRD LLP Announces that MoonLake Immunotherapeutics Investors with Substantial Losses Have Opportunity to Lead Investor Class Action Lawsuit
Globenewswire· 2025-11-04 22:00
Core Viewpoint - The MoonLake class action lawsuit alleges that MoonLake Immunotherapeutics and its executives violated the Securities Exchange Act of 1934, impacting investors who purchased or acquired its common stock [1][3]. Company Overview - MoonLake Immunotherapeutics is a clinical stage biotechnology company focused on developing therapies for inflammatory skin and joint diseases, with its primary drug candidate being sonelokimab (SLK) for treating hidradenitis suppurativa (HS) [3]. Allegations - The lawsuit claims that MoonLake made false or misleading statements regarding SLK's efficacy compared to Union Chimique Belge's BIMZELX, which is an FDA-approved monoclonal antibody for HS [4]. - Specific allegations include that SLK and BIMZELX target the same inflammatory cytokines (IL-17A and IL-17F), and that SLK's unique Nanobody structure does not provide superior clinical benefits or increased tissue penetration as claimed [4]. Stock Impact - Following the announcement of disappointing Phase 3 VELA program results on September 28, 2025, which indicated SLK's failure to demonstrate competitive efficacy against BIMZELX, MoonLake's stock price plummeted nearly 90% [5]. Legal Process - The Private Securities Litigation Reform Act of 1995 allows any investor who purchased MoonLake common stock during the class period to seek lead plaintiff status in the lawsuit, representing the interests of the class [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a leading law firm in securities fraud and shareholder litigation, having recovered over $2.5 billion for investors in 2024 alone, and is recognized for securing significant monetary relief for investors [7].
Arvinas to Present Preclinical Data for ARV-393 at the 2025 American Society of Hematology (ASH) Annual Meeting
Globenewswire· 2025-11-03 21:00
Core Viewpoint - Arvinas, Inc. is advancing its investigational drug ARV-393, a PROTAC designed to degrade the BCL6 protein, which is a significant driver of B-cell lymphomas, and will present preclinical data in December 2025 at the ASH Annual Meeting [1][3]. Group 1: About ARV-393 - ARV-393 targets the BCL6 protein, which plays a crucial role in B-cell lymphoma by repressing cell cycle checkpoints and apoptosis, making it a challenging target for traditional therapies [3]. - The drug is currently in a Phase 1 clinical trial for patients with non-Hodgkin lymphoma, indicating its potential therapeutic application in this area [3]. Group 2: About Arvinas - Arvinas is a clinical-stage biotechnology company focused on developing therapies that utilize its PROTAC platform to selectively degrade disease-causing proteins [4]. - The company is also developing other investigational drugs, including ARV-102 for neurodegenerative disorders, ARV-806 for mutated cancers, and vepdegestrant for ER+/HER2-breast cancer [4].
MediWound Successfully Completes Commissioning of Expanded GMP Manufacturing Facility for NexoBrid®
Globenewswire· 2025-11-03 13:00
Core Insights - MediWound Ltd. has successfully completed the commissioning of its expanded GMP manufacturing facility in Yavne, Israel, which is a significant step towards increasing production capacity for NexoBrid® by approximately sixfold by the end of 2025 [1][2] Company Overview - MediWound Ltd. is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair, with its FDA-approved product NexoBrid® indicated for the enzymatic removal of eschar in thermal burns [4] - NexoBrid® is approved for use in over 40 countries, including the United States, European Union, and Japan, and is designed to selectively remove non-viable tissue while preserving viable tissue [3] Manufacturing and Supply Capacity - The newly expanded facility will enable a scalable and reliable global supply of NexoBrid across more than 40 approved markets, contingent upon the completion of regulatory reviews [2] - The operational readiness of the expanded facility is expected by year-end 2025, which will help meet the growing global demand for NexoBrid [2][4]
MoonLake Immunotherapeutics (MLTX) Faces Securities Class Action After Company Reported Disastrous Phase 3 Trial Data For Sole Drug Candidate -- Hagens Berman
Globenewswire· 2025-10-16 00:19
Core Viewpoint - MoonLake Immunotherapeutics faces a securities class action lawsuit following the announcement of disappointing Phase 3 trial results for its product candidate sonelokimab (SLK), leading to a significant drop in share price by approximately 90% [1][2][6]. Company Overview - MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on treating skin inflammatory diseases, specifically targeting cytokines IL-17A and IL-17F [3][4]. Legal Proceedings - A class action lawsuit has been filed against MoonLake, alleging that the company misled investors regarding the trial design and efficacy data of SLK prior to the announcement of the trial results [1][2][3]. - The class period for the lawsuit is from March 10, 2024, to September 29, 2025, with a lead plaintiff deadline set for December 15, 2025 [3]. Trial Results and Market Reaction - The Phase 3 trial results revealed that only one of the two trials achieved statistical significance, with the efficacy being substantially lower than that of a competitor's product, BIMZELX [6]. - Following the announcement, MoonLake's share price plummeted by $55.75, representing a 90% decrease, which analysts described as a "worst case outcome" [2][6]. Product Comparison - SLK's commercial prospects were heavily reliant on demonstrating efficacy comparable to or superior to BIMZELX, which is already FDA-approved for the same indication [4]. - The lawsuit claims that MoonLake made false statements regarding the advantages of SLK's Nanobody structure over traditional monoclonal antibodies, asserting that it would lead to superior clinical benefits [5]. Investor Communication - Throughout the class period, MoonLake promoted SLK's structural advantages, claiming it could achieve benefits unattainable by monoclonal antibodies and positioned it as a potential "gold standard" treatment [5]. - The lawsuit alleges that these statements were misleading and that the company failed to disclose critical information about SLK's clinical efficacy [5][6].
Mydecine Innovations Group Closes Debt Settlements
Thenewswire· 2025-10-14 22:00
Core Points - Mydecine Innovations Group Inc. has successfully closed debt settlement agreements totaling USD $1,386,391 and CAD $9,432,107 to settle outstanding debts with various creditors [1][2] - The company issued five convertible debentures to creditors as part of the debt settlements to preserve cash for working capital and improve its financial situation [2] Debt Settlement Agreements - The company entered into debt forgiveness agreements to settle USD $1,386,391 owed to two former insiders, issuing convertible debentures with an aggregate principal amount of USD $100,000 [4] - A debt settlement agreement with CEO Josh Bartch was made to settle CAD $1,309,836 of unpaid management fees, with a convertible debenture issued for the same amount [5] - A settlement with Pioneer Garage Limited was made for CAD $7,878,792, with a convertible debenture issued under similar terms as the Bartch agreement [6] - An additional settlement with an arm's length creditor for CAD $243,479 was fully settled through a secured convertible debenture of USD $100,000, which bears interest at 1% per month [9] Share Consolidation - The company announced a share consolidation effective October 21, 2025, converting every fifty old common shares into one new common share, reducing the outstanding shares from 61,755,385 to approximately 1,235,107 [12][13] - The share consolidation aims to enhance the company's attractiveness for financing opportunities and facilitate the restructuring of existing liabilities [15]
Sharp Therapeutics to Present Pipeline and Program Updates at World Orphan Drug Congress 2025
Globenewswire· 2025-10-08 20:00
Core Insights - Sharp Therapeutics Corp. is set to present preclinical data for its lead program '901, aimed at treating Gaucher disease and GBA Parkinson's disease, at the World Orphan Drug Congress 2025 in Amsterdam from October 27 to 29, 2025 [1][2] Company Overview - Sharp Therapeutics is a preclinical-stage biotechnology company focused on developing small-molecule therapeutics for genetic diseases, with a discovery platform that produces compounds to restore activity in mutated proteins [4] Clinical Pipeline - The company’s pipeline includes programs targeting Gaucher disease, Niemann-Pick disease type C, and familial frontotemporal dementia, with '901 being the most advanced candidate designed to address lysosomal storage disorders caused by GBA enzyme deficiencies [2][3] Leadership Statement - The CEO of Sharp Therapeutics expressed the company's commitment to developing pill-based medicines that restore function in defective proteins, aiming to improve the lives of patients with genetic diseases [3]