BOSTON, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that members of the Atea management team will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on Tuesday, September 9, 2025 at 1:05 p.m. ET in New York, NY. A live webcast of the presentation will be ava ...

Core Viewpoint - FibroGen, Inc. has successfully completed the sale of its China subsidiary to AstraZeneca for approximately $220 million, significantly enhancing its financial position and extending its cash runway into 2028 [1][2][7] Financial Impact - The total consideration for the sale includes $85 million in enterprise value and about $135 million in net cash held in China, marking a $60 million increase from initial guidance [1][7] - Following the sale, FibroGen repaid its term loan facility to Morgan Stanley Tactical Value for approximately $81 million, simplifying its capital structure [2][7] Clinical Development Plans - The company is on track to initiate the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) in the third quarter of 2025 [2][4][7] - FibroGen intends to submit the Phase 3 protocol for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the fourth quarter of 2025, following a positive meeting with the U.S. FDA [3][4] Product Rights and Development - FibroGen retains rights to roxadustat in the U.S. and all markets not licensed to Astellas, excluding China and South Korea [3] - The company continues to advance the clinical development of FG-3246 and its companion diagnostic FG-3180 [4][5]

Selective APRIL inhibition has shown disease-modifying potential in IgAN patient clinical trialsJADE101 has shown ultra-high binding affinity and a differentiated pharmacokinetic and pharmacodynamic profile preclinically, supporting the potential for patient-friendly subcutaneous dosing every eight weeks or longerInterim, biomarker-rich Phase 1 healthy volunteer data are expected in the first half of 2026, and are anticipated to define dose and dosing interval selection based on biomarker responses associat ...

Core Insights - Zorevunersen shows potential as the first disease-modifying treatment for Dravet syndrome, with significant reductions in seizure frequency and improvements in cognitive and behavioral outcomes over three years of treatment [2][3][12] Efficacy Results - In Phase 1/2a studies, patients receiving initial doses of 70 mg of zorevunersen experienced a median seizure reduction of 84.8% and an increase of eight seizure-free days per 28 days at three months post-treatment [4] - In open-label extension studies, 94% of eligible patients continued treatment, with 77% remaining after three years, sustaining reductions in major motor seizure frequency [5] - Improvements in quality of life were noted, with an 18-point increase in EuroQol Visual Analog Scale (EQ-VAS) scores over three years [6] Safety Profile - Zorevunersen was generally well tolerated, with treatment-emergent adverse events (TEAEs) reported in 30% of patients in Phase 1/2a studies and 53% in open-label extension studies [7] - The most common TEAE was elevated cerebrospinal fluid (CSF) protein levels, occurring in 14% of patients in Phase 1/2a and 44% in open-label extension studies [7] Study Design - The Phase 1/2a studies involved 81 patients aged 2 to 18 with refractory Dravet syndrome, focusing on safety, pharmacokinetics, and seizure frequency [9] - The ongoing EMPEROR Phase 3 study aims to further evaluate zorevunersen's efficacy and safety in a larger population [13] Company Background - Biogen and Stoke Therapeutics are collaborating on the development of zorevunersen, which has received orphan drug designation and Breakthrough Therapy Designation from the FDA [12][14] - Stoke Therapeutics focuses on restoring protein expression through RNA medicine, with zorevunersen being their first investigational product [16]

Core Insights - Upstream Bio, Inc. announced positive top-line results from the Phase 2 VIBRANT trial for verekitug, demonstrating significant efficacy in treating chronic rhinosinusitis with nasal polyps (CRSwNP) [1][6][12] Study Results - The VIBRANT trial met its primary endpoint with a statistically significant placebo-adjusted reduction in endoscopic nasal polyp score (NPS) of -1.8 (p<0.0001) at Week 24 [1][4] - Key secondary endpoints showed a reduction in nasal congestion score (NCS) by -0.8 (p=0.0003) and a 76% reduction (p=0.03) in the need for surgery or systemic corticosteroids [1][2][5] - The trial involved 81 adults and was designed as a global, randomized, double-blind, placebo-controlled study over 24 weeks [3][12] Safety Profile - Verekitug was generally well tolerated, with no serious adverse events (SAEs) reported, consistent with previous studies [1][5][6] Mechanism and Potential - Verekitug is a monoclonal antibody targeting the thymic stromal lymphopoietin (TSLP) receptor, which is unique in its mechanism of action compared to existing therapies [1][13][18] - The results suggest that verekitug could advance the standard of care for CRSwNP and may have potential applications in other respiratory diseases, including severe asthma [6][7][18] Future Plans - Upstream Bio plans to engage with global regulatory authorities for further development and potential product approval of verekitug [7][12] - The company will present additional details from the VIBRANT trial at an upcoming medical conference [8]

Company Announcement - Theravance Biopharma, Inc. will participate in the H.C. Wainwright 27th Annual Global Investment Conference in New York City on September 9, 2025 [1] - CEO Rick Winningham will engage in a Fireside Chat during the event at 1:30 PM EDT [1] Investor Engagement - Management will host in-person meetings during the conference, and interested investors are encouraged to contact their H.C. Wainwright representative for meeting requests [1] Company Overview - Theravance Biopharma focuses on delivering impactful medicines, with FDA-approved YUPELRI® for chronic obstructive pulmonary disease (COPD) [3] - The company is developing Ampreloxetine, a late-stage investigational therapy for neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), which has the potential to be a first-in-class treatment [3] - Theravance Biopharma is committed to creating and driving shareholder value [3]

VANCOUVER, British Columbia, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced its decision to voluntarily discontinue clinical development of ZW171, a T cell engager designed to target gynecological, thoracic, and digestive system cancers. ZW171 i ...

Core Insights - Akeso has completed patient enrollment in a Phase III study for ivonescimab, targeting advanced biliary tract cancer, comparing it with durvalumab combination therapy [1] - Ivonescimab has shown significant positive results in previous Phase III studies, leading to its approval for PD-L1-positive non-small cell lung cancer [2][3] - The drug targets both PD-1 and VEGF, providing a synergistic anti-tumor effect, establishing it as a leader in immunotherapy [4] Company Overview - Akeso is a biopharmaceutical company focused on innovative biological medicines, with a robust pipeline of over 50 assets in various disease areas [10] - The company utilizes a unique integrated R&D innovation system and has developed a GMP-compliant manufacturing system [10] - Akeso aims to provide affordable therapeutic antibodies globally while creating commercial and social value [10] Development Strategy - Akeso is implementing a dual-path strategy to maximize ivonescimab's value, focusing on domestic commercialization in China and global development partnerships [5] - The company has an extensive clinical foundation with over 20 Phase II studies across more than 10 tumor types, facilitating rapid transition to registrational studies [3]

PresentationDimitris VoliotisChief Medical Officer Welcome, everybody. Welcome to our second webinar. I am Dimitris Voliotis. I'm the Chief Medical Officer for Radiopharm and it is a great pleasure for me to have you with us either for the first time or if you're already there last week, then welcome you back to, as said, our second webinars. I will do a very brief intro and a recap of last week and then lead into today's topic and presentation. Today, we have Dr. David Ulmert from UCLA. Very happy to have ...

Core Viewpoint - Pharming Group N.V. has appointed Kenneth Lynard as Chief Financial Officer, effective October 1, 2025, to strengthen its financial leadership and support its growth strategy [1][2][3] Company Overview - Pharming Group N.V. is a global biopharmaceutical company focused on developing and commercializing innovative medicines for patients with rare and life-threatening diseases [5] - The company is headquartered in Leiden, the Netherlands, and operates in over 30 markets globally [5] Appointment Details - Kenneth Lynard brings over 20 years of experience in the life sciences industry, with a strong background in financial and operational transformation [2][3] - His previous roles include CFO positions at Schoeller Allibert, Zentiva, and Affidea, as well as senior leadership at Gilead Sciences, where he contributed to significant business growth [3][4] Leadership Perspective - CEO Fabrice Chouraqui expressed enthusiasm about Lynard's appointment, highlighting his extensive finance leadership capabilities and operational experience in both the U.S. and EU [3] - Lynard emphasized his commitment to Pharming's mission of serving patients with rare diseases and his focus on operational efficiency and sustainable value creation [4]