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FibroGen Completes Sale of FibroGen China to AstraZeneca for Approximately $220 Million
Globenewswire· 2025-09-02 11:00
Total consideration for the sale of FibroGen China to AstraZeneca is approximately $220 million, a $60 million increase from initial guidanceSuccessfully repaid term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structurePhase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) remains on track to begin in 3Q 2025Cash runway extended into 2028 SAN FRANCISCO, Sept. 02, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announc ...
Atea Pharmaceuticals to Present at the Morgan Stanley 23rd Annual Global Healthcare Conference
Globenewswire· 2025-09-02 11:00
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 ...
Jade Biosciences Announces First Cohort Dosed in Phase 1 Healthy Volunteer Clinical Trial of JADE101, a Novel and Potentially Best-in-Class Anti-APRIL Monoclonal Antibody Being Evaluated for the Treatment of IgA Nephropathy
Globenewswire· 2025-09-02 11:00
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 ...
Biogen and Stoke Therapeutics Present Data at the 36th International Epilepsy Congress that Support the Potential for Zorevunersen to be the First Disease-Modifying Medicine for Dravet Syndrome
Globenewswire· 2025-09-02 11:00
– Durable reductions in seizures and continuing improvements in cognition and behavior through 3 years in patients who continued to receive zorevunersen in the open-label extension studies – – Substantial increase in seizure-free days and continuous improvements in quality of life demonstrated in patients already taking standard of care anti-seizure medicines – – Zorevunersen generally well tolerated across all studies – – Data support pivotal Phase 3 EMPEROR study now underway – CAMBRIDGE, Mass. and BEDFO ...
Upstream Bio Reports Positive Top-Line Results from the Phase 2 VIBRANT Trial of Verekitug for the Treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Globenewswire· 2025-09-02 10:00
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]
Theravance Biopharma to Present at the H.C. Wainwright 27th Annual Global Investment Conference
Prnewswire· 2025-09-02 10:00
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]
Zymeworks Announces Decision to Discontinue Clinical Development of ZW171, a Mesothelin-directed T cell Engager
Globenewswire· 2025-09-02 10:00
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 ...
Akeso Announces Completion of Patient Enrollment in Phase III Clinical Trial for Ivonescimab as First-Line Treatment for Biliary Tract Cancer Compared to PD-L1 Therapy
Prnewswire· 2025-09-02 08:00
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]
Radiopharm Theranostics Limited - Special Call
Seeking Alpha· 2025-09-02 05:15
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 ...
Pharming Group appoints Kenneth Lynard as Chief Financial Officer
Globenewswire· 2025-09-02 05:00
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]