Biotech & Genomic Medicine▲
Arrowhead Pharmaceuticals to Present New Clinical Data at European Society of Cardiology Congress
Arrowhead Pharmaceuticals, Inc. today announced that it will present important new data at the European Society of Cardiology Congress (ESC) in Munich, Germany. Detailed results from the Phase 3 SHASTA-3 and SHASTA-4 studies of plozasiran in patients with severe hypertriglyceridemia will be presented as a HOT LINE Late-Breaking Science Session on August 30, 2026. The company will also host a webcast to review ESC data and hold a Q&A on August 31, 2026. Additionally, a presentation on a Phase 3 clinical trial of vsa003 (zodasiran) in Chinese adolescents and adults with homozygous familial hypercholesterolemia is scheduled for August 31, 2026.
Business Wire·2dRead more ▾
Biotech & Genomic Medicine▼
Arrowhead Pharmaceuticals Reports $194.3 Million Net Loss, Acquires Priority Review Voucher for $215 Million
Arrowhead Pharmaceuticals reported a net loss of $194.3 million, or $1.36 per share, for the fiscal 2026 third quarter ended June 30, 2026, while revenue rose to approximately $75 million from $28 million in the prior year quarter. The company highlighted positive Phase III results from its SHASTA-3 and SHASTA-4 studies, which met all primary and secondary endpoints with median triglyceride reductions of 79% and 81%, and a 78% reduction in acute pancreatitis events in the broad SHTG population. Commercial revenue from Redemplo reached approximately $2.4 million, more than double the prior quarter, and the company expanded regulatory approvals to five geographies including the EU, Australia, Canada, China, and the U.S. Operating expenses increased to approximately $245 million, driven by a $36 million rise in R&D to $198 million and a $16 million increase in SG&A to $47 million. The acquisition of a priority review voucher for $215 million represents a significant cash outlay, with payment expected in the fiscal fourth quarter following HSR clearance, aimed at potentially accelerating FDA review of the SNDA for SHTG. Arrowhead ended the quarter with approximately $1.6 billion in cash and investments and 141.1 million common shares outstanding.
GuruFocus·22dRead more ▾
Biotech & Genomic Medicine▲
Arrowhead Completes Enrollment in Phase 3 YOSEMITE Study of Zodasiran for HoFH
Arrowhead Pharmaceuticals has completed enrollment in its global Phase 3 YOSEMITE clinical trial of zodasiran for homozygous familial hypercholesterolemia, with study completion anticipated in mid-2027. The trial originally planned to enroll 60 participants but strong patient and physician interest led to a total of 70 patients enrolled. Zodasiran is an investigational RNA interference therapeutic designed to reduce ANGPTL3 production, offering a mechanism distinct from conventional LDL-C–lowering therapies. Arrowhead intends to seek regulatory approval in multiple geographies pending successful results.
Business Wire·30dRead more ▾
Biotech & Genomic Medicine▲
Five Biotech Stocks Delivered Triple-Digit Gains in Under Two Years
RTTNews highlights five biotech and medical device stocks that generated returns of 86% to 327% since being featured on its website. Arrowhead Pharmaceuticals surged 222% to a 52-week high of $95.49 following FDA approval of its lead drug Redemplo and positive clinical data. Compass Pathways climbed 327% to a 3.5-year high of $15.40 after reporting positive Phase 3 results for its psilocybin therapy COMP360 in treatment-resistant depression. CG Oncology rose 148% to an all-time high of $77.00 on the back of encouraging data for its bladder cancer candidate Cretostimogene. Alpha Tau Medical gained 182% to a 52-week high of $14.11 driven by regulatory progress and promising clinical results for its Alpha DaRT cancer therapy. Electromed advanced 86% to a 52-week high of $47.40 supported by strong quarterly revenue and profit growth.
RTTNews·30dRead more ▾
Biotech & Genomic Medicine▲
Zhongchao Surges 190% After Reverse Split, Leading Biotech Gainers
Zhongchao Inc. led healthcare gainers on Wednesday with a 191.84% surge to $4.29 following a 1-for-3 reverse share split to maintain Nasdaq compliance. Lakewood-Amedex Biotherapeutics advanced 83.33% to $3.41 after reporting that its antimicrobial candidate Nu-3 aligns with PACCARB goals by destroying bacterial membranes, positioning it as a promising treatment for antibiotic-resistant infections and infected diabetic foot ulcers. Arrowhead Pharmaceuticals jumped 19.03% to $88.70 after its Phase 3 SHASTA-3 and SHASTA-4 trials of Plozasiran met the primary endpoint of triglyceride reduction and showed a statistically significant reduction in acute pancreatitis in severe hypertriglyceridemia patients, with an sNDA planned by year-end. LB Pharmaceuticals gained 10.93% to $35.84 after accelerating the topline data readout for its Phase 3 NOVA-2 trial of LB-102 in schizophrenia to the first half of 2027. Other notable movers included Advanced Biomed up 73.02% on no specific news, Satellos Bioscience up 14.72%, and DarioHealth up 12.86% after pricing a $23.5 million registered direct offering.
RTTNews·35dRead more ▾
Biotech & Genomic Medicine▲impact 4
Arrowhead posts late-stage trial win for plozasiran, pressuring Ionis shares
Arrowhead Pharmaceuticals announced positive late-stage trial results for its lipid-lowering drug plozasiran in patients with severe hypertriglyceridemia, sending its shares up 18% while rival Ionis Pharmaceuticals fell nearly 5%. Plozasiran met the primary endpoint and all prespecified secondary endpoints in the Phase 3 SHASTA-3 and SHASTA-4 trials, achieving median triglyceride reductions of 79% and 81% at month 12, respectively, compared to roughly 27% for placebo. No new safety events were observed, and the incidence of treatment-emergent adverse events was consistent with prior study data. Arrowhead plans to submit a supplemental new drug application to the FDA before the end of this year for a label expansion in severe hypertriglyceridemia. Ionis is advancing a competing therapy, olezarsen, which is under FDA priority review with a decision expected by June 30.
Seeking Alpha·35dRead more ▾
Biotech & Genomic Medicine▲
Parkinson's Disease Clinical Trial Pipeline Expands with Over 150 Companies Developing 200-Plus Drugs
The Parkinson's disease clinical trial pipeline has expanded significantly, with more than 150 companies now developing over 200 pipeline drugs, according to a new report from DelveInsight. Key companies such as NeuroDerm, Annovis Bio, Cerevance, Alto Neuroscience, Biogen, Denali Therapeutics, and Arrowhead Pharmaceuticals are evaluating new therapies, with approximately 11-plus drugs in late-stage development. Promising pipeline therapies include ND0612, Buntanetap, CVN424, ALTO-208, Pirepemat, ACD-856, DNL151, and NouvNeu001, among others, targeting mechanisms like alpha-synuclein inhibitors, GPR6 protein inhibitors, and dopamine receptor agonists. Recent milestones include Biogen and Denali Therapeutics reporting Phase IIb results for BIIB122 in May 2026, Cerevance completing enrollment in a pivotal Phase III trial for solengepras, and iRegene Therapeutics receiving RMAT designation for NouvNeu001 in January 2026. The report highlights a robust competitive landscape and ongoing advances in disease-modifying approaches for Parkinson's disease.
GlobeNewswire·41dRead more ▾
Biotech & Genomic Medicine▲
IgA Nephropathy Clinical Trial Space Intensifies with 25+ Companies in Active Development
The IgA nephropathy clinical trial space is intensifying, with more than 25 companies actively developing over 30 pipeline drugs, according to a new report from DelveInsight. Key players include Haisco Pharmaceutical Group, Novartis, Vertex Pharmaceuticals, Biogen, Vera Therapeutics, AstraZeneca, Roche, Ionis Pharmaceuticals, Takeda, Arrowhead Pharmaceuticals, and others. Promising therapies in various trial phases include HSK39297, Zigakibart, Povetacicept, Felzartamab, Atacicept, ULTOMIRIS, Sefaxersen, TAK-079, ARO-C3, NM8074, WAL0921, KP104, PS-002, BHV-1400, CM313, NTQ5082, RNK288, and IFX 301. Approximately 12 or more drugs are in late-stage development, targeting mechanisms such as Complement Factor B inhibition, BAFF and APRIL antagonism, antibody-dependent cell cytotoxicity, Gd-IgA1 degradation, RNA interference, and CD38 antagonism. Recent milestones include positive Phase III data for Povetacicept and Atacicept, and publication of telitacicept results in the New England Journal of Medicine.
GlobeNewswire·62dRead more ▾
Biotech & Genomic Medicine▲
Arrowhead Pharmaceuticals Wins EU Approval for REDEMPLO to Treat Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals has received marketing authorization from the European Commission for REDEMPLO, the first and only siRNA treatment for adults with familial chylomicronemia syndrome that does not require genetic confirmation of the condition. The approval is supported by Phase 3 PALISADE study data showing that 25 mg REDEMPLO reduced triglycerides by a median of 80% from baseline versus 17% for placebo, and a pooled analysis of all doses demonstrated an 83% lower incidence of acute pancreatitis compared with placebo. REDEMPLO is designed to suppress production of apolipoprotein C-III and is self-administered via subcutaneous injection once every three months. Arrowhead is now engaging with national authorities across the European Union to bring the therapy to patients as quickly as possible.
Business Wire·65dRead more ▾
Biotech & Genomic Medicine
Arrowhead Pharmaceuticals to host cardiometabolic pipeline webinar on June 29
Arrowhead Pharmaceuticals will host Part I of its 2026 Summer Series of R&D Webinars on June 29, 2026, at 11:30 AM EDT, focusing on its cardiometabolic pipeline. The event will feature a presentation by Steven Nissen, M.D., Chief Academic Officer for the Heart and Vascular Institute at the Cleveland Clinic, alongside presentations from Arrowhead management on clinical-stage RNAi candidates including plozasiran, zodasiran, and ARO-DIMER-PA. The webinar is the first in a series that will highlight multiple therapeutic areas and the company's proprietary TRiM platform. Each session will run approximately 60 to 90 minutes, with live webcasts and replays available on Arrowhead's investor relations website.
Business Wire·69dRead more ▾