Vir Biotechnology's Phase 2 trial shows promising HBsAg loss rates with tobevibart and elebsiran, particularly in patients with low baseline HBsAg levels.

The FDA issued a Complete Response Letter (CRL) for Astellas' supplemental New Drug Application (sNDA) for Izervay on November 15.

The FDA has granted Fast Track designation to PP-007, Prolong Pharmaceuticals' investigational therapy, for acute ischemic stroke (AIS).

Prolong Pharmaceuticals' PP-007 receives FDA Fast Track designation for acute ischemic stroke, potentially expediting its development.

Exicure, Inc. signed an MOU with GPCR Therapeutics to acquire GPCR USA, securing key personnel and clinical pipelines.

Inovio Pharmaceuticals, Inc., a biotechnology company focused on developing treatments for infectious diseases and cancer, is navigating through clinical advancements and operational challenges. Despite a promising product pipeline, including its lead program for recurrent respiratory papillomatosis (RRP), the company faces manufacturing setbacks that have delayed its regulatory timeline. Inovio's financial stability is under scrutiny as it burns through cash reserves, despite having a healthy current ratio. The company's future success hinges on resolving manufacturing issues, advancing its clinical trials, and navigating the competitive biotech landscape.

Recce Pharmaceuticals Ltd. has successfully completed patient dosing in its Phase II clinical trial for RECCE 327 topical gel, aimed at treating acute bacterial skin and skin structure infections. Preliminary results indicate significant symptom improvement without serious adverse events, paving the way for further regulatory trials and a Phase III study in Australia, alongside a trial in Indonesia for diabetic foot infections.

Terns Pharmaceuticals announced positive Phase 1 results for TERN-601, an oral GLP-1R agonist, showing statistically significant weight loss of up to 5.5% over 28 days.

Atea Pharmaceuticals' Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir for COVID-19 treatment did not meet its primary endpoint of reducing all-cause hospitalization or death.

Gan & Lee's GZR4, a novel once-weekly insulin analog, demonstrated favorable safety and tolerability in healthy subjects in a Phase Ia clinical study.

The Phase 3 SIERRA trial demonstrated that Iomab-B achieved a statistically significant durable Complete Remission (dCR) rate of 22% compared to 0% in the control arm for relapsed/refractory AML patients.

Arrowhead Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for plozasiran, targeting familial chylomicronemia syndrome (FCS).

Phase 3 PALISADE study reveals plozasiran significantly reduces triglycerides in patients with Familial Chylomicronemia Syndrome (FCS), regardless of genetic confirmation.

Amylyx Pharmaceuticals initiates Phase 3 LUCIDITY trial for avexitide, a GLP-1 receptor antagonist, targeting post-bariatric hypoglycemia (PBH).

JCR Pharmaceuticals is developing JR-171, a novel blood-brain barrier penetrating enzyme replacement therapy for Hurler syndrome, utilizing their proprietary J-Brain Cargo technology.

Swedish rare disease specialist Immedica Pharma has agreed to acquire Marinus Pharmaceuticals for $151M, strengthening its position in the global rare disease market through a cash tender offer of $0.55 per share.

Formosa Pharmaceuticals' licensee, Grand Pharma, reports successful Phase 3 results for CPN-303 (APP13007) in Chinese patients undergoing cataract surgery.

Vertex Pharmaceuticals increased its full-year product revenue guidance to $10.8 billion to $10.9 billion, driven by strong performance in CF and the early launch of CASGEVY.

Eton Pharmaceuticals' ET-600, a patented desmopressin oral solution, successfully demonstrated pharmacokinetic equivalence to the FDA-approved reference product in a pivotal study with 75 subjects.