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TG Therapeutics Reports 91% Revenue Surge Driven by BRIUMVI Multiple Sclerosis Treatment

Drug Approval
  • TG Therapeutics reported a remarkable 91% year-over-year revenue increase in Q2 2025, primarily driven by strong sales of its multiple sclerosis treatment BRIUMVI.
  • The company raised its 2025 BRIUMVI U.S. net revenue target to $570-575 million and increased global revenue projections to approximately $585 million.
  • BRIUMVI has gained regulatory approval in the EU, UK, Switzerland, and Australia, with management citing strong physician confidence and uptake.
  • CEO Michael S. Weiss highlighted the continued momentum across all business aspects, positioning BRIUMVI to redefine multiple sclerosis treatment expectations.

Agios Pharmaceuticals Faces FDA Delay for Pyrukynd Thalassemia Approval Amid Safety Concerns

Drug ApprovalRare DiseaseOrphan Drug
  • The FDA has extended the review period for Agios Pharmaceuticals' Pyrukynd (mitapivat) in thalassemia, pushing the PDUFA date from September 7, 2025 to December 7, 2025 due to a required Risk Evaluation and Mitigation Strategy (REMS) submission.
  • The delay stems from hepatocellular injury risks requiring stringent monitoring protocols, though Agios emphasizes no new negative safety or efficacy data prompted the extension.
  • Despite the setback, Pyrukynd demonstrated statistically significant improvements in hemoglobin levels and reduced transfusion needs in Phase 3 ENERGIZE trials, targeting a $200-300 million peak annual revenue opportunity in the U.S.
  • The company maintains a strong financial position with $1.3 billion in cash through 2027, while the stock has shown volatility with a 25.78% decline but remains up 16.03% year-to-date.

Pulsecare Medical's NxPFA™ Receives NMPA Approval as World's First Nanosecond Pulsed Field Ablation System

Drug Approval
  • Pulsecare Medical's NxPFA™ system has received marketing approval from China's NMPA, becoming the world's first commercially available nanosecond pulsed field ablation system for atrial fibrillation treatment.
  • The SCENA-AF multicenter trial demonstrated 100% acute pulmonary vein isolation success rate and 88.27% one-year treatment success rate with no device-related serious adverse events.
  • The nanosecond technology significantly reduces neuromuscular stimulation, enabling over 92.8% of procedures to be completed under conscious sedation rather than general anesthesia.
  • This third-generation PFA system addresses key limitations of microsecond PFA technologies, including reduced gas formation risk and minimized erythrocytic damage.

CDSCO Panel Recommends Approval for Vorasidenib with Phase-III Waiver for IDH-Mutant Gliomas in India

Drug ApprovalOrphan DrugTargeted Therapy
  • India's CDSCO panel has recommended approval for vorasidenib tablets (10 mg and 40 mg) with a waiver from local Phase-III clinical trials for treating IDH-mutant gliomas.
  • The dual IDH1/IDH2 inhibitor is indicated for adult and pediatric patients aged 12 years and older with Grade 2 astrocytoma or oligodendroglioma harboring IDH mutations.
  • The committee acknowledged the unmet medical need for these indications in India and noted the drug's orphan status in other countries.
  • A Phase-IV clinical trial in Indian patients will be mandatory, with the protocol to be submitted within 3 months of approval.

Zenara Pharma Secures First Generic Sertraline Capsule Approval with 180-Day Market Exclusivity

Drug Approval
  • Zenara Pharma received FDA approval for the first generic version of Sertraline Hydrochloride Capsules in 150 mg and 200 mg strengths, marking a significant milestone in psychiatric medication accessibility.
  • The approval includes Competitive Generic Therapy designation, granting Zenara 180 days of exclusive marketing rights in the U.S. market.
  • The generic sertraline capsules are indicated for treating Major Depressive Disorder in adults and Obsessive-Compulsive Disorder in both adults and pediatric patients aged six years and older.
  • According to IQVIA sales data, the reference product generated approximately $35.5 million in U.S. sales for the 12-month period ending June 2025.

FDA Approves Vostally Oral Solution, First Liquid Ramipril Formulation for Hypertension Treatment

Drug Approval
  • The FDA approved Vostally (ramipril) oral solution on July 23, 2025, marking the first liquid formulation of this ACE inhibitor for adults with hypertension who have difficulty swallowing tablets.
  • The once-daily oral liquid is indicated for treating hypertension, reducing cardiovascular risk in high-risk patients over 55, and managing post-myocardial infarction heart failure.
  • Rosemont Pharmaceuticals developed this formulation to address treatment barriers for patients unable to swallow traditional solid dosage forms.
  • The approval expands treatment options in the hypertension market, with the product expected to become available later in 2025.

FDA Approves Leqvio as First-Line Monotherapy for Cholesterol Management

Drug Approval
  • The FDA has approved an updated label for Novartis' Leqvio (inclisiran) allowing its use as monotherapy alongside diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia.
  • The approval removes the previous requirement for Leqvio to be used in combination with statin therapy, positioning it as a first-line treatment option.
  • Up to 80% of atherosclerotic cardiovascular disease patients in the US fail to reach guideline-recommended LDL cholesterol targets below 70 mg/dL.
  • Leqvio's twice-yearly dosing schedule administered by healthcare providers is designed to improve patient adherence and long-term cholesterol management.

Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

NCT05192941CompletedPhase 4
Novartis Pharmaceuticals
Posted 4/8/2022

Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.

NCT05763875CompletedPhase 3
Novartis Pharmaceuticals
Posted 3/15/2023

A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)

NCT04929249CompletedPhase 3
Novartis Pharmaceuticals
Posted 6/25/2021

Vanda Pharmaceuticals Reports Strong Q2 2025 Results with Multiple Drug Applications Under FDA Review

Drug Approval
  • Vanda Pharmaceuticals reported a 27% increase in Fanapt net product sales to $29.3 million in Q2 2025, driven by expanded sales efforts and direct-to-consumer campaigns.
  • The company has three drug applications under FDA review: Bysanti for bipolar I disorder and schizophrenia (PDUFA date February 21, 2026), tradipitant for motion sickness (PDUFA date December 30, 2025), and plans to submit imsidolimab BLA for generalized pustular psoriasis in 2025.
  • Total net product sales across all three marketed drugs reached $52.6 million in Q2 2025, representing a 4% increase year-over-year, though the company reported a net loss of $27.2 million compared to $4.5 million in Q2 2024.

FDA Approves Expanded Biktarvy Indication for HIV Treatment-Experienced Patients Restarting Therapy

Drug Approval
  • The FDA has approved a new indication for Biktarvy to treat HIV patients with treatment history who are not virologically suppressed and are restarting antiretroviral therapy.
  • The approval addresses a critical unmet need, as only 65% of people with HIV in the US are virally suppressed and gaps in care account for nearly 80% of new HIV diagnoses.
  • The expanded indication is based on evidence from treatment-naïve studies 1489 and 1490, which demonstrated rapid viral suppression and zero treatment-emergent resistance cases through five years.
  • Healthcare providers can now more confidently support a broader range of HIV patients, including those who have interrupted treatment and need to restart therapy.

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT02607930CompletedPhase 3
Gilead Sciences
Posted 11/13/2015

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT02607956CompletedPhase 3
Gilead Sciences
Posted 11/11/2015

FDA Approves First Neuroimmune Modulation Device for Rheumatoid Arthritis Treatment

Drug Approval
  • The FDA has approved SetPoint Medical's SetPoint System, the first implantable neuroimmune modulation device for adults with moderate-to-severe rheumatoid arthritis who cannot tolerate or are inadequately managed by existing biologic therapies.
  • The approval was supported by the 242-patient RESET-RA trial, which met its primary efficacy endpoint with statistically significant ACR20 improvement at 3 months and sustained benefits through 12 months.
  • The device delivers daily electrical stimulation to the vagus nerve to activate the body's natural anti-inflammatory pathways, with 75% of patients remaining free of biologic DMARDs at 12 months.
  • SetPoint Medical plans a targeted U.S. launch in 2025, followed by national expansion in early 2026, with future evaluation planned for multiple sclerosis and Crohn's disease.

Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

NCT04539964Active, Not RecruitingPhase 3
SetPoint Medical Corporation
Posted 1/11/2021

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