Atea Pharmaceuticals

RSV Treatment Landscape Expands with New Vaccines and Clinical Trials in 2024-2025

3 months ago

• Moderna's mRESVIA vaccine received MHRA approval in February 2025 for adults aged 60 and older, joining GSK's Arexvy and Pfizer's Abrysvo in the expanding RSV vaccine market. • The FDA has mandated new safety warnings for RSV vaccines regarding Guillain-Barré Syndrome risk, highlighting ongoing safety monitoring efforts in early 2025. • Multiple pharmaceutical companies including Sanofi, GSK, and Pfizer are conducting advanced clinical trials in 2024, focusing on various patient populations and novel therapeutic approaches.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Hepatology Review: FDA Updates, Viral Hepatitis Research, and MASH Advancements in December 2024

5 months ago

• The FDA updated safety information for obeticholic acid (Ocaliva) regarding liver injury risk in primary biliary cholangitis (PBC) patients without cirrhosis. • Breakthrough Therapy designation was granted to tobevibart and elebsiran by the FDA and EMA for chronic hepatitis delta (CHD) treatment, based on Phase 2 SOLSTICE trial data. • Atea Pharmaceuticals reported positive Phase 2 results for bemnifosbuvir and ruzasvir in hepatitis C virus (HCV) treatment, achieving a 98% SVR12 rate. • Belapectin, from Galectin Therapeutics, in MASH cirrhosis and portal hypertension, did not meet its primary endpoint in the Phase 2b/3 NAVIGATE trial.

Dengue Fever Clinical Trial Landscape Shows Active Global Research Efforts

5 months ago

• A global review of dengue fever clinical trials reveals ongoing research across multiple regions and countries, with a focus on G7 and E7 nations. • The trials cover various phases, assessing different endpoints and involving diverse sponsor types, including pharmaceutical companies and research institutions. • Key players like Sanofi, Takeda, and GSK are actively participating in the development of dengue fever therapeutics and preventive measures. • Recent news highlights advancements and setbacks in dengue fever drug development, such as ISLA-101's Phase 2a results and Johnson & Johnson discontinuing a Phase 2 study.

FDA Approves Multiple Breakthrough Therapies: Crenessity for CAH, Unloxcyt for Skin Cancer

5 months ago

• The FDA has approved Neurocrine's Crenessity as an adjunct therapy for classic congenital adrenal hyperplasia, offering patients a way to reduce steroid treatment burden. • Checkpoint Therapeutics received FDA approval for Unloxcyt to treat advanced cutaneous squamous cell carcinoma, targeting a $1 billion market opportunity. • Galderma's Nemluvio gains FDA approval for moderate-to-severe atopic dermatitis in patients 12 and older, with projected peak annual sales exceeding $2 billion.

Key Infectious Disease Updates: C. difficile, Salmonella Outbreak, Hepatitis C Treatment, and More

6 months ago

• Mayo Clinic Arizona found removing _C. difficile_ from gastrointestinal pathogen panels reduced unnecessary treatments and improved diagnostic stewardship. • A _Salmonella_ outbreak linked to cucumbers has sickened 68 people across 19 US states, leading to a product recall by SunFed Produce LLC. • Atea Pharmaceuticals' combination therapy for hepatitis C achieved a 98% SVR12 rate in a Phase 2 trial, paving the way for Phase 3 studies. • Gilead's lenacapavir injection demonstrated high efficacy in preventing HIV infection in Phase 3 trials, leading to NDA submission.

Atea's Phase 2 Hepatitis C Regimen Shows High Efficacy, Phase 3 Planned for 2025

6 months ago

• Atea Pharmaceuticals' Phase 2 study of bemnifosbuvir and ruzasvir for hepatitis C met its primary endpoint, demonstrating a 98% SVR12 rate in treatment-adherent patients. • The combination regimen was generally safe and well-tolerated, with no drug-related serious adverse events or treatment discontinuations reported during the trial. • Atea plans to initiate a global Phase 3 program in early 2025, aiming to simplify the regimen to a two-pill, fixed-dose combination for enhanced patient convenience.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

RSV Therapeutic Pipeline Shows Promise with Novel Therapies and Clinical Advancements

7 months ago

• Over 50 companies are actively developing more than 50 therapeutic options for Respiratory Syncytial Virus (RSV) treatment, indicating a robust pipeline. • GSK's Arexvy vaccine demonstrated encouraging Phase III results, preventing lower respiratory tract disease (LRTD) in older adults across three RSV seasons. • Merck's clesrovimab showed positive topline results in a Phase IIb/III trial as a preventive treatment for RSV in infants, highlighting potential for vulnerable populations.

Atea's Bemnifosbuvir Fails to Meet Primary Endpoint in Phase 3 COVID-19 Trial

8 months ago

• 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. • The global, randomized, double-blind, placebo-controlled trial involved 2,221 high-risk patients with mild to moderate COVID-19 receiving bemnifosbuvir or placebo. • Bemnifosbuvir was generally safe and well-tolerated in the SUNRISE-3 trial, but the company will not pursue a regulatory pathway forward for COVID-19. • Atea remains focused on developing bemnifosbuvir in combination with ruzasvir for hepatitis C treatment, with additional Phase 2 results expected in Q4 2024.