Clinical Trial News
Real-World Study Highlights Adverse Events Associated with Lenvatinib Use
A comprehensive real-world drug safety surveillance study on lenvatinib has identified significant adverse events (AEs) linked to its use, including immune-mediated hepatitis, portal vein thrombosis, and adrenal insufficiency. The study, analyzing data from 2015 to 2023, found that most AEs occurred within the first month of treatment, with a median onset time of 41 days. Specific targets of lenvatinib, such as FGFR4, PDGFRA, and KIT, were potentially linked to conditions like cholecystitis, cholangitis, and hepatic encephalopathy.
FDA Approves AstraZeneca and Ionis' Wainua for Hereditary ATTR Polyneuropathy
- The FDA has approved AstraZeneca and Ionis' Wainua (eplontersen) for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN).
- Approval was based on the NEURO-TTRansform study, demonstrating Wainua's ability to improve neuropathy impairment and quality of life.
- Merck received a Complete Response Letter (CRL) from the FDA for gefapixant, its chronic cough candidate, marking the second CRL for this drug.
- Keytruda received European Commission approval for two indications in gastrointestinal cancers, expanding its use in this therapeutic area.
AbbVie to Acquire Cerevel, Novartis' Fabhalta Approved, and Other Pharma Updates
- AbbVie is set to acquire Cerevel Therapeutics for $8.7 billion, bolstering its neuroscience pipeline with candidates targeting schizophrenia, Parkinson's disease, and mood disorders.
- The FDA has approved Novartis' Fabhalta (iptacopan), the first oral monotherapy for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder.
- Pfizer halted Phase III development of its twice-daily obesity drug, danuglipron, due to significant gastrointestinal side effects observed in Phase II trials.
- Biogen and Eisai received full FDA approval for Leqembi, an Alzheimer's disease drug shown to slow cognitive decline, expanding Medicare coverage.
BioLineRx's APHEXDA Gains Momentum in Stem Cell Mobilization for Multiple Myeloma
- BioLineRx's APHEXDA (motixafortide) receives FDA approval for stem cell mobilization in multiple myeloma patients, marking a significant advancement in over a decade.
- Commercial launch of APHEXDA in the U.S. is underway, with positive feedback from transplant centers indicating it addresses a critical unmet need for effective mobilization.
- Clinical trials explore motixafortide's potential in pancreatic cancer and sickle cell disease, demonstrating versatility across hematological and solid tumor cancers.
- Gloria Biosciences partners with BioLineRx for development and commercialization of motixafortide in Asia, including a bridging study in China for stem cell mobilization.
FDA Authorizes Updated COVID-19 Vaccines Targeting New Variants
- The FDA has authorized updated COVID-19 vaccines targeting newer variants of the SARS-CoV-2 virus, with similar side effects expected.
- Health experts recommend that older adults (65+), immunocompromised individuals, and those with conditions like diabetes or cardiovascular disease get vaccinated annually.
- Novavax's protein-based COVID-19 vaccine, a more traditional option, is awaiting FDA and CDC approval and may offer benefits when combined with mRNA vaccines.
- Concerns remain about a potential surge in COVID-19, flu, and RSV cases during the colder months, which could overwhelm hospitals.
GeoVax Advances Gedeptin and COVID-19 Vaccine Programs Amidst Financial Update
- GeoVax is focusing on advancing its Phase 2 clinical-stage products, Gedeptin for head and neck cancer, and GEO-CM04S1, a next-generation COVID-19 vaccine.
- Gedeptin, a gene-directed enzyme prodrug therapy, targets solid tumors and aims to improve the quality of life for patients with advanced head and neck cancer.
- GEO-CM04S1 differentiates itself by targeting both antibody and cellular immune responses, potentially offering more robust protection for immunocompromised individuals.
- GeoVax is actively seeking partnerships and collaborations for worldwide commercialization and distribution of its products, while also exploring non-dilutive funding opportunities.
Revolution Medicines' RAS(ON) Inhibitors Show Promise in Lung and Pancreatic Cancers
- RMC-6236 demonstrates encouraging anti-tumor activity across multiple RAS variants (G12D, G12V, and G12R), with a 38% objective response rate in non-small cell lung cancer.
- RMC-6291 shows a 50% objective response rate in lung cancer patients who progressed on prior KRAS G12C inhibitors, suggesting clinically meaningful differentiation.
- Revolution Medicines anticipates initiating a pivotal Phase 3 trial for RMC-6236 in second-line RAS-mutant non-small cell lung cancer in 2024.
- The company expects to acquire EQRx, gaining $1.1 billion in net capital to support the late-stage development of its RAS(ON) inhibitor pipeline.
ATAI Life Sciences Reports Positive Q3 2023 Financials and Advances Clinical Pipeline
- ATAI Life Sciences reported a net income of $44.2 million for Q3 2023, a significant increase compared to the previous year, driven by non-cash gains.
- R&D and G&A expenses decreased year-over-year, reflecting a streamlined approach to clinical program costs and administrative efficiencies.
- The company's current cash reserves, combined with committed funding, are projected to sustain operations into the first half of 2026.
- Key pipeline programs, including RL-007 for CIAS and VLS-01 for TRD, are progressing, with Phase 2b readout of RL-007 anticipated in H2 2024.
Biotech Stock Roundup: Aldeyra Faces Setback, Annovis Bio Shows Positive Updates, and More
- Aldeyra Therapeutics' stock plummeted after the FDA identified substantive review issues with its NDA for reproxalap for dry eye disease, potentially delaying approval.
- Annovis Bio announced positive interim analysis from its Alzheimer's Disease study on buntanetap, indicating potential treatment effects after six weeks.
- Scholar Rock plans to expand into cardiometabolic disorders, advancing SRK-439 for obesity treatment and initiating a phase II study with apitegromab in combination with a GLP-1 RA.
- Evelo Biosciences' mid-stage study on EDP2939 for moderate psoriasis failed to achieve its primary endpoint, leading to cessation of its development.
Wegovy Shows Promise in Reducing Heart Attack and Stroke Risk, Boosting Novo Nordisk and Eli Lilly Stocks
- Novo Nordisk's Wegovy demonstrated a 20% reduction in heart attack, stroke, or death from heart disease in obese, non-diabetic patients over five years.
- The positive trial results have led Novo Nordisk to seek FDA and UK approval to expand Wegovy's usage for cardiovascular risk reduction.
- Eli Lilly's Mounjaro is also being tested for similar benefits, with trial results expected in October 2027, potentially expanding its market.
- The promising data may encourage insurers to increase coverage for GLP-1 drugs like Wegovy and Mounjaro, addressing current coverage limitations.