RNA medicines developer Orbital Therapeutics has announced the successful closing of $270 million Series A financing. Orbital Therapeutics is focused on expanding the applicability of RNA-based medicines across a range of human diseases, including in the areas of next-generation vaccines, immunomodulation, and protein replacement. “Few companies can possess the know-how, technology and biologic insights to […]

The FDA has granted Biogen conditional approval for antisense oligonucleotide Qalsody (tofersen) for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the SOD1 (superoxide dismutase 1) gene, producing a rare, hereditary form of the disease. Qalsody is the first approved treatment to target a genetic cause of ALS. Tofersen was […]

Moderna and Merck have announced positive results from the Phase 2b trial evaluating Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda in patients with high-risk melanoma. The study demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival and reduced the risk of recurrence or death by 44% compared with Keytruda alone. mRNA-4157 (V940) […]

Takeda has announced positive results from a Phase 2b clinical trial of a tyrosine kinase 2 (TYK2) inhibitor in patients with moderate-to-severe plaque psoriasis, meeting its primary and secondary endpoints compared to placebo. “We are confident that we can execute a comprehensive development program and deliver a potential best-in-class therapy for patients, given Takeda’s strong background […]

Novartis has announced positive topline results from an interim analysis of a Phase 3 trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in patients with a form of early breast cancer (EBC) at risk of recurrence. Kisqali has already been approved in 99 countries worldwide, including by the FDA and the European Commission, for treatment. of […]

Boston-based Karuna Therapeutics, a clinical-stage biopharma with a focus on psychiatric and neurological conditions, has announced positive topline results from its Phase 3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium) in adults with schizophrenia. The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically […]

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling Biologics License Applications (BLAs) to the FDA for the investigational treatment exagamglogene autotemcel (exa-cel) for sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The BLAs include requests for Priority Review, which, if granted, would shorten the FDA’s review of the application to eight months from the time of […]

Biogen welcomed the VA’s recent decision to provide coverage of the company’s new Alzheimer’s drug Leqembi for veterans living with early stages of the disease. Biogen partner Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. […]

Wentworth Institute of Technology has selected Huntington Development Group to build a mixed-use life science project at 500 Huntington Ave., currently site of its main athletic field. Huntington Development Group. The approximately $ billion project calls for 640,000 square feet of life science space, retail and restaurant space. Additionally, the development will include publicly accessible […]

QurAlis has closed an oversubscribed $88 million Series B financing, bringing total funds raised to $143.5 million. QurAlis is a clinical-stage biotech developing precision medicines for ALS (amyotrophic lateral sclerosis) and other neurodegenerative diseases with genetically validated targets. The financing was led by EQT Life Sciences, investing from the LSP Dementia Fund, Sanofi Ventures, and […]