Lexington’s Frequency Therapeutics has announced that the Phase 2b study of its hearing loss therapy FX-322 has failed to meet its primary endpoint. As a result, the company will discontinue the FX-322 development program along with a related program. Frequency’s efforts will now focus on continuing to develop novel therapeutics to induce remyelination for individuals […]

Collaboration partners Sage Therapeutics and Biogen have announced that the FDA has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD. The […]

Joined by a coalition of local legislators, including state Sen. Jamie Eldridge and members of the Devens Enterprise Commission, the $1.4 billion French biotech and pharmaceutical giant celebrated the completion of and move to a “state-of-the-art” research and development facility at 67 Buena Vista Street, replacing a smaller facility on Jackson Road. Seqens President and […]

French drugmaker Ipsen plans to acquire Cambridge-based Albireo in a deal worth about $952 million. Albierio is developing bile-acid modulators to treat pediatric and adult cholestatic liver diseases. The company was spun out from AstraZeneca in 2008 and is headquartered in Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The anticipated acquisition will enrich […]

The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, have announced discontinuation of its HIV vaccine Phase 3 clinical trial based on the results of an independent data review by the study’s independent Data and Safety Monitoring Board (DSMB). The review determined that the HIV vaccine regimen was not […]

In early December, Seaport neighbors Vertex and Entrada announced a global collaboration focused on discovering and developing therapeutics for myotonic dystrophy type 1 (DM1). The collaboration includes Entrada’s program for DM1, ENTR-701, which is in late-stage preclinical development. Entrada’s EEV therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics […]

Moderna has announced positive topline data from its Phase 3 trial of its vaccine candidate, mRNA-1345, targeting respiratory syncytial virus (RSV) in older adults. The primary efficacy endpoints have been met, including vaccine efficacy (VE) of 83.7% against RSV-associated lower respiratory tract disease. Based on these results, Moderna intends to submit for regulatory approval in […]

Waltham-based, clinical-stage biopharm CinCor is slated to be acquired by British pharmaceutical giant AstraZeneca. Founded in 2018, CinCor’s mission is to bring innovation to the pharmaceutical treatment of cardio-renal diseases. Its lead asset, baxdrostat, is in clinical development for the treatment of hypertension. Under the terms of the merger agreement, AstraZeneca will acquire all of […]

Eisai and Biogen have announced that the FDA has approved lecanemab-irmb (brand-named Leqembi in the U.S.) for the treatment of Alzheimer’s disease (AD) under the Accelerated Approval Pathway. The approval is based on Phase 2 data that demonstrated that Leqembi reduced the accumulation of amyloid beta (Aβ) plaque in the brain, a defining feature of […]

Moderna and Merck have announced that the Phase 2b trial of their investigational personalized mRNA melanoma cancer vaccine (mRNA-4157/V940) in combination with Merck’s Keytruda demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival versus Keytruda alone. These results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized […]