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Home » Newsletters » BioWorld

BioWorld

Oct. 3, 2024

View Archived Issues
Purple macrophage

Resolution’s £64M series B to advance macrophage cell therapy

Resolution Therapeutics Ltd. is preparing for a phase I/II trial of its autologous engineered macrophage cell therapy, RTX-001, in the treatment of end-stage liver disease and has raised £63.5 million (US$83.3 million) to complete the study and to add further fibrotic and inflammatory disease programs to its portfolio. Recruitment to the study, to be conducted at 15 sites in Spain and the U.K., is due to start before the end of 2024, with the monocyte-derived patient macrophages being processed and modified at a facility in Edinburgh. Read More

Enara’s ‘dark antigen’ work draws more pharma backing in series B

Dark genome miner Enara Bio Ltd. has closed a $32.5 million series B that will see the lead program targeting the first of a novel class of cancer antigens it has discovered through to the clinic. Enara calls these cancer antigens “dark antigens” (the name is trademarked). It says they can be found in solid tumors irrespective of the immune phenotype, and are often expressed at high prevalence across multiple different tumors. Read More
Bladder-cancer

Multiple players rev their Engenes in bladder cancer

Engene Holdings Inc.’s recent disclosure of pivotal phase II data with nonviral gene therapy detalimogene voraplasmid (also known as detalimogene, and previously as EG-70) – along with a planned protocol refinement – added intrigue to the non-muscle invasive bladder cancer space, which continues to percolate. Read More

US CMS sets playing field for next round of Rx price negotiations

Round 2 of the U.S. Medicare price negotiations officially began late Oct. 2 with CMS’ release of its final playbook and timeline, which build on lessons learned from the first round and comments on a draft negotiations guidance that was published in May. In response to the feedback CMS received, the second round will allow for more patient-focused sessions and offer increased engagement with the makers of the drugs selected for negotiations. Read More
IPO-coins.png

Septerna joins IPO queue; 23 biopharma debuts reach $5.9B

South San Francisco-based Septerna Inc. filed an S-1 with the U.S. SEC to conduct an IPO on Nasdaq about two years and eight months after launching operations with a $100 million series A led by Third Rock Ventures. The company is focused on G protein-coupled receptor oral small molecules derived from its Native Complex Platform, aimed at treating diseases within the endocrinology, immunology and inflammation, and metabolic diseases realms. Read More

BioWorld Insider podcast: Capricor’s CEO pursues a BLA and talks rare disease

Linda Marbán, CEO of Capricor Therapeutics Inc., discusses deramiocel (CAP-1002), the company’s allogeneic cardiac-derived cell therapy, for treating Duchenne muscular dystrophy. The company just wrapped up a visit with the U.S. FDA and is prepping to file a BLA for its treatment of the rare disease. Read More

Appointments and advancements for Oct. 3, 2024

New hires and promotions in the biopharma industry, including: Allarity, Codexis, Mitorx, Spyre. Read More

Financings for Oct. 3, 2024

Biopharmas raising money in public or private financings, including: AAX Biotech, Bioage, Briacell, Emergent Biosolutions, Hemogenyx, Mithradote, Orum, Taho, TNF Pharma, Triveni. Read More

In the clinic for Oct. 3, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atyr, Kazia, Organogenesis, PDS. Read More

Other news to note for Oct. 3, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biotheus, Eliem, Emergex, Frazier, Gilead, Immunoprecise, Intelgenx, J&J, Novaliq, Verrica. Read More

Regulatory actions for Oct. 3, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Laboratoires Thea, Novaliq, Volastra. Read More

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