Spero Therapeutics

Sanofi's tolebrutinib, an oral BTK inhibitor, received FDA Breakthrough Therapy designation for non-relapsing secondary progressive multiple sclerosis (nrSPMS). Data from the HERCULES study showed tolebrutinib delayed disability progression by 31% and doubled confirmed disability improvement rates. Regulatory submissions for approval are underway in the U.S. and EU. Tolebrutinib is also being evaluated for primary progressive MS, with data expected in 2025.

Esperion Therapeutics filed NDSs in Canada for Nexletol and Nexlizet to reduce LDL-C and cardiovascular risk. Nexlizet combines bempedoic acid and ezetimibe. Shares rose 10.7% post-announcement. The drugs are approved in the U.S. and Europe, marketed as Nilemdo and Nustendi ex-U.S. (excluding Japan). Label expansions in 2024 support broader use, with net product sales up 46.2% YOY in 2024. Otsuka Pharmaceutical filed for bempedoic acid in Japan, potentially boosting future sales.

DelveInsight's report on Complicated Urinary Tract Infection (UTI) clinical trials highlights 12+ companies developing 12+ pipeline drugs, with therapies in various stages of development, including Phase III. Key companies include Spero Therapeutics, Iterum Therapeutics, Venatorx Pharmaceuticals, Nabriva Therapeutics, Allecra Therapeutics, Wockhardt, and MerLion Pharmaceuticals.

Jazz Pharmaceuticals' intravenous drug zanidatamab (Ziihera) receives FDA accelerated approval for HER2-positive biliary tract cancer, marking the first dual HER2-targeted, chemotherapy-free therapy in the U.S. The approval is based on a 52% objective response rate in a phase IIb study, with a commercial launch expected by year-end. Jazz is also conducting phase III and late-stage studies for gastroesophageal adenocarcinoma and metastatic breast cancer.

TenNor Therapeutics' Phase III trial of rifasutenizol met all primary endpoints, showing >90% eradication rate for H. pylori infection, outperforming bismuth-containing quadruple therapy (BQT) with better safety and tolerability.

Biotech company Spero Therapeutics, backed by Lundbeckfonden Ventures and Novo Nordisk Foundation’s antibiotics venture Repair, faces a significant setback.

Spero Therapeutics halted development of antibiotic SPR720 after it failed to differentiate from placebo in a Phase IIa trial for non-tuberculous mycobacterial pulmonary disease (NTM-PD). The company plans to lay off 39% of staff and focus on its other antibiotic programs, tebipenem HBr and SPR206. Spero's stock dropped 17% in premarket trading.