Lurbinectedin

10 biotech companies to watch in 2025: Anavex Life Sciences (blarcamesine for neurodegenerative diseases), Candid Therapeutics (T cell engager antibodies for autoimmune diseases), Enterprise Therapeutics (ETD001 for cystic fibrosis), Jazz Pharmaceuticals (Ziihera for biliary tract cancer), Life Biosciences (ER-100 for optic neuropathies), Ovid Therapeutics (OV888 for cerebral cavernous malformation), Skye Bioscience (nimacimab for obesity), TG Therapeutics (Briumvi for multiple sclerosis), Wave Life Sciences (WVE-006 for alpha-1 antitrypsin deficiency), and Quotient Therapeutics (somatic genomics platform for drug discovery).

Jazz Pharmaceuticals received FDA approval for Ziihera, a HER2-targeted therapy for HER2+ biliary tract carcinoma, with a list price of $35,500 per cycle. Piper Sandler reaffirmed its Overweight rating and $163 price target, highlighting growth in the oncology segment. Jazz's strong financial health supports portfolio expansion, with anticipation for 2025 data on Ziihera in first-line HER2+ gastroesophageal adenocarcinoma.

Jazz Pharmaceuticals (JAZZ) posted Q3 top-and-bottom-line beats, projecting 2024 earnings above expectations, driven by sales growth from Xywav and Epidiolex. The company received accelerated approval for Ziihera, a treatment for HER2-positive biliary tract cancer, and anticipates phase 3 PFS results on Zanidatamab. JAZZ trades at a discount to peers, making it attractive for value investors.

Small cell lung cancer (SCLC) often responds well initially but later relapses. New treatments like Imdelltra, Trilaciclib, Durvalumab, and Lurbinectedin have been FDA approved. Clinical trials are ongoing for treatments like Ivonescimab, PM8002, Adebelimab, IBI3009, YL201, ZG006, and Tarlatamb, focusing on extensive stage SCLC.

Jazz Pharmaceuticals' Phase III IMforte study showed Zepzelca with Roche’s Tecentriq significantly boosts survival in extensive-stage small cell lung cancer patients. The combo regimen improved overall and progression-free survival, with a well-tolerated safety profile. Jazz plans to file a supplemental New Drug Application for Zepzelca in 2025, aiming for first-line maintenance therapy approval.

Jazz Pharmaceuticals' Zepzelca (lurbinectedin) plus Roche's Tecentriq (atezolizumab) showed significant improvement in overall and progression-free survival in extensive-stage small cell lung cancer (SCLC) maintenance treatment, with safety consistent with known profiles. Jazz plans to submit a supplemental new drug application for this combination in the first half of 2025.

Zepzelca (lurbinectedin) combined with Tecentriq (atezolizumab) significantly improved overall survival (OS) and progression-free survival (PFS) in extensive-stage small cell lung cancer (ES-SCLC) patients compared to Tecentriq alone in the Phase III IMforte trial. The combination, well-tolerated, showed no new safety signals and is planned for FDA submission as a first-line maintenance treatment for ES-SCLC in 2025.

Pfizer pays Triana Biomedicines $49M for molecular glue degrader research; Tim Buckley joins Pfizer's board amid Starboard Value pressure; Jazz Pharmaceuticals' Zepzelca and Roche's Tecentriq combo outperforms Tecentriq alone in small cell lung cancer; MeiraGTx's Parkinson's gene therapy shows promise in small trial; Akeso raises $250M for global antibody drug trials; Inventiva gets $100M funding with Mark Pruzanski as chairman.

PharmaMar and Jazz Pharmaceuticals announce positive Phase 3 trial results for Zepzelca (lurbinectedin) combined with atezolizumab, showing significant improvement in overall survival and progression-free survival for extensive-stage Small Cell Lung Cancer (ES-SCLC) patients. Plans to submit sNDA to FDA and MAA to EMA in first half of 2025.