BioCentury This Week

→ WHAT IT COVERS BioCentury This Week examines biotech capital markets momentum amid geopolitical uncertainty, Xenon Pharmaceuticals' phase three epilepsy data validating the KV7 potassium channel target, and the shifting Friedreich's ataxia pipeline from mitochondrial stabilizers toward frataxin-restoring gene therapies, with at least five programs now in development. → KEY INSIGHTS - **Biotech follow-on strength vs.

→ WHAT IT COVERS BioCentury and Bay Helix's fifth East-West BioPharma Summit in Seoul surfaces key findings on South Korean biotech's rise, including deal flow data showing more first-in-class than follow-on assets, clinical trial competitiveness, cross-border data transfer barriers, and investor mindset gaps between Asian and Western markets. → KEY INSIGHTS - **Korean Biotech Innovation Profile:** BioCentury's deal analysis from the past two years shows South Korean biotechs rank second in...

→ WHAT IT COVERS BioCentury This Week examines Vinay Prasad's second FDA departure and its structural implications for CBER leadership, the expanding phase two fibrosis pipeline targeting IPF with over 20 programs across novel mechanisms, plus clinical setbacks for psychedelic GAD therapy and Novo Nordisk's Cagrisema head-to-head obesity trial against Lilly's tirzepatide.

→ WHAT IT COVERS Frank LeDoux, McKinsey Asia veteran and new Aulus Capital venture partner, argues biopharma should embrace a multipolar world where US, China, Europe, and emerging regions collaborate rather than compete. The episode also covers Stargardt disease treatment advances, FDA Commissioner McCary's controversial public statements, and the plausible mechanism framework for rare diseases.

→ WHAT IT COVERS Gilead acquires Arcellx for $7.8 billion to gain full control of AnitoCell, a BCMA-targeting CAR-T therapy for multiple myeloma with a 96% objective response rate. The episode also covers ctDNA validation challenges as a surrogate endpoint and FDA's reversal on Moderna's mRNA flu vaccine application. → KEY INSIGHTS - **Gilead-Arcellx Deal Structure:** Gilead pays $115 per share — above Arcellx's prior all-time high — plus a $5-per-share CVR contingent on AnitoCell reaching $6...

→ WHAT IT COVERS BioCentury This Week episode 350 examines the oral SERD landscape, covering 11 pipeline assets competing for dominance in estrogen receptor-positive breast cancer, plus FDA's refusal to file Moderna's flu vaccine application and a complete response letter issued to DISC Medicine for an orphan disease therapy. → KEY INSIGHTS - **Oral SERD market size:** Estrogen receptor-positive, HER2-negative breast cancer represents approximately 70% of all breast cancers, making oral SERDs a...

→ WHAT IT COVERS BioCentury This Week examines the 2025 biotech Series A landscape, where 146 rounds totaling $8.1B signal stabilization after four years of decline, alongside the systemic threat posed by compounded GLP-1 drugs, congressional rejection of NIH budget cuts, and a framework for reviving failed psychiatric drug candidates using modern engineering tools.

→ WHAT IT COVERS BioCentury This Week episode 348 covers the second installment of 2026 biotech catalysts, focusing on RNAi and antisense therapies across cardiovascular, neuromuscular, and renal indications, plus analysis of China's first orphan drug exclusivity law granting seven years of market protection, effective May 15, 2026. → KEY INSIGHTS - **Lp(a) Phase 3 Benchmark:** Ionis and Novartis's HORIZON trial of pelacarsen will deliver the first cardiovascular outcomes data testing whether...

→ WHAT IT COVERS China's new May 2026 gene and cell therapy rules allow 1,700 hospitals to charge for investigational treatments post-IIT completion, with national authorities responding within 20 working days. The episode also covers 2026 neuro biotech catalysts and two CNS-focused startups: Elkadonia targeting ELK1 for depression and Bexorg using post-mortem human brains for drug testing.

→ WHAT IT COVERS BioCentury's 2026 public markets preview examines why biotech's recovery—marked by XBI returning 36% in 2024 and outperforming the Magnificent Seven—may finally be durable, analyzing 23 commercial-stage companies, generalist capital rotation, sustained M&A activity, and FDA regulatory uncertainty as the primary remaining headwind. → KEY INSIGHTS - **Recovery Benchmark:** The XBI rose 36% in 2024 and 83% from its April trough, outperforming the S&P 500, tech sector, and...

→ WHAT IT COVERS BioCentury This Week covers JPMorgan Healthcare Conference takeaways, GSK's $2.2B acquisition of Wrap Therapeutics targeting food allergies, next-generation targeted protein degradation technologies including TACs and lysosomal degraders, Trump's push to codify Most Favored Nation drug pricing into legislation, and pediatric priority review voucher reauthorization progress in Congress. → KEY INSIGHTS - **GSK's Wrap acquisition strategy:** GSK paid $2.2B ($1.