Biotech Breakthroughs & Billion-Dollar Deals: This Week's Highlights

From FDA nods to mega-deals and startup breakthroughs, this issue keeps you ahead of the curve.

🧪 Clinical Pipeline Watch

🚀 Immix Biopharma’s CAR‑T trial expands — NEXICART‑2 for relapsed/refractory AL amyloidosis is now active at 14 U.S. sites, with enrollment outpacing expectations. The expansion could accelerate access to this promising BCMA-targeted treatment, with interim data set for presentation at ASCO 2025.

 🏁 GSK & Spero’s oral UTI drug stops trial early — The Phase III PIVOT‑PO study of tebipenem HBr met its primary endpoint in ~1,690 patients, demonstrating noninferiority to IV carbapenems while maintaining a clean safety profile. If approved, it could become the first oral carbapenem for complicated UTIs

💉 AbbVie’s Emrelis earns FDA accelerated approval — Telisotuzumab vedotin (Emrelis) gains approval for NSCLC with high c‑MET expression, delivering a 35% response rate in biomarker-selected patients and marking AbbVie’s first internally developed solid tumor ADC. Companion diagnostic test also approved.

📜 Regulatory Radar

🎟️ FDA launches CMC voucher pilot — The agency is piloting submission vouchers to incentivize early chemical/CMC filings and streamline review times for innovative therapies.

💰 Big Pharma, Big Deals

🔗 Sanofi to acquire Blueprint Medicines for $9.5B — Sanofi is strengthening its rare disease and precision oncology portfolio with this acquisition, bringing on Blueprint’s flagship drug Ayvakit and other pipeline assets. The all-cash deal, announced earlier this week, is aimed at expanding Sanofi’s immunology and cancer treatment capabilities.

🧬 Bristol Myers Squibb partners with BioNTech for cancer therapy — In a deal valued up to $11.1 billion, BMS is teaming up with BioNTech to co-develop and commercialize BNT327, a next-gen immunotherapy targeting solid tumors. The collaboration could lead to breakthrough treatments combining immune stimulation and anti-angiogenesis in oncology. ent value rights linked to the progress of VG-3927, Vigil’s lead Alzheimer’s asset.

💵 Royalty Pharma invests $2B in Revolution Medicines — This massive funding package includes both synthetic royalty and debt financing to support Revolution’s KRAS inhibitor program. The deal ensures financial runway without diluting ownership, with a focus on late-stage programs like daraxonrasib for pancreatic and lung cancers.

🌱 Emerging Pharma

📉 Recursion lays off 20% of staff to extend runway into 2027 — The AI-focused biotech is narrowing its pipeline and trimming operating costs amid ongoing funding headwinds. Despite the cuts, Recursion is doubling down on its strongest programs and maintaining its commitment to long-term platform development.

🧪 Actio raises $66M Series B to advance TRPV4 inhibitor — Backed by Regeneron Ventures and Canaan, Actio is developing a novel therapy for rare neurological and bladder disorders. The funding will support ongoing IND-enabling studies and preparation for early-phase clinical trials.

🌏 U.S. pharma companies ink $18.3B in China licensing deals — U.S. biopharma firms are increasingly tapping into Chinese innovation, signing 14 licensing agreements in the past year alone. The trend reflects a growing confidence in Chinese R&D, which now accounts for nearly 30% of global pharmaceutical innovation.

🔬 Trending in the Lab

🤖 Nvidia-backed SandboxAQ releases AI molecular binding data — The startup launched 5.2 million synthetic protein-drug binding datasets to speed early drug discovery, demonstrating AI’s evolving scientific role.

🤝 AstraZeneca teams up with China’s CSPC in $5.3B AI research pact — Collaboration targets discovery of immunological disease therapies using AI, with $110M upfront and milestone payments.

📊 FDA to deploy AI internally — Generative AI tools are being integrated across all FDA review centers by June 30 to streamline scientific evaluation tasks and boost efficiency.

💸 Investor Spotlight

📈 Caris Life Sciences debuts on Nasdaq, valued at $7.7B — Raised $494M in IPO; shares climbed ~29%. Proceeds will reduce debt and drive AI-powered cancer diagnostic expansion.

💰 Quadria Capital secures $1.07B for Asia healthcare fund — Exceeds original target, signaling confidence in emerging-market biopharma.

📊 Biotech startup Actio raises $66M Series B — Funds to advance TRPV4 inhibitor for rare neurological and bladder diseases; backed by Regeneron Ventures and Canaan.

📅 Upcoming Events & Conferences

• 📍 DIA Global Annual Meeting – Jun 15–19 | Washington, DC

• 📍 BIO International Convention – Jun 3–6 | San Diego, CA

• 📍 Health Innovation Summit Asia – Jul 10–12 | Singapore

💡 Did you know?

Only 1 in 10 drugs that enter clinical trials receive FDA approval, yet global R&D spending exceeds $200B annually.

Till next time,

BioPharma Update