BioTech Visionary @BioTechVisions

🔍 Vaxart Seeks Clarity as BARDA Funding Halts Again Vaxart reports a new stop-work order on a BARDA-funded, 10,000-participant Phase 2b trial of its oral COVID-19 vaccine candidate—despite having enrolled ~5,000 participants so far. The biotech says it has received no…

🥇 Novartis Scores Third Phase 3 Win This Week with Ianalumab In a remarkable clinical milestone, Novartis has announced its third Phase 3 win this week for ianalumab—this time in primary immune thrombocytopenia (ITP). The B-cell–depleting antibody significantly extended time to…

🚀 Bayer Bets Big on Undruggable KRAS — Up to $1.3B pact with Kumquat Biosciences to license a KRAS G12D inhibitor, a once-invincible oncogene mutation now entering clinical testing. Why this matters: The drug targets KRAS G12D, common in 38% of pancreatic cancer cases, 13% of…

🚀 PureTech Launches Celea Therapeutics to Transform Lung Disease Care 🌬️🔬 PureTech has unveiled Celea Therapeutics, a new venture focused on respiratory diseases. Led by former Teva North America CEO Sven Dethlefs, the spinout will advance its promising Phase 3–ready…

🚨 Pipeline Shake-Up at Gilead 🚨 Gilead Sciences has axed three R&D programs — including a Novo Nordisk-partnered MASH combo and two early-stage cancer drugs (DGKα inhibitor GS-9911 and MCL1 inhibitor zamzetoclax). The MASH candidate, combining cilofexor, firsocostat, and…

🚨 Major Breakthrough in Sjögren’s Syndrome! 🚨 Novartis has announced double Phase 3 wins for its dual-mechanism antibody ianalumab in the Neptunus 1 & 2 trials — marking the first-ever global Phase 3 studies to show a statistically significant reduction in disease activity for…

⚡ Cancer Vaccine Misses Mark — But FDA Still in Sight 🧬🎯 IO Biotech’s melanoma vaccine Cylembio, combined with Keytruda, narrowly missed statistical significance in a phase 3 trial (PFS HR: 0.77; p=0.056). Despite the setback, results showed median PFS of 19.4 months vs. 11…

🚀 $645M Lung Disease Deal Alert 🌬️💊 Expedition Therapeutics is licensing XH-S004 from Fosun Pharma for $17M upfront, with potential milestones up to $645M. The oral DPP-1 inhibitor—currently in Phase 2 for non-CF bronchiectasis and Phase 1b for COPD—aims to reduce inflammation…

📉 Gilead returns rights to Arcus’ etrumadenant, stepping back from a key asset in their $725M cancer immunotherapy deal. 🔙 The move follows Arcus' decision not to pursue phase 3 for etrumadenant in metastatic colorectal cancer, despite an FDA-confirmed path to market. 💸…

🚀 Minghui Pharmaceutical lands $131M in a “pre-IPO” round to accelerate its launch and pipeline! 💸 Led by OrbiMed and Qiming Venture Partners, the Shanghai biotech will: ✅ Support the potential launch of MH004, a topical pan-JAK inhibitor for dermatitis (Ph3, under review in…

🔁 Eli Lilly hits reset on its pain & inflammation pipeline in a major Q2 R&D clearout. ❌ Mazisotine (licensed from Centrexion) is out after underwhelming Ph2 results for diabetic neuropathic pain. ✅ In comes STC-004, a NaV1.8 inhibitor from its SiteOne acquisition, targeting…

🚀 Strand Therapeutics lands $153M Series B to push its self-replicating mRNA cancer therapies deeper into the clinic! Backed by industry giants like Regeneron, Amgen, and Eli Lilly, Strand is reshaping the future of oncology. Their lead candidate STX-001 shows early complete…

🔄 Terns to Halt Metabolic Trials After 2025, Shifts to Partnering Mode 💡 In a pivotal pivot, Terns Pharmaceuticals has announced it will halt funding for metabolic disease trials after 2025, including its lead GLP‑1 candidate TERN‑601 in obesity. Instead, it plans to seek…

🇯🇵 Astria Licenses Navenibart to Kaken for Japan in $32M Deal 🧬 Strategic global move by Astria: the company has inked a Japan-exclusive licensing deal with Kaken Pharmaceutical for its lead HAE antibody navenibart, capturing $16M upfront plus up to $16M in milestones, and…

🔬 Alltrna Slims Down Ahead of Its tRNA Medicines’ First Human Trial Flagship Pioneering-backed Alltrna is repositioning as it nears its first clinical milestone—cutting 8 jobs (12%) to refine operations around its upcoming tRNA-based therapy, engineered to tackle Stop Codon…

🚨 GAO Says NIH Broke the Law by Withholding $8B in Research Grants 💸 A major blow to actions aimed at cutting research funding: the Government Accountability Office (GAO) has ruled that the NIH illegally withheld and canceled over $8 billion in grants—terminating 1,800+ awards…

🚫 Vertex Scraps VX‑993 Next‑Gen Pain Pill After Phase 2 Miss – Journavx Expansion Scaled Back Tough week for Vertex’s pain strategy: VX‑993, the new NaV1.8 inhibitor designed to outperform Journavx, failed all three dose arms in a Phase 2 bunionectomy trial. Pain relief did not…

🛑 BioMarin Ends PKU Program BMN 390 After Immunogenicity Shortfall — Eyes Next Moves BioMarin has quietly pulled the plug on BMN 390, a preclinical PKU (phenylketonuria) therapy once positioned to improve on its existing Palynziq® treatment. Despite its promise—including the…

💸 Imunon Shelves COVID Vaccine, Seeks Partner as Cash Dwindles 🧬 Imunon has had to deprioritize its COVID‑19 vaccine program (IMNN‑101) after its cash reserves dipped under $5 million by June 2025, prompting a refocus and urgent pursuit of strategic collaboration. The company…

🔄 HMNC Misses Phase 2b Endpoint for BH‑200 but Eyes Precision Subgroup Path Forward HMNC Brain Health’s BH‑200 (vasopressin V1b antagonist) did not meet its primary endpoint in the Phase 2b OLIVE trial for stress‑axis-related major depressive disorder (MDD). The study included…