Daily Snap - 19. August 2025

Author

Joachim Eeckhout
August 19, 2025

Good morning! Yesterday, we told you how the FDA has been piling up delays in drug approvals. Well, today things got even spicier. After years of waiting for a decision on its sleep disorder drug, Vanda Pharmaceuticals scored a decisive court case win against the FDA, with the court ruling that the FDA cannot simply delay drug applications indefinitely. But this isn’t just about Vanda. The ruling cracks open the door for other companies to take the FDA to court when delays drag on too long. In other words, the regulator’s traffic jam of drug approvals might soon come with a wave of lawsuits on top. So if the FDA already felt under pressure, now it’s not just running late, it’s standing in the middle of the road, horns blaring from every direction.

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

📈 Retinopathy rally: Boehringer Ingelheim has entered a research and licensing deal with Palatin Technologies worth up to $327 million to develop new therapies for diabetic retinopathy (DR), a leading cause of adult blindness. The collaboration will focus on Palatin’s melanocortin receptor agonists, which target inflammation, vascular dysfunction, and neurodegeneration, key drivers of retinal disease. The agreement includes upfront, development, regulatory, and commercial milestone payments, plus tiered royalties. Boehringer, which is expanding its eye health portfolio, sees the approach as potentially applicable beyond DR, while Palatin, despite setbacks in its dry eye program, gains momentum with its stock rising 24% after the announcement.

🏃‍♂️Fast track ask: Stealth BioTherapeutics has resubmitted its drug elamipretide to the FDA for approval to treat Barth syndrome, a rare and often fatal genetic condition affecting muscle strength in children. After the therapy was rejected in May 2025, the company addressed FDA concerns by providing additional safety, manufacturing, and post-approval trial data. Although a six-month review period is expected, Stealth is requesting a faster “Class 1” two-month review. The therapy previously showed positive results in a small trial, with an advisory committee supporting its effectiveness despite mixed data. Stealth urges the FDA to expedite the review in line with its regulatory commitments.

🚀 Trial trek: Kriya Therapeutics, a U.S. based gene therapy biotech, has raised $313 million in a new equity financing round, one of the largest private biotech fundraises of 2025 so far. The company, which previously secured a $430 million series C between 2022 and 2023, is developing a pipeline of nine programs across neurology, metabolic health, and ophthalmology, with two currently in clinical trials. Kriya has also expanded through acquisitions of Redpin Therapeutics and Tramontane Therapeutics. While the company has not disclosed how the new funds will be used, the financing signals renewed momentum for gene therapy amid waning investor enthusiasm in the sector.

✂️Genentech ghosts: Genentech is ending its $2 billion collaboration with Adaptive Biotechnologies, originally launched in 2019 to develop personalized cancer treatments using Adaptive’s T-cell receptor (TCR) technology. The termination follows a string of cost-cutting measures at Genentech, including two rounds of layoffs this summer and the cancellation of other R&D deals. Adaptive had received $300 million upfront and will continue developing its TruTCR technology and digital TCR-antigen prediction model for oncology, immunology, and autoimmune programs. The move mirrors Genentech’s 2024 exit from a $3 billion Adaptimmune cell therapy pact amid broader restructuring of its R&D operations.

💰Cash for KRAS: Swedish biotech Anocca AB has secured €38.4 million (SEK440m) in financing to advance its T-cell receptor engineered T cell (TCR-T) therapies against pancreatic cancer. The funds will support a multi-center Phase I umbrella trial testing three non-viral TCR-T candidates targeting KRAS mutations in pancreatic ductal adenocarcinoma (PDAC). Conducted across hospitals in Sweden, Denmark, Germany, and the Netherlands, the study will enroll patients with matching HLA and KRAS mutations. With KRAS mutations driving most pancreatic cancers and survival rates below 10%, Anocca aims to pioneer scalable, personalized TCR-T therapies and expand its broad oncology pipeline.

SPEED READ

More news

  • Sarepta shared updated data showing an Elevidys-related acute liver injury hospitalization rate of 5.8% and eight total deaths; in response to a patient advocacy group’s petition for stricter labeling. Only two deaths are attributed to the treatment.

  • The European Commission approved Ogsiveo, the EU’s first authorized treatment for desmoid tumors, offering significant symptom relief and tumor control for patients needing systemic therapy.

  • Enlivex shares jumped 18% after its Phase I/II trial showed that Allocetra significantly reduced pain and improved function in knee osteoarthritis patients, especially older individuals.

  • The FDA delayed its decision on REGENXBIO’s RGX-121 gene therapy for Hunter syndrome to February 2026 to review new clinical data, amid rising investor optimism and financial strain.

  • LakeShore Biopharma received a preliminary non-binding offer from Oceanpine Capital to acquire the company at a 10.3% premium.

  • Upperton Pharma Solutions and Oxford’s Pandemic Sciences Institute are developing an oral adenovirus vectored vaccine formulation to enable needle-free, self-administered immunization and enhance global vaccine accessibility.

  • BioMed X and Novo Nordisk have partnered to develop oral peptide drug delivery technologies that prolong intestinal retention, aiming to boost absorption, bioavailability, and patient compliance.

  • Khondrion has granted Medvisis exclusive rights to commercialize its late stage investigational PMD therapy sonlicromanol in Switzerland and Liechtenstein.

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