Kriya Therapeutics: What if a single treatment could replace years of injections for millions?

Early approvals in gene therapy have proven what a single dose can do, but they also exposed a cost challenge. Most approved gene therapies carry million-dollar price tags which are only workable in ultra‑rare settings, and don’t scale to common diseases. However, common diseases affect a broader population and have massive unmet need, which results in large markets even at low prices. For instance, geographic atrophy (GA) affects around a million people in the U.S. and is rising with aging demographics, while metabolic liver disease (MASH) and neuropathic pain indications affect tens of millions of patients in the U.S. and worldwide. If gene therapy can be made repeatable, manufactured predictably, and administered in outpatient settings, its impact can be transformational for healthcare everywhere.

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In the recent years, durable gene expression, clearer regulatory guidance, and growing manufacturing know‑how are shifting the field from “one‑off” miracles to repeatable product engines. That shift is exactly where Kriya Therapeutics is aiming – building a platform with standardized processes, shared analytics, and in-house scale, to go after multiple common diseases without reinventing the wheel each time.

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Today, we are thrilled to announce our investment in Kriya, leading their Series D capital raise. We believe that Kriya’s approach is superior in terms of speed, capital efficiency, and probability of success relative to traditional, rare‑disease centric gene therapy models. For patients, that translates to broader access, simpler procedures, and a durable treatment that meaningfully improves quality of life. For payors, that means lower total cost of care, creating clearer value stories for reimbursement and coverage expansion. This is a platform built to launch many products, expand into new diseases, and grow into a category-defining gene therapy franchise.

Designing for clinics, not cleanrooms

How do you design a one-time therapy that’s administered in an outpatient setting, monitored with standard tools, and repeatable across programs?

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Kriya’s pipeline of drug candidates has been built to minimize the dimensions of risk associated with drug development. While the pipeline spans ophthalmology, metabolic and nerve diseases, the selection criteria are common across the programs.

• Validated biology: Conditions where the biology is well understood and backed by prior research, helping de-risk both safety and effectiveness of the programs.
• Clear regulatory path: Disease segments where regulatory endpoints are well established with a possibility of accelerated pathways, if unmet need is high.
• Clinic-friendly delivery: Indications with easy, clinic-based access to the target tissue where small, focal doses can achieve strong local effect with minimal spillover and manageable safety risks.
• Easy to measure results: Conditions with clear check-ins (scans, simple blood tests, symptom counts) to quantify the impact of the treatment over time.
• Access & scale: Conditions that are prevalent enough to matter where delivery and follow-up are doable outside tertiary centers and the payer value story is credible.

Platform beats “one‑off” on speed and efficiency

What actually slows gene therapy down? Analytics, tech transfer, and process changes late in development.‍

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Traditional gene therapy development often treats each program as a bespoke artisanal build. New vector tweaks, fresh analytics, new CDMOs, tech transfers, and CMC packages that get rewritten at every phase transition. This approach is slow and expensive, and it tends to create surprises late in development when manufacturing is forced to “catch up”, derailing approval and commercialisation timelines.

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Kriya’s engine is built for repetition. The focus is on the platform and not one-offs, treating each new program like a new “app” running on the same “operating system.” This involves multiple process decisions which were taken early in the development cycle.

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• Integrated R&D and manufacturing: Everything from lab experiments to GMP manufacturing happens in a single, continuous workflow with shared methods, analytics, and data systems. That means fewer hand-offs, fewer misunderstandings, and the product in R&D closely matches the product manufactured at scale.
• Repeatable by design: Standard operating procedures and common tests, for every program. Once a step is perfected, it’s reused, so new projects build on what’s already working.
• ‍Quality by Measurement: Continuously testing quality and performance metrics to ensure they are consistent across lots. Measuring these the same way every time helps spot problems early, prevent last-minute surprises, and make regulatory packages cleaner and easier to approve.
• Parallel progress & better unit economics: Common process enable running multiple programs. Reusing the same steps and tools drives down cost per batch as volume grows.

Regulatory Tailwinds: Less Guesswork, More Greenlights

Regulatory actions show that the system is learning how to evaluate this modality faster and more predictably.‍

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The current FDA leadership is pairing clearer guidance with hands-on engagement through town halls, checklists and focused guidances. At the same time, real-world evidence validating Kriya’s approach has been growing.

• Regulatory clarity: Recurring communication from the FDA has stressed on companies to “lock your process early,” reduce surprises, and make submissions more predictable. Recent gene-therapy guidances emphasize that, with good biomarkers and endpoints, accelerated paths are possible, especially when teams engage the FDA early on CMC and trial design.
• Regulatory flexibility: The 2025 “baby KJ” case, where a personalized in-vivo base editing was developed from concept to first dose in ~6 months, shows the agency can act quickly when evidence is tight and oversight is robust.
• Growing real world evidence: Independent data keep stacking up. In the eye, durable gene expression reduces the number of injections patients need. In the liver and metabolism, long-term studies (for example, with efruxifermin) show biology that can change disease course. In diabetes models, a single AAV dose has delivered multi-year control. Together, these findings show that durable expression can transform chronic care.

What’s next: Delivering the Platform Promise

Execution is the key to standardizing at scale. Under Shankar Ramaswamy’s leadership, Kriya has built a world class team which has experience in developing and commercializing gene therapies. This combination of translational, AAV CMC, and company‑building pedigree is rare and directly matched to the product engine Kriya is building.

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The tailwinds are real, and platform beats one‑off when the same chassis can carry multiple winners. If gene therapy is going to matter in common diseases, building that chassis is the only scalable plan. We at Premji Invest, are incredibly excited to partner with Shankar and the team at Kriya in this effort.