AI in Bio Weekly Review: Iambic Files for IPO, Enveda Closes $311M Series E, and FDA Codifies Non-Animal Safety Testing — September 20–26, 2026
A watershed week for TechBio: Iambic Therapeutics filed for a Nasdaq IPO and launched 41B-parameter Enchant v3 with an AbbVie pact, Enveda closed a $311M Series E at a $2.0B valuation, Genentech inked a $1.5B+ oncology bispecific alliance with Earendil Labs, BigHat dosed its first Phase 1 ADC patient alongside a $75M raise, and the FDA issued a historic direct final rule recognizing non-animal testing alternatives.
The week of September 20–26, 2026 marks an unmistakable inflection point for artificial intelligence in the life sciences. For years, the core debate surrounding TechBio has oscillated between computational capability and clinical translation. This week, that debate was decisively reshaped across three fronts: public equity markets, top-tier pharma business development, and federal regulatory policy.
In public markets, Iambic Therapeutics filed its Form S-1 registration statement to go public on the Nasdaq (ticker: IAM), disclosing that its lead AI-designed brain-penetrant HER2 inhibitor could enter registrational trials as early as next year—a filing accompanied by the launch of its 41-billion-parameter Enchant v3 model and an R&D partnership with AbbVie. In private growth capital, Enveda Biosciences closed a $311 million Series E crossover round at a $2.0 billion valuation, funding a late-stage clinical push for three assets including its oral molecular glue and metabolic programs. In biopharma licensing, Genentech committed $55 million upfront and over $1.5 billion in bio-bucks to AI biotech Earendil Labs for oncology bispecific antibodies. Meanwhile, BigHat Biosciences raised a $75 million Series C as its lead Cadherin-17 ADC dosed its first human patient.
Crucially, the regulatory landscape shifted in tandem: the U.S. FDA issued a historic direct final rule formally updating federal regulations to replace “animal tests” with “nonclinical tests,” codifying that computational models, organ-on-chips, and cell-based New Approach Methodologies (NAMs) can provide the definitive safety data required for human clinical trials under FDORA.
Below is our comprehensive, source-verified deep-dive into the developments that defined the week.
The Headlines
┌──────────────────────────────────────────────────────────────────────────────────────────┐
│ WEEK IN REVIEW: SEPTEMBER 20–26, 2026 AT A GLANCE │
├──────────────────────┬───────────────────────────────┬───────────────────────────────────┤
│ Iambic Therapeutics │ Form S-1 Nasdaq IPO ("IAM") │ Lead HER2 asset IAM1363 (Phase 1) │
│ │ Enchant v3 (41B parameters) │ Multi-year small molecule pact │
│ │ AbbVie Discovery Partnership │ with AbbVie (Onc, Neuro, Immuno) │
├──────────────────────┼───────────────────────────────┼───────────────────────────────────┤
│ Enveda Biosciences │ $311M Series E Crossover │ ENV-294 (Oral molecular glue, Ph2)│
│ │ Valuation: $2.0 Billion │ "Exercise-in-a-tablet" obesity │
│ │ Lead: Catalio Capital Mgt. │ PRISM AI metabolomics engine │
├──────────────────────┼───────────────────────────────┼───────────────────────────────────┤
│ Genentech × Earendil │ $1.5B+ Multi-Target Alliance │ Oncology bispecific antibodies │
│ │ $55M Upfront Cash │ High-throughput generative AI │
├──────────────────────┼───────────────────────────────┼───────────────────────────────────┤
│ BigHat Biosciences │ $75M Series C Financing │ First patient dosed in Phase 1/2 │
│ │ Co-leads: DFJ Growth & Premji │ BHB810 (CDH17 ADC, NCT07529808) │
├──────────────────────┼───────────────────────────────┼───────────────────────────────────┤
│ U.S. FDA │ Historic Direct Final Rule │ Replaces "animal studies" rule; │
│ │ Codifies FDORA 2022 Mandate │ 25-example public NAMs database │
├──────────────────────┼───────────────────────────────┼───────────────────────────────────┤
│ Insilico Medicine │ Pharma.AI Q3 Fall Update │ Model Context Protocol (MCP) core │
│ │ Agentic Life-Sciences Layer │ O3DC Consortium & DDD Benchmarks │
└──────────────────────┴───────────────────────────────┴───────────────────────────────────┘1. Iambic Therapeutics’ Triple-Play: Enchant v3, AbbVie Collaboration, and Form S-1 Nasdaq IPO Filing
On September 21–22, 2026, San Diego-based Iambic Therapeutics executed one of the most aggressive multi-part corporate rollouts seen in TechBio this year.
The Nasdaq S-1 Registration
Iambic filed a preliminary Form S-1 registration statement with the SEC to list on the Nasdaq Global Select Market under the ticker symbol “IAM” (Endpoints News). The offering is being underwritten by a banking syndicate led by J.P. Morgan, Jefferies, BofA Securities, and Citigroup. While initial terms listed a placeholder deal size of ~$100 million, the filing formalizes Iambic’s position as the next venture-backed TechBio to test public equity appetite following Generate Biomedicines’ (NASDAQ: GENB) debut earlier this year.
Having raised $461.8 million in private capital since its founding—backed by NVIDIA, Catalio Capital Management, Nexus Venture Partners, and Q Healthcare Holding—Iambic’s prospectus reveals extensive operational granularity:
- Lead Clinical Asset IAM1363: The company’s core capital allocation will fund the clinical maturation of IAM1363, an AI-designed, highly selective, brain-penetrant small-molecule HER2 inhibitor. Currently progressing through a Phase 1/1b multi-center dose escalation and expansion trial (NCT06253871) in advanced HER2-altered solid tumors (breast, non-small cell lung, colorectal, and gastric cancers), Iambic disclosed that it expects to initiate a pivotal registrational trial as early as 2027.
- Selectivity Profile: IAM1363 was computationally engineered to overcome a fatal flaw of traditional pan-HER inhibitors: wild-type EGFR-mediated toxicities (diarrhea, severe skin rash). By demonstrating steep selectivity for both wild-type HER2 and oncogenic HER2 mutations (including exon 20 insertions) over EGFR, while efficiently penetrating the blood-brain barrier, IAM1363 addresses intracranial metastases that develop in up to 50% of advanced HER2-positive breast cancer patients.
Enchant v3 & The AbbVie Discovery Pact
Coinciding with the SEC filing, Iambic launched Enchant v3, its next-generation generative AI foundation model (Endpoints News). Scaling to 41 billion parameters, Enchant v3 is architected as a multimodal transformer trained to predict over 6,000 preclinical and clinical molecular properties simultaneously—including ADMET liabilities, target potencies, off-target promiscuity, and complex pharmacological phenotypes.
Simultaneously, AbbVie signed a multi-year AI discovery collaboration with Iambic. Under the terms, AbbVie will deploy Iambic’s generative chemistry and structural prediction suite—combining Enchant v3 with its physics-informed NeuralPLexer engine—to design novel small-molecule candidates across target portfolios in immunology, neuroscience, and oncology. Iambic receives an undisclosed upfront payment, research funding, and eligibility for preclinical, clinical, and commercial milestones, alongside tiered royalties on commercial sales.
2. Enveda Biosciences Closes $311M Series E at $2.0B Valuation for Late-Stage Clinical Push
On September 23, 2026, Boulder, Colorado-based Enveda Biosciences announced the closing of a $311 million Series E crossover financing round, propelling the company’s valuation to $2.0 billion (BioSpace).
Investor Syndicate & Capital Foundation
The round was led by Catalio Capital Management, with heavy participation from top-tier institutional crossover funds including Durable Capital Partners, ICONIQ, Lightspeed Venture Partners, Surveyor Capital (a Citadel company), accounts advised by T. Rowe Price Investment Management, Digitalis Ventures, Alderline Group, and an undisclosed sovereign wealth fund. Existing backers Baillie Gifford, Premji Invest, FPV Ventures, True Ventures, Kinnevik, Dimension, Lifeforce Capital, and Lux Capital also re-upped. The round brings Enveda’s total capital raised since its 2019 inception to over $845 million.
Pipeline Translation: Molecular Glues and “Exercise in a Tablet”
Unlike early-stage computational platforms that rely on synthetic target benchmarks, Enveda is allocating the proceeds directly into human clinical trials for three proprietary assets:
- ENV-294 (First-in-Class Oral Molecular Glue):
- Evaluated in a Phase 2 trial in moderate-to-severe asthma (NCT07301255) and a Phase 2b dose-ranging study in adults with moderate-to-severe atopic dermatitis (NCT07643766).
- ENV-294 operates via an unprecedented mechanism of action: stabilizing a previously “unliganded” endogenous protein complex involved in inflammatory cascade dampening, rather than acting as a standard enzymatic inhibitor or cytokine antibody.
- Follows successful Phase 1b data where patients demonstrated statistically significant reductions in Eczema Area and Severity Index (EASI) scores.
- Oral Obesity Candidate (“Exercise in a Tablet”):
- Enveda revealed that a portion of the Series E proceeds is dedicated to accelerating an oral, non-incretin small molecule that mimics key downstream metabolic signaling cascades of physical exertion, heading into late-stage clinical evaluation.
- The PRISM Engine:
- Enveda’s competitive moat rests on PRISM, a generative AI metabolomics platform. PRISM uses transformer neural networks trained on millions of tandem mass spectrometry (MS/MS) fragmentation patterns to identify, annotate, and de-orphan complex natural secondary metabolites extracted from global botanical and microbial libraries—bypassing traditional natural product isolation timelines by orders of magnitude.
3. Genentech Inks $1.5B+ Bispecific Antibody Collaboration with Earendil Labs
On September 24, 2026, Roche subsidiary Genentech entered into a major multi-target research collaboration with AI-native biotechnology company Earendil Labs to discover and develop next-generation bispecific antibodies in oncology (BioSpace).
Deal Mechanics & Commercial Architecture
- Upfront & Milestones: Genentech will pay Earendil Labs $55 million in upfront cash. Earendil is eligible to receive additional research, development, regulatory, and commercial sales milestone payments that collectively surpass $1.5 billion, as well as tiered royalties on net commercial sales.
- Operational Allocation: Earendil Labs will deploy its automated generative protein design engine to conduct all target-pair epitope discovery, bispecific chain pairing, and candidate optimization through early clinical development. Following IND clearance and initial clinical proof-of-concept, Genentech will assume sole responsibility for global pivotal clinical trials, regulatory submissions, and worldwide commercialization.
Platform Significance
Founded by CEO Jian Peng (noted UIUC computational biologist) and President/co-CEO Zhenping Zhu, Earendil has emerged as a premier powerhouse in generative biologics. The Genentech transaction follows two massive autoimmune and inflammatory pacts signed with Sanofi (a $1.72B alliance in April 2025 with $125M upfront, and a $2.56B expansion in January 2026), alongside Sanofi’s equity participation in Earendil’s $787M private round in March 2026.
Designing bispecific antibodies has historically been bedeviled by heavy-chain/light-chain mispairing (“scrambling”), poor thermal stability, and low expression yields. Earendil’s platform utilizes generative structural transformers that optimize both antigen-binding paratopes and the Fc/heterodimerization interfaces in a unified loss function, enabling the automated generation of bispecifics that express cleanly at industrial CDMO titers.
4. FDA Issues Historic Direct Final Rule Updating Safety Regulations for Non-Animal Testing
On September 21, 2026, the U.S. Food and Drug Administration (FDA) issued a direct final rule that marks the most significant regulatory modernization of preclinical drug evaluation in decades (FDA Newsroom).
Codifying FDORA 2022 into Binding Code
The rule formally amends the Code of Federal Regulations (21 CFR) to replace outdated statutory terminology—specifically striking the terms “animal tests” and “animal studies” across IND submission requirements and replacing them with the inclusive terms “nonclinical tests” and “nonclinical studies.”
This regulatory action formally implements the mandate of the Food and Drug Omnibus Reform Act (FDORA) of 2022, which eliminated the 1938 Federal Food, Drug, and Cosmetic Act requirement that new drug candidates undergo animal toxicity testing before advancing into human clinical trials.
What Changes for TechBio Sponsors
- Explicit Legal Parity for NAMs: The FDA clarified that drug sponsors may now submit safety data generated entirely via validated New Approach Methodologies (NAMs)—including microphysiological systems (MPS), human organ-on-chips, high-content cellular perturbation assays, and physics-informed computational/machine learning models—where scientifically justified.
- Launch of FDA NAMs Database: Concurrently, the FDA published an official, open-access database containing 25 regulatory examples demonstrating how FDA reviewers have previously accepted non-animal alternative data across drug evaluation dockets, providing biopharma sponsors with concrete precedent.
- Statutory Schedule: The direct final rule is scheduled to take effect on February 4, 2027, following a public comment window closing on December 7, 2026. Because it directly mirrors congressional intent under FDORA, the agency does not anticipate adverse comments.
For AI-driven biology companies modeling organoid toxicology and in silico safety pharmacology, this regulatory shift transforms computational safety prediction from an exploratory supplement into an officially accepted regulatory path.
5. BigHat Biosciences Raises $75M Series C as Lead CDH17 ADC Enters Phase 1 Trials
On September 24, 2026, San Mateo, California-based BigHat Biosciences announced the completion of a $75 million Series C financing, lifting its total funding to $223 million (BigHat Biosciences).
Syndicate & Strategic Corporate Backers
The round was co-led by DFJ Growth and Premji Invest, joined by Catalio Capital Management, LG Technology Ventures, and Sigmas Group. Notably, the round included strong follow-on participation from a syndicate of pharma venture arms and Silicon Valley biotech investors: 8VC, Alexandria Venture Investments, Amgen Ventures, Andreessen Horowitz (a16z), Discovery Ventures, GRIDS Capital, Intermountain Ventures, Eli Lilly and Company, Merck Global Health Innovation Fund, Quadrille Capital, and Section 32.
Clinical Execution: First Patient Dosed in BHB810 Phase 1/2
BigHat confirmed a critical clinical milestone: the dosing of the first patient in a Phase 1/2 open-label clinical trial (NCT07529808) evaluating its lead asset, BHB810.
- Asset Profile: BHB810 is a novel, AI-designed Cadherin-17 (CDH17)-directed VHH-Fc antibody-drug conjugate (ADC) for the treatment of advanced gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma.
- Engineering Logic: CDH17 is highly expressed on gastrointestinal tumor cells but tightly sequestered in healthy intestinal junctions. BHB810 pairs a computationally optimized single-domain antibody (VHH) engineered for rapid tumor penetration with an enzyme-cleavable linker delivering monomethyl auristatin E (MMAE). In preclinical patient-derived xenograft (PDX) models, BHB810 demonstrated complete tumor regression without systemic gut toxicity.
- Second Pipeline Candidate (BHB299): BigHat also announced that it is concluding preclinical IND-enabling studies for BHB299, an avidity-driven T-cell engager targeting CEACAM6-positive solid tumors, with human Phase 1 trials scheduled to initiate in 2027.
BigHat’s proprietary Milliner platform integrates automated, robotic synthesis and wet-lab characterization with active-learning Bayesian optimization models, creating a high-frequency closed loop that evaluates thousands of engineered proteins weekly.
6. Insilico Medicine Unveils “Agentic Layer” for Pharma.AI with Model Context Protocol (MCP)
On September 21–24, 2026, Hong Kong-listed Insilico Medicine (HKEX: 3696) unveiled the preview of its Pharma.AI 2026 Q3 Fall Update, outlining a fundamental architectural shift toward autonomous scientific agents (Insilico Medicine).
Standardizing Drug Discovery on Model Context Protocol (MCP)
The central innovation of Insilico’s Fall Update is the deployment of native Model Context Protocol (MCP) servers across its entire Pharma.AI stack. Rather than requiring computational chemists and biologists to navigate siloed web dashboards, autonomous AI agents can now connect directly to Insilico’s underlying engines:
- PandaOmics Agent via MCP: Connects agents to omics target discovery, automating single-cell differential expression analyses, druggability reviews, and clinical indication prioritization.
- Chemistry42 MCP Connectors: Enables agents to trigger generative small-molecule design, 3D pharmacophore optimization with excluded volumes, property profiling, and retrosynthesis verification via the integrated ChemCensor module.
- Generative Biologics MCP Integration: Empowers agents to drive de novo antibody design loops against challenging epitopes, delivering high-affinity candidates in under 72 hours.
Open Science, Benchmarking, and Foundation Models
Insilico also announced three open-science research assets:
- O3DC Consortium (
o3dc.org): A free community index evaluating benchmark quality and documenting unlisted biases across 15 consortia and 10 evaluation categories. - DDD Benchmarks (
dddbench.insilico.com): A standardized evaluation platform combining curated clinical datasets to test AI models on real-world drug discovery challenges. - Virtual Aging Cell (VAC) Platform (
virtualcell.insilico.com): A multi-agent cellular simulation framework modeling biological age transitions, compound perturbation dynamics, and cell fate steering.
Clinical Follow-up: This platform update follows Insilico’s landmark announcement earlier this month that the first patient was dosed in the GENESIS-IPF-3 Phase 3 clinical trial (NCT07687459) for its oral TNIK inhibitor rentosertib (ISM001-055) at Peking Union Medical College Hospital, alongside the publication of Phase 2a biomarker data in Nature Biotechnology demonstrating proteomic age reversal.
Notable Shorter Moves & Regulatory Signals
Grail’s Galleri Wins Favorable FDA Advisory Committee Vote
On September 23, 2026, the Molecular and Clinical Genetics Devices Panel of the FDA’s Medical Devices Advisory Committee met to review GRAIL’s Premarket Approval (PMA) application for the Galleri® multi-cancer early detection (MCED) test (Grail).
The committee delivered a favorable advisory recommendation for Galleri’s use in adults aged 50 and older:
- Safety: Voted 10–0 (unanimous) that the test is safe.
- Benefit-Risk Profile: Voted 7–2 (with 1 abstention) that the clinical benefits outweigh the risks.
- Effectiveness: Voted 6–4 in favor of effectiveness.
Galleri uses machine learning classifiers trained on cell-free DNA (cfDNA) targeted methylation patterns to detect shared cancer signals across more than 50 cancer types and predict the tissue of origin. The vote paves the way for a potential historic FDA PMA approval in early 2027.
Precigen Granted FDA Platform Technology Designation for AdenoVerse
On September 21, 2026, Precigen (NASDAQ: PGEN) announced that the FDA granted Platform Technology Designation to its AdenoVerse® immunotherapeutic platform (Precigen). The designation was granted because the platform is already utilized in an FDA-approved commercial drug, PAPZIMEOS® (approved in August 2025 for recurrent respiratory papillomatosis; NCT06538480).
Under FDORA statutory authority, this designation allows Precigen to leverage existing CMC manufacturing, toxicology, and preclinical data from PAPZIMEOS to accelerate marketing applications for other AdenoVerse candidates—most notably its Phase 2 clinical program PRGN-2009 in HPV-associated oropharyngeal cancer (NCT05996523) and cervical cancer (NCT06157151).
The Post-AlphaFold 3 Landscape: Consensus Shifts to “Co-Folding Soups”
Across academic preprints and computational chemistry forums this week, independent benchmarking (including new data from the Tamarind Bio benchmarks) confirmed that the structural biology community has moved into a post-AlphaFold 3 paradigm. Rather than relying on a single monolithic system, leading labs are deploying ensembles—or “co-folding soups”—combining Boltz-2 (MIT), Chai-1 (Chai Discovery), and Protenix-v2 (ByteDance). Recent comparative analyses highlight that open-weights models like Protenix-v2 and Chai-1 frequently match or outperform AF3 in specialized challenges such as antibody-antigen interface geometry and cyclic peptide-protein docking, while Boltz-2 provides superior binding free energy estimations.
Strategic Analysis: The Three Converging Realities of Late September 2026
Stepping back from the individual press releases, the events of September 20–26, 2026 highlight three macro trends reshaping the biopharma ecosystem:
┌──────────────────────────────────────────────────────────────────────────────────────────┐
│ THE THREE CONVERGING FORCES OF LATE SEPTEMBER 2026 │
├──────────────────────────────────────────────────────────────────────────────────────────┤
│ 1. THE CLINICAL IPO WINDOW REOPENS FOR VALIDATED TECHBIO │
│ • Generate Biomedicines (GENB) and Iambic (IAM) prove that public markets will fund │
│ AI platforms—provided they carry proprietary Phase 1/2 clinical pipelines. │
│ • Speculative "pure-software" discovery platforms remain frozen out of IPO exits. │
├──────────────────────────────────────────────────────────────────────────────────────────┤
│ 2. REGULATORY BODIES FORMALIZE THE COMPUTATIONAL ERA │
│ • FDA Direct Final Rule replaces animal testing mandates with nonclinical NAMs. │
│ • FDA Platform Technology Designations (Precigen) enable data leverage across assets. │
│ • Grail's AdComm vote establishes regulatory pathways for AI-driven multi-cancer cfDNA│
├──────────────────────────────────────────────────────────────────────────────────────────┤
│ 3. AGENTIC ARCHITECTURES ECLIPSE STATIC PLATFORMS │
│ • Open standards like Model Context Protocol (MCP) turn AI tools into actionable APIS.│
│ • Autonomous agents now orchestrate end-to-end target ID, chemistry, and retrosynthesis│
│ directly hooked into automated robotic wet labs (BigHat Milliner, Insilico, XtalPi).│
└──────────────────────────────────────────────────────────────────────────────────────────┘1. The IPO Window Reopens—Strictly for Clinically Anchored TechBio
The TechBio IPO market is no longer hospitable to the narrative-driven software plays of 2020–2021. When Iambic filed its S-1 this week, it did not pitch itself solely as a computational platform; it pitched IAM1363, a drug candidate entering registrational clinical trials with quantifiable survival endpoints in HER2 oncology. Following Generate Biomedicines’ successful listing, public investors have drawn a clear line: algorithmic novelties will be funded by venture rounds, but public capital is reserved for molecules generating human pharmacokinetic, pharmacodynamic, and clinical response data.
2. Regulatory Infrastructure Is Catching Up to Algorithmic Reality
The FDA’s September 21 Direct Final Rule codifying non-animal alternatives under FDORA is not merely an animal welfare reform; it is a structural validation of modern in vitro and in silico biology. Historically, biopharma companies were forced to run redundant primate or canine toxicity studies even when computational models or human organ-on-chips demonstrated that the target biology was human-specific. With formal CFR language updated and a 25-example regulatory precedent database published, the regulatory bottleneck for human cell-derived and AI-predicted safety dossiers has been officially dismantled.
3. The Agentic Layer and Closed-Loop Robotics Define the New Moat
As demonstrated by Insilico Medicine’s MCP deployment and BigHat’s Milliner platform, the technological frontier has moved beyond training static generative models. The cutting-edge TechBio enterprise is now defined by autonomous agent orchestration connected to robotic physical infrastructure. When an agent can receive a target hypothesis via PandaOmics, generate 3D constrained pharmacophores via Chemistry42, verify retrosynthetic viability via ChemCensor, and submit synthesis orders to robotic synthesizers via standardized protocol APIs without human latency, the cycle time for hit-to-lead drops from 18 months to 18 days.
Summary of the Week’s Transactions & Clinical Milestones
| Company / Entity | Category | Lead Asset / Platform | Milestone / Valuation | Clinical Trial ID | Primary Source Verification |
|---|---|---|---|---|---|
| Iambic Therapeutics | Public Offering / AI Model | IAM1363 (HER2 inhibitor) / Enchant v3 (41B params) | Filed Form S-1 for Nasdaq IPO (“IAM”); AbbVie multi-target R&D alliance | NCT06253871 | Endpoints News — Iambic IPO Endpoints News — AbbVie & Enchant v3 |
| Enveda Biosciences | Venture Financing | ENV-294 (Oral molecular glue) / PRISM AI metabolomics | $311M Series E round at $2.0B valuation; funding Phase 2 trials | NCT07301255 NCT07643766 |
BioSpace — Enveda Series E |
| Genentech / Earendil Labs | Biopharma Licensing | Generative AI Oncology Bispecifics | $55M upfront; $1.5B+ total milestone value + tiered royalties | Preclinical / Early Clinical | BioSpace — Genentech Deal |
| BigHat Biosciences | Venture / Clinical Dosing | BHB810 (CDH17 VHH-Fc ADC) / Milliner platform | $75M Series C raise; first patient dosed in Phase 1/2 gastric cancer trial | NCT07529808 | BigHat Biosciences |
| U.S. FDA | Regulatory Science | Non-Animal Safety Testing (NAMs) / 21 CFR Rulemaking | Direct Final Rule replacing “animal studies” under FDORA; public database | Federal Register Docket | FDA Newsroom |
| Insilico Medicine | Software Architecture | Pharma.AI Q3 Fall Update (MCP deployment, Virtual Aging Cell) | Integrated Model Context Protocol across discovery suite; O3DC Consortium | NCT07687459 (GENESIS-IPF-3 Phase 3) | Insilico Medicine |
| GRAIL, Inc. | Diagnostic Regulation | Galleri® cfDNA Multi-Cancer Early Detection Test | FDA Advisory Committee votes favorably on PMA application (7-2 benefit/risk) | PATHFINDER 2 / NHS-Galleri | Grail |
| Precigen | Regulatory Designation | AdenoVerse® Platform (PRGN-2009 HPV cancer trials) | Granted FDA Platform Technology Designation following PAPZIMEOS approval | NCT05996523 NCT06157151 |
Precigen |