Vera’s Trutakna Cut Kidney Disease Progression Risk 76% Over Two Years as Novartis Ended an ALS Program and Bought a Brain Delivery Platform (September 17, 2026)

Last updated: September 17, 2026

Vera Therapeutics reported that Trutakna cut the risk of kidney disease progression 76% over two years in the ORIGIN 3 final analysis, with zero patients reaching dialysis, transplant, or death versus eight on placebo. Novartis ended its TREM2 ALS program and paid $125 million for Sironax’s brain delivery platform.

This page covers the ORIGIN 3 final efficacy data and what they mean for the IgA nephropathy market, Novartis’ ALS termination and Sironax platform purchase, Skyhawk’s fifteen month Huntington’s data, the BMS and Ono lawsuit against Amgen’s Opdivo biosimilar, Gilead’s once yearly lenacapavir licensing expansion, and the September 16 session for the week’s tracked names.

What did Vera’s ORIGIN 3 final analysis show in IgA nephropathy?

Trutakna held kidney function essentially flat for two years while placebo patients declined at a rate that leads to kidney failure. The final efficacy analysis of the 428 patient ORIGIN 3 trial, released Tuesday September 15, is the strongest dataset yet reported in IgA nephropathy.

Vera Therapeutics’ Trutakna (atacicept-vymj), a dual BAFF and APRIL inhibitor given by weekly self injection, received FDA accelerated approval in early July 2026 on proteinuria reduction. The final ORIGIN 3 analysis is the evidence package for converting that to full approval.

Secondary endpoints showed statistically significant reductions in proteinuria, galactose deficient IgA1, and hematuria. Safety held up: infections ran 32% versus 28% for placebo, injection site reactions 19% versus 2%, with no opportunistic infections and no clinically relevant hypogammaglobulinemia reported. The company said the annualized eGFR decline of 0.6 mL/min/1.73m² per year sits within the range nephrologists consider consistent with a normal lifespan of kidney function, a framing echoed in trade coverage against the KDIGO target of 1 point per year or less.

Vera plans a supplemental BLA in the fourth quarter of 2026 to convert accelerated approval to full approval, anticipated in 2027. The company also disclosed more than 350 patient start forms in the first ten weeks of launch.

How does Trutakna compare with Otsuka’s Voyxact and Vertex’s povetacicept?

IgA nephropathy now has a data bar, and everyone else gets measured against it. Trade coverage put Vera’s numbers directly against Otsuka’s recently approved APRIL inhibitor and ahead of Vertex’s pending decision.

The cross trial caveat applies: different trials, different populations, no head to head. Analyst reaction reported by Fierce Pharma ran in Vera’s favor, with Evercore ISI writing that Trutakna “certainly is not less efficacious” than Voyxact and Jefferies calling the 76% progression risk reduction “perhaps most differentiated.” For Vertex, the readacross is double edged. Povetacicept shares the dual mechanism, so ORIGIN 3 raises the mechanistic prior, but it also raises the bar a launch must clear against two incumbents that both now hold hard outcome style data.

The market’s response was the most interesting part. VERA closed Monday at 34.05, opened the release day at 37.14, faded to a 33.67 close on volume of roughly 10.5 million shares against 1.7 million the prior day, then fell another 5.6% Wednesday to 31.77. Two sessions, both lower, on the cleanest data the field has produced. No company disclosure explains the move; we log it as market data with no cause assigned, and we note the pattern matches what this week’s tape has done to every undated data printer.

Why did Novartis end its TREM2 ALS program?

The Astrals trial missed everything it was designed to show. Novartis confirmed by spokesperson statement that VHB937, also called lifonebart, a TREM2 targeted agent designed to boost microglial function, missed both primary and secondary endpoints in the 251 patient Phase 2 Astrals study (NCT06643481) in early stage ALS, and that ALS development is over.

No figures were released and no press release was issued; the facts here trace to company statements reported September 16 by Fierce Biotech. A separate Phase 2 trial of the same mechanism in Alzheimer’s disease continues enrolling. The termination extends a difficult stretch for Novartis R&D that this publication has tracked through the pelacarsen Lp(a) outcomes failure, the del-desiran Phase 3 miss inside the $12 billion Avidity acquisition, and the rap-cel autoimmune CAR T pause.

What did Novartis buy from Sironax?

On the same day it shut an ALS program, Novartis bought a way into the brain. Sironax announced that Novartis exercised its option and will acquire full global rights to Sironax’s brain delivery platform, technology built to carry antibodies, peptides, proteins, and gene therapies across the blood brain barrier, for a $125 million payment at closing.

The strategic read is straightforward: after a string of late stage biology failures, Novartis is buying delivery infrastructure rather than another molecule. A validated blood brain barrier shuttle is indication agnostic; it can carry whatever biology survives.

What did Skyhawk report in Huntington’s disease?

A striking number attached to a very small denominator. Skyhawk Therapeutics reported final fifteen month results from its Phase 1/2 trial of SKY-0515, an oral RNA splicing modifier that lowers huntingtin production, showing patients improved on the composite Unified Huntington’s Disease Rating Scale (cUHDRS) by 0.94 points from baseline while a weighted external natural history control declined 0.65 points, a difference of 1.59 points, p<0.001.

The design caveats matter as much as the number. The month fifteen analysis covers 15 treated patients compared against external control groups ranging from 21 to 3,569 subjects, following a 12 week randomized blinded start and a 12 month extension. Every cUHDRS component reached statistical significance against that external comparator: Total Functional Capacity +0.98 (p=0.003), Total Motor Score improvement of 9.38 points (p<0.001), Symbol Digit Modalities +4.15 (p=0.009), Stroop Word Reading +4.18 (p=0.024). At the 9 mg dose, mutant huntingtin protein fell more than 60% on average. The company reported no treatment related serious adverse events through fifteen months.

The randomized answer is coming: the Phase 2/3 FALCON-HD program has completed enrollment of 144 participants in Australia and New Zealand and is recruiting toward roughly 600 worldwide. Huntington’s is becoming the proving ground for external control evidence in neurodegeneration, with uniQure’s AMT-130 gene therapy filing, built on a similar comparison, awaiting an FDA acceptance decision expected around early November.

Who is suing Amgen over an Opdivo biosimilar?

Bristol Myers Squibb and Ono Pharmaceutical filed suit against Amgen in Delaware over seven Opdivo patents, covering the nivolumab active ingredient and treatment methods, as Amgen’s biosimilar ABP 206 approaches an FDA decision the company has said it expects by the end of 2026, per Fierce Pharma’s report of the filing.

The complaint alleges Amgen provided inadequate correspondence during the biosimilar patent exchange, particularly on manufacturing detail. BMS has told investors it expects US Opdivo biosimilar entry around 2028; Opdivo generated $5.9 billion in US revenue and more than $10 billion worldwide in 2025 per BMS’s reported results as cited in the same coverage. The suit lands while Amgen is itself defending the reference product economics of several legacy brands, and it opens a PD-1 biosimilar front that the whole checkpoint class will study closely.

What did Gilead announce for once yearly lenacapavir?

Gilead extended its access architecture to a product that does not exist yet. The company announced September 16 that its six royalty free voluntary licensing agreements now include the investigational once yearly formulation of lenacapavir for HIV prevention, so that Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons, Hetero, and Mylan (a Viatris subsidiary) can prepare manufacturing and supply for 120 high incidence, resource limited countries while Phase 3 PURPOSE 365 runs.

Context figures from the release: 1.2 million people acquired HIV globally in 2025, fewer than 4 million were on PrEP in 2024 against a 21 million target, and the twice yearly product is available in ten sub Saharan African countries today, with Gilead’s no profit supply program intended to reach up to 3 million people through 2028. Once yearly lenacapavir remains investigational with no approval anywhere. Licensing a formulation before its pivotal data reads out is a structural bet that annual dosing is the version that finally scales prevention.

What happened to Monday’s readout stocks on Wednesday?

The bounce we flagged arrived on schedule, and it arrived silently. In Wednesday’s edition we wrote that a bounce in Definium and Corbus without news would confirm that Tuesday’s selloff was liquidity mechanics rather than information, and that further Ionis drift without news would read as positioning. Wednesday delivered both.

Elsewhere on the tape: AMLX closed at 32.63, down 1.6%, a thirteenth consecutive close below the $35.50 offering price with the greenshoe disclosure window arriving around Thursday. SRRK fell 1.3% to 49.37, a third straight post approval decline with no cause assigned. RARE closed 12.88 ahead of Friday’s UX111 decision. GRAL closed 75.11 with the advisory panel’s briefing documents still unposted as of Wednesday night. All moves are exchange closes; no cause is assigned where none was disclosed.

What else moved in biotech, pharma, and medtech on September 16, 2026?

Sling Therapeutics raised a $123 million Series C led by Forbion with TPG Life Sciences Innovations and Sectoral Asset Management participating, funding Phase 3 development of linsitinib, an oral small molecule IGF-1R inhibitor for thyroid eye disease originally developed by Astellas. The Phase 3 trial is enrolling 120 patients with proptosis response at 24 weeks as the endpoint, and first patients are dosed. An oral pill aimed at Amgen’s infused Tepezza franchise is a classic convenience flank.

Ori Biotech signed a ten year partnership worth up to $120 million with an unnamed company that markets a commercial cell therapy, deploying Ori’s automated Iro manufacturing platform, per the company’s announcement reported by Fierce Pharma. Legend Biotech appointed Ingrid Zhang as CEO effective September 15 per the company’s release; the Novartis veteran, formerly its chief commercial officer with prior leadership of its China business, succeeds interim chief Alan Bash, who returns to his role as president of the Carvykti franchise. Novo Nordisk announced a collaboration with Anthropic to apply Claude models, including Claude Science, across R&D workflows and software engineering; no financial terms were disclosed. It follows Novo’s April OpenAI partnership. (Disclosure: BioMed Nexus drafts are produced with Anthropic’s Claude; we report the deal without further comment.) CMS expanded its ACCESS chronic care model to add heart failure, COPD, substance use disorder, and tobacco cessation tracks, with more than 160 companies enrolled, per MedTech Dive. Boston Scientific’s cyberattack recovery is now dated: the company said in a September 10 release that manufacturing, order fulfillment, and shipping are fully restored, while it still expects to miss third quarter and full year guidance, with quantification due on the October 28 call. And House China committee staff said drugmakers are cooperating with the panel’s probe of Chinese clinical trial sites, per Endpoints News, the latest step in the Moolenaar led inquiry we have tracked since summer.

Frequently asked questions

What is Trutakna and how does it work?

Trutakna (atacicept-vymj) is Vera Therapeutics’ weekly self injected fusion protein that blocks both BAFF and APRIL, two cytokines that drive production of the abnormal IgA that deposits in the kidney in IgA nephropathy. It holds FDA accelerated approval, granted in July 2026.

What did the ORIGIN 3 final analysis show?

Over 104 weeks in 428 patients, Trutakna patients lost kidney function at an annualized rate of 0.6 mL/min/1.73m² versus 5.6 for placebo, with a 76% reduction in kidney disease progression events and zero patients reaching dialysis, transplant, or death versus eight on placebo.

Is Trutakna fully approved by the FDA?

Not yet. It carries accelerated approval based on proteinuria reduction. Vera plans a supplemental BLA in the fourth quarter of 2026 using the ORIGIN 3 eGFR data, with full approval anticipated in 2027.

What does the ORIGIN 3 data mean for Vertex’s povetacicept?

Povetacicept, a dual BAFF and APRIL inhibitor like Trutakna, faces an FDA decision by November 30, 2026. The shared mechanism now has two year validation, but the commercial bar in IgA nephropathy has risen: any launch will be measured against Trutakna’s stabilized eGFR and Otsuka’s Voyxact.

Why did Vera’s stock fall after strong data?

No company disclosure explains it. VERA opened higher on the September 15 release, faded to a lower close on heavy volume, and fell 5.6% more on September 16. We report the moves as market data with no cause assigned; the pattern matches this week’s broader selling of data printers without near term dates.

What was VHB937 (lifonebart) and why did Novartis stop it?

VHB937 was a TREM2 targeted antibody meant to enhance microglial protection of motor neurons. Novartis confirmed the 251 patient Astrals Phase 2 trial in early ALS missed its primary and secondary endpoints and ended ALS development. An Alzheimer’s Phase 2 trial of the mechanism continues.

What exactly did Novartis acquire from Sironax?

Full global rights to Sironax’s brain delivery platform, which shuttles large molecules across the blood brain barrier, for $125 million at closing following a July 2025 option agreement. Sironax keeps selected assets built on the platform, including three clinical stage programs.

How credible are Skyhawk’s Huntington’s disease results?

The 1.59 point cUHDRS difference at fifteen months is statistically strong but comes from 15 treated patients compared against an external natural history control, not a randomized comparison. The randomized Phase 2/3 FALCON-HD program, targeting roughly 600 participants worldwide, will provide the definitive answer.

What is ABP 206 and when could it launch?

ABP 206 is Amgen’s biosimilar of Opdivo (nivolumab). Amgen has said it expects an FDA decision by the end of 2026. BMS has told investors it expects US biosimilar entry around 2028; the new Delaware patent suit over seven patents will shape that timeline.

What did Gilead’s lenacapavir licensing expansion cover?

The six existing royalty free voluntary licensees can now also manufacture the investigational once yearly formulation of lenacapavir for HIV prevention for 120 high incidence, resource limited countries, preparing supply ahead of Phase 3 PURPOSE 365 results. Once yearly lenacapavir is not approved anywhere.

When does the Amylyx offering disclosure have to come?

The underwriters’ 30 day option on the $500.2 million offering priced August 19 forces closing disclosure by approximately Thursday September 18. AMLX has now closed below the $35.50 offer price in thirteen consecutive sessions.

What is happening with Ultragenyx’s UX111 on Friday?

The FDA’s action date for UX111, Ultragenyx’s gene therapy for Sanfilippo syndrome type A, is Friday September 19. It is the next test of the agency’s rare disease review posture; no outcome exists yet and we will report what actually happens.

When is the Grail Galleri advisory committee meeting?

September 23, 2026, before the FDA’s Molecular and Clinical Genetics Panel, the first advisory committee review of a multi cancer early detection PMA. As of Wednesday night the meeting page carries only conflict waiver documents; briefing documents are expected around September 21.

Who is Legend Biotech’s new CEO?

Ingrid Zhang, effective September 15, 2026. She was previously Novartis’ chief commercial officer and led its China business earlier in her career, with prior roles at AstraZeneca, Pfizer, and McKinsey. Interim CEO Alan Bash returns to leading the Carvykti franchise as president.

Sources

Primary sources: Vera Therapeutics ORIGIN 3 final efficacy release (September 15, 2026, GlobeNewswire); Sironax option exercise and asset purchase release (September 16, 2026, GlobeNewswire); Skyhawk Therapeutics fifteen month SKY-0515 release (September 15, 2026, PR Newswire); Gilead Sciences once yearly lenacapavir access release (September 16, 2026, Business Wire); Sling Therapeutics Series C release (September 16, 2026, Business Wire); Legend Biotech CEO appointment release (September 15, 2026, GlobeNewswire); Boston Scientific operations restoration release (September 10, 2026); FDA advisory committee meeting page for the September 23, 2026 Molecular and Clinical Genetics Panel (docket FDA-2026-N-8004), checked September 16, 2026.

Trade press and market data: Fierce Pharma (Vera IgAN rivalry coverage; BMS and Ono suit against Amgen; Ori Biotech partnership; September 16, 2026); Fierce Biotech (Novartis ALS termination and Sironax deal coverage; Sling Series C; September 16, 2026); Endpoints News (Novo Nordisk and Anthropic collaboration; House China trial site probe; September 16, 2026); BioPharma Dive (Novo and Anthropic deal detail); MedTech Dive (CMS ACCESS expansion, September 16, 2026; Boston Scientific restoration, September 11, 2026); BioSpace (FDA psychedelics forum and PDUFA reauthorization coverage, September 16, 2026). Exchange closes for September 16, 2026 via market data; no cause assigned to any move without a company disclosure.

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