Grail’s Galleri Won Its FDA Panel 7 to 2 on Benefit Risk With a 6 to 4 Effectiveness Split as Roche’s Sefaxersen Hit in IgA Nephropathy (September 24, 2026)

Last updated: September 24, 2026

An FDA advisory panel voted 10 to 0 that Grail’s Galleri test is safe, 6 to 4 that it is effective, and 7 to 2 with one abstention that its benefits outweigh its risks. The FDA decides on the PMA in the coming months.

This briefing covers the September 23 advisory committee votes on Grail’s Galleri multi cancer early detection test, Roche’s Phase 3 sefaxersen win in IgA nephropathy, Immunovant’s cutaneous lupus exit, and the day’s other developments across life sciences.

How did the FDA advisory committee vote on Grail’s Galleri test?

The Molecular and Clinical Genetics Devices Panel voted in Grail’s favor on all three questions on September 23: unanimously on safety, 6 to 4 on effectiveness, and 7 to 2 with one abstention on benefit risk. Each question asked whether there is reasonable assurance for patients meeting the proposed indication.

The votes apply “for patients who meet the criteria specified in the proposed indication”: screening for the early detection of multiple types of cancer in adults aged 50 years and older, as a supplement to recommended screenings rather than a replacement. Grail announced the results in a press release at 6:17 pm ET, after the market close. The advisory vote is not binding on the agency.

Grail chief executive Josh Ofman said in the release that “today’s vote reinforces the strength of Galleri’s clinical evidence.” The company says clinical studies showed Galleri detected approximately four to seven times more cancers compared to standard of care alone, with most detected cancers found at earlier stages; those are company characterizations from the release.

Why did four panelists vote against effectiveness?

The effectiveness question carried the evidence dispute the FDA itself had teed up. The agency’s own executive summary, posted before the meeting, reported Galleri’s sensitivity for all new cancers at 35.0% in PATHFINDER 2 (N=22,698, North America, prospective) and 31.6% in the randomized NHS-Galleri trial (N=70,323 intervention arm, UK), against specificity of 99.85% and 99.74% respectively. Stage I to II detection was 24.9% in PATHFINDER 2 and 20.5% in NHS-Galleri.

According to meeting coverage, FDA staff questioned whether the data support calling Galleri an “early detection” test, and the discussion returned to the fact that NHS-Galleri did not demonstrate a reduction in combined stage III and IV diagnoses, although stage IV diagnoses alone decreased over three years of screening. The agency had also flagged, in its briefing materials, that episode sensitivity may not represent true sensitivity by stage because of differential timing of detection, and it asked the panel to consider marketing caveats making clear that a negative result does not exclude cancer and a positive result does not confirm it.

The strongest argument on the other side, also from the FDA’s own summary, is the screening status split: Galleri’s combined sensitivity was 22.9% for cancers that already have guideline recommended screening, but 47.3% for cancers with no recommended screening at all, including sensitivity above 80% for head and neck and liver cancers and 66.7% for pancreatic cancer in PATHFINDER 2. That framing positions the test as coverage for unscreened cancers rather than a rival to mammography or colonoscopy.

What happens next for Galleri’s PMA?

The FDA is expected to make a final decision on the Galleri premarket approval application in the coming months, per Grail’s release. The application, submitted January 29, 2026, is the first PMA ever filed for a multi cancer early detection test, and the agency’s decision will set the regulatory template for the class.

The open question is label language. The FDA asked its panel for input on whether stage performance “supports claims related to ‘early detection'” before the meeting, and the 6 to 4 effectiveness split keeps that question alive into the review. An approval that narrows or caveats the early detection claim would still be an approval, but it would change how the test can be marketed and how the class is reimbursed.

Why was GRAL stock halted on panel day?

Grail shares did not trade during Wednesday’s regular session; trading was halted through the advisory committee meeting, per market coverage, and exchange data shows the stock pinned at Tuesday’s 108.52 close on negligible volume. Because the vote crossed the wire at 6:17 pm ET, Thursday’s session is the first opportunity for the market to price the outcome.

The setup into that open: GRAL rose 33.7% on Monday when the briefing documents landed without major reviewer concerns, then held the gain on Tuesday and finished at 108.52, up 34.4% from Friday’s 80.77 close (our arithmetic). Monday’s move prepaid a friendly tally; what it did not price is the 6 to 4 effectiveness margin and the label discussion attached to it. Guardant Health, the closest listed readacross, closed at 176.31 on Wednesday, down 0.5%.

The payer backdrop tightened in the same week: CMS posted preliminary 2027 Clinical Laboratory Fee Schedule rates on September 22 that would cut payment for nearly 1,200 tests, 775 of them at the 15% annual reduction cap set by PAMA, with further cuts planned for 2028 and 2029, per MedTech Dive. CMS says Medicare pays about 16% more than private payers for the same lab services. Rates are due to be finalized in November, and reimbursement economics are the next fight for any approved MCED test.

What did Roche’s sefaxersen show in IgA nephropathy?

Sefaxersen, the antisense medicine Roche licensed from Ionis (formerly IONIS-FB-LRx), met the primary endpoint of its Phase 3 Imagination study in IgA nephropathy at the Week 37 interim analysis, delivering a statistically significant reduction in proteinuria measured by urine protein to creatinine ratio, per Fierce Biotech. Safety and tolerability were consistent with earlier trials. The study continues blinded through Week 105 to measure kidney function.

Sefaxersen suppresses production of complement factor B and is dosed monthly by subcutaneous injection. Roche’s global head of nephrology Jay Garg said the Week 37 proteinuria data will “hopefully lead to accelerated approval,” and the company plans regulatory discussions on that path. Analysts model about €400 million ($457 million) in sales by 2030, while Roche has guided to €1 billion to €2 billion in peak sales; Roche paid Ionis $55 million upfront for the program in 2022. All figures are per Fierce Biotech’s report.

How crowded is the IgA nephropathy market now?

Crowded, and getting more so by the quarter. Sefaxersen’s win puts a second complement factor B agent on the board next to Novartis’s oral Fabhalta, and it lands ten weeks before Vertex’s povetacicept action date, in a field where Vera’s Trutakna already reset the efficacy bar.

The tape treated the readout as a competitive event. Vera closed at 33.05, down 8.9%, giving back Tuesday’s gain and more in the session in which the sefaxersen result was reported; no company disclosure explains the move and we assign no cause. Ionis, which stands to earn royalties on sefaxersen, closed down 4.0% at 43.93 in the same session. Roche’s US shares closed at 55.06.

Why did Immunovant end its cutaneous lupus program?

Immunovant discontinued development of IMVT-1402 in cutaneous lupus erythematosus after the anti FcRn antibody missed the primary endpoint of a Phase 2 proof of concept study in 57 adults, per Fierce Biotech. Skin scores at Week 12 were statistically no better than placebo. The company pointed to numerical trends favoring the drug and said patients with deeper IgG reductions were more likely to respond, but cited “the competitive landscape and the clinical results observed” in ending the program.

IMVT-1402 continues in Graves’ disease, rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjögren’s disease. Immunovant closed at 34.54, down 7.4% on the day of the announcement.

What else moved in life sciences on September 23?

Financings kept pace. Enveda raised a $311 million Series E, taking its total raised past $500 million, with ENV-294 in Phase 2a for atopic dermatitis and asthma and ENV-308 in Phase 1 for weight maintenance after GLP-1 discontinuation, per Fierce Biotech. Basecamp Research closed a $140 million Series C alongside a six program pipeline reveal. Boehringer Ingelheim expanded its January target discovery pact with Variant Bio into cardiovascular disease, adding an upfront payment plus license and milestone payments totaling over $250 million to a deal that began with $120 million upfront, per Fierce Biotech.

Novo said it is open to a direct NYSE listing. Chief executive Mike Doustdar told the Financial Times the company is open to moving beyond its ADR structure given that the US now accounts for over half of revenue, while emphasizing Novo is not actively pursuing the change, per Fierce Pharma. Novo’s ADRs closed at 38.17, down 3.1%, a third straight decline since its capital markets day.

Lilly claimed 7 of 10 Medicare GLP-1 patients. Chief executive David Ricks told CNBC that about 700,000 seniors have started GLP-1 therapy under the Medicare bridge program since July 1 at a net price of $245 per month with a $50 copay, and that Lilly captures about 70% of those starts, per Fierce Pharma; Jefferies estimates the share is worth about $1.4 billion annualized. The figures are company statements without a primary document.

Medtech and diagnostics. Cordis won FDA approval for Selution SLR, a sirolimus eluting balloon for coronary in stent restenosis, giving Boston Scientific’s paclitaxel coated Agent its first US coated balloon competitor, per MedTech Dive (September 22). Oura is seeking up to $2.2 billion in its Nasdaq IPO at $40 to $44 per share, most of it from selling stockholders, per MedTech Dive (September 21). Cellares signed its second Asia automation evaluation, this one with a South Korean hospital, per Fierce Pharma.

Elsewhere. Flagship Pioneering won a $47 million Department of War contract for countermeasure research, per Fierce Biotech. Berkeley’s Fyodor Urnov said the bespoke gene editing drug made for Baby KJ cost $1.65 million to manufacture, per Endpoints News. Scrip reported that Scholar Rock’s Isembyld launched at a wholesale acquisition cost above $450,000 per year with a net cost around $310,000; no company pricing document has appeared, and the figures are Scrip’s alone.

How did life sciences stocks close on September 23?

All closes are official exchange settled prices; percentage moves are our arithmetic against the prior close. Grail did not trade during the session.

For the moves marked “no news found,” we checked tonight’s wire and trade press sweeps and found no company disclosure; we assign no cause to any of them.

Frequently asked questions

What were the exact FDA panel vote counts for Grail’s Galleri test?

The panel voted 10 to 0 that Galleri is safe, 6 to 4 that it is effective, and 7 to 2 with one abstention that its benefits outweigh its risks, per Grail’s September 23 press release.

Is Galleri now FDA approved?

No. The advisory committee vote is a recommendation. The FDA is expected to make a final decision on the premarket approval application in the coming months and is not bound by the panel’s votes.

What is the Galleri test?

Galleri is a blood test from Grail that screens for a shared methylation signal across more than 50 cancer types in adults aged 50 and older, intended as a supplement to recommended screenings such as mammography and colonoscopy, not a replacement.

How accurate is Galleri at detecting cancer?

Per the FDA’s executive summary, overall sensitivity was 35.0% in PATHFINDER 2 and 31.6% in NHS-Galleri, with specificity of 99.85% and 99.74% and positive predictive value of 77.0% and 66.2% respectively.

Why did some panelists doubt Galleri’s effectiveness?

Stage I to II sensitivity was roughly 20 to 25% in the two pivotal studies, NHS-Galleri did not show a reduction in combined stage III and IV diagnoses, and FDA staff questioned whether the data support an early detection claim, per meeting coverage and the FDA’s briefing materials.

What is Galleri’s strongest performance data?

For cancers with no recommended screening today, combined sensitivity was 47.3% in PATHFINDER 2, including 81.2% for head and neck and liver cancers and 66.7% for pancreatic cancer, versus 22.9% for cancers that already have guideline screening, per the FDA executive summary.

When will the FDA decide on Galleri?

Grail says the FDA is expected to make a final decision on the PMA in the coming months. The application was submitted January 29, 2026, and no action date has been disclosed.

Why was Grail stock halted on September 23?

Trading in GRAL was halted through the advisory committee meeting, per market coverage, with exchange data showing essentially no volume. The vote was announced at 6:17 pm ET, so Thursday, September 24 is the first session in which the market can react.

What is sefaxersen and how does it work?

Sefaxersen is an antisense oligonucleotide, discovered by Ionis and developed by Roche, that suppresses production of complement factor B. It is dosed monthly by subcutaneous injection and met its Phase 3 primary endpoint in IgA nephropathy by reducing proteinuria at Week 37.

How does sefaxersen compare with Novartis’s Fabhalta?

Both target complement factor B in IgA nephropathy. Fabhalta is an approved oral small molecule taken twice daily; sefaxersen is a monthly injection that just met its Phase 3 proteinuria endpoint, with kidney function data blinded until Week 105, per Fierce Biotech.

What IgA nephropathy catalysts are next?

Vera plans a Trutakna sBLA in Q4 2026, Vertex’s povetacicept has a November 30, 2026 FDA action date, Roche plans accelerated approval discussions for sefaxersen, and the Imagination trial reads out kidney function at Week 105.

Why did Immunovant stock fall on September 23?

Immunovant announced it will end development of IMVT-1402 in cutaneous lupus after a Phase 2 miss; shares closed down 7.4% at 34.54 on the day of the announcement.

What did CMS propose for lab test payment?

CMS posted preliminary 2027 Clinical Laboratory Fee Schedule rates that would cut payment for nearly 1,200 tests, 775 of them by the maximum 15% allowed annually under PAMA, with finalization due in November 2026, per MedTech Dive.

How much is Oura trying to raise in its IPO?

Up to $2.2 billion on Nasdaq at $40 to $44 per share across 50 million shares, of which 36.5 million come from selling stockholders, per MedTech Dive’s September 21 report on the filing.

Sources

Primary sources: Grail press release, “FDA Advisory Committee Votes In Favor of Approval of GRAIL’s Galleri Multi-Cancer Early Detection Test,” September 23, 2026 (6:17 pm ET, PR Newswire and grail.com); FDA executive summary, voting questions, and panel materials for the September 23 Molecular and Clinical Genetics Devices Panel (docket FDA-2026-N-8004), fetched from fda.gov September 22; exchange settled closing prices, September 23, 2026.

Trade press and coverage (attributed): Fierce Biotech (sefaxersen Imagination results, Immunovant discontinuation, Enveda Series E, Boehringer and Variant Bio expansion, Flagship contract), September 23; Fierce Pharma (Novo NYSE remarks via the Financial Times, Lilly Medicare GLP-1 remarks via CNBC, Cellares), September 23; MedTech Dive (CMS lab fee schedule, September 22; Cordis Selution SLR approval, September 22; Oura IPO terms, September 21); Endpoints News (adcomm coverage, Baby KJ manufacturing cost), September 23; STAT and Stocktwits (panel discussion and trading halt coverage), September 23; Scrip/Citeline (Isembyld pricing, September 14).

Related coverage

Read our panel eve analysis of the FDA’s Galleri briefing documents in Grail’s Galleri panel meets today on a 35% sensitivity question, how the repricing began in Grail jumped 33.7% after FDA reviewers raised no major concerns, and the kidney disease efficacy bar Vera set in Vera’s Trutakna cut kidney disease progression risk 76% over two years.