Last updated: September 23, 2026
The FDA’s Molecular and Clinical Genetics Panel meets today to vote on whether Grail’s Galleri multi cancer test is safe and effective. The FDA’s own executive summary reports 35.0% sensitivity in PATHFINDER 2, 31.6% in NHS-Galleri, and specificity above 99.7% in both.
This briefing covers the FDA’s now public Galleri briefing documents, Celldex’s double Phase 3 win in chronic hives, Viking’s maintenance dosing data, the Novartis radioligand license, the ulefnersen FUS-ALS readout, and the rest of the September 22, 2026 news, with verified market closes.
What will the FDA advisory panel vote on for Grail’s Galleri test today?
The panel votes on three questions posted to the meeting docket: whether there is reasonable assurance Galleri is safe, whether there is reasonable assurance it is effective, and whether its benefits outweigh its risks for the proposed indication. The meeting runs 9:00 am to 6:00 pm ET.
The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee convenes today, Wednesday, September 23, 2026, in a hybrid format with a live YouTube webcast, under docket FDA-2026-N-8004. It is the first advisory panel ever held on a premarket approval application for a multi cancer early detection blood test. The voting questions, posted to the meeting page and retrieved directly, read: “Is there reasonable assurance that Galleri is safe for patients who meet the criteria specified in the proposed indication?”, “Is there reasonable assurance that Galleri is effective for use in patients who meet the criteria specified in the proposed indication?”, and “Do the benefits of Galleri outweigh the risks for use in patients who meet the criteria specified in the proposed indication?” The proposed indication covers adults aged 50 and older as an addition to, not a replacement for, guideline recommended screening.
A note on sourcing: on Monday the meeting page still served only two conflict of interest waivers, and every characterization of the briefing documents in Tuesday’s edition was attributed to Reuters, STAT, and Endpoints. As of Tuesday evening the page serves the full document set, including the FDA executive summary, the panel and voting questions, the agenda, the roster, and Grail’s own executive summary. The figures below come from the FDA executive summary directly.
What does the FDA’s executive summary say about Galleri’s performance?
Across the two pivotal studies, Galleri showed 12 month episode sensitivity of 35.0% in PATHFINDER 2 and 31.6% in NHS-Galleri, specificity of 99.85% and 99.74%, and positive predictive value of 77.0% and 66.2%. Cancer signal origin accuracy exceeded 91% in both studies.
| Measure (12 month follow up) | PATHFINDER 2 (N=22,698, North America) | NHS-Galleri (N=70,323 intervention arm, UK) |
|---|---|---|
| Episode sensitivity | 35.0% (95% CI 29.8 to 40.5) | 31.6% (95% CI 28.5 to 34.8) |
| Specificity | 99.85% | 99.74% |
| Positive predictive value | 77.0% | 66.2% |
| Negative predictive value | 99.07% | 98.89% |
| False positive rate | 0.15% (32 of 21,115) | 0.26% (132 of 49,919) |
| Number needed to screen | 202 | 196 |
| Cancer signal origin accuracy | 94.3% (100 of 106 true positives) | 91.9% (238 of 259 true positives) |
PATHFINDER 2 was a prospective interventional study in North America; NHS-Galleri was a randomized controlled trial in the United Kingdom. Both tested the current MCED-V2 device version prospectively, with frozen plasma retested on the candidate device for the effectiveness analyses. The FDA asks the panel to weigh the clinical significance of the performance overall, per cancer type, and by screening status, and specifically to discuss the inter study variability between the two estimates.
Does the FDA think Galleri supports an early detection claim?
The FDA puts that question to the panel rather than answering it. Galleri detected 24.9% of stage I and II cancers in PATHFINDER 2 and 20.5% in NHS-Galleri, and the agency flags a timing bias that complicates any sensitivity by stage analysis.
| Stage detection | PATHFINDER 2 | NHS-Galleri |
|---|---|---|
| All new cancers detected | 90 of 268 (33.6%) | 259 of 820 (31.6%) |
| Stage I to II detected | 44 of 177 (24.9%) | 97 of 474 (20.5%) |
| Stage I to III detected | 62 of 208 (29.8%) | 178 of 657 (27.1%) |
The sharpest split in the document is by screening status. In PATHFINDER 2, Galleri’s combined sensitivity for cancers that already have guideline recommended screening was 22.9%, including 26.4% for breast, 47.1% for lung, 62.5% for colorectal, and 10.7% for prostate. For cancer types with no recommended screening at all, combined sensitivity was 47.3%, including 81.2% for head and neck, 81.2% for liver, 66.7% for pancreas, and 63.0% for lymphoid cancers. The test is roughly twice as sensitive where no screening alternative exists.
The agency also states a methodological caveat: true cancer status at the time of the test is unknown for cancers Galleri did not detect, so episode sensitivity may not represent true test sensitivity, particularly by stage. Among the five questions the FDA poses for discussion, one asks directly whether the performance by stage “supports claims related to ‘early detection’.” That phrase sits at the center of how a positive test would be labeled, marketed, and reimbursed. This edition goes to press before the panel convenes; the vote count and discussion belong to tomorrow’s edition.
What did Celldex’s Phase 3 EMBARQ studies show for barzolvolimab?
Both EMBARQ-CSU1 and EMBARQ-CSU2 met their primary endpoint and every key secondary endpoint in 1,939 patients with chronic spontaneous urticaria. Complete response rates at week 24 reached 49.0% to 54.0% on the 150 mg dose. Celldex shares still fell 11.6%.
Celldex Therapeutics released topline results at 6:58 am ET Tuesday: barzolvolimab, an antibody against KIT on mast cells, cut the weekly urticaria activity score (UAS7) by roughly 20 points at week 12 on both doses, against 10.7 and 11.4 points on placebo, with p values below .00001 in both studies. Per the release, complete response (UAS7=0) at week 24 was 49.0% to 54.0% on 150 mg every four weeks and 45.1% to 48.4% on 300 mg every eight weeks, versus 15.4% to 17.6% on placebo. In the omalizumab refractory population at week 12, complete response ranged 41.7% to 55.3% versus 9.3% to 15.1% on placebo, and angioedema resolution ranged 62.7% to 74.3% versus roughly 33.7%. The company called the drug well tolerated through 24 weeks and plans a BLA in 2027. Fierce Biotech reported two anaphylaxis cases and a 16% discontinuation rate, mostly withdrawal of consent, and noted the program’s July 2026 Phase 2 failure in prurigo nodularis.
CLDX closed at 33.51, down 11.6% from Monday’s 37.89 (our arithmetic from exchange closes). The company made no disclosure about the move and no cause is assigned here. The readout resolves the September/October catalyst this briefing has tracked since the Cue Biopharma CUE-221 data made barzolvolimab the live comparison in the KIT class.
How much weight loss did Viking’s VK2735 maintenance study preserve?
Per Viking’s release, every other week dosing preserved up to 97% of prior weight loss and monthly dosing up to 90%, versus 61% retained after switching to placebo, over a 12 week maintenance phase. Viking shares rose 35.7%.
Viking Therapeutics released topline maintenance data for its dual GLP-1/GIP agonist VK2735 at 7:05 am ET Tuesday. The 33 week study rolled patients from induction into a 12 week maintenance phase across less frequent dosing schedules. The company also reported that the 17.5 mg once weekly cohort reached 22% placebo adjusted mean weight loss at week 33, and said it plans a part 2 maintenance study of the oral formulation. VKTX closed at 40.85, up 35.7% from Monday’s 30.11 (our arithmetic from exchange closes).
The same session brought a second GLP-1 dataset: Roche’s enicepatide, the dual GLP-1/GIP agonist acquired with Carmot Therapeutics, met both primary endpoints in a Phase 2 type 2 diabetes trial. Per Fierce Biotech, HbA1c fell 2.65% at the 24 mg weekly dose over 48 weeks with 15.5% mean weight loss and no demonstrable plateau, 90% of patients reached an A1c of 6.5% or below, and Phase 3 glycemic and cardiovascular outcomes trials start in the first half of 2027, alongside three obesity Phase 3 trials already underway. Novo Nordisk ADRs closed at 39.40, down 1.0% in the second session after Monday’s capital markets day, with EASD in Milan opening September 28 as the next dated test of its pipeline claims.
What did Novartis pay BoomRay one day after the Telix ITM deal?
Novartis licensed a preclinical radioligand from Suzhou based BoomRay Therapeutics in a deal worth up to $900 million in milestones and royalties, per Fierce Biotech, with the upfront undisclosed. It landed one day after Telix agreed to buy ITM, Novartis’s lutetium supplier.
The licensed asset was not disclosed; BoomRay’s pipeline includes theranostics against fibroblast activation protein and Nectin-4 plus a brain tumor diagnostic. The timing is the story: ITM Isotope Technologies Munich supplies Novartis with lutetium-177, and Monday’s Telix acquisition put that supply chain inside a competitor. Tuesday’s license is the first competitive response this briefing’s Telix watch list called for. Telix’s Nasdaq listed shares closed at 11.95, up 5.7% (our arithmetic), moving back above the $11.841 equity strike in the ITM deal on day two after closing 4.5% below it on Monday.
What did the ulefnersen FUSION trial show in FUS-ALS?
Ulefnersen, the Ionis discovered antisense medicine licensed to Otsuka, met the primary endpoint of the Phase 3 FUSION study in FUS-ALS, a rare, aggressive, mutation driven form of ALS. It is the first Phase 3 win for a potential disease modifying FUS-ALS treatment.
Per the Ionis and Otsuka releases, the primary analysis covered 73 of 89 enrolled patients with ALS caused by fused in sarcoma gene mutations, roughly 0.6% of ALS and often rapidly progressive, including in adolescents. At week 72, ulefnersen significantly outperformed placebo on a combined endpoint of functional impairment and survival built from the ALS functional rating scale, time to rescue, and ventilation free survival, with superiority on neurodegeneration biomarkers and on time to death, permanent ventilation, rescue, or disease progression withdrawal. Adverse events were mostly mild to moderate. Otsuka’s chief medical officer said the company will work with health authorities “with urgency,” and Otsuka simultaneously opened an early access program. Fierce Biotech noted Otsuka paid $10 million upfront for worldwide rights in 2024, with Guggenheim modeling $14 million to $16 million in annual royalties to Ionis by the 2030s. Ionis closed up 1.9% at 45.75.
What other Phase 3 and Phase 2 data landed on September 22?
Amgen’s dazodalibep hit its first Phase 3 in Sjögren’s disease, and Vertex’s inaxaplin posted Phase 2b proteinuria reductions in APOL1 mediated kidney disease. Together with Celldex, Viking, Roche, and ulefnersen, it was six positive datasets in one session.
Amgen dazodalibep. Per Fierce Biotech, the CD40 ligand targeting fusion protein, which came with the Horizon acquisition, significantly improved ESSDAI disease activity scores versus placebo at 48 weeks in the 651 patient Oasiz 301 study in moderate to severe Sjögren’s disease, the first Phase 3 win in the program. A second Phase 3, Oasiz 303, continues in patients with milder systemic activity, and William Blair analysts cautioned the FDA will likely want both readouts positive given the distinct populations. Amgen shares closed at 410.24, up 4.3% from Monday (our arithmetic); the readout was the day’s reported context and no cause is assigned to the move. For a company that named no readout dates at Morgan Stanley two weeks ago, the data arrived unannounced.
Vertex inaxaplin. Per Fierce Biotech, the Phase 2b AMPLIFIED study of the APOL1 channel inhibitor cut urine albumin to creatinine ratio 42.7% at week 13 in 22 patients with APOL1 mediated kidney disease and modest proteinuria, and 17.3% in 17 patients with coexisting type 2 diabetes. Enrollment in the pivotal AMPLITUDE study is complete with an interim analysis expected in early 2027 that could support accelerated approval; Vertex told Endpoints it is aiming for a broad kidney disease label. Vertex closed up 0.8% at 514.99.
What else happened across the industry on September 22?
Boehringer Ingelheim signed an up to $1 billion AI oncology collaboration, BMS cut another 265 jobs, Travere’s CEO said he will step down, and three European approvals cleared, headlined by NewAmsterdam’s obicetrapib.
Boehringer Ingelheim and Envisagenics signed a multi target oncology collaboration worth up to $1 billion, per Fierce Biotech, with splits undisclosed. Envisagenics’ SpliceCore platform screens more than 14 million RNA splicing events to find tumor specific splice variants for ADCs, T cell engagers, and multispecific antibodies; the company has prior programs with BMS, J&J, and Biogen and says the proceeds help push its preclinical ALS asset ENV-375 toward the clinic. Separately, Fierce reported that AI drug discovery company Iambic is planning an IPO, joining a queue that already holds TRex Bio, Retension, ADARx, and Oura.
Bristol Myers Squibb will cut another 265 jobs tied to its New Jersey headquarters under the $2 billion annual cost savings program running through 2027, per Fierce Pharma. Travere Therapeutics CEO Eric Dube will step down; TVTX closed down 4.1% at 60.28 (our arithmetic). Lexeo Therapeutics agreed to acquire Mantle Therapeutics for $8 million, adding frataxin targeted Friedreich ataxia assets, per Fierce Biotech.
In Europe, per trade press reports: the European Commission approved NewAmsterdam Pharma’s obicetrapib as Ubeslo and the obicetrapib plus ezetimibe combination as Evlarco; J&J’s icotrokinra (Icotyde), an oral IL-23 receptor peptide, was approved for plaque psoriasis; AbbVie’s Rinvoq was approved for polyarticular juvenile idiopathic arthritis from age two; and Roche’s Susvimo won approval for twice yearly refills. In US regulatory items, Merck’s Winrevair label was updated with new Phase 3 data per Fierce’s regulatory tracker, and compounder Empower received an FDA warning letter over GLP-1 compounding, per Endpoints. STAT reported, behind its paywall, that the Medicare bridge pilot covering obesity drugs for seniors at $245 a month may hold more benefits for Lilly and Novo than initially understood; the figure is STAT’s. And US trade officials heard arguments on declining German drug prices ahead of the September 29 Section 232 tariff date, per Endpoints.
How did biotech stocks close on Tuesday, September 22?
Grail added 0.5% on panel eve after Monday’s 33.7% jump. Viking’s 35.7% gain and Celldex’s 11.6% drop were the session’s defining reactions, and Telix recrossed its ITM deal strike price.
| Ticker | Close Sept 22 | Move | Context |
|---|---|---|---|
| GRAL | 108.52 | +0.5% | Panel eve; +33.7% Monday on the briefing documents |
| VKTX | 40.85 | +35.7% | VK2735 maintenance data (vs 30.11 Monday close) |
| CLDX | 33.51 | −11.6% | Fell despite double Phase 3 win; no cause disclosed |
| TLX | 11.95 | +5.7% | Nasdaq listed shares; back above the $11.841 ITM strike |
| AMGN | 410.24 | +4.3% | Dazodalibep Phase 3 win the same session; cause not assigned |
| NVO | 39.40 | −1.0% | ADRs; second session after the capital markets day |
| IONS | 45.75 | +1.9% | Ulefnersen FUSION readout |
| VRTX | 514.99 | +0.8% | Inaxaplin Phase 2b data |
| SRRK | 51.19 | +6.3% | No news found tonight; no cause assigned; still no Isembyld price primary |
| RARE | 15.615 | +6.6% | No new disclosure found; Fayuvi pricing document still absent |
| VERA | 36.26 | +5.9% | No company disclosure; holds above its 34.05 pre readout line |
| BHVN | 14.85 | +4.4% | Second straight unexplained gain; Thursday’s +15.6% still causeless |
| DFTX | 40.32 | +2.6% | Holds above the 38.89 round trip line |
| SMMT | 17.12 | +1.3% | Ivonescimab decision November 14 |
| XENE | 39.09 | +0.3% | Third session of stabilization |
| SION | 6.02 | +0.3% | Friday’s 17.0% drop still causeless |
| ETRA | 13.62 | −2.2% | 9.2% below the $15.00 issue price (our arithmetic) |
| TVTX | 60.28 | −4.1% | CEO transition announced |
| BMY | 62.25 | flat | 265 additional New Jersey job cuts |
| NVS | 141.28 | flat | BoomRay radioligand license |
All closes are exchange closes; percentage moves are our arithmetic from the stated closes. Moves without a company disclosure carry no assigned cause.
Where does deadline gauntlet week stand?
Event one delivered early and got paid. Event two, the panel itself, happens today. AbbVie’s CERVINO data comes Friday, tariffs land September 29, and the GENEROUS Medicaid deadline closes the month on September 30.
| Dated event | Date | Status |
|---|---|---|
| Grail briefing documents | Posted Sept 21 | Delivered; full set now live on the FDA meeting page, read directly for this briefing |
| Grail advisory panel | TODAY, Sept 23 | 9:00 am to 6:00 pm ET; three votes: safety, effectiveness, benefit risk |
| AbbVie CERVINO full etentamig data | Friday, Sept 25 | The withheld medians come due |
| Section 232 pharma tariffs | Sept 29 | German drug price case heard by US trade officials Tuesday, per Endpoints |
| GENEROUS Medicaid MFN deadline | Sept 30 | 40 states plus Puerto Rico signed as of Sept 21, per CMS via Fierce Healthcare |
| GSK flu Phase 3 window | Closes Sept 30 | Start still unannounced as of tonight’s check |
Frequently asked questions
What time is the Grail FDA advisory committee meeting on September 23, 2026?
The meeting runs 9:00 am to 6:00 pm ET on Wednesday, September 23, 2026, in hybrid format, with a live webcast linked from the FDA meeting page under docket FDA-2026-N-8004.
What sensitivity did Galleri show in its pivotal trials?
Per the FDA executive summary, 12 month episode sensitivity was 35.0% in PATHFINDER 2 and 31.6% in NHS-Galleri, with specificity of 99.85% and 99.74% respectively.
What is Galleri’s positive predictive value?
77.0% in PATHFINDER 2 and 66.2% in NHS-Galleri, meaning roughly two of three to three of four positive results corresponded to a cancer diagnosed within 12 months.
How well does Galleri detect early stage cancers?
It detected 24.9% of stage I and II cancers in PATHFINDER 2 and 20.5% in NHS-Galleri. The FDA asks the panel whether that performance supports claims related to early detection.
Does Galleri work better for cancers without existing screening?
Yes, per the FDA summary. In PATHFINDER 2, sensitivity was 47.3% for cancer types without guideline recommended screening versus 22.9% for those with it, including 81.2% for liver and head and neck cancers.
Is the Grail panel vote binding on the FDA?
No. Advisory committee votes are recommendations. The FDA usually follows its panels but is not required to, and recent precedent includes approvals granted after adverse reviews and votes.
What did barzolvolimab show in Phase 3 chronic spontaneous urticaria?
Both EMBARQ studies met the primary endpoint and all key secondary endpoints in 1,939 patients, with week 24 complete response of 49.0% to 54.0% on 150 mg versus 15.4% to 17.6% on placebo, per Celldex’s release.
When will Celldex file barzolvolimab with the FDA?
Celldex plans a BLA submission in 2027, per its September 22 release.
Why did Celldex stock fall after positive Phase 3 results?
Shares closed down 11.6% at 33.51. The company made no disclosure explaining the move and this briefing assigns no cause.
What did Viking’s VK2735 maintenance study show?
Per Viking’s release, every other week dosing preserved up to 97% of prior weight loss and monthly dosing up to 90%, versus 61% after switching to placebo, and the 17.5 mg weekly cohort reached 22% placebo adjusted weight loss at week 33.
What is ulefnersen and what did the FUSION trial show?
Ulefnersen is an Ionis discovered antisense medicine licensed to Otsuka for FUS-ALS, a rare genetic form of ALS. The Phase 3 FUSION study met its week 72 primary endpoint combining functional impairment and survival, per the companies’ releases.
How much is the Novartis BoomRay radioligand deal worth?
Up to $900 million in milestones and royalties for a preclinical radioligand, per Fierce Biotech, with the upfront payment undisclosed. It was announced one day after Telix agreed to acquire ITM, Novartis’s lutetium-177 supplier.
What happens after today’s Grail panel?
The FDA takes the panel’s votes and discussion into its premarket approval decision on Galleri, on no fixed statutory clock. Tomorrow’s briefing will carry the vote count and what it means for the MCED class.
Sources
Primary sources (September 22 to 23, 2026): FDA advisory committee meeting page for the September 23, 2026 Molecular and Clinical Genetics Panel, including the FDA executive summary, voting questions, panel questions, agenda, and roster (docket FDA-2026-N-8004); Celldex Therapeutics EMBARQ-CSU1 and EMBARQ-CSU2 topline release (6:58 am ET, Sept 22); Viking Therapeutics VK2735 maintenance study release (7:05 am ET, Sept 22); Ionis and Otsuka FUSION Phase 3 releases and Otsuka early access program announcement (Sept 22); exchange closing prices, September 21 and 22, 2026.
Trade press (attributed in text): Fierce Biotech (Novartis/BoomRay, Amgen dazodalibep, Vertex inaxaplin, Roche enicepatide, Boehringer/Envisagenics, Lexeo/Mantle, Iambic); Fierce Pharma (BMS job cuts, Travere CEO, regulatory tracker); Endpoints News (Vertex label ambitions, Empower warning letter, German drug price hearing, Novo CEO interview); STAT (Medicare bridge program report, paywalled).
Related coverage
Read our Tuesday briefing on the Grail documents, the Telix ITM acquisition, and Novo’s capital markets day, and our Monday briefing that set up deadline gauntlet week.
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