Vaxcyte’s VAX-31 Met All Primary Endpoints in Its Pivotal Adult Phase 3 as Shionogi Paid $2 Billion for IntraBio and GE HealthCare Bought Sofie for $945 Million (October 6, 2026)

Last updated: October 6, 2026

Vaxcyte’s 31 valent pneumococcal vaccine VAX-31 met every prespecified primary immunogenicity endpoint in its pivotal adult Phase 3, OPUS-1, while Shionogi agreed to buy IntraBio for $2.0 billion in cash and GE HealthCare agreed to buy radiopharmaceutical manufacturer Sofie Biosciences for $945 million.

This briefing covers Monday, October 5, 2026: the OPUS-1 readout, four deal announcements, the completed AstraZeneca investment in Summit Therapeutics, the first trading reactions to Genmab’s and Novo Nordisk’s weekend news, and the day’s medtech, diagnostics, and policy items.

What did Vaxcyte’s OPUS-1 trial show for VAX-31?

OPUS-1, the pivotal adult Phase 3 of VAX-31, met all prespecified primary immunogenicity endpoints across the age groups studied, with safety similar to the licensed comparators, Vaxcyte said Monday morning. The company plans a BLA submission in the first half of 2028.

The trial enrolled 4,047 adults across roughly 30 US sites and compared VAX-31, a 31 valent pneumococcal conjugate vaccine candidate, against the two licensed benchmarks in adults: Pfizer’s Prevnar 20 (PCV20) and Merck’s Capvaxive (PCV21). Immune responses in adults 18 to 49 were also bridged to adults 50 to 64, and the company said all of those serotype comparisons met noninferiority.

Vaxcyte shares closed at $73.82 Monday, up 30.7% from the $56.48 close on October 2, the last session before the data; the percentage is our arithmetic from exchange settled closes.

How does VAX-31 compare with Prevnar 20 and Capvaxive?

On the company’s own framing, VAX-31 matched both licensed adult vaccines serotype for serotype on most comparisons and beat them where its extra breadth lives. Vaxcyte says the 31 serotype design covers approximately 95% of invasive pneumococcal disease and approximately 88% of pneumococcal pneumonia in adults 50 and older, an incremental 13 to 36% of invasive disease and 19 to 31% of pneumonia versus currently licensed conjugate vaccines. Those coverage figures are company estimates from surveillance data, not trial outcomes.

The two serotypes that missed the primary noninferiority bar against Capvaxive, serotypes 3 and 12F, met a prespecified fallback threshold instead. Serotype 3 has a long history of being difficult for conjugate vaccines. The detail matters for how regulators and, eventually, advisory committees read the package, but under the trial’s prespecified statistical plan the endpoints counted as met.

Why did Shionogi pay $2 billion for IntraBio?

Shionogi is buying a commercial rare disease business outright. The Japanese pharma agreed Monday to acquire IntraBio for $2.0 billion in upfront cash, with no contingent payments disclosed, and expects the deal to close in November or December 2026 subject to regulatory approvals.

IntraBio sells Aqneursa (levacetylleucine), approved in the US for Niemann-Pick disease type C and, since September, for ataxia-telangiectasia. The company reported net sales of $67.867 million for 2025 against an operating loss of $35.292 million. At the announced price, Shionogi is paying roughly 29.5 times IntraBio’s 2025 sales; that multiple is our arithmetic from the two figures in Shionogi’s release. IntraBio’s pipeline adds programs in Pompe disease, Fragile X syndrome, and Jordan’s syndrome. CEO Isao Teshirogi framed the deal as the next step in a rare disease build that began with the Radicava acquisition from Tanabe in 2025.

What does GE HealthCare get from Sofie Biosciences?

GE HealthCare agreed to pay $945 million in cash for Sofie Biosciences, a PET radiopharmaceutical contract manufacturer owned by Trilantic North America, with closing expected in the first half of 2027. Sofie runs 15 US manufacturing sites with 21 cyclotrons and already produces Flyrcado (flurpiridaz F18), GE HealthCare’s cardiac PET agent, alongside products for other radiopharmaceutical companies.

The logic is distribution physics. F18 labeled tracers have a roughly 110 minute half life, which makes the network of production sites near patients, not the molecule alone, the scarce asset. The deal also gives GE HealthCare US rights to FAPI-74, a Phase 3 fibroblast activation protein inhibitor PET tracer with potential across multiple cancer types. GE HealthCare said it expects the business to be accretive to revenue growth, adjusted EBIT margin, and adjusted earnings per share in the first full year, with Sofie growing in the low double digits; those are company statements.

What did Genentech license from Alector?

Genentech, Roche’s US unit, licensed global rights to AL050, Alector’s preclinical Parkinson’s disease program, for $100 million upfront plus milestone payments reported at up to $1.17 billion and tiered royalties, a total outlets put at up to $1.27 billion. The figures come from trade coverage of the companies’ announcement; we did not retrieve the release directly. AL050 is described as a brain penetrant approach to raising glucocerebrosidase (GCase) activity, one of the most genetically validated targets in Parkinson’s. Alector keeps the rest of its pipeline. Alector shares closed at $1.99, up 9.9% from Friday’s $1.81 close, our arithmetic from settled closes.

What else moved on the deal tape Monday?

Gate Bioscience’s expanded Lilly collaboration covers what the company calls molecular gates: orally available small molecules that block a target protein’s passage through the Sec61 secretory channel, sending it to degradation. Gate says the mechanism could reach roughly 4,000 secreted and membrane proteins. The release describes an upfront payment, a fee on selection of the second target, research funding, milestones, and royalties, without dollar breakdowns.

What happened to the AstraZeneca investment in Summit?

It closed. AstraZeneca completed its $2.0 billion equity investment in Summit Therapeutics on Monday, per an AstraZeneca 6-K and both companies’ announcements. We had tracked the closing window since the September 28 agreement. Per Summit’s 8-K, AstraZeneca Holdings B.V. bought 108,955.3686 shares of Class A convertible preferred stock at $18,356.14 each, equivalent to $18.3561 per common share on the 1,000 to 1 conversion ratio. Conversion still requires antitrust clearance and a charter amendment authorizing additional shares; if the amendment is not effective within 18 months, Summit must redeem the preferred for cash at market value. AstraZeneca said the funds will accelerate ivonescimab development in combination with antibody drug conjugates, including the sonesitatug vedotin collaboration in gastrointestinal cancers and the separate Datroway program with Daiichi Sankyo. Summit closed at $17.27, up 3.1% on the day. The ivonescimab FDA decision remains set for November 14.

How did the market grade Genmab’s Rina-S data and Novo’s denecimig delay?

Monday was the first trading session for both pieces of weekend news, and the grades diverged. Genmab, whose Saturday release detailed a 45.9% confirmed response rate for Rina-S in platinum resistant ovarian cancer, closed at $38.48, up 10.7% from its pre news close of $34.75. Trade coverage carried claims that the data position the drug ahead of AbbVie’s Elahere; that is commentary, not a head to head readout.

Novo Nordisk’s ADRs closed at $37.54, up 0.6% from the pre news close, after Friday evening’s disclosure that the FDA extended its review of denecimig, the once monthly hemophilia A antibody, over facility remediation. The market read the delay as logistics, not science: Novo says there were no clinical deficiencies, has not named the facility or received a new action date, and still aims for a US launch in the first half of 2027.

What medtech, diagnostics, and infrastructure news landed Monday?

Abbott detailed the commercial launch of SimpleScreen CRC, the blood based colorectal cancer screening test it licensed from Freenome, for average risk adults 45 and older. In the PREEMPT CRC validation study of more than 48,000 asymptomatic adults, the test showed 81.1% overall sensitivity for colorectal cancer, 63.5% for stage I disease, 13.7% for advanced precancerous lesions, and 90.4% specificity for advanced colorectal neoplasia. Medicare Part B patients pay nothing out of pocket. The test joins Cologuard Plus in Abbott’s screening portfolio; the company says up to 60 million Americans are due for screening. Blood draws are available at home through mobile phlebotomy or at participating labs.

Elsewhere in devices and infrastructure, per MedTech Dive: Medtronic received FDA breakthrough device designation for a drug coated balloon and disclosed FDA clearances for cardiac mapping and ablation software; ARPA-H awarded more than $100 million to biosensor development projects; the FDA said it will prioritize guidance on AI and surgical robots next year; and the agency selected the first five participants for its READI-Home decentralized trial initiative.

Who won the 2026 Nobel Prize in Physiology or Medicine?

Karl Deisseroth of Stanford, Peter Hegemann of Humboldt University, and Georg Nagel of the University of Würzburg won “for their discoveries of light-gated ion channels and optogenetics.” The technique, which lets researchers switch defined neurons on and off with light, underpins much of modern neuroscience target discovery and is the conceptual parent of the light activated gene therapy approaches now in clinical development for vision restoration.

Which stocks moved on Monday’s news?

All moves are our arithmetic from exchange settled closes against Friday, October 2 closes (Vaxcyte against its October 2 pre data close).

Frequently asked questions

What is VAX-31?

VAX-31 is Vaxcyte’s 31 valent pneumococcal conjugate vaccine candidate, designed to cover more disease causing serotypes than Pfizer’s Prevnar 20 (20 serotypes) or Merck’s Capvaxive (21 serotypes).

Did VAX-31 pass its Phase 3 trial?

Yes. Vaxcyte said OPUS-1, the pivotal adult Phase 3, met all prespecified primary immunogenicity endpoints, with safety similar to the licensed comparator vaccines.

When will Vaxcyte file VAX-31 with the FDA?

Vaxcyte plans a BLA submission in the first half of 2028, after OPUS-2 and OPUS-3 results expected in the first half of 2027.

What happened with serotypes 3 and 12F in OPUS-1?

Against Capvaxive, those two serotypes missed the primary noninferiority criterion but met a prespecified historical threshold, so the trial’s primary endpoints still counted as met under the statistical plan.

How much is Shionogi paying for IntraBio?

$2.0 billion in upfront cash, per Shionogi’s release, with closing planned between November and December 2026.

What drug does IntraBio sell?

Aqneursa (levacetylleucine), approved in the US for Niemann-Pick disease type C and for ataxia-telangiectasia. IntraBio reported $67.867 million in 2025 net sales.

Why is GE HealthCare buying Sofie Biosciences?

Sofie’s 15 site, 21 cyclotron network solves the final mile problem for F18 PET tracers, whose roughly 110 minute half life makes local manufacturing capacity the binding constraint. The deal also adds US rights to the Phase 3 tracer FAPI-74.

What is AL050?

AL050 is Alector’s preclinical Parkinson’s disease program, described as a brain penetrant approach to raising glucocerebrosidase (GCase) activity. Genentech licensed global rights for $100 million upfront, in a deal reported at up to roughly $1.27 billion with milestones.

Is the AstraZeneca investment in Summit Therapeutics final?

The $2.0 billion investment closed on October 5, 2026. Conversion of the preferred shares into common stock still requires antitrust clearance and a Summit charter amendment.

How did Genmab stock react to the Rina-S ovarian cancer data?

Genmab’s US shares rose 10.7% to $38.48 on Monday, the first session after the Saturday release of RAINFOL-01 Part C results showing a 45.9% confirmed response rate.

Did Novo Nordisk stock fall on the denecimig delay?

No. The ADRs closed up 0.6% in the first session after the news, consistent with a delay the company attributes to facility remediation rather than any clinical deficiency.

What is SimpleScreen CRC and who can get it?

SimpleScreen CRC is the FDA approved blood based colorectal cancer screening test Abbott licensed from Freenome, for average risk adults 45 and older. Medicare Part B covers it with no out of pocket cost; blood draws are available at home or at participating labs.

How accurate is Abbott’s SimpleScreen blood test?

In the PREEMPT CRC study of more than 48,000 asymptomatic adults, it showed 81.1% overall sensitivity for colorectal cancer, 63.5% for stage I cancers, 13.7% for advanced precancerous lesions, and 90.4% specificity.

Who won the 2026 Nobel Prize in Medicine?

Karl Deisseroth, Peter Hegemann, and Georg Nagel, for the discoveries behind optogenetics and light gated ion channels.

Sources

Primary sources (October 5, 2026): Vaxcyte OPUS-1 topline release (GlobeNewswire, via full syndicated carries); Shionogi press release on the planned IntraBio acquisition (shionogi.com); AstraZeneca Form 6-K and completion announcement on the Summit investment; Summit Therapeutics Form 8-K (September 28, 2026) for the investment terms; Gate Bioscience press release (via BioSpace press release carry); Abbott SimpleScreen CRC launch release (via syndicated carry); Spyre Therapeutics offering pricing release.

Trade press and other coverage (October 5, 2026): Fierce Biotech and Endpoints News on the Alector license, the Vaxcyte readout, and the Nobel Prize; MedTech Dive on the GE HealthCare acquisition of Sofie Biosciences, Medtronic’s breakthrough designation and software clearances, ARPA-H biosensor awards, FDA guidance priorities, and the Abbott launch; Fierce Pharma on Novo Nordisk’s denecimig update; RTTNews and CNBC on GE HealthCare and Sofie; GuruFocus on Alector deal terms; CMS newsroom for the Transparency in Coverage final rules. Market closes are exchange settled closes.

Related coverage

Read our Monday briefing on the Novartis Abogen deal, CSL’s Alentis bet, and the full Rina-S dataset, our Friday briefing on Regeneron’s muscle preservation data and Sanofi’s $1 billion Dupixent succession deal, and our coverage of the CMS GLOBE final rule.