The FDA approved Inovio’s Voceryq for recurrent respiratory papillomatosis on October 30, 2026, after 27% of treated adults went a year without surgery.
Last updated: November 2, 2026
The FDA granted Voceryq accelerated approval on Friday evening, October 30, 2026, to reduce surgical excisions in adults with recurrent respiratory papillomatosis. In its pivotal study, 7 of 26 evaluable patients, or 27 percent, needed no surgery over 12 months of follow up.
This page covers the Voceryq approval in full, Friday’s third quarter earnings verdicts, the TCT 2026 data wave, the week’s broken IPO debuts, and the weekend regulatory tape, with primary sources throughout.
What did the FDA approve Voceryq to do?
Voceryq is approved under the accelerated pathway to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis, a rare disease in which HPV driven growths repeatedly block the airway. Continued approval may depend on confirmatory evidence of clinical benefit.
Recurrent respiratory papillomatosis, or RRP, is usually caused by HPV types 6 and 11. The growths return after removal, so patients cycle through repeated operations, and every operation carries a risk of permanent vocal cord damage. Inovio Pharmaceuticals estimates at least 25,000 adults in the United States live with the disease, a figure the company derives from claims data.
Voceryq, previously called INO-3107, carries the nonproprietary name doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd. It is a plasmid DNA immunotherapy encoding HPV 6 and HPV 11 antigens, delivered into muscle with Inovio’s CELLECTRA 5PSP electroporation device over a nine week regimen that begins after surgical debulking of visible papillomas. Inovio says the product is the first DNA medicine approved by the FDA, a company characterization that also makes Voceryq the company’s first approved product in its history. The approval crossed the wire at 6:01 pm Eastern on Friday, after the market closed.
How well did Voceryq work in the RRP-001 study?
In the RRP-001 trial, 7 of 26 evaluable adults, or 27 percent, required no surgical excision during 12 months of follow up after treatment, against a baseline of three or more surgeries in the prior year. Inovio says that outcome is not expected in the natural history of untreated disease.
| RRP-001 measure | Result |
|---|---|
| Adults enrolled (2 or more surgeries in prior year) | 32, all completed the study |
| Efficacy population (3 or more excisions in prior 12 months) | 26 patients |
| Median prior excisions in efficacy population | 4.5 (range 3 to 8) |
| Complete response: no surgical excision over 12 months | 7 of 26 (27%; 95% CI 12 to 48) |
| Most common adverse reactions | Injection site reactions, headache, fatigue, hypertension, nausea, dizziness |
| Severe events | No grade 4 or 5 common adverse events reported |
The dataset was published in Nature Communications and The Laryngoscope. The label carries practical limits: patients are observed for at least 30 minutes after dosing, and the device is avoided over pacemakers, implantable defibrillators on the same side, metal implants and broken skin at the treatment site.
How does Voceryq’s approval change the RRP market?
Voceryq is the second immunotherapy approved for RRP, not the first. Reuters notes that Precigen’s Papzimeos became the first medicine approved in the United States for the disease last year. The race is now a contrast of modalities: an adenoviral vector against a plasmid delivered by electroporation.
Inovio’s chief executive Jacqueline Shea drew exactly that line, telling Reuters that unlike Papzimeos, which uses a modified virus to trigger an immune response, Voceryq is a DNA based immunotherapy. The commercial plan is deliberate rather than fast: Voceryq should be available to order and ship in roughly 60 days, with full field deployment in the first quarter of 2027 behind a contract field force from Syneos Health. No list price was disclosed in the release.
The accelerated approval also starts a regulatory clock. The FDA requires Inovio to submit a draft confirmatory study protocol by the end of 2026, with alignment on a final protocol expected by mid 2027. Inovio hosts a call on Monday, November 2 at 8:00 am Eastern.
The market context is unusual. Inovio shares closed Friday at $0.60, down 22.0 percent on more than 80 million shares, before the approval was announced. Monday is the first reaction session for Inovio, and for Precigen, whose shares closed at $6.94 on Friday, up 4.5 percent, also before the news. Both percentages are our arithmetic from exchange settled closes.
What did Friday’s third quarter results show?
Friday was the heaviest earnings session of the season: AbbVie, Regeneron and AstraZeneca beat and were paid, while the market punished Illumina and Stryker reports that had crossed Thursday evening. Every figure below traces to the company release or SEC exhibit.
| Company | Q3 revenue | EPS | Guidance | Friday close |
|---|---|---|---|---|
| AbbVie | $17.40B, +10.3% | Adjusted $3.82 | FY adjusted EPS raised to $13.95 to $13.99; dividend up 5.2% | $294.89, +1.4% |
| Regeneron | $5.12B, +36% | Non GAAP $20.07, +70% | Gross margin and SG&A outlook improved | $927.89, +13.3% |
| AstraZeneca | $16.21B, +7% | Core $2.79, +19% CER | FY2026 reconfirmed | $186.65 ADR, +7.0% |
| Illumina (reported Thu evening) | $1.13B, +4.2% | Non GAAP $1.62 | FY revenue and EPS guidance raised | $235.99, −18.6% |
| Stryker (reported Thu evening) | $6.52B, +7.7% organic | Adjusted $3.52, +10.3% | FY organic growth now 6.5 to 7.0%; adjusted EPS $14.80 to $14.90 | $291.86, −6.4% |
Inside AbbVie’s quarter, immunology did the work: Skyrizi reached $5.78 billion, up 22.7 percent, Rinvoq $2.71 billion, up 23.9 percent, while Humira fell 31.2 percent to $683 million. The release also disclosed a completed Apogee Therapeutics acquisition, FDA approval of Juvmo (tavapadon) for Parkinson’s disease, a submitted etentamig BLA in multiple myeloma, two breakthrough designations for Temab-A, and an amylin analog, ABBV-295, moving into Phase 2 for obesity.
Regeneron’s quarter came with a new deal: an expanded Sanofi collaboration adding next generation long acting immunology antibodies, with $1.0 billion upfront to be recognized as collaboration revenue in the fourth quarter and up to $7.0 billion in potential milestones. EYLEA HD US sales rose 62 percent to $699 million while older EYLEA fell 41 percent, and Libtayo grew 51 percent globally. The company also said it expects an FDA decision on cemdisiran in generalized myasthenia gravis next month.
AstraZeneca grew total revenue 7 percent to $16.2 billion with core EPS up 19 percent at constant currency and reconfirmed its full year guidance, with nine month oncology revenue of $21.9 billion, up 16 percent, now 47 percent of the company.
Why did Illumina and Stryker fall while Regeneron rallied?
Because the market reconstructed each quarter’s underlying growth rate and paid that, not the headline. Illumina beat on EPS and raised guidance but grew organic revenue 4.8 percent; Stryker trimmed its outlook; Regeneron’s 36 percent revenue growth had no asterisk the market objected to.
Illumina’s print carried unusual geometry: a tariff refund added a $79 million cost of goods benefit while trimming revenue by $37 million, so non GAAP EPS was $1.62 as reported but $1.44 excluding refunds. Greater China is excluded from results entirely following China’s Unreliable Entities List action. The company raised full year revenue guidance to $4.64 to $4.66 billion and EPS to $5.40 to $5.45, credited robust NovaSeq X placements, and still lost 18.6 percent of its value on Friday.
Stryker grew organically at 7.7 percent, but hips declined 1.0 percent, knees grew just 1.1 percent, and the new full year organic range of 6.5 to 7.0 percent landed as a reduction in trade coverage’s reading. The quarter absorbed $293 million of impairments and $153 million of structural charges, including costs tied to the Spinal Implants sale, and the board added $3.0 billion to the buyback. Chief executive Kevin Lobo said the quarter did fall short of expectations.
Gilead, which reported Thursday evening, saw its raised full year clear higher: shares added 3.1 percent in Friday’s first reaction session. Penumbra, which suspended guidance amid its pending Boston Scientific acquisition, slipped 0.9 percent.
What data landed at TCT 2026 in San Diego?
Sunday’s headline was Heartflow’s P4 trial: CT guided PCI planning matched intravascular ultrasound guidance on 12 month target vessel failure, 4.1 versus 4.6 percent, in 1,105 randomized patients, with procedures a median 17 minutes shorter. The result was published simultaneously in the New England Journal of Medicine.
| TCT 2026 dataset | Design | Key result |
|---|---|---|
| Heartflow P4 (investigator initiated) | Randomized, 1,105 stable CAD patients, 23 centers; CT planning (FFRCT plus Planner) vs IVUS guidance | Target vessel failure 4.1% vs 4.6% at 12 months, noninferior; median procedure 46 vs 63 minutes; contrast 150 vs 170 mL |
| Heartflow NAVIGATE-PCI registry | Prospective registry, 203 patients, uncontrolled | Treatment plans modified in roughly 70% of patients after PCI Navigator review vs angiography alone; a plan change rate, not an outcome |
| Abbott TECTONIC IDE | 335 patients, 40 US sites, severely calcified coronary disease; investigational SonicForce intravascular lithotripsy | 30 day target lesion failure 0.3%; procedural success 97%; published in JACC: Cardiovascular Interventions |
| J&J Impella analyses | Three observational and registry analyses, 1,379 patients total | 30 day mortality 6.1% in TRI-GUARD-PCI; in hospital mortality 4.7% in a PROTECT III subgroup meeting CHIP-BCIS3 criteria, vs roughly 8% cited from that trial |
The caveats matter. P4 used an earlier version of Heartflow’s planning software, and the 70 percent figure comes from an uncontrolled registry with no clinical outcomes attached. Abbott’s SonicForce system remains investigational, and the release names no submission timing. J&J’s Impella data are observational analyses set against a randomized trial, CHIP-BCIS3, that went the other way; the randomized PROTECT IV trial the field is waiting for is anticipated in 2027, per the company’s own release, and two presenters are paid J&J consultants. Anteris also reported DurAVR valve outcomes from its EMBARK study, and GE HealthCare launched the Allia Celeo interventional imaging system.
How did the week’s biotech IPO debuts trade?
Both Friday debuts finished below their offer prices, the first broken debuts since the IPO window reopened in October. Aspen Neuroscience closed at $14.89 against a $15.00 offer and Bambusa Therapeutics at $14.99 against $16.00, on a day the S&P 500 fell 1.8 percent.
| Company | Offer | Friday close (first session) | Vs offer |
|---|---|---|---|
| Aspen Neuroscience (ASPE), iPSC Parkinson’s cell therapy | $15.00, ~$140.6M gross | $14.89 | −0.7% |
| Bambusa Therapeutics (BBTX), long acting bispecifics | $16.00 upsized, ~$168.9M gross | $14.99 | −6.3% |
Percentages are our arithmetic from exchange settled closes. The contrast with two weeks ago is the story: City Therapeutics debuted 24.4 percent above its offer into a falling tape on October 16. Both closings are expected Monday, November 2, and the 424B4 filings will show whether the underwriters’ options were exercised.
What else moved in life sciences over the weekend?
The FDA’s individualized genome editing draft guidance now has a docket and a clock, HUTCHMED and AstraZeneca’s savolitinib filings were accepted in Europe and Japan, and Acumen Pharmaceuticals scrapped its only Alzheimer’s program.
The Federal Register notice for the draft guidance on individualized human genome editing products published on October 28 under docket FDA-2026-D-11783, with comments due 30 days after publication, which works out to late November by our arithmetic. The HUTCHMED and AstraZeneca filings cover Orpathys plus Tagrisso in MET driven, EGFR mutated lung cancer after progression on an EGFR inhibitor: the EMA validated the marketing authorization application and Japan’s health ministry accepted a new drug application, both on the Phase 3 SAFFRON trial, where the combination cut the risk of death 32 percent, with median overall survival of 17.8 versus 12.9 months. A US application has been under FDA review since September.
Elsewhere: Acumen Pharmaceuticals discontinued its sole Alzheimer’s asset after a Phase 2 failure, per BioSpace, and the shares closed Friday at $0.21, down 90.8 percent by our arithmetic. Setara Therapeutics launched with $90 million built around rare disease programs from Jazz Pharmaceuticals, per BioSpace. Iovance’s second session after its lung cancer data brought no bounce, closing down another 11.3 percent at $8.48. Mesoblast announced board changes Sunday evening. Zai Lab’s October equity offering closing remained absent through a fifth nightly check; tonight’s searches surfaced only the company’s 2024 vintage closing release, confirmed by the date in the document body.
Which stocks carried Friday’s story?
All closes are exchange settled; percentages are our arithmetic against Thursday’s closes.
| Ticker | Friday close | Move | Context |
|---|---|---|---|
| REGN | $927.89 | +13.3% | Q3 beat, Sanofi expansion, cemdisiran decision expected next month |
| ILMN | $235.99 | −18.6% | Fell despite an EPS beat and raised guidance; 4.8% organic growth repriced |
| AZN | $186.65 | +7.0% (ADR) | Q3 beat, full year reconfirmed, oncology 47% of revenue |
| SYK | $291.86 | −6.4% | Lowered full year outlook; hips down 1.0%; $293M impairments |
| INO | $0.60 | −22.0% | Fell on heavy volume during the session; approval crossed at 6:01 pm, Monday is the first reaction |
| IOVA | $8.48 | −11.3% | Second session after the lung cancer data; no bounce |
Context: the S&P 500 fell 1.8 percent Friday and the XBI biotech index fell 1.1 percent.
Frequently asked questions
What is Voceryq and what did the FDA approve it for?
Voceryq is Inovio’s plasmid DNA immunotherapy, formerly INO-3107. On October 30, 2026 the FDA granted it accelerated approval to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis.
Is Voceryq the first approved treatment for recurrent respiratory papillomatosis?
No. Precigen’s Papzimeos, an adenoviral immunotherapy, became the first US approved medicine for RRP last year, per Reuters. Voceryq is the second approved immunotherapy for the disease and, by Inovio’s characterization, the first FDA approved DNA medicine.
What data supported Voceryq’s accelerated approval?
The RRP-001 study, in which 7 of 26 evaluable adults, or 27 percent, needed no surgical excision over 12 months of follow up, against a baseline of at least three excisions in the prior year. The 95 percent confidence interval was 12 to 48 percent.
When will Voceryq be available to patients?
Inovio expects Voceryq to be available to order and ship in roughly 60 days, with full field deployment during the first quarter of 2027 supported by a Syneos Health field force. No list price was disclosed at approval.
What does accelerated approval require Inovio to do next?
Inovio must run a confirmatory study to verify clinical benefit. The FDA requires a draft protocol by the end of 2026, with final protocol alignment expected by mid 2027. Continued approval may be contingent on that study.
Why did Inovio’s stock fall 22 percent on the approval day?
The decline happened during Friday’s regular session, before the approval was announced at 6:01 pm Eastern. The settled close was $0.60 on more than 80 million shares. Monday, November 2 is the first session in which the market can react to the approval.
How did AbbVie perform in the third quarter of 2026?
Revenue rose 10.3 percent to $17.4 billion, with Skyrizi up 22.7 percent and Rinvoq up 23.9 percent. AbbVie raised full year adjusted EPS guidance to $13.95 to $13.99 and lifted its quarterly dividend 5.2 percent to $1.82.
What did Regeneron report in Q3 2026?
Revenue of $5.1 billion, up 36 percent, with non GAAP EPS up 70 percent to $20.07. The quarter included an expanded Sanofi collaboration worth $1.0 billion upfront plus up to $7.0 billion in milestones, and EYLEA HD US sales up 62 percent.
Why did Illumina’s stock fall 18.6 percent after raising guidance?
The company beat on EPS and raised full year guidance, but organic revenue grew 4.8 percent and the reported numbers carried tariff refund effects, including a $79 million cost benefit. The settled close marked the stock to the underlying growth rate rather than the raise.
Why did Stryker’s stock fall after its results?
Stryker set full year organic growth guidance of 6.5 to 7.0 percent, which trade coverage read as a reduction, with hips down 1.0 percent in the quarter and $293 million of impairments. The chief executive said the quarter fell short of expectations.
What is the Heartflow P4 trial and what did it show?
P4 randomized 1,105 stable coronary disease patients to CT guided PCI planning or intravascular ultrasound guidance. Twelve month target vessel failure was 4.1 versus 4.6 percent, meeting noninferiority, with procedures a median 17 minutes shorter. It was published in the New England Journal of Medicine.
What did Abbott’s TECTONIC study show at TCT 2026?
Abbott’s investigational SonicForce coronary intravascular lithotripsy system produced a 0.3 percent target lesion failure rate at 30 days and 97 percent procedural success in 335 patients with severely calcified disease. The device is not yet FDA approved and no filing timing was given.
How did the Aspen Neuroscience and Bambusa IPOs trade on debut?
Both broke their offer prices on Friday, October 30: Aspen Neuroscience closed at $14.89 against a $15.00 offer, and Bambusa closed at $14.99 against an upsized $16.00 offer, declines of 0.7 and 6.3 percent by our arithmetic.
What is the comment deadline for the FDA’s individualized genome editing draft guidance?
The Federal Register notice published October 28, 2026 under docket FDA-2026-D-11783, with comments due 30 days after publication, which is late November 2026 by our arithmetic. Check regulations.gov for the final stated date.
What are the savolitinib filings accepted in Europe and Japan?
The EMA validated a marketing authorization application and Japan’s MHLW accepted a new drug application for Orpathys plus Tagrisso in MET driven, EGFR mutated lung cancer after EGFR inhibitor therapy, based on the SAFFRON trial, where the combination extended median survival to 17.8 from 12.9 months.
Sources
Primary sources: Inovio Pharmaceuticals press release, October 30, 2026 (Voceryq accelerated approval, RRP-001 data, launch timing); AbbVie third quarter 2026 results release, news.abbvie.com, October 30, 2026; Regeneron third quarter 2026 results, 8-K exhibit 99.1, October 30, 2026; AstraZeneca 9M and Q3 2026 results announcement, October 30, 2026; Illumina Q3 FY2026 earnings release, 8-K exhibit, October 29, 2026; Stryker third quarter 2026 earnings release, exhibit 99.1, October 29, 2026; Heartflow press release, November 1, 2026 (P4 trial, NEJM publication; NAVIGATE-PCI registry); Abbott press release, November 1, 2026 (TECTONIC IDE study, JACC: Cardiovascular Interventions publication); Johnson & Johnson MedTech press release, November 1, 2026 (Impella analyses at TCT 2026); HUTCHMED and AstraZeneca release, November 1, 2026 (savolitinib EU and Japan filing acceptances, SAFFRON data); Federal Register public inspection notice, docket FDA-2026-D-11783, published October 28, 2026; Aspen Neuroscience and Bambusa Therapeutics IPO pricing releases, October 29, 2026.
Trade and wire coverage, attributed: Reuters, October 30, 2026 (Inovio approval; Papzimeos first approval context); BioSpace, October 30, 2026 (AbbVie quarter coverage; Acumen discontinuation; Setara launch); trade coverage of Illumina and Stryker reactions, October 30, 2026. Exchange settled closes from consolidated market data; all percentage moves are our arithmetic.
