Precigen's only approved drug got a rival. Precigen lost about a quarter by midday Nov. 2
Inovio says the FDA granted accelerated approval to its drug for RRP, a rare airway disease. The only other approved RRP drug is Precigen's Papzimeos. Inovio wrote in August it expected to need a clinically meaningful benefit over it.
KeyVex News··5 min readFact-checked against 8 public recordsKeyVex News··5 min readFact-checked against 8 public records
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- Until August 2025, no drug was approved for RRP, a rare disease of growths that keep coming back in the airway. Precigen's Papzimeos was the first, and it is Precigen's only approved drug.
- On Oct. 30, Inovio said Voceryq won accelerated approval, making it the second approved RRP drug. In separate trials, 51.4% of Papzimeos patients and 27% of Voceryq patients needed no surgery for a year.
- Precigen expects most of its revenue for the foreseeable future to come from Papzimeos. By midday Nov. 2, Precigen had lost about a quarter of its value; Inovio had nearly tripled.
- Inovio's August quarterly report said its cash should fund operations into late first quarter 2027. Precigen reports results for the quarter ended Sept. 30 on Nov. 4, BiopharmaWatch reported.
The approval: The FDA granted accelerated approval to Inovio's Voceryq to reduce how often adults with recurrent respiratory papillomatosis, or RRP, need surgery, the company said on Oct. 30. Accelerated approval comes before a drug's benefit is fully confirmed: Voceryq's continued approval may depend on a confirmatory study, Inovio says. RRP causes wart-like growths in the airway that keep coming back.Press release
The rival: Voceryq is the second approved drug for RRP. The first, Precigen's Papzimeos, was approved on Aug. 14, 2025, the FDA said, which called it the first approved therapy for the disease.FDA Precigen's August quarterly report (10-Q) calls that a full approval.10-Q
Why it matters: Papzimeos is Precigen's only approved drug, and the company expects most of its revenue "for the foreseeable future" to come from it, its August quarterly report says.10-Q On the first trading day after Inovio's news, at 11:32 a.m. on Nov. 2, Precigen was down 24.9%, at $5.215, and Inovio was up 192%, at $1.76, per KeyVex's quote feed.Quotes The companies' filings show what Inovio expected the FDA to require, and how much cash it reported for its launch.10-Q
Precigen's stock and the story's key datesDaily close, Aug. 1, 2025 to Oct. 30, 2026 ▲ 315.6%Show chartHide chart
- 1Aug. 14, 2025 Papzimeos is approved. The FDA approved Papzimeos for adults with RRP, the first drug for the disease, it said. Close: $1.85.
- 2May 13, 2026 First-quarter results. Papzimeos sales of $21.6 million in the quarter, Precigen's 10-Q says.
- 3Aug. 4, 2026 A first quarterly profit. Papzimeos sales of $53.1 million; Precigen's first profit from continuing operations since 2020, its 10-Q says. Close: $6.53.
- 4Oct. 30, 2026 Inovio's rival is approved. Inovio announced accelerated approval of Voceryq after the close. StockTwits reported Precigen down 27% after hours. Close, before the news: $6.94.
View the data (315 trading days)
| Date | Close | Day change |
|---|---|---|
| 2026-10-30 | $6.94 | +4.5% |
| 2026-10-29 | $6.64 | +9.2% |
| 2026-10-28 | $6.08 | −1.1% |
| 2026-10-27 | $6.15 | +1.8% |
| 2026-10-26 | $6.04 | −2.4% |
| 2026-10-23 | $6.19 | −3.1% |
| 2026-10-22 | $6.39 | −3.2% |
| 2026-10-21 | $6.60 | −3.4% |
| 2026-10-20 | $6.83 | +2.6% |
| 2026-10-19 | $6.66 | +4.3% |
| 2026-10-16 | $6.38 | −11.3% |
| 2026-10-15 | $7.20 | −2.2% |
| 2026-10-14 | $7.36 | −1.7% |
| 2026-10-13 | $7.48 | −2.3% |
| 2026-10-12 | $7.66 | −1.9% |
| 2026-10-09 | $7.81 | +2.8% |
| 2026-10-08 | $7.60 | +0.8% |
| 2026-10-07 | $7.54 | −0.1% |
| 2026-10-06 | $7.55 | −2.5% |
| 2026-10-05 | $7.74 | −9.4% |
| 2026-10-02 | $8.54 | +4.0% |
| 2026-10-01 | $8.21 | −4.1% |
| 2026-09-30 | $8.56 | +6.3% |
| 2026-09-29 | $8.05 | +3.1% |
| 2026-09-28 | $7.81 | +0.8% |
| 2026-09-25 | $7.75 | +0.6% |
| 2026-09-24 | $7.70 | +3.5% |
| 2026-09-23 | $7.44 | −5.7% |
| 2026-09-22 | $7.89 | +2.5% |
| 2026-09-21 | $7.70 | −1.0% |
| 2026-09-18 | $7.78 | −1.1% |
| 2026-09-17 | $7.87 | +5.9% |
| 2026-09-16 | $7.43 | +6.2% |
| 2026-09-15 | $7.00 | +2.2% |
| 2026-09-14 | $6.85 | 0.0% |
| 2026-09-11 | $6.85 | +2.5% |
| 2026-09-10 | $6.68 | −1.8% |
| 2026-09-09 | $6.80 | −1.0% |
| 2026-09-08 | $6.87 | −3.2% |
| 2026-09-04 | $7.10 | −0.6% |
| 2026-09-03 | $7.14 | +1.9% |
| 2026-09-02 | $7.01 | +2.2% |
| 2026-09-01 | $6.86 | −1.0% |
| 2026-08-31 | $6.93 | −0.3% |
| 2026-08-28 | $6.95 | −3.3% |
| 2026-08-27 | $7.19 | −3.1% |
| 2026-08-26 | $7.42 | +1.9% |
| 2026-08-25 | $7.28 | +1.5% |
| 2026-08-24 | $7.17 | −0.4% |
| 2026-08-21 | $7.20 | −3.2% |
| 2026-08-20 | $7.44 | +3.9% |
| 2026-08-19 | $7.16 | +6.1% |
| 2026-08-18 | $6.75 | +3.1% |
| 2026-08-17 | $6.55 | +7.4% |
| 2026-08-14 | $6.10 | −6.0% |
| 2026-08-13 | $6.49 | −5.3% |
| 2026-08-12 | $6.85 | −0.1% |
| 2026-08-11 | $6.86 | −2.0% |
| 2026-08-10 | $7.00 | −3.2% |
| 2026-08-07 | $7.23 | +4.6% |
| 2026-08-06 | $6.91 | +0.3% |
| 2026-08-05 | $6.89 | +5.5% |
| 2026-08-04 | $6.53 | −1.2% |
| 2026-08-03 | $6.61 | +5.4% |
| 2026-07-31 | $6.27 | +5.6% |
| 2026-07-30 | $5.94 | +9.0% |
| 2026-07-29 | $5.45 | −1.4% |
| 2026-07-28 | $5.53 | +2.0% |
| 2026-07-27 | $5.42 | +0.4% |
| 2026-07-24 | $5.40 | −2.5% |
| 2026-07-23 | $5.54 | +4.1% |
| 2026-07-22 | $5.32 | −3.1% |
| 2026-07-21 | $5.49 | +8.3% |
| 2026-07-20 | $5.07 | +2.4% |
| 2026-07-17 | $4.95 | 0.0% |
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| 2026-07-02 | $5.64 | +7.4% |
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| 2026-06-26 | $5.86 | +6.2% |
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| 2026-06-22 | $5.38 | +11.6% |
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| 2026-06-11 | $4.53 | +16.5% |
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| 2026-06-01 | $4.12 | −5.1% |
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| 2026-05-15 | $4.42 | −3.9% |
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| 2026-04-27 | $3.96 | −4.1% |
| 2026-04-24 | $4.13 | +4.3% |
| 2026-04-23 | $3.96 | 0.0% |
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| 2026-04-21 | $3.98 | −3.2% |
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| 2026-04-16 | $3.95 | +1.3% |
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| 2026-04-14 | $3.98 | −4.6% |
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| 2026-04-07 | $4.12 | −1.7% |
| 2026-04-06 | $4.19 | +6.3% |
| 2026-04-02 | $3.94 | +0.3% |
| 2026-04-01 | $3.93 | +1.6% |
| 2026-03-31 | $3.87 | +19.1% |
| 2026-03-30 | $3.25 | −11.4% |
| 2026-03-27 | $3.67 | −5.7% |
| 2026-03-26 | $3.89 | +25.5% |
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| 2026-03-20 | $3.28 | −1.2% |
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| 2026-03-18 | $3.27 | −7.6% |
| 2026-03-17 | $3.54 | +0.9% |
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| 2026-03-13 | $3.51 | +7.0% |
| 2026-03-12 | $3.28 | −4.1% |
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| 2026-03-10 | $3.51 | 0.0% |
| 2026-03-09 | $3.51 | +5.7% |
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| 2026-03-04 | $3.55 | +5.2% |
| 2026-03-03 | $3.38 | −6.8% |
| 2026-03-02 | $3.62 | −4.5% |
| 2026-02-27 | $3.79 | −0.5% |
| 2026-02-26 | $3.81 | −0.8% |
| 2026-02-25 | $3.84 | −3.5% |
| 2026-02-24 | $3.98 | −2.5% |
| 2026-02-23 | $4.08 | −6.8% |
| 2026-02-20 | $4.38 | −2.9% |
| 2026-02-19 | $4.51 | −7.6% |
| 2026-02-18 | $4.88 | −6.3% |
| 2026-02-17 | $5.21 | +5.7% |
| 2026-02-13 | $4.93 | +4.0% |
| 2026-02-12 | $4.74 | −3.5% |
| 2026-02-11 | $4.91 | +5.4% |
| 2026-02-10 | $4.66 | +2.2% |
| 2026-02-09 | $4.56 | +6.3% |
| 2026-02-06 | $4.29 | +1.2% |
| 2026-02-05 | $4.24 | −7.0% |
| 2026-02-04 | $4.56 | −5.0% |
| 2026-02-03 | $4.80 | −0.6% |
| 2026-02-02 | $4.83 | +7.6% |
| 2026-01-30 | $4.49 | −0.9% |
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| 2026-01-28 | $4.46 | −5.7% |
| 2026-01-27 | $4.73 | −0.4% |
| 2026-01-26 | $4.75 | −0.2% |
| 2026-01-23 | $4.76 | −1.7% |
| 2026-01-22 | $4.84 | +8.5% |
| 2026-01-21 | $4.46 | +1.6% |
| 2026-01-20 | $4.39 | −0.5% |
| 2026-01-16 | $4.41 | +6.5% |
| 2026-01-15 | $4.14 | −6.1% |
| 2026-01-14 | $4.41 | +5.8% |
| 2026-01-13 | $4.17 | +0.8% |
| 2026-01-12 | $4.13 | −9.9% |
| 2026-01-09 | $4.59 | −0.4% |
| 2026-01-08 | $4.61 | −4.9% |
| 2026-01-07 | $4.85 | +6.6% |
| 2026-01-06 | $4.55 | +8.9% |
| 2026-01-05 | $4.18 | −2.3% |
| 2026-01-02 | $4.28 | +2.4% |
| 2025-12-31 | $4.18 | −1.9% |
| 2025-12-30 | $4.26 | −4.3% |
| 2025-12-29 | $4.45 | +7.0% |
| 2025-12-26 | $4.16 | −0.7% |
| 2025-12-24 | $4.19 | +2.9% |
| 2025-12-23 | $4.07 | −7.1% |
| 2025-12-22 | $4.38 | +1.4% |
| 2025-12-19 | $4.32 | +3.6% |
| 2025-12-18 | $4.17 | +4.8% |
| 2025-12-17 | $3.98 | +2.8% |
| 2025-12-16 | $3.87 | +1.6% |
| 2025-12-15 | $3.81 | +3.3% |
| 2025-12-12 | $3.69 | +1.9% |
| 2025-12-11 | $3.62 | +3.1% |
| 2025-12-10 | $3.51 | 0.0% |
| 2025-12-09 | $3.51 | −4.9% |
| 2025-12-08 | $3.69 | +2.5% |
| 2025-12-05 | $3.60 | −4.0% |
| 2025-12-04 | $3.75 | +5.0% |
| 2025-12-03 | $3.57 | +2.6% |
| 2025-12-02 | $3.48 | −3.6% |
| 2025-12-01 | $3.61 | −5.7% |
| 2025-11-28 | $3.83 | +2.4% |
| 2025-11-26 | $3.74 | +1.9% |
| 2025-11-25 | $3.67 | −3.9% |
| 2025-11-24 | $3.82 | −1.5% |
| 2025-11-21 | $3.88 | −0.5% |
| 2025-11-20 | $3.90 | −7.6% |
| 2025-11-19 | $4.22 | −13.0% |
| 2025-11-18 | $4.85 | −1.0% |
| 2025-11-17 | $4.90 | +1.0% |
| 2025-11-14 | $4.85 | +25.6% |
| 2025-11-13 | $3.86 | −4.0% |
| 2025-11-12 | $4.02 | +1.5% |
| 2025-11-11 | $3.96 | −1.0% |
| 2025-11-10 | $4.00 | +2.6% |
| 2025-11-07 | $3.90 | −0.5% |
| 2025-11-06 | $3.92 | −1.8% |
| 2025-11-05 | $3.99 | +2.8% |
| 2025-11-04 | $3.88 | −6.7% |
| 2025-11-03 | $4.16 | +0.5% |
| 2025-10-31 | $4.14 | +2.2% |
| 2025-10-30 | $4.05 | +1.0% |
| 2025-10-29 | $4.01 | −1.2% |
| 2025-10-28 | $4.06 | −5.6% |
| 2025-10-27 | $4.30 | −0.7% |
| 2025-10-24 | $4.33 | +1.9% |
| 2025-10-23 | $4.25 | +8.7% |
| 2025-10-22 | $3.91 | −4.2% |
| 2025-10-21 | $4.08 | +3.6% |
| 2025-10-20 | $3.94 | −1.5% |
| 2025-10-17 | $4.00 | +14.6% |
| 2025-10-16 | $3.49 | −1.1% |
| 2025-10-15 | $3.53 | +10.3% |
| 2025-10-14 | $3.20 | −0.3% |
| 2025-10-13 | $3.21 | +2.9% |
| 2025-10-10 | $3.12 | −2.2% |
| 2025-10-09 | $3.19 | −0.9% |
| 2025-10-08 | $3.22 | −2.7% |
| 2025-10-07 | $3.31 | +5.4% |
| 2025-10-06 | $3.14 | −3.4% |
| 2025-10-03 | $3.25 | −2.4% |
| 2025-10-02 | $3.33 | −0.3% |
| 2025-10-01 | $3.34 | +1.5% |
| 2025-09-30 | $3.29 | −9.4% |
| 2025-09-29 | $3.63 | +3.4% |
| 2025-09-26 | $3.51 | +0.7% |
| 2025-09-25 | $3.48 | −9.7% |
| 2025-09-24 | $3.86 | +4.0% |
| 2025-09-23 | $3.71 | −3.6% |
| 2025-09-22 | $3.85 | +2.7% |
| 2025-09-19 | $3.75 | −1.3% |
| 2025-09-18 | $3.80 | −0.5% |
| 2025-09-17 | $3.82 | −1.8% |
| 2025-09-16 | $3.89 | +8.4% |
| 2025-09-15 | $3.59 | −5.3% |
| 2025-09-12 | $3.79 | −8.5% |
| 2025-09-11 | $4.14 | +1.5% |
| 2025-09-10 | $4.08 | −1.2% |
| 2025-09-09 | $4.13 | −0.7% |
| 2025-09-08 | $4.16 | −4.6% |
| 2025-09-05 | $4.36 | −4.4% |
| 2025-09-04 | $4.56 | −4.0% |
| 2025-09-03 | $4.75 | −0.2% |
| 2025-09-02 | $4.76 | +5.5% |
| 2025-08-29 | $4.51 | −0.9% |
| 2025-08-28 | $4.55 | −0.9% |
| 2025-08-27 | $4.59 | +7.7% |
| 2025-08-26 | $4.26 | +7.0% |
| 2025-08-25 | $3.98 | −4.8% |
| 2025-08-22 | $4.18 | +14.8% |
| 2025-08-21 | $3.64 | +13.4% |
| 2025-08-20 | $3.21 | −0.3% |
| 2025-08-19 | $3.22 | +9.2% |
| 2025-08-18 | $2.95 | +0.3% |
| 2025-08-15 | $2.94 | +58.9% |
| 2025-08-14 | $1.85 | −3.1% |
| 2025-08-13 | $1.91 | +6.1% |
| 2025-08-12 | $1.80 | +3.4% |
| 2025-08-11 | $1.74 | −2.2% |
| 2025-08-08 | $1.78 | −5.3% |
| 2025-08-07 | $1.88 | +2.7% |
| 2025-08-06 | $1.83 | −5.2% |
| 2025-08-05 | $1.93 | +9.7% |
| 2025-08-04 | $1.76 | +5.4% |
| 2025-08-01 | $1.67 |
Precigen closed at $1.85 on Aug. 14, 2025 and $6.94 on Oct. 30, 2026. Source: Tiingo end-of-day closes, as traded, via KeyVex.Chart data
What the trials showed
Both drugs aim the immune system at HPV types 6 and 11, the viruses that cause RRP. Both trials counted patients who needed no surgery in the 12 months after treatment.FDAPress release
In Precigen's pivotal trial, 18 of 35 patients did, or 51.4%, the FDA said.FDA In Inovio's, 7 of 26 patients in the efficacy group did, or 27%. Those 26 had needed three or more surgeries in the year before treatment, a median of 4.5.Press release
View the data
| Drug | No surgery for 12 months | Note |
|---|---|---|
| Papzimeos (Precigen) (18 of 35 patients; full approval, Aug. 2025) | 51.4% | 51.4% (18/35), per the FDA |
| Voceryq (Inovio) (7 of 26 patients; accelerated approval, Oct. 2026) | 27% | 27% (7/26), per Inovio |
Sources: FDA press announcement, Aug. 14, 2025 (Papzimeos); Inovio press release, Oct. 30, 2026 (Voceryq).FDAPress release
Inovio says that after surgery to clear the growths before the first dose, its 9-week regimen needs no more surgery during dosing.Press release Papzimeos can require surgery before its third and fourth doses if growths are visible, Inovio wrote in its August 10-Q.10-Q Precigen's August quarterly report, filed before Inovio's, says 15 of its 18 patients who needed no surgery in the first year were still responding at least 36 months after treatment.10-Q
The bar Inovio described
The FDA wants Inovio's draft protocol for the confirmatory study by the end of 2026, the company says.Press release
In August, Inovio told investors it expected the FDA would not grant that kind of approval unless Voceryq showed "a clinically meaningful benefit over existing therapies, including PAPZIMEOS."10-Q The FDA approved it on Oct. 30, Inovio says. Neither Inovio's release nor its Nov. 2 investor slides mention Papzimeos.Press releaseSlides
What each company has riding on it
Papzimeos sales reached $53.1 million in the second quarter of 2026, up from $21.6 million in the first.10-Q10-Q That second quarter gave Precigen its first profit from continuing operations since it became a health-care company in 2020.10-Q
Papzimeos sales: $53.1 million in the second quarterShow chartHide chart
View the data
| Period | Papzimeos sales | Note |
|---|---|---|
| 2025 (launch) | $3.4M | Launched in the fourth quarter of 2025 |
| Q1 2026 | $21.6M | |
| Q2 2026 | $53.1M |
The 2025 figure covers the launch, in the fourth quarter. Sources: Precigen's 2025 10-K and its 2026 10-Qs.10-K
Inovio has no product on sale yet. At June 30 it had $36.7 million in cash and investments, and "substantial doubt" about its ability to continue as a going concern, its 10-Q says. With $18.3 million raised in July, it expected the money to fund operations through a launch, if approved, and into late first quarter 2027, and said it would need more capital beyond that.10-Q
Inovio said on Oct. 30 that Voceryq would be available to order in about 60 days, with its field teams fully deployed in the first quarter of 2027. Its August filing said its cash should fund operations into late in that same quarter.Press release10-Q
What to watch
Precigen's results for the quarter ended Sept. 30, before the rival approval, and its call, the company said on Oct. 28, BiopharmaWatch reported.
Voceryq available to order and ship, about 60 days after Oct. 30, Inovio says.
Inovio's draft protocol for the confirmatory study is due to the FDA, the company says.
Inovio's full field deployment; its August 10-Q said its cash should fund operations into late in this quarter.
The paper trail
The filings cited here, with the time EDGAR accepted each one (Eastern).
| Filed (ET) | Form | Filer | What it shows |
|---|---|---|---|
| Nov. 2, 2026, 7:15 a.m. | 8-K | Inovio | The Oct. 30 approval release and the Nov. 2 investor-call slides. |
| Aug. 12, 2026, 4:00 p.m. | 10-Q | Inovio | Cash of $36.7 million, going-concern doubt, the July offering, and its expectation of the bar for accelerated approval. |
| Aug. 4, 2026, 4:08 p.m. | 10-Q | Precigen | Papzimeos sales of $53.1 million and a first profit from continuing operations. |
| May 13, 2026, 4:20 p.m. | 10-Q | Precigen | Papzimeos sales of $21.6 million in the first quarter. |
| Mar. 25, 2026, 4:54 p.m. | 10-K | Precigen | Papzimeos revenue of $3.4 million in 2025. |
Sources
11 sources, 8 of them public records
Public records
- Inovio Pharmaceuticals, Form 8-K (Items 7.01, 8.01, 9.01): Voceryq approval release and investor slidesSEC EDGAR · Nov. 2, 2026
- "INOVIO Announces FDA Accelerated Approval of VOCERYQ", press release (Exhibit 99.1)SEC EDGAR · Oct. 30, 2026
- Inovio investor call presentation, Nov. 2, 2026 (Exhibit 99.2)SEC EDGAR · Nov. 2, 2026
- Inovio Pharmaceuticals, Form 10-Q for the quarter ended June 30, 2026SEC EDGAR · Aug. 12, 2026
- Precigen, Inc., Form 10-Q for the quarter ended June 30, 2026SEC EDGAR · Aug. 4, 2026
- Precigen, Inc., Form 10-Q for the quarter ended March 31, 2026SEC EDGAR · May 13, 2026
- Precigen, Inc., Form 10-K for 2025SEC EDGAR · Mar. 25, 2026
- "FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis"U.S. Food and Drug Administration · Aug. 14, 2025
Reporting
- "PGEN Stock Craters 27% After-Hours After Rival Inovio's Rare Disease Drug Receives FDA Approval" (Anan Ashraf)StockTwits, via Yahoo Finance · Oct. 30, 2026
- Precigen third-quarter 2026 results date, as publishedBiopharmaWatch · Oct. 28, 2026
Data
- End-of-day prices for PGEN, INO, SPY and QQQ, and Nov. 2 11:32 a.m. quotes for PGEN and INO (Tiingo)KeyVex · through Nov. 2, 2026
How we got these numbers
- Prices are as traded. Closes on Oct. 30, 2026: Precigen $6.94, Inovio $0.6024. The Nov. 2 figures are the 11:32 a.m. ET last trades on IEX in KeyVex's quote feed (Tiingo): Precigen $5.215 (down 24.9%), Inovio $1.76 (up 192.2%). "Nearly tripled" is $1.76 against $0.6024, 2.92 times. KeyVex's end-of-day close for Nov. 2 was not in when this was written; intraday prices move. The S&P 500 and Nasdaq 100 lines follow SPY and QQQ, rebased. The Filings switch shows the filing markers from KeyVex's Precigen page: a selection, not every filing, and not only those tied to this story.
- Trial figures are as each source states them: Papzimeos 51.4% (18 of 35), from the FDA's Aug. 14, 2025 announcement; Voceryq 27% (7 of 26 in the efficacy population, 95% confidence interval 12% to 48%), from Inovio's release. The trials enrolled different patients and were not designed to be compared. Papzimeos sales are from Precigen's filings: $3.4 million in 2025, $21.6 million and $53.1 million in the first two quarters of 2026.
- The header image was generated for KeyVex by an image model; it is an illustration, not a photograph of a real Precigen or Inovio site. This is a reading of the companies' filings, the FDA's announcement and news reports, not investment advice.