Inovio Wins First FDA Approval as VOCERYQ Clears the Accelerated Path

Inovio closed at about 60 cents on October 30, down 22% on the day. That evening the FDA approved its first product, and the stock more than tripled. Pulmonx needed only 6% sales growth to add a third to its share price.

Inovio Wins Accelerated FDA Approval for RRP Therapy VOCERYQ

Inovio Pharmaceuticals (Nasdaq: INO) said on October 30 that the FDA granted accelerated approval to VOCERYQ to reduce how often adults with recurrent respiratory papillomatosis (RRP) need surgery. RRP causes wart-like growths in the throat and airways, driven by HPV types 6 and 11. CEO Jacqueline Shea told Reuters that every operation carries a risk of permanent vocal cord damage. Shares jumped 257% in extended trading, and RTTNews put the stock at $2.06 on November 2, up roughly 242%.

Accelerated approval lets the FDA clear a drug on early evidence, with continued approval tied to a confirmatory study. Inovio owes the agency a draft protocol for that study by the end of 2026 and expects to settle the final design by mid-2027.

The efficacy population was 26 patients who had needed three or more surgeries in the prior year, a median of 4.5. Seven of them, 27%, needed no surgery in the 12 months after treatment. All 32 enrolled patients completed the study.

VOCERYQ should be available to order in about 60 days, with a full launch in the first quarter of 2027. No price has been disclosed. Inovio also won’t have the market to itself. Precigen’s PAPZIMEOS was approved for RRP last year and posted $74.7 million in net sales in the first half of 2026. Precigen shares fell 27% after hours on Inovio’s news.

The rally landed on a stock that has leaned hard on dilution. In July, Inovio sold 21.05 million shares with warrants exercisable at $1.10. With the underwriter’s option, those warrants cover up to 48.4 million shares, and the raise netted $18.3 million. At $2, they are in the money. Market capitalization was about $62 million at the October 30 close.

Pulmonx Returns to Revenue Growth, Stock Jumps 33%

Pulmonx Corporation (Nasdaq: LUNG) reported third-quarter revenue of $22.8 million on October 27, up 6% from a year earlier. CEO Glen French called it a return to year-over-year growth. The stock rose about 33% the next session.

The company sells the Zephyr Endobronchial Valve, a device placed in the airways of patients with severe emphysema. Most of the improvement came from costs. Operating expenses fell 18% to $24.9 million and the net loss narrowed to $8.4 million from $14.0 million. Adjusted EBITDA loss dropped 57% to $3.5 million.

Management kept full-year revenue guidance at $90 million to $92 million and now expects gross margin of about 77%. Cash stood at $52.7 million on September 30.

Even after the jump, the stock trades more than 90% below its first trading price in October 2020, with a market value near $129 million at the October 30 close.

INO, LUNG: Forward-Looking FAQ

Sources

• SEC EDGAR / Inovio: INOVIO Announces FDA Accelerated Approval of VOCERYQ (Form 8-K, Exhibit 99.1), October 30, 2026
• SEC EDGAR / Inovio: Form 8-K on VOCERYQ approval and confirmatory study timeline, November 2, 2026
• Reuters (via WMBD): US FDA approves Inovio’s treatment for rare throat disease, shares surge, October 30, 2026
• RTTNews: Healthcare Stocks Trade Higher: INO Surges 245%, IDXX Gains Over 20%, TEM Rises 12%, November 2, 2026
• Stocktwits: PGEN Stock Craters 27% After-Hours After Rival Inovio’s Rare Disease Drug Receives FDA Approval, October 30, 2026
• SEC EDGAR / Inovio: Form 8-K on $20.0 million public offering, July 29, 2026
• SEC EDGAR / Inovio: Form 10-Q for the quarter ended June 30, 2026
• MarketChameleon: Inovio Pharmaceuticals (INO) summary, data as of October 30, 2026
• SEC EDGAR / Pulmonx: Pulmonx Reports Third Quarter 2026 Financial Results (Form 8-K, Exhibit 99.1), October 27, 2026
• RTTNews: Biotech Stocks Rise: GMAB Surges, LUNG And AXGN Gain Over 30%, October 28, 2026
• The Motley Fool: Pulmonx (LUNG) quote and price history
• MarketChameleon: Pulmonx (LUNG) summary, data as of October 30, 2026

Editorial Disclosure

Sources: SEC Forms 8-K and 10-Q, company press releases, named financial press. Securities discussed: Inovio Pharmaceuticals, Inc. (Nasdaq: INO) and Pulmonx Corporation (Nasdaq: LUNG). aktiego.com has received no compensation from any company, IR firm, or third party mentioned. No aktiego.com staff or principal holds a position in INO or LUNG. Inovio: VOCERYQ received accelerated approval; continued approval may be contingent on a confirmatory study whose protocol is not yet final; the efficacy population was 26 patients in an open-label Phase 1/2 study; a competing RRP therapy already holds FDA approval; the company raised capital through dilutive offerings in April and July 2026, and July 2026 warrants for up to 48.4 million shares carry a $1.10 exercise price; its other programs are investigational. Pulmonx: unprofitable, with a Q3 2026 net loss of $8.4 million and cash of $52.7 million as of September 30, 2026; adjusted EBITDA is a non-GAAP measure. Precigen, Inc. is named for competitive context only and is not a security discussed. Small cap and micro-cap stocks listed on the CSE, TSX, TSXV, and Nasdaq are speculative investments carrying significant risk including potential total loss of capital. Coverage on aktiego.com is provided for informational and educational purposes only. aktiego.com is not a registered investment advisor. Nothing in this article constitutes financial, investment, or professional advice. Readers are encouraged to conduct their own due diligence and consult a qualified financial advisor before making any investment decisions. For more information please see our full DISCLAIMER.