Candel Therapeutics, Inc. (NASDAQ: CADL) shares fell about 39% to $5.11 in after-hours trading Thursday. The cancer immunotherapy develoCandel Therapeutics prostate cancerper said it now plans to submit its FDA application for aglatimagene in prostate cancer in mid-2027, later than the fourth-quarter 2026 target it gave in August. Candel also reported a wider third-quarter loss and set up a new $50 million at-the-market stock program, which lets it sell shares gradually into the market. As a result, the stock became one of the biggest decliners in the PRISM Pharmaceuticals Index.

Key Points

• Candel now plans to submit its Biologics License Application (BLA) for aglatimagene in prostate cancer in mid-2027, pending ongoing FDA talks. The cause is timing tied to refining certain assays, the lab tests used to measure the product.
• Q3 net loss widened to $21.9 million from $11.3 million, as R&D spending nearly doubled to $15.6 million.
• Cash of $203.1 million should fund operations into the second quarter of 2028.
• Candel signed a new $50 million at-the-market stock agreement with Jefferies.

Candel (CADL) Resets Its BLA Timeline

Aglatimagene besadenovec (also known as CAN-2409) is Candel’s lead therapy. It uses a modified adenovirus, a common cold-type virus, injected directly into the tumor to trigger the patient’s immune system against the cancer. Its pivotal Phase 3 trial in intermediate- to high-risk localized prostate cancer met its main goal, and the results were published in The Lancet Oncology. In addition, the FDA has already granted the therapy Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations, both meant to speed review.

Until now, Candel had planned to file for approval in the fourth quarter of 2026. On Thursday, however, the company said it remains in talks with the FDA and that timelines for “certain assay refinement” now point to a mid-2027 submission. In other words, the delay stems from manufacturing and testing work rather than from new clinical data. Even so, it pushes a potential launch out by several quarters.

CEO Paul Peter Tak said Candel continued to “make significant progress across the business” as it builds toward becoming a commercial-stage company.

Q3 Results: Spending Climbs Ahead of a Potential Launch

Candel’s third-quarter net loss nearly doubled to $21.9 million, or $0.28 per share, from $11.3 million a year earlier. Still, the per-share loss came in $0.07 better than analysts expected. Research and development expenses rose to $15.6 million from $8.5 million, driven by clinical trial, manufacturing and staffing costs. Total operating expenses roughly doubled to about $23 million.

On the other hand, the balance sheet stayed solid. Cash rose to $203.1 million from $119.7 million at the end of 2025, and Candel extended its expected runway into the second quarter of 2028, from the first quarter of 2028 previously.

Why the Stock Fell So Hard

Before Thursday, CADL had climbed about 49% this year on expectations of a 2026 filing and a 2027 launch. As a result, the delay hit a stock that was priced for that timeline.

The new stock program added to the pressure. Candel can now sell up to $50 million of shares through Jefferies, on top of roughly $50 million already sold under an earlier agreement from August 2025. For shareholders, that means more potential dilution while the company waits longer for possible product revenue.

Beyond Prostate Cancer: The Rest of the CADL Pipeline

Candel is also testing aglatimagene in other cancers. In non-small cell lung cancer (NSCLC), a Phase 2a study reported median overall survival of 24.5 months, and those results were recently published in the Journal for ImmunoTherapy of Cancer. A Phase 3 trial in NSCLC, called AURORA, is ongoing. Candel also runs programs in pancreatic cancer and brain tumors.

What It Means for the PRISM Pharmaceuticals Index

Even after Thursday’s regular-session drop, CADL remains one of the strongest performers in the PRISM Pharmaceuticals Index. The stock closed at $8.39 Thursday, about 479% above its price when the index launched on January 2, 2024. PRISM MarketView has followed Candel’s progress, including its FDA recognition for the prostate cancer therapy and its advances across multiple trials.

Going forward, investors will watch for FDA feedback on the assay work and any further change to the mid-2027 target. They’ll also watch how much stock Candel sells under the new program. Management holds its earnings call at 9:30 a.m. ET today.

The post Candel Therapeutics Pushes Its Prostate Cancer Filing to Mid-2027, Sending Shares Down 39% After Hours appeared first on PRISM MarketView.

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