FDA approves Imfinzi plus enfortumab vedotin for bladder cancer
Published November 14, 2026 · Updated November 14, 2026 · 4 sources
The FDA approved perioperative Imfinzi with enfortumab vedotin for cisplatin-ineligible muscle-invasive bladder cancer. ATLAS data for AZN and JNJ included.
The exposed companies and what ATLAS says about each
There is no market close after the event yet: the reaction will be visible at the close of November 16. This page will be updated then with the actual change. In the meantime, here is the data for each company.
Developer of Imfinzi, approved in the US for muscle-invasive bladder cancer with enfortumab vedotin. · Healthcare
AstraZeneca is the developer of Imfinzi, the drug approved in this regimen [1][2]. Its latest available close was $184.45 on November 13, before the event. The ATLAS fair value estimate is $228.09 (range $158.29 to $334.38), and the dividend yield is 1.75%.
Latest available close
$184.45Close of November 13
Fair value (ATLAS)
$228.09Fair range: $158.29 to $334.38The price ($184.45) is 19.1% below that figure.
Chance of a rise in 1 month
51%Probability of closing higher than today within 21 sessions.Normal range: half of the scenarios end between $175.85 and $194.37; 9 in 10, between $160.92 and $212.41.
Agreed to invest in Francis Medical, developer of the Vanquish prostate cancer ablation device. · Healthcare
Johnson & Johnson is not part of this approval. It is included because it agreed to invest in Francis Medical, developer of the Vanquish prostate cancer ablation device, so it is another company active in cancer care [4]. Its latest available close was $285.75 on November 13. The ATLAS fair value estimate is $200.74 (range $127.36 to $271.34), and the dividend yield is 1.85%.
Latest available close
$285.75Close of November 13
Fair value (ATLAS)
$200.74Fair range: $127.36 to $271.34The price ($285.75) is 42.4% above that figure.
Chance of a rise in 1 month
52%Probability of closing higher than today within 21 sessions.Normal range: half of the scenarios end between $274.88 and $299.04; 9 in 10, between $255.10 and $322.23.
Recent results (EPS)
Oct 132.59 actual vs 2.53 est.Beat expectations
Jul 152.90 actual vs 2.85 est.In line
Apr 142.70 actual vs 2.68 est.In line
Jan 212.46 actual vs 2.46 est.In line
Dividend
1.85% dividend yieldNext ex-dividend date: November 24, 2026 · 5.28 $ over the last 12 months
The FDA approved AstraZeneca's Imfinzi (durvalumab) with enfortumab vedotin before surgery for adult patients with muscle-invasive bladder cancer who cannot or will not receive cisplatin-based chemotherapy [2]. There is no close after the event yet; the first session that can reflect it is November 16, and this page will be updated then.
AstraZeneca's headline says perioperative Imfinzi was approved in the US in a new regimen with neoadjuvant enfortumab vedotin for patients with muscle-invasive bladder cancer [1].
The FDA approved durvalumab (Imfinzi; AstraZeneca) with 3 cycles of enfortumab vedotin (Padcev; Astellas), followed by single-agent durvalumab after radical cystectomy. It applies to adults with muscle-invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy [2].
The approval rests on the phase 3 VOLGA trial, presented at the ESMO Congress 2026. Versus cystectomy alone, 24-month event-free survival was 63.5% versus 45.1%, and 24-month overall survival was 78.4% versus 69.4% [2].
Grade ≥3 adverse events were more frequent with durvalumab-EV (71.1% vs 50.2%). Reported EV-related events included skin reactions (48.7%) and neuropathy (17.5%) [2].
What ATLAS data show
ATLAS fair value figures are model estimates, not promises. For AstraZeneca, the estimate is $228.09 and the November 13 close of $184.45 was 19.13% below it. The estimate's range runs from $158.29 to $334.38. For Johnson & Johnson, the estimate is $200.74 and the November 13 close of $285.75 was 42.35% above it, within a range of $127.36 to $271.34. These figures describe model output and do not advise any action.
The market reaction will be visible at the close of November 16, the first session that can reflect the event, and this page will be updated then. Any later move in prices would be a coincidence in time, not proof of cause. The data come from closes and may change.
What you get with ATLAS
Fair value of each company, with its range, against today's price.
Chance of a rise in 1 month and the normal price range, from a calibrated model.
Earnings: next date, estimated EPS and surprise history.
Dividends and alerts by email when a company reports.
Perioperative durvalumab (Imfinzi) with 3 cycles of enfortumab vedotin before bladder removal, then durvalumab alone after surgery, for muscle-invasive bladder cancer in adults who are cisplatin-ineligible or have refused it [2].
When will the market reaction be visible?
At the close of November 16, the first session that can reflect the event. The page will be updated then.
Why is Johnson & Johnson on this page?
It agreed to invest in Francis Medical, maker of a prostate cancer ablation device [4]. It is included for its activity in the sector, not because this approval affects it.
Closing prices, fair value, probabilities, earnings and dividends: ATLAS own data as of November 14, 2026. How we calculate fair value.
Information, not advice. This content is informational and is not an investment recommendation or an offer to buy or sell securities. ATLAS estimates come from statistical models using public data, can be wrong, and past performance does not guarantee future results. Disclaimer
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