Pfizer (NYSE:PFE) scores FDA approval but Wall Street reaction muted

Pfizer (NYSE:PFE) scores FDA approval but Wall Street reaction muted

New York, July 12, 2026, 17:19 (EDT)

U.S. markets are shut for the weekend, so investors are waiting to see if Friday’s FDA approval of Padcev with Keytruda will do much for Pfizer Inc. ’s earnings. So far, no big move. Pfizer slipped 0.33% to $24.17 on Friday, down 0.62% since the July 2 close before the July 4 break. The S&P 500 rose 1.2% last week. The FDA cleared the drug based on a 47% lower risk of recurrence, progression or death, which looks strong clinically. But investors want more proof that sales to bladder-cancer patients can make up for Pfizer’s patent losses.

Pfizer’s Q1 results hid the real story in the details. Padcev added $165 million in sales to reach $591 million. It made up only 4.1% of Pfizer’s total revenue, but that jump generated about 22% of the company’s $736 million revenue growth for the quarter. That mismatch is why the new label is important. A flat launch won’t cut it.

Last-week scoreboardJuly 10 closeFridayWeek
Pfizer $24.17down 0.33%down 0.62%
S&P 5007,575.39up 0.42%up 1.20%
Pfizer relative to S&P 500off 0.75 pointsoff 1.82 points

Pfizer’s weekly move is calculated from the July 2 close before the holiday break. Pfizer traded 27.5 million shares on Friday, which is about 31% under its 65-day average. The stock didn’t see a wild reaction even with the approval landing during market hours.

Padcev is an antibody-drug conjugate, an antibody with a cancer-killing payload, co-developed with Astellas Pharma Inc. (TYO:4503). Keytruda is Merck & Co. Inc.’s immunotherapy. The new label allows doctors to use the combo before and after bladder-removal surgery in adults with muscle-invasive bladder cancer, including patients fit for cisplatin chemo. Pfizer says there are about 25,500 new U.S. cases a year in this group. Duke oncologist Christopher Hoimes called the combo “a potential new standard of care.” Pfizer commercial chief Aamir Malik said it is the “first approved platinum-free combination regimen.” Pfizer

The difference in efficacy was big. “Event-free survival” tracks how long patients live with no return or spread of cancer. A pathological complete response means surgeons found no invasive cancer in the tissue they took out.

Phase 3 outcomePadcev plus KeytrudaGemcitabine plus cisplatin
Two-year event-free survival79.4%66.2%
Risk of recurrence, progression or death47% lowerReference group
Risk of death35% lowerReference group
Pathological complete response55.8%32.5%
Severe or worse adverse events75.7%67.2%

Mount Sinai oncologist Matthew Galsky called the data a “shift away from traditional cisplatin-based chemotherapy.” The mortality readout carries commercial weight because it’s a clearer endpoint than just tumor shrinkage for doctors weighing whether to switch standard treatment. Merck.com

Pfizer picked up a competitive boost last week after AstraZeneca Plc’s Wainua missed the mark in a late-stage trial for transthyretin amyloid cardiomyopathy, the same heart disease treated by Pfizer’s Vyndaqel. Wainua did not cut cardiovascular deaths or repeat heart events. Analysts had seen Wainua’s peak sales reaching $2 billion. “Comes as a surprise,” Sachin Jain told Reuters. The setback doesn’t remove competition from the field, but weakens one of Pfizer’s challengers for a key growth drug. Reuters

Pfizer didn’t get all good news this week. A U.S. appeals court upheld the loss of two patents that Pfizer’s Wyeth unit had tried to enforce against AstraZeneca’s Tagrisso lung cancer drug. That decision wipes out a $107.5 million award Pfizer had won. It’s not a big number for Pfizer, but the court’s move shows that buying up patents doesn’t always bring steady returns.

The downside is pretty clear. Most people expected the Padcev decision after trial success, but the combo saw more severe side effects, and profits are split with partners. Pfizer is also looking at about $1.5 billion in lost revenue for 2026 as patents run out and cheaper competitors show up. If doctors are slow to use Padcev, payers push for discounts, or guidance stays flat, Padcev would help but not solve things for the company.

U.S. inflation gets the spotlight with consumer-price numbers Tuesday, July 14, then producer prices Wednesday, and retail sales Thursday as Q2 earnings start to pick up. Pfizer isn’t due to report until August 4. The expanded Padcev approval hit after Q2 closed, so next month’s report won’t show sales pickup from new use—investors will look for details on launch strategy and any adjusted outlook. The true sales impact lands in Q3 results.

Pfizer’s approval helps its oncology portfolio for now, but leaves 2026 earnings forecasts unchanged. At Friday’s close, the $0.43 per-share quarterly payout delivers about a 7.1% yield. That gives the stock some income appeal, but the market’s still not pricing in much growth. For shares to rally, Padcev has to keep up its Q1 growth as its label widens. If not, the FDA green light is just a bet on possible future profits instead of a full recovery.

Mateusz Kaczmarek

Mateusz Kaczmarek is a financial and technology journalist at TS2.tech. His coverage ranges from stocks and artificial intelligence to semiconductors and developments across global markets. He graduated from the Poznań University of Economics and Business and worked in financial analysis before becoming a business journalist. Follow Mateusz Kaczmarek on Google News.

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