Shares of Pfizer Inc. (PFE) were getting some attention on Wednesday. The reason? The U.S. Food and Drug Administration decided to give its full, formal blessing to a cancer treatment combo. It's the kind of news that can make a stock move, especially when the broader market is having a decent day with the S&P 500 up.
So, what exactly got approved? The FDA gave the full nod to Braftovi (that's the drug name encorafenib) when it's used in a specific cocktail. The regimen combines Braftovi with cetuximab and a fluorouracil-based chemotherapy. It's for adults with metastatic colorectal cancer—that's cancer that has spread—who have a particular genetic glitch called a BRAF V600E mutation.
This isn't coming completely out of left field. The FDA had already given this combo an accelerated approval back in December 2024 for use as a first-line treatment. Think of accelerated approval as a conditional "we see promising data, go ahead for now while we gather more info." A full approval is the agency saying, "Yep, the data checks out, this is officially good to go."
The decision to upgrade it to a full approval hinges on results from a big Phase 3 clinical trial called BREAKWATER. The data showed the regimen delivered meaningful improvements in how long patients lived without their cancer getting worse (progression-free survival) and in overall survival.
We got more pieces of that positive data puzzle earlier this year. In January, results showed the Braftovi combo with a different chemo backbone (FOLFIRI and cetuximab) led to a much higher confirmed objective response rate—that's a fancy way of saying tumors shrank a lot—compared to standard care (64.4% vs. 39.2%). Then in February, Pfizer announced the regimen also showed a statistically significant improvement in progression-free survival for patients with that specific mutation.
This approval could be a meaningful step for Pfizer's oncology business. The Braftovi regimen is also being looked at by regulators in Europe and is already approved in some other countries. Expanding its footprint could help Pfizer grab a bigger slice of the market for treating this type of cancer.
Now, let's talk about the stock itself, because the news hit on a day when the market, particularly the tech sector, was doing well. Sometimes a stock can ride that wave.
From a technical analysis perspective, the picture for Pfizer is a bit mixed. The stock is currently trading a few percentage points below its key short-term and medium-term moving averages, which hints at some recent softness. That said, zoom out and the 12-month view is pretty good—shares are up about 29% and are closer to their 52-week high than their low.
The momentum indicators are telling two different stories. The Relative Strength Index (RSI) is sitting right at 50, which is the definition of neutral—no strong push up or down. Meanwhile, the MACD indicator is below its signal line, which is typically read as a bearish signal. So you've got neutral versus bearish, which adds up to... unclear momentum.
On the chart, traders might be watching $27.50 as a key level of resistance to break through, with $25.00 acting as a potential support level if the stock pulls back.
What do the analysts think? The consensus on the Street seems to be a collective shrug, rating the stock a Hold. The average price target among analysts is $29.42, which isn't a huge leap from where it was trading. Recent moves by specific firms include Barclays initiating coverage with an Underweight rating and a $25 target in February, and Cantor Fitzgerald maintaining a Neutral stance with a $27 target around the same time.
When the news hit, Pfizer shares were essentially flat, up a minuscule 0.02% at $27.14. So the market's initial reaction was muted, perhaps because some of this good news was already expected after the accelerated approval and positive trial readouts. The real test will be how this approval translates into prescriptions and, ultimately, sales for Pfizer's cancer portfolio.
