Washington just changed the game 🏛️

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Good morning, folks. Jeff Bishop here,

Every once in a while, an entire industry gets a green light. 

Not from investors or from Wall Street…

From Washington.

That's exactly what appears to be happening in one of biotech's most controversial corners.

For years, companies developing these treatments faced an uphill battle. Even promising science wasn't always enough, because nobody knew whether regulators would ever embrace the idea.

Now the political winds appear to be shifting.

Health Secretary Robert F. Kennedy Jr. has publicly said his department is working to make these therapies available in clinical settings within about a year.

That's a remarkable statement, and one that could have major implications for companies already deep into clinical development.

One company, in particular, has put itself in an enviable position.

Its lead treatment has already received the FDA's coveted Breakthrough Therapy Designation, a status reserved for drugs that may offer a substantial improvement over existing options.

Its pivotal Phase 3 study has already enrolled more than 86% of patients.

The company recently added another $50 million to its balance sheet, giving it roughly $200 million in cash as it pushes toward what could be its biggest catalyst yet.

Investors appear to be catching on…

The stock has already climbed nearly 90% since early June.

Normally, that kind of move would make me question whether I'd missed it.

But I doubt that's the case here.

In biotech, it's not unusual for investors to begin positioning months before a pivotal data readout.

Meanwhile, every Wall Street analyst currently covering the company rates it a Buy, with the average price target sitting several times above where shares are trading.

Of course, analyst targets aren't guarantees. But when you combine that with FDA momentum, government tailwinds, and a major clinical milestone on the horizon, I think it's worth paying close attention.

That's why I wanted to put this company on your radar before today's opening bell.

Click here to see this morning's “tactical trade” idea.

To Your Success,