Stand at the top of a snowy hill with a small snowball.
Now, begin to roll it down the hill. As you do, it begins to become bigger and bigger. It begins to build momentum. The same thing happens with stocks if we spot them early enough.
In fact, if we can spot a potential story ahead of the herd, we can take a position and wait. We can get a jumpstart with our snowball. Then, as other investors begin to wake up to the opportunity we’re already in, our snowball gets bigger and bigger and picks up momentum.
Typically, we can do this with biotech stocks facing an FDA decision, Phase III trial data release, a PDUFA date, or even an advisory panel committee date.
Look at Denali Therapeutics (SYM: DNLI).
In early April, the US FDA will make its decision on Denali Therapeutics on tividenofusp alfa for the treatment of Hunter syndrome, a rare genetic disorder where the body lacks the enzyme needed to break down cellular waste.
The treatment received priority review. And, as noted by Carole Ho, MD, Chief Medical Officer and Head of Development of Denali Therapeutics, “If FDA-approved, tividenofusp alfa would mark the first significant advancement in nearly two decades for enzyme replacement therapy for individuals living with Hunter syndrome because of its potential for delivery to tissues throughout the brain and the body,” as quoted by Neurology Advisor.
MannKind Corp. (SYM: MNKD)
On May 29, the US FDA will make its decision on the company’s Afrezza inhalation powder in children and adolescents living with type 1 or 2 diabetes.
So far, based on Phase 3 trial results, Afrezza shows comparable glycemic control to rapid-acting injected insulin, offering a potential needle-free mealtime option that may reduce injection burden and weight gain in pediatric patients.
Also, as noted by MNKD in its earnings press release, the “FDA accepted for review the supplemental Biologics License Application (sBLA) for Afrezza in pediatrics, with a PDUFA target action date of May 29, 2026; if approved, it would be the first needle-free insulin option for pediatric patients.”
Arvinas Inc. (SYM: ARVN)
On June 5, the US FDA will make its decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer.
Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader which is being developed with Pfizer, as a potential monotherapy for estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.
And, according to Phase 3 trial data, “once-daily oral treatment with vepdegestrant led to a significant and clinically meaningful improvement in PFS—the primary endpoint—compared with monthly intramuscular fulvestrant in patients with ER-positive/HER2-negative advanced breast cancer harboring ESR1 mutations,” as noted by ASCO Daily News.
Today's Market News: Buy This Stock Now
In 2000, I told Barron's magazine that a very popular, well-loved dot-com stock was headed for a world of hurt.
That prediction proved spot on.
Soon after, the stock dropped 90%.
I fielded a lot of attention for that contrarian call.
And I expect this time around will be no different...
Because today, I'm pounding the table with the opposite message.
The very same company that I warned about over two decades ago is now the lifeblood of AI data centers.
Yet almost no one has caught up with the story this time around.
While the media gloms onto the AI Chip Wars story... they've completely missed this company's essential role in building out data centers.
Their hardware is so essential that the data center industry uses enough of it to stretch around the world 8 times – in a single building!
So, if you own Nvidia stock now, you might be well-served to sell those shares and check out this under-the-radar play instead.
Or if you missed the boat on Nvidia, this is a rare second chance to target tremendous profit potential as AI data centers spring up in every corner of the world.
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