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 Jazz Pharmaceuticals (SYM: JAZZ), for example.
On August 18, the US FDA is expected to make its decision on Dordaviprone for treatment of recurrent H3 K27M-Mutant diffuse glioma – an aggressive brain tumor.
Helping, “Dordaviprone is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for August 18, 2025. If approved in the U.S., the therapy may be eligible for a Rare Pediatric Disease Priority Review Voucher (PRV),” as noted by JAZZ.
“Dordaviprone is also being studied in the ongoing Phase 3 ACTION trial to evaluate its use in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting.”
Outlook Therapeutics (SYM: OTLK)
On August 27, the US FDA is expected to make its decision on ONS-5010 for the treatment of wet age-related macular degeneration.
According to Julia A. Haller, MD, ophthalmologist-in-chief at Wills Eye Hospital and an Outlook Therapeutics Board member:
“The 3-month data from NORSE EIGHT provides additional evidence to confirm what retina specialists expected. The clinical trial continues to demonstrate that ONS-5010 injections result in immediate and sustained anatomic efficacy, with steady gains in visual acuity and reliable, consistent safety.”
Scholar Rock Holding (SYM: SRRK)
On September 22, the US FDA is expected to make its decision about the company’s treatment of spinal muscular atrophy.
Earlier this year, “The U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for apitegromab, an investigational muscle-targeted treatment that is being developed to provide clinically meaningful improvement in motor function for people living with spinal muscular atrophy (SMA) who are receiving an SMN-targeted treatment,” as noted in an SRRK press release.
Apitegromab’s regulatory submissions are based on positive efficacy and safety data from the pivotal Phase 3 SAPPHIRE trial, which resulted in positive topline data in October 2024.
Suggested Reading: Forget Nvidia, This “Ghost Town” Company Holds the Key to the AI Boom
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Nvidia, AMD, Intel, Taiwan Semiconductor Manufacturing, Google, Microsoft, Apple, Tesla, Oracle, Palantir, IBM…
They all need this little-known company’s product.
And this company has a virtual monopoly in the U.S.
That means this company that’s located in an American ghost town — with only 30 people — could be the key to the $100 trillion AI boom.
