This Pharma Stock Secured Kevin O’Leary’s Dream Deal: 10 Years of FDA-Backed Exclusivity

By Stocks News   |   3 weeks ago   |   Stock Market News
This Pharma Stock Secured Kevin O’Leary’s Dream Deal: 10 Years of FDA-Backed Exclusivity

If you’ve ever watched Shark Tank, you know the golden question: “Do you have a patent?” That question turns the sharks from mildly interested to full-blown bidding war like a light switch… and then as we all know Kevin O’Leary hits them with the words “royalty deal” right after. But why is the patent so important? Because protection equals power. Well, biotech just had its own Shark Tank moment, and the company on stage was Phathom Pharmaceuticals.

Pharma Stock

Earlier this week, Phathom scored a massive win from the FDA: a full 10-year New Chemical Entity (NCE) exclusivity for its acid-taming drug Voquezna. No generic competition until May 3rd, 2032. And Wall Street loves that sort of news. Shares of PHAT doubled, jumping 108% in a single trading session.

Pharma Stock

Phathom stock went from clinically depressed to clinically euphoric because exclusivity in pharma is like a moat filled with alligators and lava… nobody’s crossing that thing. For the next decade, Phathom owns the acid reflux market for Voquezna like Disney owns my kids’ childhood.

Pharma Stock

If you saw that word and thought, what? Voquezna (vonoprazan to be nerdy) is Phathom’s not so secret weapon in the war on gastrointestinal misery… think heartburn, GERD, and H. pylori infections. It’s part of a new class of meds called potassium-competitive acid blockers (PCABs) that work faster and longer than traditional PPIs (proton pump inhibitors). 

Voquezna had already been approved in combo packs… Voquezna Triple Pak and Dual Pak… for H. pylori, and those combos had previously received GAIN Act designation (a special FDA perk for drugs that target infectious diseases). That designation gave those products 10 years of exclusivity. Phathom filed a citizen petition basically saying, “Hey, our solo tablets contain the same active ingredient. We deserve the same protection.” The FDA agreed… and just like that, Voquezna’s Orange Book listing got a new expiration date of May 2032.

Pharma Stock

Needham quickly upgraded their outlook, reiterating a Buy with a price target of $28. Guggenheim chimed in with an upgrade as well. Meanwhile, analyst consensus sits at $17.63, with the high estimate still hugging that $28 level. Considering PHAT (great ticker name) was trading under $10 before the announcement, that’s a potential upside of over 80%.

Now here’s the one thing to take away from this news: investors weren’t only reacting to exclusivity… they were pricing in stability. The biggest overhang on Phathom’s story has been this regulatory uncertainty. That’s gone now. And with the Voquezna launch already showing signs of life (Q1 2025 net revenue: $28.5 million, up significantly), this patent fortress could turn into a recurring revenue machine.

Pharma Stock

In addition to the FDA goodwill… they’re also sitting on $212 million worth of cash savings, aiming to reach profitability by 2026 without begging Wall Street for more dough (which is impressive for Big Pharma). To do this, they’ve cut back on operating expenses, said bye-bye to underperforming TV ads, and are focused on leveraging their salesforce with GI specialists.

Currently, Voquezna is covered for over 120 million lives, representing 80%+ of the U.S. commercially insured population. And even with some oopsies (like supply chain issues and a shift away from pediatric trials) investors seem to agree that Phathom is back in the game.

Pharma Stock

At the time this article was published Stocks.News did not have positions in companies mentioned in article.

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