I’m not sure I actually need to introduce you to the tiny biotech stock that just shattered the glass ceiling this week, but I’d never shortchange my readers like that…

Meet Summit Therapeutics. They’re the little biotech based out of Menlo Park, California, that just dropped some absolutely insane clinical trial results for their experimental lung cancer drug, ivonescimab. And let’s just say, Wall Street’s biotech nerds are losing their collective minds.

(Source: Giphy) 

Summit's stock? Up 106% this week and a humble 1,125% year-to-date. Yeah, you read that right. It’s quickly becoming the hottest thing in biotech since CRISPR.

(Source: MarketBeat) 

Summit’s lead drug candidate, ivonescimab, went toe-to-toe with one of the biggest names in cancer treatment — Merck’s Keytruda — and came out swinging. In a Phase 3 study, ivonescimab reduced the risk of disease progression or death by 49% vs. Keytruda in newly diagnosed lung cancer patients. That’s right, it nearly halved the risk.

(Source: Yahoo Finance) 

Now, if you didn’t know, Keytruda is the reigning king of cancer drugs, pulling in a cool $25 billion a year for Merck. So yeah, ivonescimab potentially dethroning Keytruda? That's the biotech equivalent of David slaying Goliath.

Summit’s stock absolutely exploded after the announcement, and it didn’t stop there. On Thursday, the company raised $235 million in a private placement of shares at $22.70 a pop. Who bought in? Just a bunch of institutional and insider investors who clearly see the writing on the wall. This cash infusion is going straight into the ivonescimab war chest as Summit looks to take on multiple cancer types.

(Source: Market Watch) 

One analyst even called ivonescimab a “therapeutic plateau violator”, which sounds like the kind of thing you’d hear in a sci-fi movie but is apparently a good thing in biotech.

With that said, Ivonescimab isn’t just your run-of-the-mill cancer drug. It’s a bispecific antibody that does two things at once. It blocks PD-1, which helps your immune system detect and attack cancer cells (kind of like how Keytruda works), and it inhibits VEGF, which cancers use to grow new blood supplies. This dual-action seems to give it an edge over regular PD-1 inhibitors like Keytruda.Translation? More efficacy, fewer cancer cells getting cozy in your lungs.

(Source: Zacks Ratings) 

Now fair warning though, before you start planning your early retirement on the back of Summits stock, remember: biotech stocks are wildly unpredictable. The trial that got everyone hyped up was only conducted in China. For ivonescimab to make it big in the U.S., Summit needs to run global trials — and that’s where things can get dicey. They’ve already kicked off a global Phase 3 trial (Harmoni-3), but the outcome is anyone’s guess.

(Source: Biospace) 

And let’s not forget, FDA approval is a massive hurdle for any biotech company. Just because the drug looks great in trials doesn’t mean it’s a guaranteed home run. The FDA has a way of throwing cold water on even the hottest drugs. (Except for Oxycontin, which defrauded “flew” through FDA phases with flying colors… and we all know what happened with that. *sigh*) 

However, despite the risks, most analysts are feeling pretty bullish. Citigroup just raised its price target to $19, Stifel Nicolaus went to $25, and HC Wainwright is sitting high at $30. They’re all betting that ivonescimab could be a blockbuster if and when it hits the market.

(Source: TipRanks) 

With the stock now up over 1,300% from its 52-week low, Summit has gone from unknown underdog to biotech darling in the blink of an eye. But the big question is whether that momentum can last as the company faces more trials and the ever-watchful FDA.

My take? There’s no denying it: Summit Therapeutics is having its moment in the sun, and ivonescimab is looking like a potential game-changer. But the biotech game is ruthless — one bad trial or FDA hiccup, and this stock could come crashing down faster than you can say “bispecific antibody.” (Which I have no idea what that means, I just saw the term in my research and thought - sounds scary enough). 

(Source: Giphy) 

That said, with a 49% reduction in death risk and a $235M war chest, Summit is setting itself up to be a major player in the cancer drug space. If ivonescimab can keep delivering, this could be the start of something huge.

In the meantime, keep an eye on this stock going forward. It definitely has momentum on its side, and if Harmoni-3 proves to be as successful as Summit's “China-Only” trials… well, baby, we'll be off to the races!

In the meantime, stay safe and stay, frosty friends! Until next time…

P.S. Our Stocks.News premium members just came off a big +96% banger yesterday! The best part? It still has room to run. Click here immediately for the details. 

Stocks.News holds positions in Merck & Co. Inc. as mentioned in the article.