SMMT Summit Therapeutics Inc

$SMMT I looked into recent FDA decisions to see when it was scheduled when the actual decision was delivered from FDA to the company when the company made a public announcement Before the scheduled deadline - 61.1% Exactly on the deadline - 36.1% After the deadline - 2.8% Here’s some recent actual company readouts and only one was negative, and that was more due to manufacturing capability than the actual drug: Company Scheduled FDA deadline Actual FDA decision Public announcement Achieve (ACHV) - CRL Sat., June 20 Sat., June 20 Mon., June 22 MannKind (MNKD) - Approved Sun., July 26 Thurs., July 23 Fri., July 24 Ultragenyx (RARE) - Approved Sat., Sept. 19 Thurs., Sept. 17 Thurs., Sept. 17 Incyte/Mirum - Approved Sat., Sept. 26 Fri., Sept. 25 Fri., Sept. 25 Opus/Viatris - Approved Sat., Oct. 17 Fri., Oct. 16 Fri., Oct. 16 I undertook this thinking we’d be more likely to know Monday but actual recent numbers show we are actually MORE LIKELY to know Thursday/Friday

$SMMT Hey dudes! Whether you’re riding the bull wave or hanging with the bears, get ready to catch some serious waves over the next three weeks! ESMO brings 10 ivonescimab presentations, including major Akeso Phase III data. We’ve got Q3 earnings (date pending), the Nov. 4 shareholder meeting, the Nov. 14 FDA decision target, and possibly a HARMONi-3 readout! Add AstraZeneca’s $2B investment to the mix, and we’ve got one heck of a swell building! Bulls or bears, grab your boards. These next few weeks could be a wild ride!

$SMMT Glad I had one more chance to get some discounted shares this morning, but I’ll be glad when this part is over 🤣

$SMMT been waiting 4 years for 1 more week. To say this has been a journey is an understatement.

$SMMT Time and time again the data has shown to be better than anything on the market. End of story.

$SMMT Astro Zeneca invested 2 Billion in Summit in October, the clear assumption is they know something we don't know. This was my rationale for getting in today at 15.

$SMMT Ignore the noise. You may have noticed many articles and investor “reports” citing true facts but in a biased manner, or industry articles citing anonymous sources for news events that occurred months ago, making it seem urgent and relevant to the upcoming FDA approval. Yes, HARMONi missed the primary OS endpoint analysis, as specified in the statistical analysis plan. It was a statistical near-miss. However, no one can argue that there is not a consistent survival benefit in the direction and magnitude of the OS HR, which is also consistent across Asian and Western geographies. Since the near-miss, with additional follow-up, the totality of evidence weighs heavily in favor of an approval. FDA nor Summit explained why FDA mandated a statistically significant OS. Just because the FDA said it was necessary is alone insufficient regulatory rationale. Amivantamab was approved for the same indication on the basis of similar results as ivonescimab: statistically significant PFS and a favorable but not statistically significant OS. FDA and JnJ agreed upon a Post Market Committment (PMC), which required JnJ to update the survival benefit by January 2026. As of October, more than two years after FDA approval, that report remains “Delayed.” Thus, the unmet medical need in this NSCLC indication remains high, as the survival benefit of the only drug approved has not yet been established. If FDA does not approve ivonescimab (issues a CRL) solely on the basis of OS without appropriate scientific rationale, other than “we told you so,” Summit would be right to file a Formal Dispute Resolution. And, investors would be right to submit a Citizen’s Petition. Long.

$SMMT How to interpret results for difficult-to-treat biliary cancer (BTC) presented today by Akeso at the ESMO Presidential Symposium: This is a signal win. Results indicate that patients treated with ivonescimab + chemotherapy had a 25% lower risk of dying from BTC than patients treated with standard of care therapy. FYI - a HR of 0.80 or lower, which corresponds to a survival benefit of 20% or higher, has the potential to change the standard of care. If SMMT confirms Akeso’s signal win in the global registration-enabling Ph II/III trial, there’s a strong likelihood that ivo+chemo becomes the new standard of care therapy in 2029-2030. Long.

$SMMT !!! Less than 2 Days!!! IMO… Next 24 hours…. Sharpen your Crayons, Make sure the box is full, Top off your glue, Put Your Helmets on tight, We Fixin to Risim with The Tisim LFG!!!

$SMMT Strong. $MLTX strong. $ABCL strong. $CAPR strong. $TGTX pullback a gift; added significantly. Exciting times as some of the better Bios are getting attention again and SP reflecting. Follow/Subscribe for more suggestions and perspective. Would love to hear yours too. That's how we find these gems and learn. Let's make some (more) money. Cheers!

$SMMT $XBI Disclaimer: This is not an investment advice, just my dd. - SMMT had 70 job opening until Nov 2. Suddenly, it shot up to 106. All these jobs has mostly one title: Executive Oncology Account (Region). These all posted on Nov 3 and beyond. - Coincidently the company ER PR mentioned no ER call but they will have a call after FDA decision. - Until Nov 2, company hiring declined but then suddenly shot with exclusively Sales hiring on Nov 3. Again, this could be a nothing burger, investment decision is yours, you can thank me later if it works out but do not blame me if it does not. Take your own decision. I am just sharing what my dd found.

$SMMT Lightweights you’ve never heard of would try and have you believe AstraZeneca put $2 billion into shares at $18.36, one month before the FDA decision, without thinking approval was the likely outcome. Apparently one of the most sophisticated drug developers in the world just got caught up in FOMO and never asked what those shares would be worth after a rejection. Fascinating theory. I’ll stick with Bob, Dr. Clow, and the brain trust at AstraZeneca.

$SMMT cngrats guys , for those who didnt panic and averaged thier price, even though its not Nov 14th yet!

$SMMT Simplify Asset Management bought 510,106 shares of Summit Therapeutics (NASDAQ:SMMT) in Q3, worth about $8.6 million, per its latest 13F filing. Other institutions also opened new positions in Q3: Oppenheimer ($257K), Kingswood Wealth Advisors ($482K), Citizens Financial Group ($188K), and Evergreen Capital Management ($229K). Inspire Investing raised its stake 9.9% to 40,228 shares ($680K). Institutions and hedge funds own 4.61% of the stock.

$SMMT Well, folks, there’s no way all that good news was priced into SMMT. This selloff makes absolutely no sense to me.

$SMMT More news here. Ivonescimab Plus Chemotherapy Demonstrates Overall Survival Superiority Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract Cancer in HARMONi-GI1 Study Conducted by Akeso in China "First Regimen to Achieve a Statistically Significant and Clinically Meaningful Overall Survival Benefit over an Anti-PD-(L)1 Antibody Combined with Chemotherapy in a Phase III Clinical Trial in BTC Ivonescimab Plus Chemotherapy Reduced the Risk of Death by 25% Compared to Durvalumab Plus Chemotherapy; OS Hazard Ratio 0.75"

$SMMT Are you betting the Front Line (Long and Strong) or the Back Line (Short)? Some will WIN and some will LOSE. 💸 or ⚰️

$SMMT worst case into Saturday’s PDUFA: a CRL could gap this down 40%. Don’t let the 75% insider ownership fool you. Duggan not selling doesn’t create a floor. Only ~156M shares float, so the float sets the price for every share, and a thin float means bigger moves both ways. What softens a miss: AZ’s $2B means no cash crunch, HARMONi-3 is still the bigger catalyst, and AZ’s ADC combo trials don’t depend on this one indication. *Size your position like a binary event, because it is one. Not a prediction, just a risk check.

$SMMT I’m bullish and long. I could see the following from the FDA: ~ Regular approval with postmarketing requirements: The FDA concludes that efficacy is adequately established, but requires Summit to collect additional data afterward. The argument the shorts and bears are keying on is missing the original OS target even though they did hit it successfully as the data matured. So I’m prepared for a possible partial approval which would lead to short term price erosion. In addition to the coordinated Fierce Pharma FUD, consider the short interest data from yesterday: October 30 FINRA short interest report 42,263,053 shares of SMMT shorted +1,366,400 increase in shorts in a 2 week period The reason I’m posting this is to convey that I can see potential for short term erosion, but it won’t affect my Long position and Bullish outlook. Remember Astra Zeneca’s $2B investment and the AZ CEO saying (quote): “Summit is the next generation” of oncology therapies.

$SMMT Ive been waiting for this move, hopefully much more $$$$ to come. Good luck to all those who believed.