Retired Cardiac Surgeon, Healthcare Investor/Trader
Texas
Joined April 2024
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$XBI
Should be a 🌶️ morning tomorrow:
$DFTX — Topline Results from Phase 3 Panorama Study in Generalized Anxiety Disorder.
$CRBP — Conference Call to Discuss Topline Data from CANYON-1 Clinical Trial and the Potential of CRB-913 In Obesity
$CGEM — Virtual Analyst and Investor Event to Showcase Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data
$SMMT — full data re: ivonescimab OS win
Arie Blitz retweeted
The cleanest $CELC question is not “approval odds.”
It is what the Day 0 label lets investors believe.
Watch:
-population language
-prior therapy / line setting
-combo framing
-safety / tolerability language
-any wording that limits the commercial imagination
The FDA decision is first. The label read is the trade.
The FDA deserves credit for revisiting decisions made under an overly rigid view of evidence. Placebo-controlled trials are often the best way to answer a medical question. But in a rare, fatal disease affecting a small number of boys, the best trial design in a statistics lecture may be the wrong one at the bedside.
This is not an argument for lower standards. It is an argument for standards that can recognize circumstance. If the disease is devastating, the biology plausible, the untreated course predictable and the patient population tiny, FDA should be able to consider evidence short of a placebo trial while still requiring serious follow-up.
The troubling part is that these life-or-death judgments have seemed too dependent on who is running the agency. That is bad for patients, bad for physicians and bad for biotech companies trying to understand the rules.
If the current FDA is willing to restore some consistency, it deserves praise. Patients are not a distraction from the agency’s mission. They are the mission.
It is striking how quickly new FDA leaders are walking back decisions made under Prasad, Makary, and Hoeg
$RGNX
Trader Beware!
The #ASCO26 abstracts will be posted tomorrow at 5 pm EDT. What this means, and what is doesn't.
-- No late-breaker abstracts tomorrow. You will not see the plenary session data from $RVMD, Akeso / $SMMT, $JNJ or $LLY. If you're eager to see any LBA data, you'll need to wait for the actual meeting.
-- All regular abstracts will be posted tomorrow night. This can be confusing and frustrating...
-- Per ASCO rules, companies can report ALL their data tomorrow evening via press release, even if the abstract only contains old data. Some companies will choose this route.
-- BUT, companies choosing to report full data tomorrow via press releases cannot show data slides or posters. Those must be withheld until the actual meeting.
-- Some companies may choose to only show abstracts tomorrow, and wait for the meeting to present new/updated data.
Personally, I hate this system. If I made the rules, I would reserve all full/updated data for the actual meeting.
Good luck tomorrow. Happy #ASCO26 abstract release night for all who observe.
Very impressive start.
Alpha Tau Announces Groundbreaking Interim Results from its U.S. Alpha DaRT® Recurrent Glioblastoma Trial, with 100% Local Disease Control, 67% Complete Response Rate, and Favorable Safety Profile Observed - Conference Call Scheduled for 8:30am ET
alphatau.com/single-post/alp…
The weight loss sector is back in the saddle again.
Kailera overtakes Moderna-era IPO with $625M raise $KLRA firstwordpharma.com/story/71…
Arie Blitz retweeted
Kailera overtakes Moderna-era IPO with $625M raise $KLRA firstwordpharma.com/story/71…
#TVTX Approval for Filspari: Not quite clean, but good enough, given the endpoint issue.
$TVTX Approval
ir.travere.com/press-release…
Arie Blitz retweeted
Sarepta Therapeutics $SRPT shares rise on early promise for rare disease drugs. New results from small studies could support the beleaguered company’s pivot.
statnews.com/2026/03/25/sare… via @damiangarde
Friday (tomorrow) is the PDUFA for RYTM's Imcivree for acquired hypothalamic obesity—in contradistinction to its prior approvals for genetic causes of obesity. While it is already approved for Bardet-Biedl syndrome (BBS), Pro-opiomelanocortin (POMC) deficiency, Proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency, and Leptin receptor (LEPR) deficiency, a recent trial to expand to other genetic causes failed to meet its primary endpoint. The latter should not affect this PDUFA one way or the other.
We’ve flagged $RYTM IMCIVREE PDUFA as a BPIQ Suspected Big Mover 🚨
Stock could swing ±20%+ on FDA decision
Get the FREE Big Mover Report 👇
offers.bpiq.com/big-mover-lp
2nd time is the charm? All we need now is for RFK Jr. to focus on food instead of pharma and then perhaps the FDA can get back to orderly, predictable business.
Our story:
Vinay Prasad, key Makary ally and a focus of controversy at FDA, is leaving the agency statnews.com/2026/03/06/fda-… via @LizzyLaw_
Why does it feel like the management teams at $LLY and $NVO are throwing a whole pot of spaghetti at the wall—and then writing a press release about whichever strand sticks? LOL. firstwordpharma.com/story/70…
Hims & Hers to Stop Offering Wegovy Copycat Drug After Regulatory Scrutiny barrons.com/articles/hims-he… via @BarronsOnline
Hims & Hers will stop offering its Wegovy 'copycat' drug after regulatory scrutiny. They’ve been down this road before and knew better. In my view, greed clouded judgment and pushed them to mass-market compounded semaglutide in violation of FDA regulations. Glad regulators stepped in. barrons.com/articles/hims-he… via @BarronsOnline