$OCUL importantly the change to 40 weeks in SOL-R: "preserves trial integrity and enables our near-term NDA strategy while protecting longer-term efficacy assessments and remaining in alignment with FDA guidance"
$OCUL Just on the change to 40 weeks and comarison of SOL-1 and SOL-R dosing (answering different questions)
$CABA so far so good is what I’m saying. Looking forward to dose escalation data 1H27.
$CABA No IEC-HS in 71 patients. The design reasons are plausible and the record is clean so far, but a sample that size can’t rule out a rate of a few percent. If that changes, we’ll hear about it. Zero so far isn't the same as zero.
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$HELP new board member: Dr. Suresh Durgam.
Former Chief Medical Officer at Intra-Cellular — helped get CAPLYTA approved across schizophrenia, bipolar depression, and adjunctive MDD. That last one is exactly HLP003’s lane.
Second Intra-Cellular guy to come over — CEO Halstead ran that playbook too. He’s stacking the board with the team that already took the closest comp drug through FDA approval in the same indication.
Adding that kind of regulatory experience to your board is what you do when you’re building for an NDA.
~weeks to topline.
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$GLSI my current thinking is the company may announce a major partnership before the end of the year with non-refundable up front and investment, rather than buyout. This mainly due to the language around expected discussions intensifying from the company and the now 4-month management lockup period, the shortest in its history as a public company. If that doesn't happen, hold through data and my estimates show that is around early 2028.
$HELP ripped ~9% AH on a CEO share-award plan that didn’t even disclose the price targets he needs to hit to get the shares. Now it’s down 11%+ from yesterday’s close. Neither move makes much sense to me.
In from 6.2, holding through Q4 APPROACH data.
Insiders buying hard into the catalyst:
• CGO: 290K shares across 3 buys
• Exec Chair: 295K shares across 3 buys
• ~585K total, $11.59–12.47, zero sales, all filed voluntarily
Why I think the PoS beats a typical Ph3 CNS bet:
• Ph2: 100% response, 71% remission at 12mo, off two doses
• FDA Breakthrough Therapy
• Enrollment done ahead of schedule, baseline severity matched Ph2
• COMPASS already cleared Ph3 in the same psilocin/psilocybin class
The angle I like most, it’s adjunctive:
• Add-on for the 50–60% of MDD patients who don’t respond well enough to their SSRI
• Not the crowded TRD niche, slots in earlier, far bigger pool
• Kramer (Helus): “we see ourselves being used prior to somebody being determined to be treatment resistant”
• Claude estimates $2.5–3B peak US sales if it gets there
Not a sure thing, Ph3 CNS never is. But I think the risk/reward looks good here. ~8–10 weeks to data.
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$AARD Sun Nelson (See Remarks) Sells 68% of his shares at 5.15/share "He took the bonus — which presumably has clawback provisions requiring him to stay — but he also dramatically reduced his equity exposure. That combination suggests he expects to collect his salary and bonus, but doesn't believe the stock is going higher."
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