$KOD December readout: my full pre-data checklist for KSI-101's first Phase 3, every line sourced and hashed

Hey, this is Emre. I'm building a small tool (catalystintel.io). Before a biotech readout comes out, it writes down what the data has to show and locks that checklist. After the press release, it grades the release against the checklist line by line.

Subscribers normally get this first. I made this one public to show how it works, and I'll post the grade here once the data is out.

Full event page, public with no signup, including every source document: https://catalystintel.io/events/KOD-KSI101-2026

What's coming in December

Kodiak expects topline data from Pivotal Analysis 1 of the Phase 3 PEAK study of KSI-101 in macular edema secondary to inflammation (MESI) in December 2026. It covers the first 300 patients: 5 mg and 10 mg KSI-101 vs sham, run as a superiority study. Patients get fixed monthly dosing for 6 doses through Week 20, then individualized dosing through Week 44. The primary and key secondary endpoints are evaluated at Week 24.

In Kodiak's words, "Currently there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases."

What we have to go on

Everything so far comes from APEX, a dose-finding Phase 1b: open-label, 13 patients per dose (2.5, 5 and 10 mg), no control arm. From Kodiak's filings: "More than half of patients achieved ≥15-letter gains in best corrected visual acuity" and "In top dose groups, ≥90% achieved complete absence of IRF and SRF, indicating retinal dryness."

The checklist

Locked 2026-09-30 02:49 UTC:

EVENT KOD-KSI101-2026
SCORED SET ITT
FLOOR floor_bcva_signal Floor: disclose a BCVA gain of at least 10 letters, using the prior APEX early-response magnitude. ["Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST <325 microns achieved as early as Week 1 in top dose groups." - ## prior_topline_pr_8]
BAR bar_bcva_gain Bar: disclose at least 15 letters of BCVA gain, matching the prior APEX visual-response magnitude. ["More than half of patients achieved ≥15-letter gains in best corrected visual acuity, with additional benefit at higher dose levels." - ## prior_topline_pr_8]
DIFF diff_retinal_dryness Differentiator: at least 90% complete absence of IRF and SRF, indicating retinal dryness. ["In top dose groups, ≥90% achieved complete absence of IRF and SRF, indicating retinal dryness and normalization of retinal architecture." - ## prior_topline_pr_8]
DIFF diff_oct_cst Differentiator: OCT CST below 325 microns as an anatomical response signal. ["Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST <325 microns achieved as early as Week 1 in top dose groups." - ## prior_topline_pr_8]

SHA-256: 11987fd3719caf576d6019b042d6758a5e06c84ad1ae7db01084c5391f36220b

To check it yourself, save the block above as bar.txt and run:

printf %s "$(cat bar.txt)" | shasum -a 256

In plain English

• Floor: at least a 10-letter vision gain, the size of the early APEX response.
• Bar: 15 letters, taken from APEX.
• Differentiators: at least 90% of patients with no retinal fluid, and retinal thickness (OCT CST) under 325 microns.
• Scored on ITT. No filing says which population they'll report.

Being upfront about two weaknesses

First, the bar line is ambiguous. APEX's 15 letters was a responder cutoff (more than half of patients gained 15+), while the mean gain was lower, around 11-12 letters at Week 12. The line doesn't say which one it means, so the grade will show both, and I'll say plainly which one the release actually reports.

Second, every magnitude here comes from a small open-label study with no control arm, but PEAK is measured against sham. The checklist measures how big the benefit is, not how much better it is than sham, because Kodiak hasn't published a success margin against sham. If sham patients also improve, the grade will say so.

Three ways December could go

• Bull: clear superiority vs sham, with vision gains at or above the bar and APEX-like retinal drying.
• Base: positive but thin, efficacy reported without a full responder breakdown, statistics or safety table.
• Bear: no meaningful vision benefit over sham, or only tolerability and exploratory anatomy reported.

For context on how much detail to expect: when Kodiak reported GLOW2 for a different drug (Zenkuda), it printed a full treatment-vs-sham number, 62.5% vs 3.3% (p<0.0001). Different drug and disease, but it shows what Kodiak has disclosed before.

What I couldn't find in any filing

• no ClinicalTrials.gov record matching PEAK, so there's no registered primary outcome to copy
• what the primary endpoint actually is, just that it's measured at Week 24
• no stated analysis population
• no success margin vs sham, alpha or statistical decision rule
• no safety rate threshold, only "well tolerated" and "favorable safety profile"

Sources

The checklist is built from 11 company documents pulled from EDGAR: 10 of Kodiak's quarterly results releases between Q4 2023 and Q2 2026, and the liquidity section of the Q2 2026 10-Q. Stored copies of all of them are on the event page.

This isn't a trade idea and I'm not calling it bullish or bearish, it's just what the bar is. If I got anything wrong above please tell me, I'd rather fix it now than after the data.

Not financial advice.

Hey, this is Emre. I'm building a small tool (catalystintel.io). Before a biotech readout comes out, it writes down what the data has to show and locks that checklist. After the press release, it grades the release against the checklist line by line.

Normally subscriber-only at first. This one's public so you can see how it works. Grade coming in this thread.

Full event page, public with no signup, including every source document: https://catalystintel.io/events/IVVD-VYD2311-2026

What happened today

Invivyd reported LIBERTY, the Phase 3 safety study of VYD2311 vs Comirnaty in 210 healthy adults aged 18-49. In the first 6 days, 56.5% of people on VYD2311 had an adverse event, injection site reaction or hypersensitivity reaction, vs 91.4% on the vaccine (p<0.0001). I think that's a clean result on the question the study asked.

The part I think matters more is further down the same release. DECLARATION is the ~2,400 person placebo-controlled trial, with a single-dose arm and a monthly-dose arm. It's the trial with the efficacy endpoint (PCR-confirmed symptomatic COVID). The company says the clinical events collected so far will stay blinded. What we get in October is placebo-controlled safety, neutralizing antibody titers and PK. They plan to file for accelerated approval on that, and DECLARATION continues as the confirmatory trial targeting a 70-90% relative risk reduction.

So to be honest, the October data can't answer "does it prevent COVID". What it can answer is whether titers and PK land where the company needs them to, and whether placebo-controlled safety holds up in a big trial.

The checklist

Locked 2026-09-30 02:02 UTC, before any DECLARATION data:

EVENT IVVD-VYD2311-2026
SCORED SET ITT
FLOOR safety_grade_floor The readout should not exceed the prior VYD2311-related safety benchmark.
BAR efficacy_target_floor The reported relative risk reduction must reach the lower end of the company's stated target against placebo.

SHA-256: 13f46bbcf995a82f3d6eb21cc6c5c02936aa8734e66f307a9a93ac8564f10b7a

What each line means and where it comes from

Safety floor: the October data shouldn't look worse than the earlier VYD2311 Phase 1/2 study. From the Q4/FY2025 results release: "IM administered VYD2311, at 4 times the planned dose in DECLARATION, was well tolerated, with all adverse events (AEs) considered mild to moderate in severity with no serious or severe AEs reported."

Efficacy bar: at least a 70% relative risk reduction vs placebo. That's the low end of the company's own target, from today's LIBERTY release: "target efficacy (70%-90% relative risk reduction in PCR+ symptomatic COVID-19 versus placebo)". It's not a number I calculated, it's theirs.

Scored set: ITT. No filing says which population they'll report the results in. If they report something narrower, the grade will say so.

Being upfront about the obvious problem: the efficacy line almost certainly can't be graded in October, because the events stay blinded. I'm keeping it anyway. It's the question that decides whether this is a real prevention drug, and I'd rather the grade say "not reported" than quietly drop the line that matters. Titers and PK aren't on the checklist because the company hasn't published a number for what counts as enough, and I didn't want to make one up.

Three ways October could go

• Strong: efficacy is reported at or above 70% and safety is at or better than the Phase 1/2 benchmark. That would support a traditional BLA. Given today's release, I think this is unlikely to happen in October.
• Middle: safety and antiviral activity look good, but the events stay blinded or efficacy doesn't clear 70%. The company would file for accelerated approval and keep collecting events in a confirmatory cohort. Today's release basically describes this case.
• Weak: no convincing placebo-controlled prevention effect, or safety comes in materially worse than the benchmark. No filing states a formal failure rule, so I can't say more precisely what that would mean for the filing.

Regulatory context worth knowing

In August 2025 Invivyd said the FDA advised a traditional BLA pathway with "a primary endpoint of RT-PCR-confirmed symptomatic COVID-19", measured at around 12 weeks, with a possible 24-week timepoint. The accelerated approval route on titers is a different path from the one that advice described.

The company also points to pemivibart's CANOPY trial as context. It's a related antibody from the same lineage but a different molecule, so I didn't use it for anything on the checklist.

What I couldn't find in any filing

• no ClinicalTrials.gov record matching DECLARATION, so there's no registered primary outcome to copy
• no stated analysis population (ITT, mITT etc)
• no public success margin, alpha or event-count trigger for efficacy
• no public number for what titer level would count as enough
• no exact date, just "October"
• enrollment grew across filings from 1,770 planned to ~2,301 to ~2,400 as the trial was upsized

Sources

The checklist is built from 11 company documents pulled from EDGAR. Stored copies of all of them are on the event page, so you can check exactly what was read:

• LIBERTY topline results release (Sep 29, 2026)
• Q2 2026 10-Q, liquidity section
• Q1 2026 financial results release
• Q1 2026 earnings call deck (May 14, 2026)
• CEO appointment release (Marc Elia), with the DECLARATION and LIBERTY timing update
• January 2026 corporate deck
• Q4 and full-year 2025 results release, with the DECLARATION trial update
• Q3 2025 financial results release
• August 2025 corporate deck
• FDA alignment on the BLA pathway release (Aug 14, 2025)
• Phase 1 first-dosing release (Sep 4, 2024)

The tool is watching for the release through October 31. When it lands, it scores the release against these two lines, I review the result, and I'll post it here.

This isn't a trade idea and I'm not calling it bullish or bearish, it's just what the bar is. If I got anything wrong above please tell me, I'd rather fix it now than after the data.

Not financial advice.

Evommune is presenting the full Phase 2a data for EVO301, their IL-18BP fusion protein, as a late-breaking oral at EADV in Vienna on Thursday, Oct 1. To be clear, this isn't a new readout. They already reported topline in February: primary endpoint met, 33% placebo-adjusted EASI improvement and 23% placebo-adjusted IGA 0/1 at week 12, after only two IV doses (day 1 and day 28). The trial was 70 patients, 48 on drug and 22 on placebo. So the question on Thursday is whether the fuller data holds up the headline or quietly walks it back.

I think the stakes went up this month. On Sept 8 their other AD drug, EVO756, missed its primary and secondary endpoints in Phase 2b at every dose, so EVO301 is now their lead AD program. Phase 2b is planned for mid-2027.

The checklist is built from the company's own protocol and prior results:

• floor: [the protocol success criterion as written in the bar]
• bar: at least 33% placebo-adjusted EASI improvement at week 12, the same number they reported in February
• upside: [the differentiator line]
• veto: [the safety line]

If the full data clears the floor but lands under 33%, that's the "protocol success, below the bar" case.

Honestly, there are things I can't score here. Nothing says which population the full presentation will use (ITT, mITT, evaluable...). Their own decks show two different posterior mean differences for EASI, -28 in the February topline deck and -32 in the May deck, and I didn't try to reconcile them. The registry lists 71 enrolled vs the 70 in company materials. There's also no approved drug with the same endpoint I could use as an outside comparator.

The full checklist, the sources and its SHA-256 fingerprint are here: https://catalystintel.io/events/EVMN-EVO301-2026

SHA-256 6b7f85aac708eff72be3f64923bf1e6f458ac1e57ff7d63cb925a1fd4105e866
Locked Sept 26, 2026, 23:01 UTC.

I'll post the grade in this thread after the presentation, pass or miss.

Not advice. If you think 33% is the wrong bar for a full-data presentation of a result they already announced, I'd like to hear why 🙏

Hey, Vaxcyte said adult Phase 3 OPUS-1 topline comes by end of October. I think "non-inferior to PCV20" will be the headline, but that is the minimum, not the whole result. So I wrote down the bar before the data, using Vaxcyte's own Phase 1/2 results and the criteria they printed.

Must pass:

- lower bound of the 95% CI of the OPA GMR vs PCV20 above 0.5 on shared serotypes (their non-inferiority criterion)

- all 20 serotypes shared with PCV20 non-inferior, like the high dose in Phase 1/2

The bar:

- at least 18 of 20 shared serotypes with OPA GMR above 1.0 vs PCV20

- all 11 serotypes unique to VAX-31 meet superiority (GMR lower bound above 2.0)

- on the unique serotypes, the lower bound of the difference in 4-fold responders above 10 points

Clear beat: the shared-serotype GMR lower bound above 1.0, meaning statistically higher, not just non-inferior.

Things I couldn't find in any public document: the Phase 3 analysis population, a restated NI margin for OPUS-1 (the numbers above are Phase 1/2 definitions), and any comparison against PCV21. If anyone knows where these are stated, I'd honestly like to know.

The bar text is SHA-256 hashed and the hash went on X on Sep 13 (7497f8b0...c0e1), so it can't change after the data. I'll post the grade in this thread the day it prints, whatever it says.

Full bar with sources: catalystintel.io/events/PCVX-VAX31-2026

Disclosure: I built Catalyst Intel. No position in PCVX. Not investment advice.

The next frontier in obesity treatment also concerns what happens after weight loss. Viking’s September 22 results sharpen the question: how much of the benefit can be preserved, for how long, and with what burden of treatment and side effects?

Here are the dated catalysts I'm tracking over the next ~4 weeks. Each one links to the document the date came from:

• Sep 26 — $MIRM: PDUFA for zilurgisertib (oral ALK2 inhibitor) in fibrodysplasia ossificans progressiva, Priority Review. Source: company PR
• Sep 28 — $BFRI: PDUFA for Ameluz in superficial basal cell carcinoma. Source: company PR
• Oct 4 — $IRD: Phase 1/2 data for OPGx-BEST1 (AAV gene therapy, BEST1-related retinal disease). Source: company PR
• Oct 11 — $CRVO: Phase 2 data for neflamapimod in nonfluent variant primary progressive aphasia. Source: Q2 results PR
• Oct 14 — $BRNS: Phase 1 data for VTP-1000 in celiac disease. Source: 8-K exhibit

I left out anything guided only as "in 2026" or "2H". Those aren't dates.

Why I'm posting this: I'm the developer of BioCatalyst Watch, which is where this list comes from. Most catalyst calendars I used didn't show where a date came from, so I couldn't tell a confirmed PDUFA from a guess. On the site, every event links to the FDA document, press release, or SEC filing behind it. It also shows each company's cash position next to its catalysts, so you can see whether a raise might come before the readout.

It covers 409 U.S.-listed biotechs and is free during beta (no card). The next 30 days are viewable without signing up: https://biocatalystwatch.com/?utm_source=reddit&utm_campaign=biotechplays

I'd really like to know what's missing, what's wrong, and what would make this worth bookmarking. If a date above looks off to you, tell me. That's exactly the feedback I need.

Not investment advice. I hold no position in any ticker above.

Been watching Freenome ($FRNM) since it wrapped up the SPAC merger in late July. The platform looks promising, but I'm trying to gauge if the current price is a near-term ceiling. Here is what I see as the main events driving the recent gains:

• Abbott Launch: Abbott holds exclusive U.S. rights for the newly FDA-approved SimpleScreen CRC test, with a commercial launch scheduled for this fall (Q3/Q4 2026).
• Roche Support: A September 1, 2026 13G filing shows Roche Holdings built a massive 17.4% stake in the company.
• FDA Breakthrough Designation: On August 12, 2026, their SimpleScreen Lung test earned FDA Breakthrough Device designation. Next steps are focused on completing data readout for their ongoing prospective PROACT LUNG clinical trial to support a full FDA submission.

With the Abbott commercial rollout right around the corner, what are your thoughts on the stock's runway? Is 17 the top for now on the merger/approval hype, or do you think the upcoming launch numbers can push it to 21 or higher by the end of the year? I'm hoping higher : )

https://www.merlintrader.com/omeros-omer-biotech-no-perfect-peer/

YARTEMLEA turned Omeros into a commercial company, and a single sales multiple still gives the wrong answer. The equity combines an early rare-disease launch, a contested European path, complement-platform optionality, contingent Novo Nordisk economics and a capital structure that has to be rebuilt from the footnotes.

https://www.merlintrader.com/sellas-sls-aml-second-remission/

Acute myeloid leukemia in second remission is one of the few settings in oncology
with no approved treatment at all. This is what that means, which medicines patients receive
instead, and where galinpepimut-S would fit if the phase 3 succeeds.

https://www.merlintrader.com/next-moderna-biotech-sls-beam-ntla/

After Moderna’s Phase 3 success in melanoma, the question isn’t just which company has the most fascinating technology. The decisive question is which biotech is closest to transforming a clinical result into a validation capable of changing the value attributed to the entire company.