catalystintel.io

$TNGX — Tango Therapeutics’ vopimetostat and TNG456: topline results, expected January 2027. Before the readout, we wrote down what a good result has to show, and sealed it. The full bar, with a source for every line: catalystintel.io/events/TNGX… What’s coming In Tango Therapeutics’ own words (8-K, Oct 23, 2026): “The Company now expects to report data from its Phase 1/2 clinical trial of vopimetostat monotherapy in a cohort of patients with NSCLC in January 2027 and data from its Phase 1/2 clinical trial evaluating TNG456 as a monotherapy in NSCLC, glioblastoma, and other cancers in January 2027.” What we locked 2 lines: 1 minimum that must be met; 1 target that sets the bar. Each quotes a company document. Subscribers have the numbers now; they open to everyone 30 days after the readout. What happens next When the results print, the verdict lands in this thread: every reported number beside the sentence it came from, measured against the bar as sealed. Beat, in line, thin or miss. Arithmetic, not opinion. Proof it was written first SHA-256 02aae02791da8daf9beb0bbd5b4600fc36f09b438fe3c997698ff89e4c512233 Once the bar opens, anyone can recompute this fingerprint from its text. #Biotech Research, not advice. Not an RIA. Positions: none.

$RZLT — Rezolute’s ersodetug: topline results in Tumor hyperinsulinism (tumor HI), expected December 2026. Before the readout, we wrote down what a good result has to show, and sealed it. The full bar, with a source for every line: catalystintel.io/events/RZLT… What’s coming In Rezolute’s own words (8-K, Sep 24, 2026): “Enrollment is in progress and topline results are expected before the end of 2026.” What we locked 3 lines: 1 minimum that must be met; 1 target that sets the bar; 1 extra that would make it a beat. Each quotes a company document. Subscribers have the numbers now; they open to everyone 30 days after the readout. What happens next When the results print, the verdict lands in this thread: every reported number beside the sentence it came from, measured against the bar as sealed. Beat, in line, thin or miss. Arithmetic, not opinion. Proof it was written first SHA-256 8f930339f9c4670b07ab0b4fa0ebeed8275a86d0a62266e84d3af6605f7096ab Once the bar opens, anyone can recompute this fingerprint from its text. #Biotech Research, not advice. Not an RIA. Positions: none.

$ANAB — ANAPTYSBIO’s Jemperli (dostarlimab): FDA decision (PDUFA), expected February 2027. Before the decision, we wrote down what a good result has to show, and sealed it. The full bar, with a source for every line: catalystintel.io/events/ANAB… What’s coming In ANAPTYSBIO’s own words (8-K, Sep 21, 2026): “The FDA has assigned a PDUFA action date of February 2027” What we locked 3 lines: 1 minimum that must be met; 1 target that sets the bar; 1 extra that would make it a beat. Each quotes a company document. Subscribers have the numbers now; they open to everyone 30 days after the decision. What happens next When the FDA decides, the verdict lands in this thread: every reported number beside the sentence it came from, measured against the bar as sealed. Beat, in line, thin or miss. Arithmetic, not opinion. Proof it was written first SHA-256 008a6a6f3ce55f74a14d914bee95fc5b0f3de6452187d60aee16057cf570f01b Once the bar opens, anyone can recompute this fingerprint from its text. #Biotech Research, not advice. Not an RIA. Positions: none.

$KOD — Kodiak Sciences’ KSI-101: topline results in Macular edema secondary to inflammation (MESI), expected December 2026. Before the readout, we wrote down what a good result has to show, and sealed it. The full bar, with a source for every line: catalystintel.io/events/KOD-… What’s coming In Kodiak Sciences’ own words (8-K, Sep 28, 2026): “We also remain on track to announce topline data in December 2026 for KSI-101 in the Phase 3 PEAK study in patients with macular edema secondary to inflammation (MESI), in which KSI-101 is being evaluated for superiority against sham-treated patients.” What we locked 4 lines: 1 minimum that must be met; 1 target that sets the bar; 2 extras that would make it a beat. Each quotes a company document. Subscribers have the numbers now; they open to everyone 30 days after the readout. What happens next When the results print, the verdict lands in this thread: every reported number beside the sentence it came from, measured against the bar as sealed. Beat, in line, thin or miss. Arithmetic, not opinion. Proof it was written first SHA-256 11987fd3719caf576d6019b042d6758a5e06c84ad1ae7db01084c5391f36220b Once the bar opens, anyone can recompute this fingerprint from its text. #Biotech Research, not advice. Not an RIA. Positions: none.

$IVVD — Invivyd’s VYD2311: topline results in COVID-19 pre-exposure prophylaxis, expected October 2026. Before the readout, we wrote down what a good result has to show, and sealed it. The full bar, with a source for every line: catalystintel.io/events/IVVD… What’s coming In Invivyd’s own words (8-K, Sep 29, 2026): “DECLARATION sVNA titers, PK, and safety data expected in October 2026; COVID-19 events to remain blinded and DECLARATION planned to serve as the ongoing, confirmatory trial” What we locked 2 lines: 1 minimum that must be met; 1 target that sets the bar. Each quotes a company document. Subscribers have the numbers now; they open to everyone 30 days after the readout. What happens next When the results print, the verdict lands in this thread: every reported number beside the sentence it came from, measured against the bar as sealed. Beat, in line, thin or miss. Arithmetic, not opinion. Proof it was written first SHA-256 13f46bbcf995a82f3d6eb21cc6c5c02936aa8734e66f307a9a93ac8564f10b7a Once the bar opens, anyone can recompute this fingerprint from its text. #Biotech Research, not advice. Not an RIA. Positions: none.

PCVX / VAX-31 OPUS-1 topline is due by end of October. Vaxcyte's OPUS-1 is the one I'm tracking this month. In their 8-K on Sept 3 they narrowed topline from "Q4" to "by the end of October." OPUS-1 dosed 4,049 adults aged 50+ and compares VAX-31 head-to-head with both Prevnar 20 and Capvaxive. The checklist is built from their own high-dose Phase 1/2 result, since that's the dose that went into Phase 3: floor: all 20 serotypes shared with PCV20 meet non-inferiority (lower bound of the GMR CI > 0.5) bar: at least 18 of 20 with a GMR above 1.0, and all 11 VAX-31-only serotypes meet superiority upside: shared serotypes with a statistically higher response (lower bound > 1.0) For reference, the Phase 1/2 middle dose was 20/20 non-inferior but only 13/20 above 1.0. That's what "clears the floor, misses the bar" would look like. The low dose missed non-inferiority on 2 of 20. Honestly, there's a lot this can't score. There's no prior VAX-31 vs Capvaxive number anywhere, so I have no threshold for it, and I think that's where the real debate is. The margins come from the Phase 1/2 definitions, not a Phase 3 analysis plan. Safety was only ever described in words ("similar to PCV20"). They also had $2.5B in cash at 6/30, so I didn't treat financing as a factor. The full checklist, the sources and its SHA-256 fingerprint are here, free: catalystintel.io/events/PCVX…. I'll post the grade in this thread when the data comes out, pass or miss. Not advice. If you think a threshold is set wrong, I'd like to hear why 🙏

OCGN / OCU410ST GARDian3 topline is guided for 2027 Hey, I'm Emre. Quick recap if you missed the PCVX post: I'm building a tool that writes down what a readout has to show to count as a pass before the data comes out. It locks that list, publishes a SHA-256 fingerprint so the list can't be quietly edited, and then grades the press release against it line by line with the source quoted. PCVX is still pending (due by end of October). This is the second event I'm tracking. Ocugen's GARDian3 is a Phase 2/3 trial of OCU410ST, a one-time subretinal gene therapy for Stargardt disease. There's no approved treatment for Stargardt today. The trial randomizes 51 patients 2:1 (34 treated, 17 untreated controls). The primary efficacy endpoint is structural: how fast the atrophic lesion grows on FAF imaging at 12 months, not vision. So a lesion hit with weak vision still counts on the primary, but a vision-only hit doesn't. The checklist is built from their own Phase 1 numbers, since that's what the company tied GARDian3 to: bar: lesion growth at least 48% slower in treated eyes vs untreated, which was the Phase 1 12-month result upside (any one): a BCVA gain of at least 9 letters vs untreated, 100% of treated eyes stable or better on visual function, or at least a 116% relative reduction in ellipsoid-zone loss (exploratory) There's no floor. I couldn't find any weaker number the company printed for the primary, so it's pass or miss on the 48%. Now the part I think matters more. I haven't locked this one, and the tool won't let me. The only timing Ocugen has given in a filing is "2027," which is a 364-day window. A checklist can only be sealed when the window is 45 days or less. Their decks say 2Q 2027 topline and a mid-2027 BLA, but that's still too wide. When they name a month, it locks and I'll post the fingerprint here. Until then it's a draft and can change, and I don't want to pretend otherwise. Honestly, there's a lot here I can't score, more than with PCVX. The 48% comes from 6 evaluable treated eyes out of 9 patients enrolled in Phase 1. I think repeating that in a randomized trial against untreated controls is a high bar, and that's where I'd expect the real debate. The company's own numbers also moved. The registry and the Aug 2025 PR say 48% slower at 12 months, while 2026 decks citing Khanani et al. say 54%. On vision, the registry says nearly 2 lines (9 letters) and later decks say nearly 1 line. I used the registered figures and didn't try to reconcile them. Nothing public says which population gets analysed (ITT, mITT, evaluable...). I assumed ITT because it's randomized. There's no public success criterion, alpha or power either. A September 2026 deck says the data monitoring committee already did the 8-month interim and recommended continuing, with a change to get 8-month lesion follow-up on everyone. So the "does it continue" question is mostly answered. What's left is the size of the effect. Safety is only described in words ("No SAE"), with no counts, so there's no safety line. Not advice. If you think 48% is the wrong bar, or that it should be 54%, I'd like to hear why 🙏

EVMN / EVO301 full Phase 2a data is presented at EADV on Oct 1. 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: catalystintel.io/events/EVMN… 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 🙏

$PCVX - Vaxcyte's VAX-31: Phase 3 topline results in adult pneumococcal disease, expected October 2026. Before the readout, we wrote down what a good result has to show, and sealed it. The full bar, with a source for every line: catalystintel.io/events/PCVX… What's coming : Vaxcyte says topline safety, tolerability and immunogenicity data from the adult Phase 3 OPUS-1 trial are "now expected by the end of October", narrowing earlier guidance of the fourth quarter. (8-K, Sep 10, 2026) What we locked: 3 criteria: the primary immunogenicity endpoints, the non-inferiority margin, and safety. Each quotes a company document. Subscribers have the numbers now; they open to everyone 30 days after the readout. What happens next : When the results print, the verdict lands in this thread: every reported number beside the sentence it came from, measured against the bar as sealed. Beat, in line, thin or miss. Arithmetic, not opinion. Proof it was written first: SHA-256 7497f8b0abfee8cac8baf9d1906706d0333c82f8ba7aca36298bc84c8ac5c0e1 Once the bar opens, anyone can recompute this fingerprint from its text. #Biotech Research, not advice. Not an RIA. Positions: none.