What the Round Table Is Predicting in Biotech Markets

Seventeen FDA decisions fall due between 30 October 2026 and 29 June 2027, and KXCO's Round Table has called every one. Its model portfolio holds the thirteen Nasdaq companies behind those decisions, and it was signed and anchored on chain before the FDA acts on any of them.

A Round Table call is a prediction, signed before the FDA acts, of whether a filing is more or less likely than the average filing to be approved at its first review. It is a call on the FDA's decision, not on the share price. Six of the seventeen are called above average and eleven below, per the Round Table's signed calls, and the portfolio holds all seventeen.

The model portfolio

The portfolio holds the shares of the thirteen companies from the signing on 16 October 2026 until the FDA decides on each filing. No company carries more than 15%, per the portfolio's own rules.

The three heaviest weights belong to the three companies with more than one decision in the book. BridgeBio (Nasdaq: $BBIO) and Cogent Biosciences (Nasdaq: $COGT) carry 15.00% each, and Praxis Precision Medicines (Nasdaq: $PRAX) carries 14.26%, per the signed portfolio.

The other ten carry one filing each, per the same portfolio. Cullinan Therapeutics (Nasdaq: $CGEM) carries 7.12%. Intellia Therapeutics (Nasdaq: $NTLA) and Pharvaris (Nasdaq: $PHVS) carry 5.94% each, and Belite Bio (Nasdaq: $BLTE) carries 5.70%. Inovio Pharmaceuticals (Nasdaq: $INO) and Mineralys Therapeutics (Nasdaq: $MLYS) carry 5.67% each, and Inhibrx Biosciences (Nasdaq: $INBX) carries 5.40%. Savara (Nasdaq: $SVRA) and Vanda Pharmaceuticals (Nasdaq: $VNDA) carry 4.84% each, and Apnimed (Nasdaq: $APMD) carries 4.62%.

The book runs on four rules:

• Entry is the last close before signing.

• Each position closes at the first close after the FDA's decision is announced. A target date the FDA moves carries the position to the new date, and a withdrawn filing closes at the first close after the withdrawal is announced.

• A closed position's proceeds are held as cash, not reinvested.

• At each decision the book is reported against an equal-weight book of the same seventeen positions and against the XBI biotech index, from the same close.

The calls

Six filings are called above average: BridgeBio's BBP-418 and infigratinib, Cogent's bezuclastinib in gastrointestinal stromal tumours (GIST), Praxis's relutrigine, Belite Bio's tinlarebant, and zipalertinib, which Taiho sponsors and Cullinan co-develops. The other eleven are called below average. Exhibit 2 sets out all seventeen in date order, with the disease each filing treats.

Where the book doubles up

Three companies carry more than one decision. BridgeBio has BBP-418 for LGMD2I/R9 on 27 November and infigratinib for achondroplasia on 4 February 2027, both called above average. Cogent Biosciences has three bezuclastinib filings: gastrointestinal stromal tumours (GIST) on 30 November, nonadvanced systemic mastocytosis on 30 December and advanced systemic mastocytosis on 29 June 2027. Praxis has relutrigine on 27 December and ulixacaltamide on 29 January 2027.

Hereditary angioedema draws two sponsors. Intellia's Lonvo-z, an in vivo CRISPR therapy, and Pharvaris's deucrictibant, an oral small molecule, are both filed for it, with FDA targets on 10 March and 23 April 2027. The Round Table calls both below average.

The calendar

The decisions bunch in two runs. Eight fall between 30 October and 30 December 2026, the next eight run from 29 January to 23 April 2027, and Cogent's advanced systemic mastocytosis filing comes last, on 29 June 2027. On the dial, a solid mark is called above average and an open mark below.

Exhibit 4. The decision calendar. Source: KXCO, Round Table, 16 October 2026; target dates as the sponsors have disclosed them. The dial also shows filings the Round Table follows that are not in the portfolio.

Exhibit 5. The next 90 days. Source: KXCO, Round Table, 16 October 2026. Green marks have no regulatory concern recorded, amber marks have one, and grey marks are filings outside the portfolio.

The first five decisions

The book's first five decisions arrive within six weeks. INO-3107, Inovio's DNA medicine for recurrent respiratory papillomatosis, comes first, on 30 October, and the Round Table calls it below average.

Savara's molgramostim for autoimmune PAP follows on 22 November, called below average. BridgeBio's BBP-418 on 27 November and Cogent's bezuclastinib in GIST on 30 November are both called above average. Vanda's Quimilza for generalised pustular psoriasis comes on 12 December, called below average.

The calls by quarter

Exhibit 7 sets every filing the Round Table follows as a tile in the quarter of its FDA date, dark where the call is above average and light where it is below. Of the portfolio's seventeen filings, eight fall in the fourth quarter of 2026, six in the first quarter of 2027 and three in the second. The above-average calls sit in the first two of those quarters, three in each, and all three of the second quarter's filings are called below average.

Exhibit 7. Source: KXCO, Round Table, 16 October 2026. Deramiocel, Anito-cel, CagriSema and vosoritide are filings the Round Table follows that are not in the portfolio; vosoritide carries no call.

The record behind the calls

Exhibit 8 shows the opening rows of the Round Table's FDA board: each filing's target date and status, the share price and the analysts' consensus target as read on 14 October 2026, the evidence recorded, and any regulatory concern on the public record.

Exhibit 8. Source: KXCO, Round Table, 16 October 2026; prices and consensus targets per stockanalysis.com, read 14 October 2026.

Signed before the event, scored after it

The calls and this portfolio were fixed before the FDA acts on any filing in them. The portfolio was signed with ML-DSA-87, the NIST post-quantum signature standard (FIPS 204), and its fingerprint was anchored on KXCO's chain at block 5,373,251 at 03:08 UTC on 16 October 2026, per the portfolio's signed attestation. Each decision will be scored as it lands, against an equal-weight book and the XBI biotech index, and a loss will be published exactly as a gain is.

The first test comes on 30 October, with Inovio's INO-3107.

A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register, not on where any share price will go. No money is invested. Past decision-day moves describe a handful of events and predict nothing.

Conflicts. KXCO, its affiliates and personnel may hold or trade the securities discussed.

Share prices, analysts' consensus targets and options figures are as read on 14 October 2026 and have since changed. Listings are per the SEC's company ticker file, read 16 October 2026.

Sources: the sponsors' own announcements and SEC filings, Cboe delayed quotes, stockanalysis.com and the SEC's company ticker file, as named under each exhibit; the calls and the model portfolio are KXCO's Round Table's.

Shayne Heffernan, Ph.D., is the founder of the KnightsBridge Group (shayneheffernan.com).

This commentary is for informational purposes and does not constitute investment advice.