KXCO's FDA Ontology Ranks Lorundrostat First After Its 10 November Update

KXCO's FDA ontology is KXCO's research record on drugs filed with the US Food and Drug Administration (FDA), published at kxco.ai/fda, a page KXCO calls a room. The room was rebuilt in a full update on 10 November 2026, and its first screen has a new answer: "#1 in the next 90 days: Lorundrostat (Mineralys, MLYS), decision 22 Dec, potential return +86%."

Lorundrostat is Mineralys Therapeutics' investigational, highly selective aldosterone synthase inhibitor for uncontrolled or resistant hypertension. The FDA has set 22 December 2026 as its target date for a decision on the new drug application (NDA). Between the room's price reads of 20 October and 10 November 2026, each taken before the US market opened, Mineralys's shares fell from $20.92 to $15.79, or 24.5%. The major banks' median target of $44.50, read on 20 October 2026, now sits 182% above the share price.

The same update read Mineralys's quarterly report to 30 September 2026. It shows $624.7m of cash and investments at that date, and on KXCO's calculation Mineralys is funded to 12 October 2029, even in the case where it must repay its $100.0m loan by 30 June 2028. That date falls 11.2 quarters after the FDA's decision.

Relutrigine led the first screen before this update, and its FDA decision is due on 27 December 2026. Before relutrigine, the leader was Inovio's INO-3107. As Live Trading News reported on 31 October 2026, the room had ranked INO-3107 first for nine days, the FDA approved it on its target date, and the record took in the FDA's letter the same night. The room's decision-day study records Inovio's shares at +145.5% on the approval, or +149.1% net of the XBI biotech index.

This article sets out what the 10 November update read, what it changed, and how the ontology ties each figure on the page to the document it came from.

Exhibit 1 source: the first screen of kxco.ai/fda, at phone width, read on 10 November 2026, with prices read at 00:36 UTC that day.

What one full update reads

The update read the market again. The share prices on the page are stockanalysis.com prices read at 00:36 UTC on 10 November 2026, and the options figures are Cboe delayed quotes for the first expiry after each decision.

It read the filing dates again. Mineralys's quarterly report of 4 November 2026 still gives lorundrostat's target date as 22 December 2026.

It read six companies' quarterly reports for the three months to 30 September 2026 by hand: Mineralys, Praxis Precision Medicines, Cogent Biosciences, Savara, BioMarin Pharmaceutical and Intellia Therapeutics. Each cash figure on the page is marked "per the 10-Q balance sheet, read by hand", and every line behind those figures is quoted from the filing. KXCO's check found all 258 of the 258 quoted passages word for word in the filings at the SEC.

It searched the SEC's full-text index for decision dates outside the board, which is the room's list of 32 drugs, with dates and evidence. The wider calendar now lists 32 decision dates from 28 companies not on this board, each as the company's own SEC filing states it.

Then it rebuilt every view from the record, the sourced entities and claims behind the page. In the room's words, each figure shows its source and the time it was read.

Exhibit 2 source: the headline band of Decisions ahead on kxco.ai/fda, at phone width, read on 10 November 2026.

The band in Exhibit 2 shows the calendar the update works to. Twelve FDA decisions fall due in the next 90 days, to 8 February 2027. The nearest are Capricor's deramiocel and Savara's molgramostim, both on 22 November 2026. On quotes read on 10 November 2026, options price a move of as much as ±74% for a single decision alone, on deramiocel.

Why the ranking moved

The first screen ranks each pending decision by its potential return. In the room's words, potential return is "the probability of approval times the upside to the major banks’ median price target, less the probability of refusal times the fall on a refusal". The probability is how often applications like this one cleared their first FDA review. Where the company is the drug, the fall on a refusal is to the company’s net cash per share, read by hand from its latest filing. Otherwise it is the largest refusal-day fall the room has measured. The room has measured four refusal days, net of the XBI biotech index: −9.7%, −35.1%, −5.7% and +3.4%, so that largest fall is −35.1%.

The banks' targets in this update are the ones the room read on 20 October 2026, so the ranking moved with the share prices and the cash. Exhibit 3 sets the six filings ranked on the first screen of 10 November against the same six on the page as built on 3 November, whose prices were read on 20 October 2026.

Exhibit 3 source: the first screen of kxco.ai/fda on 10 November 2026, and the same screen as built on 3 November 2026, from KXCO's record of that build; prices per stockanalysis.com, read at 01:18 UTC on 20 October and 00:36 UTC on 10 November 2026.

• Mineralys (MLYS) fell 24.5%. Lorundrostat's upside to the banks' median rose from 113% to 182%, and its potential return from +41% to +86%.

• Praxis Precision Medicines (PRAX) rose 28.0%, from $260.17 to $333.09. Relutrigine's upside fell from 104% to 59%, and its potential return from +68% to +35%.

• Cogent Biosciences (COGT) rose 11.8%, from $30.01 to $33.55. Bezuclastinib's potential return moved from +65% to +50%.

• Savara (SVRA) rose 8.9%, from $4.63 to $5.04, and its 30 September report lowered its net cash. Molgramostim's potential return moved from +43% to +30%.

• BridgeBio Pharma (BBIO) rose 14.7%, from $67.94 to $77.94. BBP-418's potential return moved from +37% to +22%.

• Quimilza, from Vanda Pharmaceuticals (VNDA), held at +33%.

A share that rises towards the banks' median target leaves less upside to rank, and a share that falls while the targets stand leaves more.

Lorundrostat, the new first

Mineralys submitted the NDA in December 2025, for lorundrostat in the treatment of hypertension in combination with other antihypertensive drugs. The FDA accepted the filing on 6 March 2026. No document states the review class, and the record infers a standard review.

The application rests on two registrational trials, Launch-HTN and Advance-HTN:

• Launch-HTN is a Phase 3 trial of adults whose blood pressure remained uncontrolled on two to five antihypertensive medicines, with 1,083 randomised. It met its primary endpoint: lorundrostat 50 mg achieved a 16.9 mmHg reduction in systolic blood pressure and a 9.1 mmHg placebo-adjusted reduction (p < 0.0001) at week 6.

• Advance-HTN is a Phase 2 trial with 285 randomised. It recorded a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction (p = 0.001) on 24-hour ambulatory monitoring at week 12.

Mineralys reports that lorundrostat was well tolerated in both trials.

The room's finding on the filing, written and approved on 14 October 2026, reads: "The record holds completed Launch-HTN results for Mineralys's lorundrostat, and its precedent, baxdrostat, was approved by the FDA for adults with hypertension in May 2026." The record holds no complete response letter, refusal to file, advisory committee vote against, safety finding, request for more information or inspection finding against the filing.

Four major banks cover Mineralys, three with a buy rating and one with a hold. Options price a move of ±21.7% for the decision alone, and ±38.9% across the whole straddle to 15 January 2027.

Mineralys's cash, its loan and the FDA date

Mineralys's report for the quarter to 30 September 2026 shows cash and cash equivalents of $101.3m and investments of $523.4m, $624.7m in all. Its senior secured term loan was carried at $25.0m due within a year and $73.3m beyond, $98.3m in all, against $100.0m of principal drawn. On the room's reading of its operating cash flow, the company spends $43.1m a quarter.

The same report sets the downside in the ranking. After $98m of debt at 30 September 2026, Mineralys's net cash comes to 37.6% of the share price, so the first screen takes a refusal as a fall of 62%, to that net cash. Lorundrostat's potential return rests on the company's balance sheet as well as on the banks' targets.

The loan terms tie the company's financing to the FDA's decision. Mineralys drew a Tranche A Loan of $100.0m on 2 June 2026. A Tranche B Loan of $150.0m is subject to approval by the FDA of the lorundrostat NDA, and a Tranche C Loan of $150.0m depends on that approval and on net sales milestones. If that approval has not come by 30 September 2027, the term loans are repaid in four equal instalments from 30 September 2027.

KXCO's calculation takes the case without approval. The Funded to view counts $25.0m of loan principal on 30 Sep 2027, 31 Dec 2027, 31 Mar 2028 and 30 Jun 2028, if the FDA has not approved lorundrostat by 30 September 2027, and still finds Mineralys funded to 12 Oct 2029. It counts none of the loans that approval would bring: under the room's rule, payments that depend on sales, approval or a lender's discretion are not counted.

Exhibit 4 source: Mineralys's 10-Q for the quarter to 30 September 2026, and Funded to, the first screen and lorundrostat's brief on kxco.ai/fda, read on 10 November 2026.

Exhibit 4 draws that chain as a knowledge graph, from the same documents. The quarterly report, the loan terms, the FDA's target date, the share price and the banks' targets are separate things, each with its source, joined by typed links to the figures they set. Solid links are figures a filing states; dotted links are figures KXCO works out from them. Exhibit 5 shows the result on the live page.

Exhibit 5 source: Funded to on kxco.ai/fda, at phone width, read on 10 November 2026: the view's scale and the Mineralys row, with the rows between them left out.

Six quarterly reports, read by hand

Mineralys was one of six companies whose reports to 30 September 2026 the update read by hand. Funded to ranks 12 companies by the quarters their own cash carries them past their nearest FDA decision, fewest first. For each company below, the cash is quoted from its 10-Q at 30 September 2026 and the funded-to date is KXCO's calculation.

• Praxis Precision Medicines (PRAX) held cash and cash equivalents of $361.9m, marketable securities of $383.5m and long-term marketable securities of $540.7m, $1,286.0m in all, with no debt on the report. It is funded to 5 Sep 2030, past relutrigine's decision on 27 December 2026 and ulixacaltamide's on 29 January 2027.

• Cogent Biosciences (COGT) held cash and cash equivalents of $217.5m and short-term marketable securities of $573.7m, $791.1m in all, against convertible senior notes carried at $223.7m. It is funded to 1 Mar 2029. Cogent has three FDA dates for one drug, bezuclastinib: 30 November 2026 for gastrointestinal stromal tumours (GIST), under Priority Review; 30 December 2026 for non-advanced systemic mastocytosis; and 29 June 2027 for advanced systemic mastocytosis.

• Savara (SVRA) held cash and cash equivalents of $29.8m and short-term investments of $99.8m, $129.6m in all, and spends $42.5m a quarter. It is funded to 21 May 2027, when its cash reaches the 70% of principal ($21.0m) its lender requires from 1 Apr 2027, and molgramostim's FDA decision is due on 22 Nov 2026.

• Intellia Therapeutics (NTLA) held cash and cash equivalents of $156.1m, marketable securities of $318.0m and noncurrent marketable securities of $140.7m, $614.8m in all. It is funded to 17 Apr 2028, when its cash reaches the $75m its lender can require, with lonvo-z's FDA decision due on 10 Mar 2027.

• BioMarin Pharmaceutical (BMRN) held cash and cash equivalents of $736.0m. The room deducts the $70.0m upfront payment for the BMN 450 licence agreed in October 2026, which BioMarin's 10-Q says it will make without giving a day. BioMarin's business generates cash, so Funded to lists it as cash generative rather than ranking it.

One FDA decision, named in many filings

The wider calendar comes from a full-text search of companies' SEC filings for FDA decision dates. A filing often names a date that belongs to another company, and the ontology resolves each date to the company whose application it is. Exhibit 6 draws four such decisions.

• Vertex Pharmaceuticals (VRTX) reports that its application for accelerated approval of povetacicept in IgA nephropathy is under priority review, with a target date of 30 November 2026. Akebia Therapeutics (AKBA), Jade Biosciences (JBIO) and Zai Lab (ZLAB) name the same date in their own filings. The calendar lists it once, under Vertex, from Vertex's 10-Q.

• Capricor Therapeutics (CAPR) announced that the FDA extended the target date for deramiocel from 22 August 2026 to 22 November 2026. Dyne Therapeutics (DYN) and Entrada Therapeutics (TRDA) name the same date in their own quarterly reports. The board carries it once, under Capricor.

• Royalty Pharma (RPRX) names two dates in one filing: Pharvaris's deucrictibant on 23 April 2027 and Zenas BioPharma's obexelimab on 27 May 2027. Pharvaris (PHVS) states its own date in its own filing and is on the board. The calendar lists obexelimab under Zenas BioPharma (ZBIO), from its own 8-K.

Exhibit 6 source: the ten SEC filings linked above, and the wider calendar and Decisions ahead on kxco.ai/fda, read on 10 November 2026.

The same scan found 24 dates in filings that are not the filer's own current decision date, among them an expected Day-74 letter, an investor day and the day a new chief executive takes office. The ontology keeps each one off the wider calendar and records why.

The ontology also joins one medicine's names. Inovio's 8-K of 2 November 2026 announces "VOCERYQ™ Now Approved Formerly known as INO-3107", and the room now lists the filing as INO-3107 (VOCERYQ), approved 30 October 2026.

The board's FDA dates to the end of 2026

In date order, per Decisions ahead:

• Fourth quarter of 2026, with no day given: Novo Nordisk's CagriSema (NVO).

• 22 November 2026: Capricor's deramiocel (CAPR) and Savara's molgramostim (SVRA).

• 27 November: BridgeBio's BBP-418 (BBIO).

• 30 November: Cogent's bezuclastinib in GIST (COGT).

• 12 December: Vanda's Quimilza (VNDA).

• 22 December: Mineralys's lorundrostat (MLYS).

• 23 December: anito-cel, from Arcellx, acquired by Gilead (GILD).

• 27 December: Praxis's relutrigine (PRAX).

• 30 December: Cogent's bezuclastinib in non-advanced systemic mastocytosis.

The record behind the page

As at 31 October 2026, the record behind kxco.ai/fda held 501 entities, 520 claims, 32 drugs and 646 sources. Each pending filing has a one-page brief with its trials quoted at source and its regulatory history. Lorundrostat's brief also carries its options, its short interest and what to watch, which it lists as 18 December 2026, the last options expiry before the decision; 22 December 2026, the FDA's target date; and 15 January 2027, the first options expiry after it.

A reader can trace a figure to its document from the page itself. On the first screen, dotted figures open their source on hover. In lorundrostat's brief:

• The options figures name Cboe delayed quotes, the at-the-money straddle on the first expiry after the decision, with the quote time.

• The short interest, 8.4% of all shares, the fifth lowest of 14 companies measured, names FINRA consolidated short interest, settlement 15 October 2026.

• Launch-HTN's primary endpoint is quoted as registered at clinicaltrials.gov: the change in automated office systolic blood pressure at week 6, against placebo.

• Mineralys's cash cites its 10-Q for the period ending 30 September 2026, read at 00:49 UTC on 10 November 2026.

The ranking leaves out a filing whose figures the room has not read. Anito-cel is not ranked, because its net cash is not read.

KXCO's FDA ontology is proprietary AI from KXCO. It incorporates human knowledge and research with the power of KXCO's mathematical and other models.

Built for an investor's own holdings

This public page is a sample. It covers 20 pending FDA filings, chosen to show what the research can do. A KXCO room built for a fund covers any number of stocks, with live quotes, alerts, export and a data feed.

For investors and institutions, that is the record behind this update, built around their own book: each holding's FDA dates, trials, cash, loans, bank targets and filings in one place, each figure with its document. Investors and institutions that want that record for their own holdings can request a briefing from KXCO.

The room is open to read, view by view: the first screen, Decisions ahead, Funded to, Market expectations and lorundrostat's brief. More on what KXCO builds is at kxco.ai.

Stocks mentioned: $MLYS (NASDAQ), $PRAX (NASDAQ), $COGT (NASDAQ), $SVRA (NASDAQ), $BBIO (NASDAQ), $VNDA (NASDAQ), $NTLA (NASDAQ), $BMRN (NASDAQ), $VRTX (NASDAQ), $AKBA (NASDAQ), $JBIO (NASDAQ), $ZLAB (NASDAQ), $CAPR (NASDAQ), $DYN (NASDAQ), $TRDA (NASDAQ), $RPRX (NASDAQ), $PHVS (NASDAQ), $ZBIO (NASDAQ), $INO (NASDAQ), $GILD (NASDAQ) and $NVO (NYSE).

The room's figures are a model kept for research and not an offer, a solicitation or a recommendation to buy or sell any security, and not personal advice. KXCO is a software company and holds no financial licences.

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