BioMed Nexus Daily Updates
Your essential biotech, medtech, and pharma recap — no noise, just what matters.
Tuesday, October 13, 2026
📌TL;DR
First Tracks' ANB033 met its Phase 1b gluten challenge endpoints in celiac disease: villus height to crypt depth ratio +0.49 placebo adjusted (p=0.009), IEL density p<0.001, symptoms significantly better from Day 1, no serious adverse events, per the company's release. TRAX closed up 6.9%.
Mirum's Livmarli met the Phase 3 EXPAND primary in cholestatic pruritus from ultra rare cholestatic liver diseases (0.98 point placebo adjusted reduction, p=0.0004) and all five secondary endpoints, per its release; a US sNDA is planned for H1 2027.
Bristol Myers announced two pivotal wins without disclosing a single figure: Phase 3 ALOFT-IPF met its primary at the 60 mg dose (120 mg not significant), and ACTION-1 met its interim PFS primary, the first Phase 3 win for an alpha isotope radiopharmaceutical. BMY closed down 2.6%.
Medtronic's MiniMed exchange offer was oversubscribed more than five to one: 298,024,452 shares tendered, 55,032,401 accepted, preliminary proration ~18.3%, final factor expected October 14, per its release. MDT closed up 3.9%.
Freenome fell 16.2% in the first session after its Sunday ACG late breaker announcement; no new company disclosure explains the move.
Johnson & Johnson opens the Q3 earnings season this morning, per published calendars.
⚡ Executive Takeaway
Monday was the day the market showed us it now audits press releases rather than reads them. Four positive readouts crossed in one session, and the only ones that got paid were the ones that showed their work. First Tracks published every endpoint, every p value, and a full safety table within hours of its announcement; it closed up. Bristol Myers announced two pivotal wins, the kind of morning that once moved a big pharma for a week, and published not one number between the two releases; it closed down. This is learned behavior, and it is nine days old. When Merck printed a noninferiority win in September with the safety rates withheld, the withheld numbers turned out to be the story, and the market took the lesson: a topline without figures is not information, it is a promise of information, and promises now trade at a discount until the tables arrive. For anyone drafting a topline release this earnings season, the disclosure bar just moved.
The complete ANB033 and EXPAND endpoint tables, the MiniMed exchange math, and the day's movers, all below. 👉 Read Full Analysis
🧬 Immunology
The CD122 class got its second celiac win in five days. TRAX
First Tracks Biotherapeutics reported that ANB033, a CD122 antagonist that blocks IL-15 and IL-2 signaling, protected celiac patients through a 14 day, 6 gram daily gluten challenge in Cohort 1 of its Phase 1b study. The villus height to crypt depth ratio held nearly flat on drug while placebo patients deteriorated, a placebo adjusted benefit of +0.49 (p=0.009), intraepithelial lymphocytes separated at p<0.001, and symptoms separated from the first day of the challenge, with no serious adverse events and no discontinuations on drug. The result lands five days after FB102 hit in the same disease with the same target, converting last week's class effect question into a class. A late stage celiac trial is planned for 2027, with Cohort 2 mucosal healing data due in Q1 2027. TRAX closed at 34.05, up 6.9%, our arithmetic.
💊 Rare Disease
Livmarli swept every EXPAND endpoint, and the stock did not move. MIRM
Mirum's Livmarli (maralixibat) met the primary endpoint and all five prespecified secondary endpoints of Phase 3 EXPAND in cholestatic pruritus from ultra rare cholestatic liver diseases, including biliary atresia: a 0.98 point placebo adjusted reduction in pruritus severity (p=0.0004), serum bile acids down 70.1% versus 3.5% for placebo, and even wider separation in the biliary atresia native liver subgroup. Safety matched the known IBAT inhibitor profile, diarrhea aside. A US supplemental application is planned for the first half of 2027, stretching Livmarli toward a broader cholestatic population. The market's answer was silence: MIRM closed at 86.06, up 0.1% on the day of a clean Phase 3 win, after rising 5.7% on Friday before the announcement, a move no disclosure has explained.
🫁 Big Pharma Pipeline
Bristol Myers won twice in one morning and disclosed nothing. BMY
Phase 3 ALOFT-IPF met its primary endpoint: admilparant 60 mg significantly slowed the decline in forced vital capacity at Week 52 in idiopathic pulmonary fibrosis, while the 120 mg dose did not reach significance, per the release. Hours apart, Bristol Myers said ACTION-1 met its interim primary endpoint, with RYZ101, its actinium 225 radiopharmaceutical, significantly extending progression free survival in SSTR positive GEP-NETs after progression on lutetium 177 therapy, the first Phase 3 win for an alpha isotope radiopharmaceutical in any indication. Neither release contained an efficacy figure; both defer to future medical meetings. BMY closed at 57.58, down 2.6%. ALOFT-PPF, fully enrolled in progressive pulmonary fibrosis, reads out in early 2027.
🏭 Medtech
Investors tendered five Medtronic shares for every one the exchange could take. MDT
Medtronic's MiniMed exchange offer closed oversubscribed by more than five to one: holders tendered 298,024,452 shares against 55,032,401 accepted, a preliminary proration factor of about 18.3%, with the final figure expected October 14, per Monday's release. Medtronic will distribute 252,813,348 MiniMed shares at the 4.5939 ratio, and odd lot holders who tendered everything escape proration. The demand is the message: investors wanted the standalone diabetes company at the embedded discount, in size. MDT closed at 91.93, up 3.9%.
🩸 Diagnostics
Freenome's first reaction session erased a sixth of the company. FRNM | ABT
Freenome closed at 13.22, down 16.2%, in the first session after Sunday's announcement that its next generation SimpleScreen colorectal data will be a late breaking oral at ACG this Wednesday. Nothing in that announcement was new: the figures were July's topline (colorectal cancer sensitivity 80.4%, advanced precancerous lesions 18.2%, at 90% specificity). We checked the company's investor page and the wire indexes Monday night and found no new disclosure that explains the move. Wednesday's podium detail, and the supplemental PMA that carries Abbott's $70 million milestone, are now the tape to watch.
🌱 Private and Newly Public
A Chinese Phase 2b resurfaced in the US, and the IPO queue grew by two. Tortugas (private) | Aspen (filed) | Bambusa (filed)
Tortugas Neuroscience said obuprazine, the D2/D3 partial agonist and 5-HT2A antagonist it licensed from Hansoh Pharma, cleared every dose cohort on PANSS at Day 42 in a 363 patient Chinese Phase 2b in acute schizophrenia run by Hansoh, with placebo adjusted reductions up to 16.7 points, per its release as reported by Fierce Biotech; the ex Sage team now wants FDA clearance for a US trial. And the IPO queue grew by two: Aspen Neuroscience (autologous Parkinson's cell therapy sasineprocel) and Bambusa Therapeutics (long acting bispecifics in atopic dermatitis and COPD) both filed Friday per their SEC filings, no terms yet, joining a window that has cleared every recent deal at face value or below.
📋 Quick Hits
AbbVie published new Phase 3 AFFIRM congress data on subcutaneous SKYRIZI induction in Crohn's disease Sunday, reporting higher clinical and endoscopic response rates versus placebo across all efficacy endpoints; the topline dates to March and the US filing to April, so this is congress evidence behind a known result.
Castle Biosciences presented ACG 2026 data showing its TissueCypher test influences clinical management and prompts risk aligned intervention in Barrett's esophagus, a management impact argument rather than a new accuracy claim.
Teva set an R&D Day for November 11 in New York; Weltruza's launch price remained unpublished as of Monday night.
A correction on encaleret: BridgeBio's acceptance release, which we retrieved Monday night, confirms the May 8, 2027 action date but names Fast Track and orphan designations, not the priority review we carried Monday from a wire summary. The date stands; the priority review characterization did not trace to primary and we withdraw it.
Merck's first session after the full BRUNELLO table was flat: MRK closed at 145.45, down 0.1%, with the commercial questions already in the price.
📖 In Today's Full Analysis
Be sure to read the full article for all the details, including:
The complete ANB033 endpoint and safety tables, set against FB102's week old bar
Every EXPAND endpoint, including the biliary atresia native liver subgroup
The MiniMed exchange math, line by line, and what an 18.3% proration says
The day's movers table, from Freenome's 16.2% drop to Bristol Myers' double win paradox
🔒 BioMed Nexus Pro
In Today's Pro Brief...
🧠 One class, two playbooks: how FB102 and ANB033 built the same case with different trials, and which design wins the pivotal era
💊 What Bristol Myers' silence buys: the dose inversion read on admilparant, and why the first alpha Phase 3 makes supply the moat
📊 The exchange that cleared at five to one, and the five questions J&J answers this morning
🎯 Plus the week's coming catalysts, with the full calendar returning in Friday's edition
Four wins, one payment. The market has stopped applauding toplines and started auditing them, and this morning J&J takes the first exam of earnings season. What are you watching? Reply to this email.
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