Last updated: October 13, 2026
Four positive readouts landed on October 12: First Tracks’ ANB033 protected celiac patients through a gluten challenge, Mirum’s Livmarli met every Phase 3 EXPAND endpoint, and Bristol Myers Squibb reported wins in pulmonary fibrosis and neuroendocrine tumors, both without figures.
This report covers the trial results, the Medtronic MiniMed exchange outcome, and the market reactions of Monday, October 12, 2026, with primary sourcing throughout.
What did First Tracks’ ANB033 show in celiac disease?
ANB033 kept intestinal damage and symptoms at bay through a two week gluten challenge. The placebo adjusted benefit on the villus height to crypt depth ratio was +0.49 (p=0.009), with intraepithelial lymphocyte density and symptoms also significantly better than placebo.
First Tracks Biotherapeutics (Nasdaq: TRAX) reported Cohort 1 of its randomized, placebo controlled Phase 1b study Monday morning. Patients with celiac disease received three subcutaneous loading doses of ANB033 at Weeks 0, 2, and 4, then ate 6 grams of gluten daily for 14 days, roughly two slices of bread delivered as cookies. Thirty two patients completed dosing and the challenge (17 on ANB033, 15 on placebo); the safety set was 34.
| Endpoint (Week 6, LS mean change) | ANB033 | Placebo | Placebo adjusted | p value |
|---|---|---|---|---|
| Vh:Cd ratio | −0.17 | −0.66 | +0.49 | 0.009 |
| IEL density | −1.20 | +18.83 | −20.03 | <0.001 |
| VCIEL composite | −0.25 | −3.59 | +3.33 | 0.002 |
Symptoms told the same story. Placebo patients deteriorated on the Celiac Disease Symptom Diary while ANB033 patients did not, with statistically significant separation on total score from Day 1 through Day 7 of the challenge and on moderate to severe symptoms from Day 1 through Day 12. Permitted GI rescue medication use was 6% on ANB033 versus 47% on placebo. There were no serious adverse events; moderate adverse events were 16.7% versus 75.0% for placebo, and no ANB033 patient discontinued. Injection site erythema was more common on drug (27.8% versus 12.5%).
ANB033 is a CD122 antagonist that blocks IL-15 and IL-2 signaling. That makes this the second positive celiac readout for the CD122 class in five days, after FB102 hit its Phase 2 endpoint on October 8. The class question we posed Monday morning, class effect or molecule specific, broke decisively toward class effect. ANB033 carries FDA Fast Track designation; First Tracks plans a late stage celiac trial in 2027, expects Cohort 2 topline data (12 week mucosal healing) in the first quarter of 2027, an eosinophilic esophagitis Phase 1b topline in the third quarter of 2027, and Phase 2 starts in vitiligo and one additional indication in the first half of 2027. TRAX closed at 34.05, up 6.9% from Friday (our arithmetic).
What did Mirum’s Phase 3 EXPAND study of Livmarli show?
EXPAND met its primary endpoint and all five prespecified secondary endpoints. Livmarli reduced the pruritus severity score by 1.81 points versus 0.83 for placebo, a treatment difference of 0.98 points (p=0.0004), in children with ultra rare cholestatic liver diseases.
Mirum Pharmaceuticals (Nasdaq: MIRM) released topline results from the Phase 3 EXPAND study of Livmarli (maralixibat) in cholestatic pruritus from ultra rare cholestatic liver diseases, including biliary atresia, on Monday before its 8:30 am ET investor call. The randomized, double blind, placebo controlled study enrolled 52 patients aged 6 months and older (46 pediatric, 6 adult) on maralixibat 285 µg/kg twice daily or placebo for a 20 week double blind period.
| Endpoint | Livmarli | Placebo | Difference | p value |
|---|---|---|---|---|
| ItchRO(Obs) change, Weeks 13 to 20 (pediatric primary) | −1.81 | −0.83 | −0.98 | 0.0004 |
| Days with pruritus improvement (pediatric) | 86.0% | 49.1% | +36.9 pts | 0.0008 |
| Serum bile acid change (overall) | −70.1% | −3.5% | −69.0 pts | <0.0001 |
| ItchRO(Obs), biliary atresia native liver subgroup | −2.16 | −1.01 | −1.15 | 0.0002 |
| Serum bile acids, biliary atresia subgroup | −75.5% | −9.0% | −73.1 pts | <0.0001 |
Safety was consistent with the known profile of an IBAT inhibitor: treatment emergent adverse events were nearly identical between arms (96.0% versus 96.3%), serious events were balanced (20.0% versus 18.5%, none drug related on Livmarli), and the separations were in diarrhea (64.0% versus 11.1%) and abdominal pain (20.0% versus 14.8%). One Livmarli patient (4.0%) discontinued for an adverse event; there were no deaths. Mirum plans a US supplemental new drug application in the first half of 2027.
The market’s response was the notable part: MIRM closed at 86.06, up 0.1% on the day of a clean Phase 3 win. The stock rose 5.7% on Friday before the readout was announced, a move no disclosure explained then or since.
What did Bristol Myers Squibb announce in pulmonary fibrosis?
The Phase 3 ALOFT-IPF trial of admilparant met its primary endpoint at the 60 mg dose, with a statistically significant benefit on forced vital capacity at Week 52. The 120 mg dose slowed decline but did not reach significance. No figures were disclosed.
Admilparant (BMS-986278) is an oral LPA1 antagonist that Bristol Myers Squibb (NYSE: BMY) calls potentially first in class in idiopathic pulmonary fibrosis. ALOFT-IPF (NCT06003426) randomized roughly 1,255 adults aged 40 and older 1:1:1 to 60 mg twice daily, 120 mg twice daily, or placebo for at least 52 weeks. The company said the drug was well tolerated at both doses, with adverse event discontinuations low and similar to placebo, and that it will engage health authorities on planned regulatory submissions. Detailed results go to a future medical meeting. The companion Phase 3 in progressive pulmonary fibrosis, ALOFT-PPF, is fully enrolled with about 1,057 patients and reads out in early 2027.
The dose inversion is the detail to watch. A higher dose that misses while the lower dose hits is a win, but it narrows the filing story to one dose and invites regulator questions about dose response. William Blair reported that management said an acute liver injury case that prompted an earlier protocol amendment occurred in the 120 mg arm and was adjudicated as unlikely related to treatment; the topline release itself did not address liver safety. In its Phase 2 program, Bristol Myers has cited a 62% relative reduction in the rate of lung function decline over 26 weeks in IPF at the 60 mg dose.
What is RYZ101 and what did the ACTION-1 trial show?
RYZ101 is an actinium 225 based radiopharmaceutical. ACTION-1 met its primary endpoint at a planned interim analysis, significantly extending progression free survival versus standard of care in patients with SSTR positive GEP-NETs who progressed after lutetium 177 therapy. No figures were disclosed.
The release calls this the first Phase 3 result for an alpha isotope targeted radiopharmaceutical in any indication. The comparison arm was investigator’s choice: high dose or high frequency somatostatin analogues, everolimus, or sunitinib. Patients had already progressed on lutetium 177 based therapy, meaning RYZ101’s pivotal evidence sits directly downstream of the incumbent isotope rather than beside it. Safety was described as consistent with the known profile; detailed results go to a future meeting, and RayzeBio, the Bristol Myers subsidiary that developed the drug, plans to engage the FDA on a submission. The FDA granted orphan drug designation in gastroenteropancreatic neuroendocrine tumors in August 2026. Roughly 18,000 new US GEP-NET diagnoses occur each year, per the release.
For all the pipeline news, BMY closed at 57.58, down 2.6% on the day. Both releases withheld every efficacy figure, and after last week’s lesson in withheld numbers, the market graded the wins against the roughly $4.1 billion RayzeBio acquisition and the Eliquis and Opdivo exclusivity losses they must eventually offset, figures widely reported but not restated by the company Monday.
What were the results of Medtronic’s MiniMed exchange offer?
The exchange was heavily oversubscribed. Holders tendered 298,024,452 Medtronic shares against 55,032,401 accepted, a preliminary proration of about 18.3%. Medtronic will distribute 252,813,348 MiniMed shares at the final ratio of 4.5939.
Medtronic (NYSE: MDT) announced preliminary results Monday for the exchange offer that completes the MiniMed diabetes split off. The offer expired at midnight on October 9; the final proration factor is expected on October 14. Odd lot holders with fewer than 100 shares who tendered everything are exempt from proration. MiniMed Group lists on Nasdaq as MMED.
| Exchange offer item | Figure |
|---|---|
| Medtronic shares tendered | 298,024,452 |
| Tendered by guaranteed delivery | 93,311,404 |
| Odd lot shares tendered | 757,890 |
| Medtronic shares accepted | 55,032,401 |
| Preliminary proration factor | ~18.3% |
| Exchange ratio | 4.5939 MiniMed per Medtronic share |
| MiniMed shares to be distributed | 252,813,348 |
A tender queue more than five times the acceptance capacity says investors wanted the standalone diabetes company at the offered discount. MDT closed at 91.93, up 3.9% on the day of the announcement.
Why did Freenome’s stock fall 16.2% on Monday?
Freenome (Nasdaq: FRNM) closed at 13.22, down 16.2% from Friday, in the first session after its Sunday announcement that next generation SimpleScreen validation data will be a late breaking oral presentation at ACG 2026 on Wednesday, October 14. No new company disclosure explains the move.
The figures in Sunday’s announcement were the July 9 topline (colorectal cancer sensitivity 80.4%, advanced precancerous lesion sensitivity 18.2%, high grade dysplasia 41.9%, at 90% specificity), not new data. We checked Freenome’s investor page and the wire indexes Monday night and found no additional disclosure. The presentation itself lands Wednesday, with the supplemental PMA filing and Abbott’s $70 million milestone contingent on the next generation test still the thread to watch.
What else happened in biotech and pharma on October 12, 2026?
A direct answer first: a Chinese Phase 2b schizophrenia win surfaced in the US, two biotechs joined the IPO queue, AbbVie put congress data behind a known Crohn’s topline, and Merck’s first session after the full BRUNELLO table was flat.
Tortugas Neuroscience said obuprazine (TRTL-107), a D2/D3 partial agonist and 5-HT2A antagonist licensed from Hansoh Pharma, met the primary endpoint in a 363 patient Phase 2b run by Hansoh in China: every dose cohort beat placebo on PANSS at Day 42, with placebo adjusted reductions of 16.7, 13.2, and 14.7 points across the three dose ranges, per the company’s release as reported by Fierce Biotech. Tortugas, launched in spring 2026 with $106 million and former Sage Therapeutics leadership, plans to seek FDA clearance for a US trial.
The IPO queue grew by two. Aspen Neuroscience, whose autologous Parkinson’s cell therapy sasineprocel converts a patient’s own skin cells into dopamine neurons, and Bambusa Therapeutics, whose long acting bispecific BBT001 targets IL-4Rα and IL-31 in atopic dermatitis, both filed to go public on Friday per their SEC filings, with no terms yet. Aspen held $72.4 million in cash and Bambusa $71.5 million at the end of June. Neither priced; the recent window has cleared deals at face value, with debuts at or below offer.
AbbVie published new Phase 3 AFFIRM data on subcutaneous SKYRIZI induction in Crohn’s disease on Sunday, reporting higher rates of clinical and endoscopic response versus placebo across all efficacy endpoints. The AFFIRM topline dates to March 2026 and the US submission to April; Sunday’s release is congress evidence behind a known result, not a new readout.
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, a date to watch for Weltruza launch detail and Uzedy franchise commentary. Weltruza’s price remains unpublished as of Monday night.
A correction on encaleret. Monday’s edition reported, attributed to a wire carry, that the FDA accepted BridgeBio’s encaleret application with priority review. The acceptance release itself, which we retrieved Monday night, confirms the May 8, 2027 target action date but names Fast Track and orphan drug designations, not priority review, and the roughly ten month review clock is standard timing. The date stands; the priority review characterization did not trace to the primary source and we are withdrawing it.
Merck’s first session after Saturday’s full BRUNELLO table closed at 145.45, down 0.1%: the market had already marked remigromig’s commercial questions into the stock before the data arrived.
Which stocks moved on the day’s news?
Five moves carried a story on Monday. Closes are exchange settled; percentages are our arithmetic versus Friday, October 9.
| Ticker | Close (Oct 12) | Move | Context |
|---|---|---|---|
| FRNM | 13.22 | −16.2% | First session after the ACG late breaker announcement; figures were July vintage; no new disclosure |
| TRAX | 34.05 | +6.9% | ANB033 celiac Phase 1b win; second CD122 class win in five days |
| MDT | 91.93 | +3.9% | MiniMed exchange oversubscribed; ~18.3% preliminary proration |
| BMY | 57.58 | −2.6% | Two pivotal wins announced, both without figures |
| MIRM | 86.06 | +0.1% | Flat on a clean Phase 3 win; Friday’s +5.7% preceded the announcement |
What is coming up this week?
Johnson & Johnson opens the Q3 earnings season Tuesday morning, October 13, per published calendars, the first management to be graded against the capital questions this earnings season raises. Medtronic’s final proration factor is expected October 14, alongside Freenome’s late breaking ACG oral on the next generation SimpleScreen test. TRexBio’s and Retension’s IPO closings are expected on or about October 13.
Frequently asked questions
What is ANB033 and how does it work?
ANB033 is a subcutaneous antibody from First Tracks Biotherapeutics that antagonizes CD122, blocking IL-15 and IL-2 signaling, pathways central to the immune attack on the intestinal lining in celiac disease.
Did ANB033 meet its endpoints in celiac disease?
Yes. In Cohort 1 of its Phase 1b gluten challenge study, ANB033 preserved the villus height to crypt depth ratio (placebo adjusted +0.49, p=0.009), prevented the rise in intraepithelial lymphocytes (p<0.001), and prevented symptom worsening, with no serious adverse events.
How does ANB033 compare with FB102 in celiac disease?
Both are CD122 class antibodies with positive placebo controlled celiac readouts within five days of each other in October 2026. FB102’s Phase 2 hit on Vh:Cd with p=0.0176; ANB033’s Phase 1b hit with p=0.009. Designs differ, so cross trial comparison is indirect.
When will First Tracks start a pivotal celiac trial?
The company expects a late stage celiac trial to start in 2027, with Cohort 2 mucosal healing data due in the first quarter of 2027 and an eosinophilic esophagitis readout in the third quarter of 2027.
What did Mirum’s EXPAND trial test?
EXPAND tested Livmarli (maralixibat) against placebo for 20 weeks in 52 patients aged 6 months and older with cholestatic pruritus from ultra rare cholestatic liver diseases, including biliary atresia.
Did Livmarli work in biliary atresia patients?
In the biliary atresia with native liver subgroup, Livmarli improved the pruritus score by 2.16 points versus 1.01 for placebo (p=0.0002) and cut serum bile acids 75.5% versus 9.0% (p<0.0001).
When will Mirum file for the EXPAND indication?
Mirum plans a US supplemental new drug application in the first half of 2027.
What is admilparant and what did ALOFT-IPF show?
Admilparant is Bristol Myers Squibb’s oral LPA1 antagonist. In the Phase 3 ALOFT-IPF trial in idiopathic pulmonary fibrosis, the 60 mg dose significantly slowed the decline in forced vital capacity at Week 52; the 120 mg dose did not reach significance. Figures were not disclosed.
Why does the admilparant 120 mg miss matter?
It narrows the regulatory story to a single dose and raises dose response questions regulators typically probe. It also matters commercially: the approved IPF drugs are poorly tolerated, so a well tolerated 60 mg dose that works is the whole pitch.
What is RYZ101 and why is the ACTION-1 result notable?
RYZ101 delivers actinium 225, an alpha emitting isotope, to SSTR positive GEP-NETs. ACTION-1 is the first Phase 3 win for any alpha isotope targeted radiopharmaceutical, and it came in patients who had already progressed on lutetium 177 therapy.
What is the MiniMed proration factor?
Preliminarily about 18.3%: holders who tendered Medtronic shares will have roughly 18.3% of them accepted for exchange into MiniMed stock, subject to the final count expected October 14. Odd lot holders who tendered all their shares are exempt.
Why did Freenome fall 16.2% on Monday?
No new company disclosure explains the move. The session followed Sunday’s announcement that next generation SimpleScreen data will be presented at ACG on October 14; the figures in that announcement were the July 2026 topline.
When does Johnson & Johnson report Q3 2026 earnings?
Tuesday morning, October 13, 2026, per published earnings calendars, opening the pharma and medtech Q3 season.
What is the status of BridgeBio’s encaleret application?
The FDA accepted the NDA for encaleret in ADH1 with a target action date of May 8, 2027, per BridgeBio’s acceptance release, which names Fast Track and orphan drug designations. An earlier wire characterization of the review as priority did not trace to the primary source.
What is obuprazine?
Obuprazine (TRTL-107) is a D2/D3 partial agonist and 5-HT2A antagonist licensed by Tortugas Neuroscience from Hansoh Pharma. In a 363 patient Chinese Phase 2b run by Hansoh, all dose cohorts significantly improved PANSS scores at Day 42 versus placebo, per the company’s release as reported by Fierce Biotech.
Sources
Primary sources (October 12, 2026 unless noted): First Tracks Biotherapeutics press release and investor page (ANB033 Cohort 1 results); Mirum Pharmaceuticals press release (EXPAND topline, carried in full); Bristol Myers Squibb press releases (ALOFT-IPF and ACTION-1 topline); Medtronic press release (preliminary exchange offer results); BridgeBio NDA acceptance release, July 22, 2026 (encaleret action date and designations); Freenome July 9, 2026 topline release (SimpleScreen figures); AbbVie press release, October 11, 2026 (AFFIRM congress data); Castle Biosciences press release (TissueCypher ACG data).
Trade and market coverage: Fierce Biotech (Bristol Myers analyst context; Tortugas and Hansoh results; Aspen Neuroscience and Bambusa IPO filings); William Blair commentary as reported by Fierce Biotech (admilparant liver injury adjudication); published earnings calendars (Johnson & Johnson Q3 date). Closing prices are exchange settled closes; percentage moves are our arithmetic.
