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Bristol Myers' lung pill won at 60 mg. The doubled 120 mg dose fell short.

Bristol Myers said its lung-fibrosis pill beat placebo at 60 mg in a 1,255-patient trial. Its Oct. 12 release gives no size for the benefit, calls the drug well tolerated, and has no word on liver cases BioPharma Dive reported.

KeyVex News··5 min readFact-checked against 5 public records
KeyVex News··5 min readFact-checked against 5 public records
BMY$59.12▼ 0.8%Close, Oct. 9. Prices from Tiingo.
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  1. In an earlier, smaller trial, 30 mg twice a day did no better than placebo; its authors concluded 60 mg slowed decline. The big trial kept 60 mg and added 120 mg.
  2. Only 60 mg cleared the bar. The 120 mg dose slowed decline too, but not by a statistically significant margin: the gap could be chance, so it does not count as a win.
  3. The release says the trial met its goal, not by how much. On safety it calls the drug "well-tolerated" and says side-effect dropouts were "low and similar to placebo."
  4. On Sept. 30, BioPharma Dive reported that a spokesperson confirmed liver-related events, including a death, and said it is unclear whether that patient got the drug. The release does not mention the liver.
  5. Bristol Myers reports third-quarter results Oct. 29. Full trial data go to a medical meeting it has not dated.

The result: Bristol Myers Squibb said before the market opened on Oct. 12 that its pill admilparant met its main goal in a Phase 3 trial in idiopathic pulmonary fibrosis, a disease that scars the lungs.ReleaseInvesting.com The win came at 60 mg twice a day, the dose an earlier, smaller trial's authors said slowed decline.Phase 2 The doubled dose, 120 mg, "slowed the decline" but "was not statistically significant," the company said.Release

The gap: The release says how the trial came out, not by how much: it gives no lung-capacity figure for either dose. Its chief medical officer, Cristian Massacesi, describes admilparant as "a promising, clinically meaningful investigational therapy for IPF." On safety, it calls the drug's profile "well-tolerated" across both doses and says discontinuations due to side effects were "low and similar to placebo." It does not mention the liver.Release

Why it matters: Twelve days earlier, a company spokesperson confirmed a "limited number" of liver-related safety events in testing of admilparant, including a patient's death, BioPharma Dive reported on Sept. 30. The spokesperson said it was unclear whether that patient received the drug.BioPharma Dive So how much the drug helps, and how safe it is, cannot yet be read from Bristol Myers' own numbers.Release

The stock: Bristol Myers closed at $59.12 on Oct. 9, the last close before the results.Prices Investing.com reported the shares up 5.7% before the open on Oct. 12, after this result and a second Phase 3 win that morning, in a cancer drug called RYZ101.Investing.com By 10:41 a.m. Eastern, the stock traded at $57.12, down about 3.4% from the Oct. 9 close, in Tiingo's IEX quote.Quote

Bristol Myers' stock and the trial's key datesDaily close, July 1 to Oct. 9, 2026 ▲ 4.7%Show chartHide chart
Bristol Myers' stock and the trial's key datesDaily close as traded. Numbered dots mark the story's key dates, not what moved the stock. Story shows July 1 to Oct. 9, 2026, the last close before the results; switch ranges, compare with the S&P 500, or show the filing markers from KeyVex's Bristol Myers page.
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Daily closes as traded · Close Prices from Tiingo.comColored dots are filings · White numbered dots are the news in this story · BMY on KeyVex
  1. 1Sept. 29, 2026 Shares fall late in the day. Bristol Myers and Contineum shares fell sharply late in the day and rebounded early the next, BioPharma Dive reported. Close: $62.86.
  2. 2Sept. 30, 2026 Bristol Myers confirms a death in testing. A spokesperson confirmed a "limited number" of liver-related events, including a patient death, and said it is unclear whether the patient received admilparant, BioPharma Dive reported. Close: $62.40.
  3. 3Oct. 9, 2026 Last close before the results. The ALOFT-IPF topline came out before the market opened on Oct. 12. Close: $59.12.
View the data (71 trading days)
DateCloseDay change
2026-10-09$59.12−0.8%
2026-10-08$59.58−0.2%
2026-10-07$59.70+0.2%
2026-10-06$59.59+1.3%
2026-10-05$58.81−3.8%
2026-10-02$61.15−0.5%
2026-10-01$61.46−1.5%
2026-09-30$62.40−0.7%
2026-09-29$62.86−1.6%
2026-09-28$63.88+1.6%
2026-09-25$62.86+2.2%
2026-09-24$61.50+0.6%
2026-09-23$61.15−1.8%
2026-09-22$62.25−0.6%
2026-09-21$62.62−0.7%
2026-09-18$63.06+0.4%
2026-09-17$62.84−1.2%
2026-09-16$63.60−0.2%
2026-09-15$63.73−0.6%
2026-09-14$64.10+0.7%
2026-09-11$63.64−0.2%
2026-09-10$63.75−1.0%
2026-09-09$64.41−0.4%
2026-09-08$64.69−3.2%
2026-09-04$66.82−1.9%
2026-09-03$68.09+0.6%
2026-09-02$67.66+1.1%
2026-09-01$66.92+0.2%
2026-08-31$66.81+0.3%
2026-08-28$66.58−0.6%
2026-08-27$66.95−0.9%
2026-08-26$67.57−0.5%
2026-08-25$67.92+1.0%
2026-08-24$67.28+0.4%
2026-08-21$67.01+2.4%
2026-08-20$65.47−3.2%
2026-08-19$67.61+2.4%
2026-08-18$66.05+2.2%
2026-08-17$64.63+1.3%
2026-08-14$63.83−1.3%
2026-08-13$64.65+1.5%
2026-08-12$63.70+0.1%
2026-08-11$63.61−1.9%
2026-08-10$64.84+0.2%
2026-08-07$64.72+0.9%
2026-08-06$64.15+0.8%
2026-08-05$63.63−3.4%
2026-08-04$65.89+0.6%
2026-08-03$65.47+0.2%
2026-07-31$65.31+0.7%
2026-07-30$64.86+2.8%
2026-07-29$63.10−0.8%
2026-07-28$63.60+1.7%
2026-07-27$62.56+0.8%
2026-07-24$62.09+0.9%
2026-07-23$61.51+1.2%
2026-07-22$60.76−0.3%
2026-07-21$60.93+1.3%
2026-07-20$60.16−1.0%
2026-07-17$60.74+0.4%
2026-07-16$60.51+3.0%
2026-07-15$58.72+3.1%
2026-07-14$56.95−4.0%
2026-07-13$59.34+3.1%
2026-07-10$57.58−0.6%
2026-07-09$57.94+0.7%
2026-07-08$57.54−0.7%
2026-07-07$57.97+2.2%
2026-07-06$56.70−2.5%
2026-07-02$58.13+3.0%
2026-07-01$56.44

As of the Oct. 9 close, $59.12. Source: Tiingo end-of-day closes, as traded, via KeyVex.

Where the two doses came from

In a Phase 2 trial, the mid-stage test before a drug's final round, Bristol Myers tried 30 mg and 60 mg twice a day for 26 weeks. The results were published in February 2025.Phase 2 Among about 280 IPF patients, lung capacity fell 2.7 points of its predicted normal value on placebo, 2.8 on 30 mg and 1.2 on 60 mg.Phase 2Chart data The 30 mg dose did no better than placebo. The authors concluded that 60 mg slowed lung function decline, though in the IPF group alone the paper's 95% confidence range for the gap, -0.1 to 3.0 points, spans zero, so no difference cannot be ruled out.Phase 2

In Phase 2's IPF group, 60 mg showed the smallest decline; 30 mg matched placeboPoints of predicted lung capacity (FVC) lost over 26 weeks, by arm. Lower is better.
View the data
ArmLung capacity lost over 26 weeksNote
Placebo (IPF cohort)2.7 ptsRate of change in percent of predicted FVC over 26 weeks: -2.7%
Admilparant 30 mg (twice daily)2.8 pts-2.8%
Admilparant 60 mg (twice daily)1.2 pts-1.2%. The 60 mg dose is the one that met the Phase 3 goal on Oct. 12, 2026

Source: Phase 2 trial of admilparant, IPF cohort (n = 278 randomized), Am J Respir Crit Care Med, February 2025.

For Phase 3, the company kept 60 mg and added 120 mg, double it. Both Phase 3 trials, in IPF and in a related disease called progressive pulmonary fibrosis, test the two doses against placebo for at least 52 weeks.Release The IPF trial, called ALOFT-IPF, enrolled 1,255 adults. Its main efficacy goal is the change in forced vital capacity, a lung-capacity measure, in millilitres up to week 52, the federal trial registry shows.Registry

What the liver cases were

The liver questions surfaced in a change to the trial program. In May, Bristol Myers submitted an amendment for its European sites to the long-term safety study that follows patients from its Phase 3 Aloft trial, BioPharma Dive reported.BioPharma Dive It called liver injury a "newly classified important potential risk" and required closer monitoring of patients with high liver enzymes, the outlet reported.BioPharma Dive

Most of the events were "mild, transient, or demonstrated patterns consistent with hepatic adaptation," the amendment said, according to BioPharma Dive. The patient who died had multi-organ failure, with liver damage, and had underlying lung disorders and other complications, the outlet reported. Outside monitors who review unblinded safety data have each time recommended the study continue, the spokesperson said.BioPharma Dive

Admilparant blocks a receptor called LPA1.Release The class has a past: Bristol Myers dropped an earlier drug that works the same way because of liver toxicity, BioPharma Dive reported.BioPharma Dive Analysts quoted by the outlet read the new cases two ways. RBC Capital Markets analyst Brian Abrahams wrote that the news is "likely to reaffirm historical concerns around liver toxicity" for the class. He added there are "too many variables to conclude" whether there is a true signal. "It may not be a drug-related issue, let alone an LPA1-class issue," Leerink Partners analyst Roanna Ruiz wrote.BioPharma Dive

Shares of Contineum Therapeutics, which is developing a similar drug, fell sharply late on Sept. 29 and rebounded early the next day, BioPharma Dive reported.BioPharma Dive They closed down about 10% on Sept. 29 and up about 17% on Sept. 30.Prices Analysts called the brief pullback in both stocks "overdone," the outlet reported.BioPharma Dive

What comes next

Bristol Myers says it will finish evaluating the data, talk with health authorities about planned filings for approval, and present detailed results "at a future medical meeting." It gave no date.Release The second Phase 3 trial, in about 1,057 patients with progressive pulmonary fibrosis, is fully enrolled. Its topline results are due in early 2027.ReleaseRegistry

As of Oct. 12, Bristol Myers had published no figure for the benefit at either dose.Release Its spokesperson had said it is unclear whether the patient who died received the drug, BioPharma Dive reported.BioPharma Dive

What to watch

  1. Bristol Myers reports third-quarter results, with a call at 8 a.m. Eastern.

  2. Topline results from ALOFT-PPF, the second Phase 3 trial, in progressive pulmonary fibrosis.

  3. Detailed ALOFT-IPF results, including the size of the effect at each dose, at a future medical meeting.

Sources

10 sources, 5 of them public records

How we got these numbers

  • Prices are end-of-day closes as traded, not adjusted for dividends. Daily moves are close to close. The chart ends at the Oct. 9, 2026 close, the last before the results; the Oct. 12 figures are Investing.com's premarket report and one intraday IEX quote (last trade $57.12 at 10:41 a.m. Eastern against the $59.12 close, down 3.38%), not a close. Every Bristol Myers close in the chart's Story range is in its data table. The S&P 500 and Nasdaq 100 lines follow SPY and QQQ, also as traded, rebased to Bristol Myers' close at the start of the range shown. The Filings switch shows the filing markers from KeyVex's Bristol Myers stock page, a selection of congressional trades, insider sales, Form 144 notices, 8-Ks and lobbying filings: not every filing, and not only those tied to this story.
  • The Phase 2 figures are the rates of change in percent of predicted forced vital capacity over 26 weeks in the IPF cohort, as the published abstract reports them (placebo -2.7%, 30 mg -2.8%, 60 mg -1.2%). The chart shows the size of each decline. In the IPF cohort the paper gives the gap between 60 mg and placebo as 1.4 points, with a 95% confidence interval of -0.1 to 3.0, and concludes that 60 mg slowed lung function decline. Phase 2 and Phase 3 measure lung capacity differently (percent of predicted versus millilitres) and run for different lengths, so the Phase 2 numbers are not a forecast of the Phase 3 effect.
  • Contineum's moves are from KeyVex's as-traded closes: $12.73 on Sept. 28, $11.50 on Sept. 29 (down 9.7%) and $13.42 on Sept. 30 (up 16.7%).
  • The liver-safety details come from BioPharma Dive's Sept. 30, 2026 report, which quotes a Bristol Myers spokesperson and the European protocol amendment. KeyVex did not obtain the amendment itself.

How KeyVex News works. Our stories are researched, drafted and checked with AI tools from public records. Every figure is checked against the filing it cites, and each story passes a final review before publication. Corrections are made in place and noted at the top of the story.

KeyVex News reports on public records. Nothing here is investment advice or a recommendation to buy or sell any security. Close prices from Tiingo.com.

The image shown with this story is AI-generated.

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