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BMY Reports Mixed Phase III Trial Results, Stock Down
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Key Takeaways
Bristol Myers Squibb's admilparant met its primary endpoint at 60 mg but not at the 120-mg dose.
RYZ101 significantly improved progression-free survival in advanced GEP-NETs in the Phase III ACTION-1 trial.
Bristol Myers Squibb will assess admilparant data and expects ALOFT-PPF trial results in early 2027.
Bristol Myers Squibb (BMY - Free Report) announced mixed phase III results for admilparant, its investigational treatment for idiopathic pulmonary fibrosis (IPF).
The company also reported positive results from the phase III ACTION-1 trial evaluating RYZ101 in advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
While RYZ101 met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS), admilparant met its primary endpoint only at the lower of the two doses tested. Consequently, the stock declined following the announcements despite the positive cancer trial results, reflecting investor concerns about admilparant’s inconsistent dose response.
While BMY stock opened higher, it reversed course and ended trading down 2.6% on Oct. 12.
Shares of Bristol Myers have gained 6.8% year to date compared with the industry’s growth of 2.6%.
Image Source: Zacks Investment Research
More on BMY’s Phase III Results Evaluating Admilparant in IPF
Admilparant is an investigational oral lysophosphatidic acid receptor 1 (LPA1) antagonist, which is being evaluated in adults with IPF.
The phase III ALOFT-IPF trial evaluated admilparant at 60-mg and 120-mg doses, administered twice daily for at least 52 weeks, against placebo. Top-line results from the study showed that it met its primary endpoint at the 60-mg dose, with admilparant demonstrating a statistically significant improvement versus placebo in the absolute change in forced vital capacity (FVC) from baseline at week 52.
FVC is an important measure of lung function, and slowing its decline is a key treatment objective in patients with IPF.
The 120-mg dose slowed the decline in FVC but failed to achieve statistical significance.
The mixed results across the two doses have likely disappointed investors, particularly given the positive efficacy signals reported in earlier-stage studies.
In a global phase II trial, treatment with admilparant 60 mg twice daily for 26 weeks reduced the rate of lung function decline by 62% versus placebo in patients with IPF and a 69% reduction in patients with progressive pulmonary fibrosis (PPF).
Although the phase III results support the drug’s potential, the failure of the higher dose to meet statistical significance introduces some uncertainty regarding the consistency of its efficacy.
The safety findings were encouraging. Admilparant demonstrated a well-tolerated safety profile at both doses, with low rates of discontinuation due to adverse events that were similar to placebo.
IPF is characterized by irreversible scarring of lung tissue and a progressive decline in lung function.
BMY will conduct a comprehensive evaluation of the ALOFT-IPF data and engage with health authorities to support planned regulatory submissions.
The company expects top-line results from the fully enrolled phase III ALOFT-PPF trial in early 2027. The outcome will be key to determining whether admilparant can demonstrate broader efficacy across pulmonary fibrosis populations.
Detailed Results of BMY’s Phase III Study on RYZ101
In a separate announcement, BMY reported positive top-line results from the planned interim analysis of the phase III ACTION-1 study evaluating RYZ101 in patients with somatostatin receptor-positive GEP-NETs whose disease had progressed following treatment with Lu177-based therapy.
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS, as assessed by blinded independent central review, compared with investigator’s choice of standard of care. The comparator treatments included high-dose or high-frequency long-acting somatostatin analogues, everolimus or sunitinib. Safety results were consistent with the known safety profile of RYZ101.
RYZ101 is an investigational targeted radiopharmaceutical therapy comprising DOTATATE linked to actinium-225, a potent alpha-emitting radioisotope.
The positive ACTION-1 results mark a milestone for BMY’s radiopharmaceutical portfolio. The study represents the first phase III trial to report results for an alpha-isotope-based targeted radiopharmaceutical therapy in any indication. The findings could support RYZ101’s development as a potential treatment for patients with advanced GEP-NETs who have progressed following a Lu177-based therapy.
The FDA granted RYZ101 Orphan Drug Designation for GEP-NETs in August 2026.
Patients enrolled in the trial will continue to be followed for overall survival.
BMY’s Efforts to Strengthen Portfolio/ Pipeline
BMY is undergoing a meaningful shift in its revenue mix, with its growth portfolio taking on a larger role and increasingly offsetting the pressure from mature products facing generic competition.
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
The company is actively reshaping its portfolio through new approvals, label expansions and pipeline development. The recent pipeline progress has been impressive as well.
The FDA granted accelerated approval to iberdomide, in combination with daratumumab and hyaluronidase-fihj and dexamethasone under the brand name Zenbexus, for adults with multiple myeloma who have received at least one prior line of therapy. Zenbexus is the first FDA-approved cereblon E3 ligase modulator, adding a novel protein-degradation approach to BMY’s oncology portfolio.
The latest clinical updates provide a mixed picture of its pipeline progress. RYZ101’s success in the phase III ACTION-1 study strengthens the company’s radiopharmaceutical prospects. However, admilparant’s mixed dose-level results in the phase III ALOFT-IPF trial introduce uncertainty, despite the statistically significant benefit demonstrated at the 60-mg dose and the favorable safety profile at both doses.
Meanwhile, shares of Contineum Therapeutics (CTNM - Free Report) plunged 36% following BMY’s announcement.
BMY’s IPF study results create uncertainty for CTNM’s investigational candidate PIPE-79 for IPF.
Contineum is evaluating PIPE-791 in a phase II study.
Over the past 60 days, loss per share estimates for Amarin have narrowed from 65 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 51 cents to 50 cents.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 62.27%.
Over the past 60 days, earnings per share estimates for Corcept Therapeutics have increased from $1.13 to $1.86 for 2026. Over the same period, estimates for 2027 earnings per share have risen from $2.35 to $3.48.
Corcept Therapeutics’ earnings missed estimates in two of the trailing four quarters, beat in one and met in the other, with the average surprise being 240.74%.
View the Zacks #1 Rank List
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BMY Reports Mixed Phase III Trial Results, Stock Down
Key Takeaways
Bristol Myers Squibb (BMY - Free Report) announced mixed phase III results for admilparant, its investigational treatment for idiopathic pulmonary fibrosis (IPF).
The company also reported positive results from the phase III ACTION-1 trial evaluating RYZ101 in advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
While RYZ101 met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS), admilparant met its primary endpoint only at the lower of the two doses tested. Consequently, the stock declined following the announcements despite the positive cancer trial results, reflecting investor concerns about admilparant’s inconsistent dose response.
While BMY stock opened higher, it reversed course and ended trading down 2.6% on Oct. 12.
Shares of Bristol Myers have gained 6.8% year to date compared with the industry’s growth of 2.6%.
Image Source: Zacks Investment Research
More on BMY’s Phase III Results Evaluating Admilparant in IPF
Admilparant is an investigational oral lysophosphatidic acid receptor 1 (LPA1) antagonist, which is being evaluated in adults with IPF.
The phase III ALOFT-IPF trial evaluated admilparant at 60-mg and 120-mg doses, administered twice daily for at least 52 weeks, against placebo. Top-line results from the study showed that it met its primary endpoint at the 60-mg dose, with admilparant demonstrating a statistically significant improvement versus placebo in the absolute change in forced vital capacity (FVC) from baseline at week 52.
FVC is an important measure of lung function, and slowing its decline is a key treatment objective in patients with IPF.
The 120-mg dose slowed the decline in FVC but failed to achieve statistical significance.
The mixed results across the two doses have likely disappointed investors, particularly given the positive efficacy signals reported in earlier-stage studies.
In a global phase II trial, treatment with admilparant 60 mg twice daily for 26 weeks reduced the rate of lung function decline by 62% versus placebo in patients with IPF and a 69% reduction in patients with progressive pulmonary fibrosis (PPF).
Although the phase III results support the drug’s potential, the failure of the higher dose to meet statistical significance introduces some uncertainty regarding the consistency of its efficacy.
The safety findings were encouraging. Admilparant demonstrated a well-tolerated safety profile at both doses, with low rates of discontinuation due to adverse events that were similar to placebo.
IPF is characterized by irreversible scarring of lung tissue and a progressive decline in lung function.
BMY will conduct a comprehensive evaluation of the ALOFT-IPF data and engage with health authorities to support planned regulatory submissions.
The company expects top-line results from the fully enrolled phase III ALOFT-PPF trial in early 2027. The outcome will be key to determining whether admilparant can demonstrate broader efficacy across pulmonary fibrosis populations.
Detailed Results of BMY’s Phase III Study on RYZ101
In a separate announcement, BMY reported positive top-line results from the planned interim analysis of the phase III ACTION-1 study evaluating RYZ101 in patients with somatostatin receptor-positive GEP-NETs whose disease had progressed following treatment with Lu177-based therapy.
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS, as assessed by blinded independent central review, compared with investigator’s choice of standard of care. The comparator treatments included high-dose or high-frequency long-acting somatostatin analogues, everolimus or sunitinib. Safety results were consistent with the known safety profile of RYZ101.
RYZ101 is an investigational targeted radiopharmaceutical therapy comprising DOTATATE linked to actinium-225, a potent alpha-emitting radioisotope.
The positive ACTION-1 results mark a milestone for BMY’s radiopharmaceutical portfolio. The study represents the first phase III trial to report results for an alpha-isotope-based targeted radiopharmaceutical therapy in any indication. The findings could support RYZ101’s development as a potential treatment for patients with advanced GEP-NETs who have progressed following a Lu177-based therapy.
The FDA granted RYZ101 Orphan Drug Designation for GEP-NETs in August 2026.
Patients enrolled in the trial will continue to be followed for overall survival.
BMY’s Efforts to Strengthen Portfolio/ Pipeline
BMY is undergoing a meaningful shift in its revenue mix, with its growth portfolio taking on a larger role and increasingly offsetting the pressure from mature products facing generic competition.
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
Bristol Myers Squibb Company price-consensus-eps-surprise-chart | Bristol Myers Squibb Company Quote
The company is actively reshaping its portfolio through new approvals, label expansions and pipeline development.
The recent pipeline progress has been impressive as well.
The FDA granted accelerated approval to iberdomide, in combination with daratumumab and hyaluronidase-fihj and dexamethasone under the brand name Zenbexus, for adults with multiple myeloma who have received at least one prior line of therapy. Zenbexus is the first FDA-approved cereblon E3 ligase modulator, adding a novel protein-degradation approach to BMY’s oncology portfolio.
The latest clinical updates provide a mixed picture of its pipeline progress. RYZ101’s success in the phase III ACTION-1 study strengthens the company’s radiopharmaceutical prospects. However, admilparant’s mixed dose-level results in the phase III ALOFT-IPF trial introduce uncertainty, despite the statistically significant benefit demonstrated at the 60-mg dose and the favorable safety profile at both doses.
Meanwhile, shares of Contineum Therapeutics (CTNM - Free Report) plunged 36% following BMY’s announcement.
BMY’s IPF study results create uncertainty for CTNM’s investigational candidate PIPE-79 for IPF.
Contineum is evaluating PIPE-791 in a phase II study.
BMY’s Zacks Rank and Stocks to Consider
BMY currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Amarin (AMRN - Free Report) and Corcept Therapeutics (CORT - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, loss per share estimates for Amarin have narrowed from 65 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 51 cents to 50 cents.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 62.27%.
Over the past 60 days, earnings per share estimates for Corcept Therapeutics have increased from $1.13 to $1.86 for 2026. Over the same period, estimates for 2027 earnings per share have risen from $2.35 to $3.48.
Corcept Therapeutics’ earnings missed estimates in two of the trailing four quarters, beat in one and met in the other, with the average surprise being 240.74%.