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BMY Gains on News of Continuation of Alzheimer's Disease Study
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Key Takeaways
BMY gained after opting to continue the phase III ADEPT-2 study on Cobenfy for Alzheimer's psychosis.
The decision followed data review, FDA consultation and a DMC recommendation to enroll more patients.
BMY excluded data from select sites over execution issues and remains blinded as enrollment continues.
Shares of Bristol Myers Squibb (BMY - Free Report) gained 5.62% after the company announced the continuation of the phase III ADEPT-2 study on Cobenfy in psychosis associated with Alzheimer's disease.
The news cheered the investors, as most of them likely expected that the company would announce the failure of the study.
The decision to continue the study follows review of site-level data and the recommendation of the data monitoring committee.
BMY had expected to announce data from the ADEPT-2 study by the end of this year. This readout is now postponed to next year.
Nonetheless, the decision to continue with the study still appeased the investors.
Shares of Bristol Myers have lost 9.9% year to date against the industry’s growth of 19.9%.
Image Source: Zacks Investment Research
More on BMY’s Decision to Continue ADEPT-2 Study
The late-stage ADEPT-2 is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Cobenfy in patients with psychosis associated with Alzheimer’s disease dementia.
The trial is designed to evaluate the primary endpoint of change in the Neuropsychiatric Inventory-Clinician (NPI-C) Hallucinations and Delusions (H+D) score, as well as the key secondary endpoint of Clinical Global Impression-Severity (CGI-S). It also includes additional assessments of the safety and tolerability of Cobenfy compared with placebo.
BMY identified irregularities due to clinical trial execution at a small number of study sites following a thorough blinded review of the ADEPT-2 study data.
The company decided to exclude patient data from those sites from the primary analysis prior to database lock.
Post consultation and agreement with the FDA, an independent party conducted an interim efficacy and safety analysis, which was then reviewed by the DMC.
The DMC recommended that the study continue by enrolling additional patients to the original target study population. Consequently, Bristol Myers will continue patient enrollment and advance the program as advised by the DMC.
BMY remains blinded to the study data.
Please note that Cobenfy is currently approved for the treatment of schizophrenia in adults.
Additional trial results from the ADEPT program evaluating psychosis associated with Alzheimer’s disease — including ADEPT-2, ADEPT-1 and ADEPT-4 — are anticipated by the end of 2026.
BMY Is Looking to Diversify Portfolio
Bristol Myers is looking to expand its pipeline/portfolio, as the legacy portfolio is being adversely impacted due to the continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane.
BMY’s Growth Portfolio, comprising drugs like Opdivo, Opdivo Qvantig, Reblozyl, Breyanzi, Camzyos and Opdualag, among others, has stabilized its revenue base amid generic competition for its legacy drugs.
The approval of Cobenfy (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults, has diversified the portfolio further. Cobenfy represents the first new pharmacological approach to treating schizophrenia in decades. The initial uptake is encouraging, with sales of $105 million year to date.
The drug is anticipated to become a meaningful growth driver for BMY’s top line as it pursues label expansions across new indications.
In October, the FDA granted Fast Track Designation to BMS-986446, a potential best-in-class anti-microtubule binding region-tau (anti-MTBR-tau) antibody. The candidate is currently in phase II development for the treatment of early Alzheimer’s disease.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has risen 20.8% year to date. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.4%.
In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 34 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 69 cents. Year to date, shares of FOLD have gained 3.8%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.28 to $7.29 for 2025. During the same time, EPS estimates for 2026 have increased from $7.78 to $7.81. Year to date, shares of ANIP have rallied 49.5%. ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 21.24%.
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BMY Gains on News of Continuation of Alzheimer's Disease Study
Key Takeaways
Shares of Bristol Myers Squibb (BMY - Free Report) gained 5.62% after the company announced the continuation of the phase III ADEPT-2 study on Cobenfy in psychosis associated with Alzheimer's disease.
The news cheered the investors, as most of them likely expected that the company would announce the failure of the study.
The decision to continue the study follows review of site-level data and the recommendation of the data monitoring committee.
BMY had expected to announce data from the ADEPT-2 study by the end of this year. This readout is now postponed to next year.
Nonetheless, the decision to continue with the study still appeased the investors.
Shares of Bristol Myers have lost 9.9% year to date against the industry’s growth of 19.9%.
Image Source: Zacks Investment Research
More on BMY’s Decision to Continue ADEPT-2 Study
The late-stage ADEPT-2 is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Cobenfy in patients with psychosis associated with Alzheimer’s disease dementia.
The trial is designed to evaluate the primary endpoint of change in the Neuropsychiatric Inventory-Clinician (NPI-C) Hallucinations and Delusions (H+D) score, as well as the key secondary endpoint of Clinical Global Impression-Severity (CGI-S). It also includes additional assessments of the safety and tolerability of Cobenfy compared with placebo.
BMY identified irregularities due to clinical trial execution at a small number of study sites following a thorough blinded review of the ADEPT-2 study data.
The company decided to exclude patient data from those sites from the primary analysis prior to database lock.
Post consultation and agreement with the FDA, an independent party conducted an interim efficacy and safety analysis, which was then reviewed by the DMC.
The DMC recommended that the study continue by enrolling additional patients to the original target study population. Consequently, Bristol Myers will continue patient enrollment and advance the program as advised by the DMC.
BMY remains blinded to the study data.
Please note that Cobenfy is currently approved for the treatment of schizophrenia in adults.
Additional trial results from the ADEPT program evaluating psychosis associated with Alzheimer’s disease — including ADEPT-2, ADEPT-1 and ADEPT-4 — are anticipated by the end of 2026.
BMY Is Looking to Diversify Portfolio
Bristol Myers is looking to expand its pipeline/portfolio, as the legacy portfolio is being adversely impacted due to the continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane.
BMY’s Growth Portfolio, comprising drugs like Opdivo, Opdivo Qvantig, Reblozyl, Breyanzi, Camzyos and Opdualag, among others, has stabilized its revenue base amid generic competition for its legacy drugs.
The approval of Cobenfy (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults, has diversified the portfolio further. Cobenfy represents the first new pharmacological approach to treating schizophrenia in decades. The initial uptake is encouraging, with sales of $105 million year to date.
The drug is anticipated to become a meaningful growth driver for BMY’s top line as it pursues label expansions across new indications.
In October, the FDA granted Fast Track Designation to BMS-986446, a potential best-in-class anti-microtubule binding region-tau (anti-MTBR-tau) antibody. The candidate is currently in phase II development for the treatment of early Alzheimer’s disease.
BMY’s Zacks Rank & Stocks to Consider
BMY currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) , Amicus Therapeutics (FOLD - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has risen 20.8% year to date. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.4%.
In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 34 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 69 cents. Year to date, shares of FOLD have gained 3.8%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.28 to $7.29 for 2025. During the same time, EPS estimates for 2026 have increased from $7.78 to $7.81. Year to date, shares of ANIP have rallied 49.5%. ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 21.24%.