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Bristol Myers (BMY) Announces Milvexian Phase II Study Results

Bristol Myers Squibb BMY has announced mixed results from the mid-stage AXIOMATIC-SSP dose-ranging study of experimental candidate milvexian.

The data was presented in a Hot Line session at the European Society of Cardiology Congress 2022.

Milvexian is a potential first-in-class oral factor XIa (FXIa) inhibitor (anti-thrombotic) being studied for the prevention and treatment of major thrombotic conditions.

The candidate is being developed in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson JNJ.

AXIOMATIC-SSP is a mid-stage global, randomized, double-blind, placebo-controlled, dose-ranging study that evaluated the efficacy and safety of milvexian for the prevention of new symptomatic ischemic stroke or new covert brain infarction in patients receiving aspirin and clopidogrel following an acute ischemic stroke or transient ischemic attack (TIA).   Approximately 1,242 patients were randomized to receive one of seven regimens of oral milvexian given twice- or once-daily or to receive 40 mg of subcutaneous enoxaparin o.nce-daily.

Study results showed an approximate 30% relative risk reduction in recurrent symptomatic ischemic strokes. It also reflected a favorable safety profile in three arms (either 25, 50 or 100 mg) compared to placebo when used in combination with background antiplatelet therapy in patients with an acute non-cardioembolic ischemic stroke or transient ischemic attack.

The primary objective of this study was to detect a dose response for the composite endpoint of symptomatic ischemic stroke + MRI detected covert brain infarction across a 16-fold dose range. However, a dose response was not observed. In patients treated with milvexian, no fatal bleeding and no increase in symptomatic intracranial hemorrhage were observed.

This is the second study to read out from the AXIOMATIC program and completes milvexian’s phase II development.

Despite the dose response not being observed, Bristol Myers stated that the results from this study (AXIOMATIC-SSP) and the previously reported findings from the phase II study of milvexian in total knee replacement reinforce the candidate’s potential. It also said that a phase III study is expected to be initiated later in the year.

Bristol Myers announced a collaboration with Johnson & Johnson’s Janssen in 2018 to develop and commercialize next-generation cardiovascular therapy.

Shares of Bristol Myers have gained 7.1% in the year so far against the industry’s decline of 23.6%.

 

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The approval of potential new drugs and label expansion of existing drugs will add an incremental revenue stream, which should boost growth in the coming quarters as one of the top drugs, Revlimid, is facing generic competition, which is affecting the top line and will erode sales further.

Bristol Myers currently carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals BOLT and Dynavax DVAX.  Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.

Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.



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