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This was a low-key week for the biotech sector before the onset of the first-quarter earnings season. Biotech giant Bristol Myers Squibb BMY was down on data from the schizophrenia study while Regeneron REGN was in the spotlight on updates on key drugs.
Recap of the Week’s Most Important Stories:
BMY Stock Down on Study Data
Bristol Myers announced disappointing top-line results from the phase III ARISE study on schizophrenia drug Cobenfy (xanomeline and trospium chloride). The study is evaluating the efficacy and safety of Cobenfy as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia.
Treatment with Cobenfy as an adjunctive demonstrated a 2.0-point reduction in the Positive and Negative Syndrome Scale total score compared to placebo with an atypical antipsychotic at week six. However, this data did not reach the threshold for statistical significance for the primary endpoint. Shares of BMY were down following the data announcement.
Preliminary analyses suggest that Cobenfy as an adjunctive treatment to an atypical antipsychotic was associated with improvements in symptoms of schizophrenia compared to placebo plus an atypical antipsychotic for certain patients.
Last week, BMY announced that the FDA updated the label for the heart disease drug Camzyos. The label updates include simplified twice-yearly echo monitoring for eligible CAMZYOS patients in the maintenance phase and expanded patient eligibility with reduced contraindications.
Updates From REGN
Regeneron announced a significant expansion of its manufacturing capacity in the United States through a new agreement with FUJIFILM Diosynth Biotechnologies. Per the agreement, Regeneron will nearly double its large-scale manufacturing capacity in the United States by accessing Fujifilm’s new state-of-the-art biopharmaceutical facility. The total investment is estimated to exceed $3 billion.
Last week, Regeneron announced that the FDA has issued a complete response letter (CRL) to the company’s supplemental biologics license application (sBLA) seeking addition of extended dosing intervals (up to every 24 weeks) for Eylea HD (aflibercept) Injection 8 mg across all approved indications.
While the CRL did not identify any issue with the safety or efficacy of EYLEA HD in its approved indications and dosing regimens, the FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label).
The regulatory body accepted Regeneron’s sBLA seeking approval of Eylea HD for both the treatment of macular edema following retinal vein occlusion, and for broadening the dosing schedule to include every four-week (monthly) dosing across approved indications. The target action date is Aug. 19, 2025, following the use of a Priority Review voucher.