Earnings Updates, In Brief: Alkermes, Celldex, Jazz, United Therapeutics, Bayer
Alkermes discontinues development of a Phase I pain drug but is on track with schizophrenia drug launch; Celldex gains “breakthrough” designation for rindopepimut; Jazz halts a mid-stage trial due to safety issues; United Therapeutics talks up PAH drug; and Bayer CEO slams German government for lack of VC support.
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Celldex Therapeutics will initiate Phase I/II trials of its immunotherapy varlilumab in combination with Bristol’s PD-1 inhibitor nivolumab this year and is exploring multiple other combinations.
FDA labeling for just-approved pulmonary arterial hypertension drug Orenitram (treprostinil) suggests the oral drug could replace United Therapeutics’ other formulations, though it was not specifically studied for that. Company says it was surprised by the approval, which came well ahead of the user fee date, and plans to launch in six months.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.