Biotech Stock Roundup: BIIB Halts AD Study, AMGN Posts Positive MM Drug Data & More
Zacks Investment Research | Sep 17, 2019 10:33PM ET
It was a busy week for the biotech sector, with updates from quite a few players. While Amgen (NASDAQ:AMGN) reported positive data on its multiple myeloma drug combination, Biogen’s (NASDAQ:BIIB) studies in Alzheimer’s disease disappointed. Meanwhile, Alder (NASDAQ:ALDR) surged as it signed an acquisition agreement with Danish pharmaceutical company, Lundbeck and Aimmune Therapeutics (NASDAQ:AIMT) got a favorable recommendation from an FDA committee.
Recap of the Week’s Most Important Stories:
Biogen Stops Late-Stage Studies on Alzheimer's Candidate: Biogen and its Japan-based partner Eisai announced that the Allergenic Products Advisory Committee (APAC) convened by the FDA voted in favor of pipeline candidate, Palforzia. The committee supported the use of the drug in children and teens with peanut allergy. The APAC voted in favor of the candidate’s effectiveness in the ratio of 7 to 2. The committee also voted in the ratio of 8 to 1 in favor of the safety data in conjunction with additional safeguards, which are adequate to support the use of the drug. Palforzia, the proposed trade name of AR101, is a complex, biologic oral immunotherapy (OIT) candidate, which is designed to reduce the incidence and severity of allergic reactions.
As part of its original BLA submission, Aimmune has proposed several risk-management measures in line with the recent Advisory Committee discussion. Trading was halted on Sep 13, owing to the scheduled meeting of APAC.
Acceleron Discontinues Mid-Stage Muscular Dystrophy Study: Acceleron Pharma Inc. (NASDAQ:XLRN) announced the discontinuation of a phase II study evaluating its pipeline candidate, ACE-083, in patients with facioscapulohumeral muscular dystrophy (FSHD). Although ACE-083 demonstrated a robust, statistically significant increase in mean total muscle volume (the primary endpoint of the trial), the increase failed to translate to statistically significant improvements in functional tests. The candidate did not achieve functional secondary endpoints in the study either. Consequently, Acceleron discontinued further development of the candidate in FSHD patients.
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Biotech Stock Roundup: AMGN’s Lung Cancer Candidate, ALXN’s Deal With Eidos in Focus )
Stay tuned for more pipeline updates.
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