Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of prime importance as far as pharma/biotech companies are concerned. These companies spend a significant amount on advancing their pipelines.
Last week, Alnylam Pharmaceuticals Inc. (ALNY) initiated the EXPLORE study (n~100) in patients suffering from hepatic porphyrias with a history of recurrent attacks. The prospective, multi-center observational study will primarily characterize the natural history, clinical management and disease burden of patients suffering from hepatic porphyrias. The study will also characterize a number of disease features of hepatic porphyrias.
Alnylam currently has ALN-AS1, a subcutaneously administrated ribo nucleic acid interference (RNAi) therapeutic that targets aminolevulinic acid synthase 1 (ALAS-1), in its pipeline being developed for the treatment of hepatic porphyrias. The company intends to file an investigational new drug application or its equiovalent for the candidate by the end of this year or early next year. Results from the EXPLORE study will help in designing the clinical trials on ALN-AS1.
Alnylam has advanced several candidates in the recent past. Late last month, it initiated the DISCOVERY study (n=1000) evaluating the prevalence of transthyretin (TTR) mutations in patients suspected to be suffering from cardiac amyloidosis. The main objective of the study is to characterize the frequency of TTR mutations (read more: Alnylam Starts New Study on Cardiac Amyloidosis Patients).
Alnylam is yet to have an approved product. With most of its candidates either in the early or mid-stages of development, we expect investor focus to remain on the company’s pipeline. Any hiccups in pipeline development will weigh heavily on the stock.
Alnylam carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Mallinckrodt (MNK), PDL BioPharma, Inc. (PDLI) and Pluristem Therapeutics, Inc. (PSTI). All these stocks hold a Zacks Rank #1 (Strong Buy).
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