In prior articles on Amicus Therapeutics (NASDAQ:FOLD) I spoke of the significant value creation potential of successful clinical trials. If Amicus could show investors
that its lead drug migalastat was both safe and effective as a
treatment for Fabry disease, the market would reward the company with a
substantially higher valuation.
That has happened. Data from the
'012 study and additional extension data from the '011 study have
established that migalastat offers comparable efficacy to enzyme
replacement therapy (or ERT) and meaningful benefits to cardiac and
renal function. While the path to FDA approval is still a little murky,
investors should have more information relatively soon and I believe the
odds now favor approval and commercial success - at least in a subset
of patients with amenable mutations. Migalastat's future as a part of
combo therapy is still uncertain, but offers further upside, as do
clinical programs in Pompe's disease and MPS-1.
Amicus
Therapeutics has risen more than 160% over the past year, but still
looks undervalued on the basis of its market potential in Fabry disease.
With a more convenient administration (it's an oral medication) and a
potential safety benefit, there could be still more upside from pricing
and/or market share. Value creation through de-risking the Pompe and
MPS-1 programs is certainly still possible (positive data will support
higher odds of regulatory/commercial success), but those events are
further off.
Read the full article here:
Amicus Therapeutics Has Driven Value Through The Clinic
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