That bang you heard last week was the door slamming on Neurochem's
Neurochem had tested KIACTA in one small phase 3 study as a potential treatment for amyloid A amyloidosis, a rare, life-threatening complication that can occur in patients with some types of chronic inflammatory diseases.
A European Union approval for KIACTA was Neurochem's last plausible shot at getting KIACTA approved in a large market. Neurochem still has one more chance with the Swiss health-care authorities, but that country's population -- 7.5 million -- doesn't represent a large market.
KIACTA has been rejected for marketing twice in the U.S., with the latest approvable letter coming in August. Two weeks ago, Neurochem announced that the FDA had accepted KIACTA for review a third time, with a target PDUFA date of April 2 next year.
Neurochem has no ongoing or planned studies to correct the past FDA concerns about KIACTA. Like other drugmakers (such as Neurocrine Biosciences
With KIACTA not being approved any time soon, and Neurochem electing to try to market its other drug candidate Alzhemed as a supplement (good luck), Neurochem's pipeline is left with one early-stage Alzheimer's disease drug candidate.
Neurochem's market capitalization is about $35 million above the $71 million in cash and investments on its balance sheet, but that doesn't include the boatloads of convertible debt that will be turning into shares over the coming years.
Even approaching penny-stock levels, shares of Neurochem are overpriced considering that it has no viable drug candidates anywhere close to approval from the FDA or EMEA.