Memory Pharmaceuticals (MEMY) put a clinical trial for its Alzheimer's drug on hold to answer Food and Drug Administration questions.
The Montvale, N.J., company also raised $26.7 million in a private investment in public equity, or PIPEs, deal.
Memory said the FDA told the company it won't review toxicology reports submitted with its investigational new drug application until it receives "further explanations of revisions that were made to those reports since they were submitted with the Company's first IND for this trial in May."
Memory said the FDA also deferred assessment of the adequacy of the Investigator's Brochure for the trial pending submission of the additional information. It believes that no additional studies or data will be required to address the FDA's questions and that, as a result, it should be able to provide to the FDA, by early November, the information necessary to facilitate the FDA's review.
Memory also closed the first tranche of its private placement of common stock. It issued 23.2 million shares of common stock and warrants for the purchase of approximately 7.1 million additional shares of common stock at an exercise price of $1.33 per share. The closing of the second tranche, which is expected to raise an additional $5.5 million through the sale of approximately 5 million newly issued shares, is subject to stockholder approval. The company intends to call a special stockholders meeting to approve the second tranche as soon as practicable.