On January 12, 2021, Aldeyra received from the U.S. Food and Drug Administration (“FDA”) preliminary written comments in preparation for a Pre-IND (“Investigational New Drug”) Type B meeting regarding ADX-2191 for the treatment of primary vitreoretinal lymphoma (“PVRL”), a rare cancer that occurs in the eye. Aldeyra believes the comments indicated that submission of a New Drug Application (“NDA”) for ADX-2191 for the treatment of PVRL may be possible without performing clinical trials. In the first quarter of 2021, Aldeyra expects to hold a teleconference with the FDA to discuss the preliminary written comments and clarify the ADX-2191 NDA submission requirements for the treatment of PVRL. Aldeyra has applied for and expects to receive orphan designation for ADX-2191 for the treatment of PVRL in the first half of 2021.
On January 13, 2021, Aldeyra issued a press release announcing that it intended to make a public offering of its Common Stock. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
On January 13, 2021, Aldeyra issued a press release announcing that it priced a public offering of its Common Stock. A copy of the press release is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Various statements contained in this Current Report on Form 8-K are “forward-looking statements” under the securities laws, including, but not limited to, statements regarding Aldeyra’s plans and expectations for ADX-2191. In some cases, you can identify forward looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “on track,” “scheduled,” “target,” “design,” “estimate,” “predict,” “potential,” “aim,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes