{"url_path":"/sec/eltp/8-k/2026-06-15/item-7-01","section_key":"item-7-01","section_title":"Item 7.01 Regulation FD Disclosure.**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-15","source_url":"https://www.sec.gov/Archives/edgar/data/1053369/0001493152-26-028610-index.html","accession_number":"0001493152-26-028610","cik":"0001053369","ticker":"ELTP","issuer_name":"ELITE PHARMACEUTICALS INC /NV/","edgar_url":"https://www.sec.gov/Archives/edgar/data/1053369/0001493152-26-028610-index.html","primary_entity_key":"0001053369","primary_entity_name":"ELITE PHARMACEUTICALS INC /NV/"},"word_count":428,"has_tables":true,"body_markdown":"**Item\n7.01 Regulation FD Disclosure.**\n\n \n\nIn\na press release on June 15, 2026, Elite Pharmaceuticals, Inc., or Elite, reported positive results from a pivotal bioequivalence study\nfor an undisclosed generic drug product in a class of medications called anticonvulsants. The results indicate that the generic product\nis bioequivalent to the branded product.\n\n \n\nThe\nstudies conducted were open-label, randomized, balanced, single oral dose, two-treatment, two-period, two-sequence, crossover bioequivalence\nstudies in normal, healthy, adult, human subjects under fasting conditions. The results indicated that the generic product is bioequivalent\nto the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and\nDrug Administration.\n\n \n\nA\ncopy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01\nand contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the\nSecurities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of Elite’s filings\nunder the Securities Act of 1933, as amended, or the Securities Act, or the Exchange Act, whether made before or after the date hereof,\nexcept as shall be expressly set forth by specific reference in any such filing.\n\n \n\n**Caution\nConcerning Forward-Looking Statements**\n\n****\n\n \n\nThis\nCurrent Report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of\n1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation\nto the subject matter of this current report, readers are cautioned that such forward-looking statements involve risks and uncertainties\nincluding, without limitation, Elite’s ability to obtain FDA approval of the ANDA or the timing of such approval process, delays,\nuncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results,\nperformance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied\nby these forward-looking statements. These forward-looking statements are not guarantees of future action or performance, the timing\nor results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory\nauthorities, intellectual property protections and defenses, are discussed in Elite’s filings with the Securities and Exchange\nCommission, including its reports on Forms 10-K, 10-Q and 8-K. Elite is under no obligation to update or alter its forward-looking statements,\nwhether as a result of new information, future events or otherwise."}