Common Stock, par value $0.0001
- Symbol
- BNTC
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
Benitec Biopharma Inc.
BNTCNASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On October 5, 2026, Benitec Biopharma Inc. (the “Company”) issued a press release providing an update following the receipt of formal feedback from the U.S. Food and Drug Administration ("FDA") related to the Type C meeting between the Company and the FDA in the third quarter of the 2026 calendar year.…
Press release in this filing
Benitec Biopharma Announces Regulatory Update Following Type C Meeting with FDA for BB-301 Pivotal Study →Company context
Benitec Biopharma Inc. (NASDAQ: BNTC) is a clinical-stage biotechnology company developing disease-modifying genetic medicines designed to improve the lives of people with life-threatening, genetically defined diseases. The company’s proprietary “Silence and Replace” DNA-directed RNA interference (ddRNAi) platform combines RNA interference, or RNAi, with gene therapy to create medicines designed to facilitate sustained silencing of disease-causing genes and simultaneous delivery of replacement genes that restore normal cellular function following a single administration. The company’s lead investigational candidate, BB-301, is the first and only disease-modifying genetic medicine in clinical development for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD)-related dysphagia.
Current securities
Registered securities in this filing
Benitec Biopharma Inc. · 8-K · Filed 2026-10-05
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On October 5, 2026, Benitec Biopharma Inc. (the “Company”) issued a press release providing an update following the receipt of formal feedback from the U.S. Food and Drug Administration ("FDA") related to the Type C meeting between the Company and the FDA in the third quarter of the 2026 calendar year. A copy of the press release, which is attached hereto as Exhibit 99.1, is furnished pursuant to this Item 7.01.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be incorporated by reference into any filing of the Company, whether made before, on or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such filing. The information contained in Item 7.01 of this Current Report on Form 8-K Report, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
Filed exhibits (1)
Benitec Biopharma Announces Regulatory Update Following Type C Meeting with FDA for BB-301 Pivotal Study • The BB-301 pivotal trial remains on track to begin in mid-2027 • Discussions regarding an open-label, single-arm, pivotal study for BB-301 are ongoing, and based on these discussions, the FDA requested additional available data, including data from the Benitec-sponsored OPMD Natural History Study • Final pivotal study design expected to be confirmed in 1Q 2027 • Benitec will present interim clinical results from the ongoing BB-301 Phase 1b/2a study as a late-breaking poster presentation, which will encompass 12-month follow-up data for all six Cohort 1 patients and interim follow-up data for all three Cohort 2 patients, at the European Society of Gene and Cell Therapy (ESGCT) Annual Congress in Hamburg, Germany, October 27-30, 2026 HAYWARD, Calif., October 5, 2026 - Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or the “Company”), a clinical-stage biotechnology company developing disease-modifying genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (ddRNAi) platform, today announced the receipt of formal feedback from the U.S. …
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