Array Biopharma (ARRY) Says FDA Accepted Binimetinib NDA as Advanced NRAS-Mutant Melanoma Treatment
FREE Breaking News Alerts from StreetInsider.com!
StreetInsider.com Top Tickers, 4/25/2024
- S&P 500 ends higher as markets weigh rising yields, upbeat corporate results
- Meta Platforms reports softer Q2 revenue guidance on plans to boost spending on AI
- IBM (IBM) announces mixed Q1 results, HashiCorp acquisition; shares down
- Equities mixed as investors eye earnings; yen on intervention watch
- ServiceNow (NOW) stock falls as refreshed subscription outlook trails estimates
- Meta Platforms (META) Tops Q1 EPS by 39c, Offers Guidance
- Hasbro (HAS) brand strength sees earnings top expectations
- IBM (IBM) announces mixed Q1 results, HashiCorp acquisition; shares down
- Seagate Technology (STX) Enters $600M Asset Purchase Agreement with Avago
- Crude Inventory Declined 6.4 Million Barrels Last Week
- After-hours movers: Meta, Ford, IBM, ServiceNow and more
- Midday movers: Tesla, Boeing rise; Uber, Old Dominion Freight fall
- After-hours movers: Tesla, Texas Instruments, Seagate, Visa and more
- Midday movers: PepsiCo, JetBlue fall; GM, Danaher and UPS rise
- After-hours movers: Cadence Design Systems, Cleveland-Cliffs, Riot Platforms, and more
Array BioPharma Announces FDA Acceptance of Binimetinib NDA for Patients with Advanced NRAS-Mutant Melanoma
September 1, 2016 8:01 AM EDTBOULDER, Colo., Sept. 1, 2016 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) today announced that the FDA has accepted its New Drug Application (NDA) for binimetinib with a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2017. Array completed its NDA submission of binimetinib in late June 2016 based on findings from the pivotal Phase 3 NEMO (NRAS MELANOMA AND MEK INHIBITOR) trial in patients with NRAS-mutant melanoma. The FDA also indicated that it plans to hold an advisory committee meeting (ODAC) as part of the review process. As... More
