Under the terms of the revenue-sharing agreement, Idorsia is entitled to receive quarterly payments of 8% of the net sales of ponesimod products from Actelion Pharmaceuticals Ltd. Legal update on milestones regarding clazosentan and related ongoing arbitrationFollowing the demerger from Actelion and the transfer of a share purchase agreement with Axovan vendors, Idorsia holds a license agreement to develop and commercialize clazosentan. In doing so, Idorsia … Made In NYC |
In addition, a positive trend on daytime functioning was observed on 25 mg, consistent with the results of the first study. The Investor Relations website contains information about Neurocrine Biosciences's business for stockholders, potential investors, and financial analysts. If we do our job well, daridorexant alone should be enough for us to achieve sustainable profitability within a relatively short period of time, which means our additional pipeline assets will bring significant growth opportunities. Non-GAAP net loss in the first half of 2020 amounted to CHF 138 million: the CHF 51 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 9 million), share-based compensation (CHF 13 million), an accrual in relation to the arbitration (CHF 24 million) and a negative non-cash financial result (CHF 6 million). US GAAP net loss in the first half of 2020 amounted to CHF 189 million compared to CHF 232 million in the first half of 2019. The Phase 3 study incorporates the learnings from the previous clazosentan program to identify patients at high risk of vasospasm and delayed cerebral ischemia, the optimal dose, the best measure to demonstrate efficacy and an optimized set of patient management guidelines to ensure patient safety. We are conscious to remain flexible and nimble in how we commercialize our portfolio, building the core capabilities required to successfully launch our products, while being prepared to partner where we need support to reach the primary care market.”. At this stage, it is difficult to predict the outcome of the ongoing arbitration which is substantially completed. This has resulted in extended recruitment times for the ongoing studies, as indicated in April 2020, and the company is taking steps to accelerate recruitment in an attempt to regain some ground lost during peak period of the pandemic. », Veeva's Offering Chosen by Idorsia to Drive Digital Engagement, Janssen announces the presentation of additional ponesimod data at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting, Syneos Health-Idorsia Collaborate to Launch Daridorexant in US, Idorsia selects Syneos Health as commercialization partner to launch daridorexant in the United States, Daridorexant Phase 3 results in insomnia presented at SLEEP 2020, Daridorexant Phase 3 results in insomnia to be presented at SLEEP 2020, Idorsia Pharmaceuticals Ltd : Daridorexant Phase 3 results in insomnia to be presented at SLEEP 2020, Idorsia announces financial results for the first half 2020, Diluted weighted average number of shares, Vasospasm associated with aneurysmal subarachnoid hemorrhage, Positive results in both pivotal Phase 3 studies of daridorexant with improved overall sleep and daytime functioning of patients with insomnia, Neurocrine Biosciences exercised option to license Idorsia's novel treatment for rare pediatric epilepsy, Establishment of Idorsia Pharmaceuticals US Inc. commercial operations and leadership team, Merger of Vaxxilon Ltd into Idorsia creating a new unit specialized in synthetic carbohydrate vaccines to prevent infections, Janssen submitted New Drug Application to the US FDA and European Marketing Authorization Application for ponesimod for treatment of adults with relapsing multiple sclerosis – Idorsia has a revenue-sharing agreement in respect to ponesimod, Issuance of 11 million new shares receiving gross proceeds of CHF 330 million, US GAAP operating expenses HY 2020 at CHF 236 million, Non-GAAP operating expenses HY 2020 at CHF 193 million, Updated guidance for 2020: US GAAP operating expenses around CHF 530 million and non-GAAP operating expenses around CHF 490 million (both measures exclude unforeseen events, potential milestone payments and any potential award granted in the ongoing arbitration – see legal update below), Nine-months 2020 Financial Results reporting on October 22, 2020, Full-Year 2020 Financial Results reporting on February 4, 2021, First Quarter 2021 Financial Results reporting on April 22, 2021.
US GAAP operating expenses in the first nine months of 2019 amounted to CHF 375 million (of which CHF 327 million R&D and CHF 48 million SG&A expenses), whilst operating expenses in the first nine months of 2018 amounted to CHF 290 million (of which CHF 245 million R&D and CHF 45 million SG&A expenses). -- New Three-Year Gene Therapy Data for Parkinson's Disease Part of 30 Abstracts to be Presented at 2020 Psych Congress and the MDS Virtual Congress 2020 -- - INGREZZA® (valbenazine) Data Analyses from Long-Term Phase III Studies Demonstrate Sustained Clinical Benefit, Safety and Tolerability in, Live Webcast will be on September 9, 2020 SAN DIEGO , Sept. 2, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the Citi 15 th Annual BioPharma Virtual Conference at 12:35 p.m. You may need to download version 2.0 now from the Chrome Web Store. A Phase 2 study is planned for the second half of 2020. Senior Vice President, Head of Investor Relations & Corporate Communications. Idorsia intends to use the net proceeds from the rights offering primarily to support the regulatory filing and, if approved, commercial launch of daridorexant, its dual orexin receptor antagonist, and fund the clinical development of other late-stage compounds such as aprocitentan, clazosentan, lucerastat, cenerimod, and selatogrel as well as early-stage pipeline assets.
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