Avadel Pharmaceuticals plc. (AVDL), a biopharmaceutical company operating in the US, has declined 14.41% in aftermarket trading sessions and is changing hands at $8.55 at the time of writing. On Friday, AVDL closed the day at $9.99 after increasing 6.96% during the mid-day session. The increase came after the announcement of an ongoing FDA review of the NDA.
Review of AVDL NDA
On Friday, AVDL announced that U FDA had notified the company regarding the review of the New Drug Application (NDA) for FT218. FDA said that the review of FT218 was still ongoing and no action was to be taken in October. The company was informed by FDA that there were no information requests at the time and a new target action date was to be provided as early as possible. FDA accepted AVDL NDA for FT218 in February 2021. It assigned a target action date of 15th October 2021. The NDA submission to FDA was supported by the positive data from the crucial phase-3 study, namely REST-ON. The study was completed under a Special Protocol Agreement (SPA) with FDA. Greg Divis, Chief Executive Officer of Avadel, commented on the development that the company is confident that the package it has submitted to FDA would be enough to satisfy all of its requests.
Q2 2021 financial results
On 9th August, AVDL reported the financial results for the second quarter of the fiscal year 2021, which ended on 30th June. The company had cash and cash equivalents of $67.14 million on 30th June. The total assets in possession of the company were $282.59 million, while the total liabilities were $163.71 million. The research and development expenses for the period were $6.8 million against $4.1 million for the same period of 2020. The general and administrative expenses for the period were $15.2 million against $7.1 million for the same period of 2020. The net loss for the quarter was $19.6 million against $30.9 million for the same period of 2020. The net loss per basic and diluted share for the three months was $0.33 against $0.49 for the same period of 2020.
What’s ahead for AVDL?
According to the statistics, AVDL has surged 53% during the last quarter, mainly on the back of excellent financial performance. Analysts believe that any positive update by the FDA regarding the review of FT2018 could provide a major boost to performing ANDL.
