Vanda Gets $466M Unsolicited Offer from Cycle Amid Ongoing Row with FDA

2024-06-07

并购上市批准

Pictured: Boardroom overlooking a city/iStock, ismagilov Vanda Pharmaceuticals on Thursday confirmed that it has received an unsolicited and non-binding takeover offer from Cycle Pharmaceuticals for $8 per share, a price Vanda’s stock has not traded at since January 2023. Cycle in a separate announcement noted that its per-share offer represents a 63% premium to Vanda’s closing price on May 23, 2024, the day before Cycle submitted its takeover proposal, and a 58% premium to the biotech’s closing share price on Wednesday. The deal’s total cash consideration is $466 million. According to Cycle, its offer “delivers immediate, compelling and certain cash value for Vanda shareholders, with a highly attractive premium,” noting that the deal would also benefit patients given Cycle’s “proven commercial strategy in the U.S., a strong distribution footprint and an established track record of delivering medicines and individualized support to patients.” Cycle’s offer also trumps Future Pak’s revised takeover bid. Filed in May 2024, Future Pak’s new proposal was valued at $7.25 to $7.75 per share plus certain contingent value rights (CVR). Vanda previously turned down an initial proposal from Future Pak, which offered a similar per-share price range without the CVR. Vanda said on Thursday that its board of directors will “carefully review and determine” its course of action regarding Cycle’s offer. The company is staying mum on the further details of the deal and its interest in the offer, but has said that shareholders currently have no need to take any action. Cycle’s takeover offer comes as Vanda is engaged in a regulatory row with the FDA. In February 2024, the agency denied to approve Vanda’s supplemental New Drug Application (sNDA), which was seeking to use its oral drug Hetlioz (tasimelteon) to treat insomnia as characterized by difficulty with sleep initiation. At the time, Vanda said that “no deficiencies were disclosed by the FDA in the notification.” The biotech slammed the regulator’s rejection, saying that it “believes that the timing of the FDA’s communication is part of an ongoing violation of the Federal Food Drug, and Cosmetic Act (FDCA),” which requires the regulator to “either approval a new drug application or provide an opportunity for a hearing within 180 days after the filing of an application.” Vanda filed its sNDA on May 4, 2023, which means the FDA’s FDCA-mandated deadline was on October 31, 2023. “The FDA has not complied with the statute and has not timely approved the application or provided an opportunity for a hearing within the statutorily prescribed timeframe,” according to the biotech. In a rare move, the FDA on Friday released documentation detailing its reasons for rejecting Hetlioz and giving Vanda the option to seek a hearing. According to the regulator, the biotech’s application “does not provide substantial evidence of effectiveness for tasimelteon and does not demonstrate that the drug is safe for the treatment of insomnia.” Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构