Essential Tremor

Biogen and Sage Therapeutics are discontinuing further development of their drug Zurzuvae as a potential treatment for major depressive disorder, a move that follows last year’s FDA rejection of the therapy in that indication. The regulator had asked the companies to provide more evidence of efficacy from additional clinical testing. In its report of third quarter 2024 financial results posted Wednesday, Biogen said the discontinuation decision is based on the “significant new investment and time we expect would be needed to conduct additional studies.” Going forward, the two Cambridge, Massachusetts-based companies plan to focus their efforts on commercializing this drug in postpartum depression, for which it was approved last year. But postpartum depression is a much smaller market than major depressive disorder, which means Zurzuvae is unlikely to achieve the lofty sales once expected for the pill. With the renewed focus on Zurzuvae for postpartum depression, Sage will discontinue Zulresso, a product that in 2019 became the first FDA-approved postpartum depression drug. Zulresso is administered as a 60-hour infusion, a challenging dosing regimen that has limited market uptake of this Sage drug. By contrast, Zurzuvae is a pill taken once daily for 14 days. For the nine months ended Sept. 30, Sage reported Zulresso accounted for $3.1 million in revenue, down 63% compared to the same period in 2023. Sage said Zulresso will be commercially available until Dec. 31. Sponsored Post The Future of Hospitals and Pharma Companies Will Depend on Strength of Healthcare Analytics Insights PurpleLab® stands out from others in this sector by providing its data analytics services to several different groups of users across healthcare and pharma companies. By Stephanie Baum The collaboration between Biogen and Sage dates to 2020. Biogen committed $1.5 billion up front to begin the R&D alliance focused on depression and movement disorders. Results have been disappointing. Besides Zurzuvae’s rejection in major depressive disorder, collaboration on the movement disorders program SAGE-324 is ending. In July, the companies reported this oral drug failed a Phase 2 test in essential tremor. Biogen gave Sage a termination notice for SAGE-324 last month. When the termination becomes effective in February, Sage will become fully responsible for the program. In its quarterly report, Sage said it plans to evaluate other potential indications for this drug. In a note sent to investors, Leerink Partners analyst Marc Goodman said the discontinuation of further development of Zurzuvae in major depressive disorder was expected. While Leerink projects the drug could achieve $200 million to $300 million in peak sales in postpartum depression, physicians have told the firm they’re skeptical of a paradigm shift in treatment and the black box warning on the product’s label could further limit use. Sage does have other programs in the pipeline, but the company will have fewer workers to support them. In its quarterly report, the company said it will commence a business restructuring to strengthen its balance sheet and focus on the ongoing launch of Zurzuvae for postpartum depression. Sage said it will shed about 33% of its workforce. With the restructuring, the company said it expects to have enough capital to support operations into 2026.

EDEN PRAIRIE, Minn., Oct. 24, 2024 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it will be participating in The ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. The ThinkEquity Conference gathers institutional investors, corporate clients, and other industry professionals to highlight groundbreaking innovations and financial strategies. Ron McClurg, CFO, will be presenting at 9:00 am ET on October 30th. The Company will also hold one-on-one investor meetings throughout the day. Interested investors can register to attend and schedule on-on-one meetings here. The presentation will also be live-streamed at the following link: https://wsw.com/webcast/tep25/nmtc/1682208. About ThinkEquityThinkEquity is a boutique investment bank founded by professionals who have collaborated for over a decade, collectively financing over $50 billion in public and private capital raises, restructurings, and mergers and acquisitions. Past ThinkEquity conferences have featured over 70 company presentations, 700+ attendees, and 500+ one-on-one meetings, providing a valuable platform for companies and investors to connect. To register to attend The ThinkEquity Conference, please follow this link. About NeuroOneNeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson's disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit www.nmtc1.com. IR ContactQuinn Callanan, CFA or Brian Prenoveau, CFAMZ Group – MZ North AmericaNMTC@mzgroup.us (949) 694-9594

After a string of mid-stage failures this year, plus a blow to its major depression commercial plans last year, Sage Therapeutics is trimming its workforce by 33%, including more than halving its R&D staff. The biotech said Thursday morning it will also reshape its early-stage pipeline and will make most of the workforce culls by the end of this quarter. The departures include CFO Kimi Iguchi, chief technology and innovation officer Matt Lasmanis, and a few SVPs. Its operating chief Chris Benecchi will now also oversee finance and other functions. The goal is to focus on its launch of Zurzuvae in postpartum depression and prepare for a clinical readout of dalzanemdor in Huntington’s disease by year’s end. The experimental dalzanemdor, an NMDA receptor positive allosteric modulator, has already failed two Phase 2 trials in Parkinson’s and Alzheimer’s this year. Sage’s other clinical medicine, SAGE-324, flunked on an essential tremor mid-stage test in July. Biogen then walked away from that part of their tie-up. “We are being deliberate and purposeful in our efforts to reorganize the company with the goal of having the flexibility to execute immediate priorities and build for long term growth and value creation,” CEO Barry Greene said in a press release. “This is difficult but necessary and we believe it will right-size Sage for future growth potential.” The moves will affect more than 165 employees and costSage $26 million to $28 million. It will push Sage’s runway out an undisclosed distance. The company will report quarterly earnings on Oct. 29.