A delayed newsletter due to some travels to Costa Rica this week! Several pieces of news from Biogen as the company unfortunately announces big changes whilst offering to acquire the remaining shares of Sage Therapeutics. Lykos Therapeutics announces multiple changes to the Board. J&J acquires Intra-Cellular Therapies and receives expanded approval for Spravato, Lophora raises a financing round, and Coave Therapeutics raises its Series A.
- Psychedelics company Lykos Therapeutics announces changes to its Board of Directors as five members exit. Independent directors Gisselle Acevedo, Jeff George, Scott Giacobello and Jason Pyle alongside Kris Lotlikar (appointed by non-profit, MAPS) have all resigned from their respective roles. This news comes months after the FDA rejection for their MDMA-assisted PTSD therapy. Ron Beller and Joe Green have been named as new Directors, joining Dan Grossman, Dawn McCollough, and Preferred Director Suprotik Basu.
- Johnson & Johnson announce acquisition of Intra-Cellular Therapies for $14.6 billion USD. Through this deal, the Pharma giant would gain access to Calypta, an FDA approved treatment for schizophrenia and depressive episodes associated with bipolar disorder, and other experimental drugs under development.
- Lophora successfully raises $3M. The financing round will be used to advance CNS drug, LPH-5, through Phase I trials after recently receiving EMA approval. LPH-5 is a proprietary psychedelic-based molecule designed to address CNS conditions where current treatment options are limited or ineffective.
- As Biogen announces mass layoffs, the company has submitted a proposal to acquire the outstanding shares of Sage Therapeutics not already owned by the company. The $470 million buyout offer follows the FDAs rejection of zuranolone for major depressive disorder (despite the approval for postpartum depression). As a response to the buyout offer, Sage has brought a lawsuit against Biogen and stresses that no shareholder action is required as of now.
- Coave Therapeutics raises €32 Million ($33 Million) in Series A Financing. This round was co-led by Novo Holdings A/S and Bpifrance (as part of the InnoBio investment strategy) and joined by leading US and EU investors Invus and UI Investissement alongside existing investors. The funding will be used to advance Coave’s proprietary ALIGATER? platform that aims to enhance targeting, specificity, efficacy and manufacturability of genetic medicine. It will also be used to advance the biotech's programs towards CTA/IND stage.
- Following FDA Priority Review, Johnson & Johnson gets FDA approval for SPRAVATO? (esketamine) as first and only monotherapy for adults with treatment-resistant depression. The drug alone me its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours.
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Anavex Life Sciences
reports positive Phase IIb/III data assessing 3-years of continuous treatment with oral blarcamesine for early Alzheimer's Disease patients. Blarcamesine exhibited a favorable safety profile with no treatment-related deaths and improved cognition and function over the 3 year period.
