Deraphan

Roche pours more capital into North Carolina manufacturing siteAstraZeneca's direct US stock listing to start in FebExciva raises €51M to fund mid-stage work on Alzheimer's agitation drugCapricor plans February submission for DMD dataRoche pours more capital into North Carolina manufacturing siteRoche's Genentech unit said Tuesday that it will more than double its investment in a biomanufacturing facility located in Holly Springs, North Carolina. The drugmaker had originally committed $700 million to construct the site, breaking ground in August. Now, it has upped its spend on the site to about $2 billion, increasing production volume and manufacturing capacity. The pharma has promised to spend $50 billion over the next five years to boost manufacturing and R&D across both its pharmaceutical and diagnostics divisions in the US.The Holly Springs facility, expected to come online by 2029, will produce treatments for metabolic conditions such as obesity. It's slated to generate more than 500 high-wage manufacturing positions and over 1500 construction jobs. AstraZeneca's direct US stock listing to start in FebAstraZeneca will withdraw from NASDAQ and begin listing on the New York Stock Exchange (NYSE) starting February 2, following through with plans outlined last September. The move affects the company's American Depositary Shares, which will be replaced on the NYSE with its ordinary shares.Prior to announcing its plans to list on the NYSE, reports had suggested that AstraZeneca CEO Pascal Soriot was considering switching the company's listing across the Atlantic amid frustration with the UK's operating environment. However, the move to the NYSE has been explained by the drugmaker as part of wider plans to double its revenue by 2030, with 50% of this coming from the US.AstraZeneca's ordinary shares are also traded on the London Stock Exchange and NASDAQ Stockholm.Exciva raises €51M to fund mid-stage work on Alzheimer's agitation drugExciva closed a €51-million ($59 million) series B round, which will primarily be used to fund a Phase II study of Deraphan for treating agitation in patients with Alzheimer's disease (AD). The German biotech's lead programme combines the NMDA receptor channel blocker dextromethorphan with EXV-801, a triple-acting agent that is a CYP2D6 inhibitor and a 5-HT2A/2C receptor inverse agonist. Exciva hopes that combining the two modes of action will deliver a broad and synergistic treatment targeting various domains of neuropsychiatric symptoms associated with dementia, without affecting the dopaminergic system and accelerating cognitive decline.The round was co-led by Gimv and EQT Life Sciences, with new investors Fountain Healthcare Partners, LifeArc Ventures, Carma Fund and Modi Ventures joining existing backers Andera Partners and LBBW.Capricor plans February submission for DMD dataAfter receiving a complete response letter (CRL) from the FDA in July, Capricor Therapeutics thinks it's now resolved all the agency's concerns with its Duchenne muscular dystrophy (DMD) treatment, deramiocel. The rejection was prompted by a lack of supporting data, but findings from the Phase III HOPE-3 study, shared in December, back Capricor's case for approval. The allogeneic cardiosphere-derived cell therapy slowed disease progression by 54% versus placebo as at 12 months as measured by the performance of upper limb total score, meeting its primary endpoint (see – KOL Views Q&A: Capricor’s deramiocel has doubts to assuage but DMD cell therapy offers intriguing commercial profile).The FDA has now indicated that the full study report from HOPE-3 will be sufficient to address the CRL, according to Capricor. The company plans to submit the data to the agency in February, after which it expects to receive a new PDUFA date for deramiocel.Elizabeth Eaton contributed to this report.