Neurological
The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.
A new small-molecule approach to turning on beneficial genes to counteract disease-causing mutations is being pioneered by Insmed’s UK-based scientists.
The drugmaker announced positive results from two Phase III trials for the drug in narcolepsy type 1 that analysts said bode well for the OX2R agonist class as a whole.
The updated US FDA label modifies dose titration based on TRAILBLAZER-ALZ 6, a study that showed a more gradual rise in dosing levels reduced ARIA-E incidence without reducing amyloid clearance.
The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.
Still holding out hope after multiple rejections for the tyrosine kinase inhibitor.
Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.
Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.
Oral RNA splicing modulator has gone into a Phase II/III trial
Wales-based group launches with $140m series A.
Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.
Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.
The Phase II TREM2 agonist is not part of Sanofi’s planned acquisition.
All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.
But the French major is still keen on early-stage M&A.
Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.
Deal snapshot: With several internal non-opioid pain candidates in Phase II or earlier, Lilly looks to add R&D potential in pain with $1bn buyout of SiteOne.
The Italian drugmaker gets rights to Phase III-ready asset radiprodil.
The French drugmaker is expanding its neurology activities with the $470m deal.
The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.