DUBLIN – Alnylam Pharmaceuticals Inc. is on track to secure its third FDA approval in successive years, as its siRNA drug, lumasiran, hit all its marks in a phase III trial in patients with primary hyperoxaluria type 1 (PH1). The drug is already undergoing regulatory review and has a Dec. 3 PDUFA action date. It is undergoing accelerated assessment in Europe as well.
LONDON – After all the controversy and a huge dose of hype, there is no clinical benefit from the use of hydroxychloroquine in patients admitted to the hospital with COVID-19, according to headline data from a large randomized trial of potential drugs for the infection currently running in the U.K.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcturus, Aurinia, Avenue, Lysogene, Magenta, Nektar, Novartis, PDS, Tetra.
PERTH, Australia – Melbourne, Australia-based Dimerix Ltd. saw its shares gain 66% on the news that its lead candidate, DMX-200, has been chosen to enter the global REMAP-CAP platform trial as a potential treatment for COVID-19-related acute respiratory distress syndrome (ARDS).
New interim phase II data from Replimune Group Inc., of Woburn, Mass., show RP-1 and Opdivo (nivolumab, Bristol-Meyers Squibb Co.) produced multiple complete responses and a high rate of deep responses in anti-PD-1/anti-CTLA-refractory melanoma.
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allakos, Amgen, Aprea, Astrazeneca, Beyondspring, BMS, Complexa, Horizon, Innovent, Janssen, Lilly, Novartis, Replimune, Spring Bank, Valerion.
A key opinion leader (KOL) consulted by SVB Leerink deemed Roche Holding AG’s anti-TIGIT drug results “really huge” and “quite amazing,” affirming the Basel, Switzerland-based firm’s lead in the field. The phase II data from the study known as Cityscape rolled out at the virtual American Society of Clinical Oncology (ASCO) meeting.
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