Reneo Pharmaceuticals Inc.’s $93.8 million IPO last month brought renewed attention to primary mitochondrial myopathy (PMM), a genetic disorder that impairs oxidative phosphorylation, affecting mainly muscles. The San Diego-based firm sold about 6.2 million shares at $15 each, but the stock (NASDAQ:RPHM) has since taken a dive, closing May 19 at $8.83.
There’s been a change of plans. Following a preliminary review of briefing materials for a type C meeting, the FDA told Reata Pharmaceuticals Inc. that a pre-NDA meeting is instead the next best step in the development of omaveloxolone (RT-408) for treating Friedreich’s ataxia (FA).
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acceleron, Apeiron, Astrazeneca, Biomarin, CNS, Cytokinetics, Galapagos, Idera, Immunocore, Pfizer, Silence, Veru.
DUBLIN – Bergenbio ASA joins an expanding list of companies whose candidate drug has failed to attain the primary endpoint of a clinical trial in COVID-19.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amarin, Apnimed, Bergenbio, Catalyst, Cybin, GSK, I-Mab, Leo, Medicago, Metacrine, Mustang, Novo Nordisk, Realta, Roche, Sarepta, Seven and Eight, Shield.
To accelerate drug development targeting the pandemic, the FDA issued final guidance May 17 on master protocols for drugs intended to prevent or treat COVID-19 infections. Although the guidance is geared toward developing COVID-19 drugs, the FDA said it expects master protocols to continue to play an important role in addressing the public health needs in future pandemics.
As investors await interim data this quarter from Arcus Biosciences Inc.’s ARC-7 phase II effort with domvanalimab (AB-154) in non-small-cell lung cancer, the anti-TIGIT space continues to bubble, with Wall Street busy trying to sort out the odds of various players.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Amo, Antengene, Appili, Athenex, Baudax, Foghorn, Galera, GSK, Incyte, Knopp, Regeneron, Sanofi, Seelos.
Little more than two years ago, Biogen Inc. plunked down about $800 million for gene therapy developer Nightstar Therapeutics plc, which had an X-linked retinitis pigmentosa drug in its pipeline. Top-line results from the phase II/III Xirius study of cotoretigene toliparvovec (BIIB-112), administered by subretinal injection, show the one-time therapy missed its primary endpoint of producing a statistically significant improvement in the proportion of treated study eyes.
Allogeneic chimeric antigen receptor T cell (AlloCAR T) specialist Allogene Therapeutics Inc.’s promise of data readouts at this year’s American Society of Clinical Oncology meeting, along with the virtual CD19 forum slated by the company for May 19, whetted investor thirst in the space.
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