Eli Lilly and Co.’s complete response letter (CRL) from the U.S. FDA relating to accelerated approval of Alzheimer’s disease (AD) candidate donanemab set off a round of speculation regarding not only what the move might mean for the pharma giant but also for others in the embattled therapeutic space and beyond. The answer, if you believe analysts: not much.
Upcoming catalysts from Annexon Biosciences Inc. put some joy into shares as the firm talked up its prospects during the recent J.P. Morgan Healthcare Conference, where attendees heard Jan. 8 about the news ahead with C1q protein complex inhibitor ANX-005 in Huntington’s disease (HD) as well as progress in Guillain-Barre syndrome (GBS), and more. The stock (NASDAQ:ANNX) enjoyed a 43% stock boost in the days after JPM, rising from $4.79 on Jan 8 to $6.84 on Jan. 13.
Looking ahead to potential commercialization of its late-stage tau PET imaging agent, Aprinoia Therapeutics Inc. has chosen to go public via a merger with special purpose acquisition company (SPAC) Ross Acquisition Corp. II in a deal that has an equity value of $280 million. The funding is aimed at getting candidate 18F-APN-1607 to the market in China.
Irlab Therapeutics AB’s phase IIb exploration of the dopamine D3-receptor with the Ipsen SA-partnered oral antagonist mesdopetam in Parkinson’s disease (PD) levodopa-induced dyskinesia (LID) fell short in terms of the primary endpoint, but the company is holding out hope. Mesdopetam missed the primary endpoint of change in daily hours of “on” time – periods of adequate PD control – without troublesome dyskinesia as shown in patient diaries, the company said.
A psychiatric disorder rarely comes alone. More than half of all individuals who meet the diagnostic criteria for any psychiatric disorder are diagnosed with more than one condition. That high degree of comorbidity is often viewed as a consequence of the heterogeneity of psychiatric disorders – and as evidence that psychiatric diagnoses poorly reflect the underlying brain biology. Data published in Nature Human Behaviour on Jan. 12, 2023, has identified another likely contributor to the high degree of overlap between different psychiatric disorders.
A drug that Novartis AG discontinued in fragile X syndrome in 2014 after it failed in two phase II/III trials has been in-licensed by neuroscience specialist Stalicla SA, which plans to revive the prospects of the glutamate receptor antagonist by applying its precision medicine technology to identify likely responders.
Recent news from Quralis Corp. and Xenon Pharmaceuticals Inc. highlighted the potential for targeting the Kv7 potassium channel, of special interest to a handful of developers lately.
Eli Lilly and Co., through its wholly owned subsidiary Prevail Therapeutics Inc., is delving more deeply into gene therapies. In a new collaboration, Prevail will use privately held Capsida Biotherapeutics Inc.’s adeno-associated virus engineering platform, coupling the tech with Prevail’s gene therapies to target causes of CNS diseases.
Newron Pharmaceuticals SpA has reported positive six-month data for its selective sodium channel blocker, evenamide, as an add-on therapy to antipsychotic drugs in chronic, treatment-resistant schizophrenia. Patients who had responded at the initial six-week evaluation showed continued improvements in symptoms of psychosis, while others who had not responded at six weeks did so by six months.
Over the past few years, the pandemic clearly has put a spotlight on vaccines and the infectious disease space. But the struggle to adjust in COVID-19’s wake also brought into stark relief another high unmet need. “Coming out of COVID, there was a mental health focus coming into play,” said Andrew Levin, partner and managing director at investment firm RA Capital Management who is also serving as interim CEO at Lusaris Therapeutics Inc., a 2021 startup targeting neuropsychiatric and neurological conditions, with an initial focus on treatment-resistant depression.
RSS
