As amyotrophic lateral sclerosis continues to make headlines, candidates bearing varied approaches proliferate and the indication likely allows for multiple players, given the prospect of a combo regimen.
Amid a mix of controversy and clinical progress, the Alzheimer’s Association International Conference 2021 kicked off July 26 in Denver and online, delivering both new clinical data and insights into a key form of dementia affecting as many as 35 million people worldwide and growing. While interest in Biogen Inc.'s recently approved Aduhelm (aducanumab) remained high, new data on investigational therapies from Synaptogenix Inc. and Inmune Bio Inc. also drew attention, weighing on shares of both companies. New epidemiological research also revealed the first evidence that reducing air pollution may improve cognitive function and reduce dementia risk.
Alzamend Neuro Inc.’s positive preclinical data for AL-002 sent the company’s stock (NADAQ:ALZN) more than 70% higher before the market opened July 23. The Tampa, Fla.-based biopharma is researching a mutant-peptide sensitized cell for treating Alzheimer’s disease. The positive data came from a GLP toxicology study using a transgenic mouse model.
DUBLIN – Coave Therapeutics unveiled a new identity and a new gene therapy platform, as it closed a €21.2 million (US$25 million) extension to its long-running series B round, which takes the total raise to €33 million.
Amylyx Pharmaceuticals Inc.’s oversubscribed, $135 million series C financing led by Viking Global Investors will help lay the groundwork for commercializing in Canada and Europe, as well as for a second phase III study in the U.S. with lead candidate AMX-0035 for amyotrophic lateral sclerosis.
Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
A sometimes contentious policy roundtable on how to handle Alzheimer’s disease therapies followed the July 15 meeting of the California Technology Assessment Forum, an independent evidence appraisal committee of the Institute for Clinical and Economic Review (ICER). CTAF’s 15 panelists voted unanimously that the evidence was not adequate to prove Biogen Inc.’s recently approved Aduhelm (aducanumab) superior to supportive care alone.
Orexo AB enrolled the first patient in a pivotal trial of its digital therapeutic Modia plus sublingual buprenorphine/naloxone for treatment of opioid use disorder (OUD). Orexo’s Zubsolv, the combination of buprenorphine and naloxone used in the study, has been employed to help U.S. patients with OUD since 2013.
Members of the California Technology Assessment Forum (CTAF), an independent appraisal committee of the Institute for Clinical and Economic Review (ICER), discussed – and voted on – the safety vs. efficacy and other aspects of Biogen Inc.’s embattled Aduhelm (aducanumab), the amyloid beta-targeting therapy recently approved for Alzheimer’s disease. It didn’t go well for Biogen.
Paq Therapeutics Inc. closed a $30 million series A round to take forward a novel approach to the targeted degradation and removal of a wide range of molecular substrates and defective organelles by developing drug molecules that can tap into autophagy, the cell’s general waste disposal and recycling system.
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