Akcea’s three-year run as a semi-independent company is coming to an end.

Ionis announced early Monday morning that they will be reacquiring the public shares of its lipid-focused spinout Akcea. Akcea began as a fully-owned subsidiary before Ionis put about a quarter of its shares on the public markets. Now, for about $500 million — $18.15 per share — Ionis will buy that quarter back.

The acquisition was a 60% premium on Akcea’s stock entering Monday, although it will immediately give Ionis access to the $390 million in cash Akcea had on hand.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN