Amylyx (AMLX) Go Kaboom!

The Above Chart Looks Nice..Goldman Sachs (see below) had $46 Price Target.

Market Capitalization at 9:20 $1.29 billion – with a ‘B.’

Market Capitalization at 9:31 $200 million – with a UGH!. $1 billion – POOF.

Shameless plug: Might be a good time for those licking their wounds to look at one of our favorite clients, GeoVax (GOVX).

Killer, 44-Page Report on GeoVax (GOVX).

Amylyx’s ALS Drug Fails in Late-Stage Confirmatory Study.

Wait, What! What the hell is a confirmatory study!

March 8 (Reuters) – Amylyx Pharmaceuticals (AMLX), is considering withdrawing its approved treatment for amyotrophic lateral sclerosis from the market after it failed in a late-stage trial to confirm benefits, sending its shares crashing 80% on Friday.

“We will follow the science and will do what’s right for the community, which may include voluntarily removing the product from the market,” co-CEO Justin Klee said.

The drug, branded as Relyvrio and the company’s only product in market, was approved in September 2022 based on mid-stage trial data in 137 patients that showed the treatment slowed disease progression and extended life expectancy.

But in the larger study of 664 patients, Relyvrio failed to confirm the reported benefit of slowing disease progression, with no significant difference seen in patients treated with the drug and placebo.

The drug, branded as Relyvrio and the company’s only product in market, was approved in September 2022 based on mid-stage trial data that showed the treatment slowed progression of the disease and extended life expectancy by nearly 10 months.

The drug, which has a list price of $158,000 per year in the U.S., generated sales of $380.8 million in 2023.

ALS, also known as Lou Gehrig’s disease, breaks down nerve cells in the brain and spinal cord that make muscles work, leading to progressive paralysis and death.

Full Article

Live by the FDA gavel, die by the FDA gavel.

Joshua Cohen, adopted a new Rule 10b5-1 trading plan on December 15, 2023. The aggregate number of shares of the common stock authorized to be sold under this new arrangement is 60,000. That probably made the wife less nervous with over 3,023,002 shares owned worth $57 million, tied up in one stock.

Then he wakes up this morning and it’s worth $8.5 million.

Amylyx was founded on one simple, unanswered question: What causes neurons to die? Co-CEOs Josh Cohen and Justin Klee began their journey of uncovering the answer, building a world-class company dedicated to ending the suffering caused by relentless progressive neurodegenerative diseases, 11 years ago in 2013.

“We have assembled a team with deep scientific, clinical, business and leadership experience, bolstered by expertise in biotechnology to help realize our goal.” Our Chief Financial Officer, James Frates, brings over 20 years of experience as the Chief Financial Officer of Alkermes. Our Chief Medical Officer, Camille L. Bedrosian, brings nearly 30 years of experience in building successful clinical development and translation research programs in the pharmaceutical industry, including as Chief Medical Officer at Ultragenyx, Alexion, and ARIAD Pharmaceuticals.

Our Chief Technical Operations Officer, Tom Holmes, brings more than 25 years of leadership experience at Biogen in supply chain, pharmaceutical manufacturing and program management. Our Chief Legal Officer and General Counsel, Gina M. Mazzariello, brings more than 20 years of corporate and commercial legal experience in the healthcare industry, including holding leadership positions at Boehringer Ingelheim USA, Inc.

This team brings a diverse set of skills uniquely suited to drive successful commercialization of AMX0035 in ALS while continuing to advance our pipeline, including studying AMX0035 in other indications, and to explore new approaches and compounds in-house and in partnership with leading clinicians and researchers.

Well alrighty then..