Amylyx Pharmaceuticals (AMLX) Stock Price: Why It Increased Over 3% Today

By Amit Chowdhry ● Jun 13, 2022
  • The stock price of Amylyx Pharmaceuticals Inc (NASDAQ: AMLX) increased by over 3% during intraday trading today. This is why.

The stock price of Amylyx Pharmaceuticals Inc (NASDAQ: AMLX) increased by over 3% during intraday trading today. Investors are responding positively to Amylyx Pharmaceuticals announcing that Health Canada has approved ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine), with conditions, for the treatment of amyotrophic lateral sclerosis (ALS). 

The clinical data demonstrated a statistically significant and clinically meaningful benefit in functional outcomes for people with ALS taking ALBRIOZA (also known as AMX0035) compared to people taking a placebo, either as a stand-alone therapy or when added to existing treatments for ALS. This decision marks the first marketing approval for ALBRIOZA issued to Amylyx worldwide.

ALS is known as a relentlessly progressive and fatal neurodegenerative disorder caused by motor neuron death in the brain and spinal cord. Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis, and eventually death. And the vast majority of people with ALS (>90%) have sporadic disease, showing no clear family history. About 3,000 Canadians are currently living with ALS, and the average life expectancy from symptom onset is two to five years. Approximately 1,000 people die from ALS in Canada every year, with a similar number of diagnoses annually.

The approval of ALBRIOZA was authorized under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy. And one of the conditions of the approval is the provision of data from the ongoing Phase 3 PHOENIX trial. And other conditions include additional planned or ongoing studies. Amylyx anticipates topline results from the PHOENIX trial in 2024.

The approval of ALBRIOZA is based on data from CENTAUR, a multicenter Phase 2 clinical trial in 137 participants with ALS encompassing a 6-month randomized placebo-controlled phase and an open-label long-term follow-up phase – which demonstrated that participants treated with ALBRIOZA scored, on average, 2.32 points higher on the Amyotrophic Lateral Sclerosis Functional Rating Scale – Revised (ALSFRS-R) over a period of 24 weeks. And detailed data from CENTAUR were published in the New England Journal of Medicine, Muscle & Nerve, and the Journal of Neurology, Neurosurgery, and Psychiatry.

As part of Amylyx’ continued commitment to the ALS community, the Amylyx Care Team (ACT) Support Program provides insurance navigation, treatment coordination and educational support for people living with ALS who have been prescribed ALBRIOZA and their caregivers. And the eligibility and enrollment into the ACT Support Program can be discussed with prescribing health care professionals.

KEY QUOTES:

“For nearly a decade, we have been committed to creating more meaningful moments for people living with ALS and their families. We are excited with Health Canada’s decision to approve ALBRIOZA with conditions. ALBRIOZA is a therapy that demonstrated in our CENTAUR trial a statistically significant and clinically meaningful impact on function, alone or in addition to existing ALS therapies. We are grateful to the people who participated in our clinical trials, their families, the researchers, and the ALS community for helping to make this milestone happen.”

— Justin Klee and Joshua Cohen, Co-CEOs and Co-Founders of Amylyx

“I have always had a love for life and a passion for global advocacy. Thanks to new innovations in ALS treatment and care, I’ve been able to continue my advocacy work in new ways as part of the fight for new treatment options for the ALS community. New therapies like ALBRIOZA are critical to help me and others have a fuller life. The ability to live more independently for longer is incredibly meaningful.”

— Norman MacIsaac, who has been living with ALS since 2014

“For more than 30 years, I have been involved with caring for people living with ALS, and we have had major breakthroughs in research and made strides in drug development. The approval of ALBRIOZA is a testament to this progress. New treatment options that can slow disease progression are critical to give people living with ALS more time as we work toward a cure.”

— Angela Genge, MD, FRCP(C), Director of the ALS Global Centre for Excellence at the Montreal Neurological Institute

“We are delighted that this Health Canada approval represents the advancement in available treatment options for people living with ALS, but there is still more work to be done. ALS is a devastating disease and can move with startling swiftness. It is incredibly important that all Canadians across the country are able to benefit from these and other innovations to come, as quickly as possible following regulatory approval. We are hopeful that decision-makers throughout the drug access and reimbursement process will work expeditiously to provide timely and equitable access for all Canadians who may benefit. There is simply no time to wait with this disease.”

— Tammy Moore, CEO of the ALS Society of Canada

“The approval by Health Canada, the first for Amylyx globally, is an important milestone and first step. We anticipate that ALBRIOZA will be available commercially in Canada within the next six weeks. We are prepared to work with the pan-Canadian Pharmaceutical Alliance (pCPA) and federal, provincial and territorial governments to negotiate the listing of ALBRIOZA expeditiously, so that eligible Canadians living with ALS can obtain access as quickly and efficiently as possible.”

— Chris Aiello, General Manager and Head of Canada at Amylyx

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.