Amylyx Pharmaceuticals

Last updated
Amylyx Pharmaceuticals
Company type Public
Nasdaq:  AMLX
ISIN US03237H1014
IndustryPharmaceuticals
Founded2013;11 years ago (2013)
Founder
  • Joshua Cohen
  • Justin Klee
Headquarters Cambridge, Massachusetts
Key people
  • Joshua Cohen
  • Justin Klee
Website www.amylyx.com OOjs UI icon edit-ltr-progressive.svg

Amylyx Pharmaceuticals, Inc is a biopharmaceutical company headquartered in Cambridge, Massachusetts. Amylyx is best known for AMX0035, an experimental therapy for amyotrophic lateral sclerosis. AMX0035 was approved for medical use in Canada as Albrioza, in June 2022, [1] and in the United States, as Relyvrio, in September 2022. [2] It was withdrawn in April, 2024.

History

Amylyx Pharmaceuticals was founded in 2013 by Joshua Cohen and Justin Klee when the two were undergraduate students at Brown University. [3] [4] The two proposed that taurursodiol and sodium phenylbutyrate together might prevent dysfunction of mitochondria and the endoplasmic reticulum, safeguarding neurons. [4] Klee and Cohen were advised by Rudolph E. Tanzi, who ultimately served as the founding chair of Amylyx's scientific research board. After Klee and Cohen were able to achieve strong results in pre-clinical research, Tanzi connected the two to his colleagues at Massachusetts General Hospital, which culminated in clinical trials and FDA approval. [5] The company was granted $2.2 million by the ALS Association with funds raised through the Ice Bucket Challenge. [6]

Amylyx went public in January 2022. [7] The company's shares began trading on the Nasdaq on January 7, 2022 under the symbol AMLX.

After a disappointing Phase 3 trial of AMX0035 failed to produce significant differences versus a placebo, [8] on April 4, 2024 Amylyx announced they would begin the process of withdrawing Albrioza and Relyviro from the North American market. [9] Amylyx received praise for keeping its pre-approval promise to stop selling the drug if it turned out to be ineffective, an usually ethical move for a which the FDA rarely requires. The company cited its independence from major pharmaceutical companies as a reason it could do so. [10]

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References

  1. ↑ "Amylyx Pharmaceuticals Announces Health Canada Approval of Albrioza for the Treatment of ALS" (Press release). Amylyx. 13 June 2022. Archived from the original on 14 June 2022. Retrieved 13 June 2022.
  2. ↑ "FDA Approves New Treatment Option for Patients with ALS". U.S. Food and Drug Administration (FDA) (Press release). 29 September 2022. Archived from the original on 29 September 2022. Retrieved 29 September 2022.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. ↑ James, Beth. "Biotech company Amylyx emerges from scientific curiosity of Brown undergrads". Engineering | Brown University. Retrieved 2022-11-15.
  4. 1 2 Belluck, Pam (2020-10-16). "Drug May Extend A.L.S. Patients' Lives by Several Months, Study Finds". The New York Times .
  5. ↑ Keshavan, Meghana (2020-09-02). "Experimental drug for ALS, dreamed up in a dorm room, offers patients glimmer of hope". STAT. Retrieved 2022-11-15.
  6. ↑ "A new ALS treatment has ties to the Ice Bucket Challenge. Here's how". www.boston.com. Retrieved 2022-11-15.
  7. ↑ Beltran, Luisa. "The Year's First Three IPOs All Struggled. This Is Why". www.barrons.com. Retrieved 2022-11-16.
  8. ↑ "Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS".
  9. ↑ "Amylyx Pharmaceuticals Announces Formal Intention to Remove RELYVRIO®/ALBRIOZA™ from the Market; Provides Updates on Access to Therapy, Pipeline, Corporate Restructuring, and Strategy".
  10. ↑ Jon Hamilton (May 15, 2024). "Lots of drug companies talk about putting patients first — but this one actually did". NPR.
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