Entering text into the input field will update the search result below

Clinical Data Reaffirm That Lumasiran Will Almost Certainly Be Alnylam's Third Commercial Product

Stephen Simpson profile picture
Stephen Simpson


  • Full results from the pivotal ILLUMINATE-A study support the efficacy of the drug in treating PH1, with meaningful improvements in urinary oxalate levels in the lumasiran group.
  • There were hints of improved long-term outcomes, but the ILLUMINATE-A study was too short to expect significant clinical outcomes.
  • Lumasiran will likely reach the market first, but Dicerna's nedosiran could be a very competitive product.
  • Alnylam shares look undervalued below $150.

Alnylam (NASDAQ:ALNY) is well on its way to having its third commercial product before the end of 2020. A prior release of positive top-line data from the company's pivotal ILLUMINATE-A study of lumasiran already indicated approvable efficacy, but the full data presented on Sunday June 7 added some valuable context to what should be a worthwhile commercial opportunity for the company.

As I indicated in my last article on Alnylam, I still regard this stock as a long-term holding in my portfolio, but I wasn't as excited about the near-term price performance potential in early May. With the shares down about 10% since then, the opportunity is more interesting now, though I have some modest "strategic" concerns that the strong rally in biotech relative to the S&P could leave the sector more vulnerable to near-term profit-taking as investors regain confidence in a stronger/quicker post-Covid-19 economic recovery.

ILLUMINATE-A Casts Lumarsiran In A Favorable Light

Investors already knew that the ILLUMINATE-A study met the key endpoints that will serve as gating factors with the FDA (the PDUFA date is December 3, 2020). What Alnylam's Sunday update provided was more incremental data on other endpoints and safety.

ILLUMINATE-A was a small study (n=39), with two-to-one randomization between the drug and placebo, though the size of the study is not unusual relative to other rare/ultra-rare disease studies. Safety was not problematic; while injection site reactions were a common issue (about one-third of lumasiran patients), there were no serious or severe adverse events and the one drug discontinuation seems unrelated to the drug (fatigue and attention issues). With the exception of that one patient, all eligible patients rolled over into the open-label extension study.

Turning to efficacy, lumasiran showed a 65% mean reduction in 24-hour urinary oxalate versus baseline and a 53.5% reduction relative to placebo, with a mean-max

This article was written by

Stephen Simpson profile picture
Stephen Simpson is a freelance financial writer and investor. Spent close to 15 years on the Street (sell-side, buy-side, equities, bonds); now a semi-retired raccoon rancher. That last part isn't entirely true. Probably.

Analyst’s Disclosure: I am/we are long ALNY. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

Recommended For You

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.
Is this happening to you frequently? Please report it on our feedback forum.
If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh.