Pharmaceutical filing citing a Journal of the American Society of Nephrology paper — Alnylam Pharmaceuticals, 2016-08-04
Alnylam PharmaceuticalsAlnylam PharmaceuticalsNASDAQ ALNY
Filings SEC · Quote Yahoo cited a paper published in the Journal of the American Society of Nephrology as a basis for its claims in a regulatory filing submitted to the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website. The company read the manner in which the paper was written and the scope it actually demonstrated in sequence. The stock price movement over one month following the filing was compared to past cases of the same type to determine its position. This is a retrospective judgment written after knowing the results. The paper was read only up to the abstract.
The disclosure is written in the press release as follows:
A 8-K is a form that a U.S.-listed company files with the Securities and Exchange Commission when it needs to inform shareholders of material events. The item numbers in the document filed by Alnylam Pharmaceuticals on 2016-08-04 were 2.02 Earnings Release and 9.01 Financial Statements and Exhibits. The company cited a paper published in Journal of the American Society of Nephrology in the press release attached to it. The sentence citing the paper, copied verbatim from the original, is as follows.
The Company also announces today the publication of pre-clinical data with ALN-GO1 for the treatment of primary hyperoxaluria type 1 (PH1) in the Journal of the American Society of Nephrology (Liebow et al., J Am Soc Nephrol, 2016; doi:10.1681/ASN.2016030338).
What the reader should first check is where the company placed the paper in the press release. Next, the reader should determine whether the paper supports the entire company claim or only a part of it. To answer the latter question, one must read the full paper. This article, which has read only the abstract, cannot provide an answer to that.
The scope of the paper discussed in the abstract is limited to this.
The paper's title is An Investigational RNAi Therapeutic Targeting Glycolate Oxidase Reduces Oxalate Production in Models of Primary Hyperoxaluria and it was published in Journal of the American Society of Nephrology on 2016-07-18. The authors are affiliated with Alnylam Pharmaceuticals (United States) and the University of Alabama at Birmingham. The summary at the beginning of the paper is called abstract. This article has read only up to this point. The paragraph was written by a person after filtering a draft generated by a machine through numerical comparison, so it is of a different grade than a full reading of the paper.
This is a paper reporting on the development process of ALN-GO1, a treatment targeting primary hyperoxaluria type 1 using RNA interference to suppress an enzyme. This disease causes excessive oxalate production due to enzyme deficiency, leading to kidney stone accumulation and eventually end-stage renal failure. Currently, the only certain treatment is combined liver and kidney transplantation, which requires lifelong immunosuppression and surgical risks. As this is a paper discussing the drug development stage, the effectiveness in human patients is outside the scope of this paper.
What the abstract does not answer remains in the full text and appendices. This article, which has not gone beyond the abstract, leaves the blanks as they are. Readers should determine for themselves which sentence in the abstract corresponds to the cited excerpt from the company, by comparing the two citations above.
One month later, the stock price was within the middle half of the sample.
The remaining return, after subtracting the portion that moves with the overall market, is called excess return. The date is written as a trading day, counting only the days the stock market is open. In calendar terms, 20 trading days are about a month. The excess return for the day of the regulatory filing and the following month are listed in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| Five trading days before the filing | +4.2% | The extent of movement before the filing |
| On the day of the filing | −0.8% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +2.9% | One week |
| Cumulative +1~+20 trading days | −4.7% | One month |
A bundle of past cases of the same type is called a sample. The position counted from the bottom is expressed as a percentile. The one-month excess return of -4.7% in this case is within the bottom 56% of the 142 cases in the sample, placing it in the lower half.
| Sample scale (20 trading days) | Tenth from the bottom | Fourth from the bottom | median | top 25% | top 10% | This case |
|---|---|---|---|---|---|---|
| Excess return | −31.9% | −20.1% | −7.4% | +5.5% | +19.5% | −4.7% |
Half of the sample falls between the two marks in the middle of the table. From the table, one confirms whether this case is inside or outside. The sample collects cases where U.S. listed companies wrote papers in 8-K over the past ten years. The company itself is excluded from the sample. The numbers written here are past facts, not rules to apply to the next case.
After the regulatory filing, the company issued such documents
After the filing date, the company issued three 8-K filings, listed only by item numbers. In 8-K filings without titles, the item number indicates the type of content. One can determine whether it was an earnings announcement or a contract based on that number. What exactly occurred is read in the original text of each link.
- 2016-09-19 8-K Items 1.01, 5.02, 7.01, 9.01 — Material contract execution · Officer and director changes · Reg FD disclosure · Financial statements and exhibits
- 2016-10-05 8-K Item 8.01, 9.01 — Other Events · Financial Statements · Exhibits
- 2016-11-02 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
What this article does not answer
This article, which reads only the abstract, does not answer what method the paper used, what it reviewed, or what extent it showed. How many times the paper cited by the company has been cited afterward can be verified again through the OpenAlexOpenAlex
Data source · Website citation count. What will be seen next is whether the company's next 8-K again cites the same paper.
Glossary
- 8-K
- A voluntary report submitted to the Securities and Exchange Commission when a U.S. listed company has news to inform shareholders. Types are indicated by item numbers such as earnings, contracts, and executive changes. All events in this article come from this document.
- Excess return
- The remainder after subtracting the overall market return from the stock return. It is used to observe the movement of the company alone by removing the portion of the market's collective rise and fall.
- Trading day
- A date counting only days when the stock market is open. Since weekends and holidays are excluded, 20 trading days correspond to about a month on a calendar.
- Sample and percentile
- A bundle of past cases of the same type is a sample, and the position from the bottom within it is expressed as a percentile. A percentile of 10 means that nine out of ten cases performed better than this case.
- Abstract
- An abstract is placed at the beginning of a paper. The author writes in a few sentences what was done, how it was done, and what results were obtained. Without reading the full text, one cannot know the details or limitations of the methods.