Pharmaceutical regulatory filing citing a JAMA Network Open paper — Tonix Pharmaceuticals, 2025-01-08
Tonix PharmaceuticalsTonix PharmaceuticalsNASDAQ TNXP
Filings SEC · Quote Yahoo cited a paper published in JAMAJAMA
Journal · Website Network Open as a basis for its claims in a regulatory filing with the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website. The company read the manner in which it wrote the paper and the actual scope the paper demonstrated, in sequence. The stock price movement over one month following the filing was compared to past cases of the same type, and the position was noted. This is a retrospective judgment written after knowing the results. The paper was read only up to the abstract.
The disclosure wrote the paper in the press release like this
When a U.S. listed company has something to inform shareholders, the report submitted to the Securities and Exchange Commission is called 8-K. The item numbers of the document submitted by Tonix Pharmaceuticals on 2025-01-08 were 7.01 Reg FD Public · 8.01 Other Events · 9.01 Financial Statements·Attached Documents. The company cited a paper published in JAMA Network Open in the attached press release. The sentence citing the paper, copied verbatim from the original, is as follows.
JAMA Netw Open. 2024;7(11):e2444488. doi : 10.1001/jamanetworkopen.2024.44488. PMID: 39535796; PMCID: PMC11561685.
What readers should look at first is where the company placed the paper in the press release. Next is to 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 reads only the abstract, cannot answer it.
The scope of the paper mentioned in the abstract is up to here.
The paper title is Gabapentinoids and Risk of Hip Fracture and it was published in JAMA Network Open on 2024-11-13. The authors' affiliations are Monash University · Institut Universitaire de Gériatrie de Montréal · Université Laval · Université de Montréal. The summary published at the beginning of the paper is called abstract. What this article has read is only up to there. This paragraph was rewritten by a person after filtering a draft written by a machine reading the abstract through numerical comparison, so it is a different grade from a full-text reading and a definitive judgment.
A study using hospital records from Victoria, Australia, examined whether neuropathic pain medications such as gabapentin or pregabalin are associated with hip fracture risk in the elderly. Among more than 28,000 patients hospitalized for fractures, those who had been prescribed these medications before the fracture were selected, and their prescriptions in the two months immediately before the fracture and the two months before that were compared within the same individuals. Prescriptions were more frequent in the two months immediately before the fracture, and this difference was greater among frail individuals and those with chronic kidney disease. Since this is an observational study, it does not claim that the medications caused the fractures, only that they occurred together.
What the abstract does not answer remains in the full text and appendices. This article leaves the gaps as they are. Readers are to 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 in the bottom quarter of the sample.
The remaining return after subtracting the portion that moves with the overall market is called excess return. Dates are recorded in trading days, counting only the days when the stock market is open. In terms of the calendar, 20 trading days is roughly one month. The excess return on the day of the filing and for the following month are presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| Five trading days before the filing | −24.7% | The extent of movement before the filing |
| On the filing date | −9.4% | On the filing date or the first trading day thereafter |
| Cumulative over +1 to +5 trading days | −16.6% | One week |
| Cumulative over +1 to +20 trading days | −31.8% | One month |
A bundle of past cases of the same type is called a sample. The position counted from the bottom is expressed in percentiles. The one-month excess return of -31.8% in this case is within the bottom quarter, at the 11% position from the bottom among 142 cases in the sample.
| 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% | −6.9% | +5.5% | +19.5% | −31.8% |
Half of the sample falls between the two central marks on the chart. One checks the chart to see whether this case lies within or outside the range. The sample collects cases where U.S.-listed companies cited papers in 8-K filings over the past ten years. The company itself is excluded from the sample. The numbers listed here are historical facts, not rules applicable to future cases.
There are 23 additional cases where the same company cited a paper in 8-K, which are included in the table below.
| Filing date | Journal of the cited paper | Excess return over one month |
|---|---|---|
| 2018-01-22 | PLoS ONE | −15.3% |
| 2020-12-04 | Genome biology | +20.9% |
| 2020-12-23 | Genome biology | +32.1% |
| 2021-11-23 | JCI Insight | −11.5% |
| 2021-12-14 | JCI Insight | −23.9% |
| 2022-01-04 | JCI Insight | −38.1% |
| 2022-01-11 | JCI Insight | −31.8% |
| 2022-03-14 | Nature Structural & Molecular Biology | −9.3% |
Documents issued by the company after the filing
Only item numbers are listed for the three 8-K filings issued by the company after the filing date. In 8-K filings without titles, item numbers indicate the type of content. One can determine whether it was an earnings announcement or a contract by the item number. The specific event is read in the original text of each link.
- 2025-02-03 8-K Items 1.02,2.02,3.03,8.01,9.01 — Termination of significant contract · Earnings announcement · Change in rights of security holders · Other events · Financial statements and exhibits
- 2025-02-04 8-K Items 5.02,7.01,8.01,9.01 — Officer/Director Changes · Reg FD Disclosure · Other Events · Financial Statements and Exhibits
- 2025-02-06 8-K Item 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Exhibits
What this article does not answer
This article, which reads only the abstract, cannot answer what method the paper used, what it reviewed, and how far it showed. How many times the paper cited by the company has been cited afterward can be checked 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.
Explanation of terms
- 8-K
- A voluntary report submitted to the U.S. Securities and Exchange Commission when a listed company has something to inform shareholders. It is categorized by item numbers such as earnings, contracts, and officer changes. All events in this article come from this document.
- Excess return
- The portion of a stock's return that remains after subtracting the overall market return. It is used to observe the movement specific to the company by removing the portion attributable to the market as a whole.
- Trading day
- A date counting only the days the stock market is open. Since weekends and holidays are excluded, 20 trading days correspond to approximately one calendar month.
- Sample and percentile
- A bundle of past cases of the same type is a sample, and the position from the bottom is expressed as a percentile. A percentile of 10 means that nine out of ten cases performed better than this case.
- Abstract
- A summary 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, the details and limitations of the method cannot be known.