Pharmaceutical filing citing a New England Journal of Medicine paper — Tonix Pharmaceuticals, 2024-02-28
Tonix PharmaceuticalsTonix PharmaceuticalsNASDAQ TNXP
Filings SEC · Quote Yahoo cited a paper published in the New England Journal of Medicine in a regulatory filing with the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website. The company read the way it wrote the paper and the actual scope of the paper in order. It described where the stock price movement over the following month compared to past cases of the same type. This is a hindsight 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 filed with the Securities and Exchange Commission is called 8-K. The item numbers of the document filed by Tonix Pharmaceuticals on 2024-02-28 were 7.01 Reg FD Public · 8.01 Other Events · 9.01 Financial Statements·Attached Documents. The company cited a paper published in New England Journal of Medicine in the attached press release. The sentence citing the paper, copied verbatim from the original, is as follows.
N Engl J Med . 2024. 390(7):589-600 https://doi.org/10.1056/nejmoa2309439 2. Sanofi press release.
What readers should first look at is where the company placed the paper in the press release. Next, they 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 only read the abstract, cannot provide an answer.
The scope of the paper mentioned in the abstract is limited to this
The paper title is Inhibition of CD40L with Frexalimab in Multiple Sclerosis and it was published in New England Journal of Medicine on 2024-02-14. The authors are affiliated with Inserm · University Hospital of Basel · Hospital Base. The summary published at the beginning of the paper is called abstract. This article only read up to that point. This paragraph was rewritten by a person after filtering a draft written by a machine reading the abstract by numerical comparison, and thus differs in grade from a full-text reading and original judgment.
It is a phase 2 trial dividing relapsing multiple sclerosis patients into four groups and administering an antibody blocking CD40L intravenously or subcutaneously or a placebo. The primary endpoint was the number of new enhancing lesions on brain MRI at week 12, which was significantly lower in the intravenous group compared to the placebo group. The trial was designed so that all participants could receive the real drug after the blinded period ended, and most completed that period. Since it is a 12-week trial, long-term outcomes such as relapse or disability progression are not included in this paper.
The abstract does not answer; it remains in the main text and the appendix. This text, which does not go there, leaves the blank as it is. Readers compare the two citations above to determine which sentence in the abstract corresponds to the excerpt cited by the company.
A month later, the stock price was within the middle half of the sample.
The return excluding the portion attributable to movement with the overall market is called excess return. Dates are recorded as trading days, counting only the days the stock market is open. In terms of the calendar, 20 trading days are approximately one month. The excess return on the day of the regulatory filing and for the following month are presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| 5 trading days before the filing | −2.5% | The extent to which it had already moved before the filing |
| regulatory filing day | +2.1% | filing day or the first trading day thereafter |
| cumulative +1~+5 trading days | −1.1% | one week |
| cumulative +1~+20 trading days | −16.7% | 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 −16.7% in this case is within the bottom 32% of the 142 samples and is within 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% | −6.9% | +5.5% | +19.5% | −16.7% |
Half of the sample falls between the two middle marks in the table. Check the table to see whether this case falls inside or outside of that range. The sample consists of cases where U.S.-listed companies cited papers in 8-K filings over the past decade. The company itself is excluded from the sample. The numbers listed here are historical facts, not rules to apply to future cases.
The same company had 23 additional instances where papers were mentioned in 8-K filings, which are listed together in the table below.
| Filing date | The journal of the paper | Excess return in 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% |
After the filing, the company issued this document
Three 8-K filings issued by the company after the filing date are listed with only item numbers. In 8-K filings without titles, the item numbers indicate the type of content. Whether it was an earnings announcement or a contract can be identified by the number. The details of what occurred are read in the original text via each link.
- 2024-03-05 8-K Item 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Exhibits
- 2024-03-06 8-K Item 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Exhibits
- 2024-03-07 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 abstracts, cannot answer what the paper re-examined, how, and to what extent. How often the paper cited by the company has been cited afterward can be re-confirmed through OpenAlexOpenAlex
Data source · Website citation counts. 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 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 see the movement unique to this company by removing the portion where the market as a whole rose or fell.
- trading day
- a count of days when the stock market is open. weekends and holidays are excluded, so 20 trading days are about a 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 was found. without reading the full text, details and limitations of the method cannot be known.