Pharmaceutical filing citing a New England Journal of Medicine paper — Tonix Pharmaceuticals, 2024-03-05
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 submitted to the Securities and Exchange Commission is called 8-K. The item numbers of the document submitted by Tonix Pharmaceuticals on 2024-03-05 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 3. Lassiter G., et al.
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 discussed 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 there. 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 the CD40L-blocking antibody praluzumab intravenously in high doses or subcutaneously in low doses, or a placebo. The primary endpoint was the number of new enhancing lesions on brain MRI at week 12, with the intravenous group having an average of 0.2 lesions compared to 1.4 in the placebo group. The subcutaneous group was in between. The trial was designed so that all participants could receive the real drug after the blinded period, and most participants completed that period. Since it is a 12-week phase 2 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.
One month later, the stock price was in the bottom quarter of the sample.
The return remaining after subtracting the portion that moves with the entire market is called excess return. The date is written as trading day, counting only the days when the stock market is open. In terms of a calendar, 20 trading days are approximately one month. The regulatory filing day in this case and the excess return for the following month are listed in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| 5 trading days before the filing | +8.0% | The extent to which it had already moved before the filing |
| regulatory filing day | −3.6% | filing day or first trading day thereafter |
| +1~+5 trading day cumulative | −13.9% | one week |
| +1~+20 trading day cumulative | −49.9% | 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 −49.9% in this case is in the bottom quarter, at the 4% level 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 | −31.8% | −20.1% | −6.9% | +5.5% | +19.5% | −49.9% |
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 in the table below together.
| Filing date | The academic 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, so it is possible to determine whether it was an earnings announcement or a contract. The details of what happened can be read in the original text of each link.
- 2024-03-06 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Attached documents
- 2024-03-07 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Attached documents
- 2024-03-11 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 many times the paper cited by the company was cited afterward can be re-confirmed 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 executive changes. All the 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 of this company alone 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 within it 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, the details and limitations of the method cannot be known.