Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
Published . Updated .
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension.
Directly affected
- No company is named in this report.
Indirectly affected
- ACHC ACADIA HEALTHCARE COMPANY INC
GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- ASND ASCENDIS PHARMA A/S
GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- ATYR ATYR PHARMA INC COM NEW
GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- BBIO BRIDGEBIO PHARMA INC
GA selected BBIO as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- DVA DaVita HealthCare Partners, Inc.
GA selected DVA as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- GEHC GE HEALTHCARE TECHNOLOGIES I
GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
Price reaction, T-5 to T+3
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extensio…
Source: FDA
Price since this story was published: Acadia Healthcare (ACHC)
Since the first closing price after “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act,” Acadia Healthcare (ACHC) is +8.13%. The S&P 500 fund (SPY) is +0.15% over the same days, a +7.98% difference versus the market.
Disclosure records for Acadia Healthcare (ACHC) within two months of 27 Sep 2026
- Gilbert Cisneros sell BridgeBio Pharma (BBIO) ($1,001 - $15,000). That is 2 days after publication, inside 30 days. The filing is listed beside the story “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act.”
- Rohit Khanna buy GE HealthCare Technologies (GEHC) ($1,001 - $15,000). That is 16 days before publication, inside 30 days. The filing is listed beside the story “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act.”
- Rohit Khanna buy GE HealthCare Technologies (GEHC) ($1,001 - $15,000). That is 55 days before publication, inside 60 days. The filing is listed beside the story “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act.”
- Rohit Khanna buy GE HealthCare Technologies (GEHC) ($1,001 - $15,000). That is 59 days before publication, inside 60 days. The filing is listed beside the story “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act.”
- Rohit Khanna buy GE HealthCare Technologies (GEHC) ($1,001 - $15,000). That is 59 days before publication, inside 60 days. The filing is listed beside the story “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act.”
Public disclosure filings, not a recommendation. The filing link is the source document. News use of these reports still sits under 5 U.S.C. § 13107(c).
Who gains and who loses around Acadia Healthcare (ACHC)
Companies tied to this story
- ACHC Acadia Healthcare
In “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act,” Acadia Healthcare (ACHC) is linked, with no stored direction, medium confidence. Reason on file: GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- ASND Ascendis Pharma A/S
Ascendis Pharma A/S (ASND) is linked, with no stored direction, medium confidence in the 27 Sep 2026 story “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act.” Reason on file: GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- ATYR aTYR PHARMA
For “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act,” aTYR PHARMA (ATYR) is linked, with no stored direction, medium confidence. Reason on file: GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- BBIO BridgeBio Pharma
For “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act,” BridgeBio Pharma (BBIO) is linked, with no stored direction, medium confidence. Reason on file: GA selected BBIO as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- DVA Davita
In “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act,” Davita (DVA) is linked, with no stored direction, medium confidence. Reason on file: GA selected DVA as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- GEHC GE HealthCare Technologies
For “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act,” GE HealthCare Technologies (GEHC) is linked, with no stored direction, medium confidence. Reason on file: GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
Acadia Healthcare (ACHC)
The 27 Sep 2026 story “Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act” names Acadia Healthcare (ACHC) because of this story.
What ties Acadia Healthcare (ACHC) to the headline is this: GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
Ascendis Pharma A/S (ASND) is here too. Its reason reads: GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
The price range for Acadia Healthcare (ACHC), and the dates in the story
ACHC traded between 26.75 and 32.03 across 20 sessions. The latest close on file is 30.20. ASND traded between 219.69 and 240.84 across 20 sessions. The latest close on file is 229.99. ATYR traded between 0.17 and 0.41 across 20 sessions. The latest close on file is 0.17.
A simple score for Acadia Healthcare (ACHC)
46 out of 100
“Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act” scores 46 out of 100. The score uses 1 sources, and 6 linked companies.