Portada›Miércoles 24 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 24 de septiembre de 2025

Los 23 documentos que 16 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← martes 23 de septiembre de 2025 · jueves 25 de septiembre de 2025 →

¿Lo quieres en tu correo cada mañana, y solo de tus empresas? Crear una cuenta.

Emisiones y dilución

1. ATAIAtaiBeckley Inc.424B3Prospecto suplementario o de reventaEDGAR
2. BHSTBIOHARVEST SCIENCES INC.424B7Prospecto de reventa de tenedoresEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …Company, or otherwise at least as favorable to the Company as those previously obtained, or at all. Importantly, the inclusion in note 1B to the audited annual consolidated financial statements and in “Substantial Doubt About the Company’s Ability to Continue as a Going Concern” in the report thereto of Ziv Haft Certified Public Accountants (Isr.) (PCAOB ID# 1185) of disclosure regarding the Company’s ability to continue as a going concern may negatively impact the Company’s…
3. HYPDHYPERION DEFI, INC.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …regained compliance with the Minimum Bid Price Requirement. Nasdaq Stock Market Listing Rule 5810(c)(3)(A)(iv) states that any listed company that fails to meet the Minimum Bid Price Requirement and has effected a reverse stock split over the prior one-year period, or has effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one, will not be eligible for an automatic…
4. IMRXImmuneering Corp424B5Nueva emisión de acciones con precioEDGAR
5. MNPRMonopar Therapeutics424B5Nueva emisión de acciones con precioEDGAR
6. PEPGPepGen Inc.424B5Nueva emisión de acciones con precioEDGAR
7. QUREuniQure N.V.424B5Nueva emisión de acciones con precioEDGAR
8. TTRXTurn Therapeutics Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …development. We expect to incur additional losses for the foreseeable future, and it is possible we may never achieve or maintain profitability. Our consolidated financial statements therefore express substantial doubt about our ability to continue as a going concern. ​ • We have a limited operating history and there are inherent uncertainties and risks in pharmaceutical and medical device product development and commercialization. ​ • If we fail to obtain or generate…

   En el documentoDebilidad material en el control internotexto original ▸

   …large, well-established companies with long-standing relationships, extensive clinical data, and recognized brands, as well as against new companies with innovative products. ​ ​ 15 TABLE OF CONTENTS • We identified a material weakness in our internal control over the accuracy of our financial reporting. Any failure to maintain an effective control over financial reporting may result in material misstatements of our consolidated financial…
9. VORVor Biopharma Inc.S-3Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024, as set forth in their report (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements), which is incorporated by reference in this prospectus and elsewhere in the registration statement. Our financial statements are incorporated…

   En el documentoContrasplit de accionestexto original ▸

   …registration statement will not be reviewed or be subject to further review. On August 25, 2025, we held a special meeting of our stockholders and received Stockholder Approval. On September 18, 2025, we effected a reverse stock split of our common stock at a ratio of 1-for-20, without any adjustment to the total number of shares of common stock authorized by our certificate of incorporation. The registration statement of which this…
10. BIAFbioAffinity Technologies, Inc.S-1Capacidad de emisión registradaEDGAR

Participaciones y control

1. MNPRMonopar TherapeuticsSC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. BCDABioCardia, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
2. IMRXImmuneering Corp8-KVenta de acciones no registrada (colocación privada)EDGAR
3. IVVDInvivyd, Inc.8-KCambio en el consejo o la direcciónEDGAR
   En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸

   …requirement set forth in Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”) for continued listing on The Nasdaq Global Market. As previously disclosed, on April 21, 2025, the Company received a letter from Nasdaq, notifying the Company that it was not in compliance with the Minimum Bid Price Requirement because the Common Stock had closed below the $1.00 per share minimum for 30 consecutive business days. To regain compliance with the Minimum Bid Price Requirement, the Common Stock was required…
4. QUREuniQure N.V.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   EX-99.1 2 qure-20250924xex99d1.htm EX-99.1 Exhibit 99.1 uniQure Announces Positive Topline Results from Pivotal Phase I/II Study of AMT-130 in Patients with Huntington’s Disease ​ ~ Pivotal study met primary endpoint; high-dose AMT-130 demonstrated statistically significant 75% disease slowing at 36 months as measured by cUHDRS compared to a propensity score-matched external control ~ ​ ~ High-dose AMT-130 also demonstrated…

   En el documentoDesignación de terapia avanzada (RMAT)texto original ▸

   …who made this possible. We are eager to discuss the data with the FDA at our pre-BLA meeting expected later this year, with the goal of submitting a BLA in the first quarter of 2026.” ​ AMT-130 has been granted Breakthrough Therapy designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. ​ Investor Conference Call and Webcast Information ​ uniQure management will host an investor conference call and webcast today,Wednesday, September 24 at8:30 a.m. ET…

   En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

   …who made this possible. We are eager to discuss the data with the FDA at our pre-BLA meeting expected later this year, with the goal of submitting a BLA in the first quarter of 2026.” ​ AMT-130 has been granted Breakthrough Therapy designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. ​ Investor Conference Call and Webcast Information ​ uniQure management will host an investor conference call and webcast today…
5. ALLRAllarity Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
6. BKHABlack Hawk Acquisition Corp8-KOtros hechos relevantesEDGAR
7. HYPDHYPERION DEFI, INC.8-KNuevo acuerdo materialEDGAR
8. IBACIB Acquisition Corp.8-KNuevo acuerdo materialEDGAR
9. LNAILunai Bioworks Inc.8-KCambio de estatutosEDGAR
10. MNPRMonopar Therapeutics8-KNuevo acuerdo materialEDGAR
11. PEPGPepGen Inc.8-KOtros hechos relevantesEDGAR
12. QUREuniQure N.V.8-KNuevo acuerdo materialEDGAR

← martes 23 de septiembre de 2025 · jueves 25 de septiembre de 2025 →

Esto mismo, cada mañana y solo de tus empresas. Sigue a las que te interesen y recibe en tu correo lo que presenten ante la SEC, en castellano. Crear una cuenta. ¿Ya tienes cuenta? Entrar.

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