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Jueves 15 oct 2026SEC · NASDAQ biomédico

Portada›Lunes 22 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 22 de septiembre de 2025

Los 30 documentos que 25 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

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El día, bloque a bloque

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Por qué unas líneas van en color

Va en color lo que cambia el capital o avisa de un riesgo: las emisiones con precio (424B1, 424B2, 424B4 y 424B5), los 8-K con item 1.02, 1.03, 2.04, 3.01, 3.02 y 4.02, y cualquier documento en el que haya aparecido una frase vigilada, que va citada debajo. Lo demás va en tinta normal. Una cita marcada «por primera vez» es una frase que no estaba en el informe previo del mismo tipo de esa empresa. La etiqueta del formulario lleva a su explicación.

Emisiones y dilución

  1. BNTCBenitec Biopharma Inc.S-3Capacidad de emisión registradaEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…sales, marketing, manufacturing and distribution requirements; • greater than expected expenses, expenses relating to litigation or strategic activities; • the impact of, and our ability to remediate, the identified material weakness in our internal controls over financial reporting; • our ability to satisfy our capital needs through increasing revenue and obtaining additional financing; and • the impact of local, regional and national…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Form S-3 (File No. 333-277310) with the SEC registering up to $125 million of our common stock, debt securities, warrants, and units (the “February 2024 S-3 Shelf”). Subsequently, in October 2024, we entered into an open market sales agreement and filed a prospectus supplement related to an at-the-market offering of up to $75 million of our common stock registered under the February 2024 S-3 Shelf. On November 1, 2024, we filed a registration statement on Form S-3 (File No. 333-282957) with the SEC registering…
  2. ELABPMGC Holdings Inc.S-1Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…containing a microorganism transformed with a vector expressing myostatin and activin A on the cell surface as an active ingredient Going Concern As of December 31, 2024, management has determined there is substantial doubt about the Company’s ability to continue as a going concern. The Company may need to obtain funds to support its working capital, the methods of which include, without limitation, the following: ● this offering; ● other available sources of financing (including…
    En el documentoContrasplit de accionestexto original ▸…Skincare. On November 13, 2024, PMGC Capital LLC (“PMGC Capital”) was incorporated under the laws of the state of Nevada. PMGC is the sole shareholder of PMGC Capital. On November 27, 2024, the Company completed a reverse stock split on a ratio of two hundred old shares of common stock for every one new post reverse split common share. In addition, on March 10, 2025, the Company completed a second reverse stock split on a ratio of…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…does not purport to be complete and is subject to and are qualified in their entirety by a copy of the Northstrive Secondment Agreement, filed herein as Exhibit 10.32. 31 ● On April 24, 2025, the Company entered into an At-The-Market Issuance Sales Agreement (the “Sales Agreement”) with Univest Securities, LLC (“Univest”), under which the Company may issue and sell from time to time, shares of its common stock, par value $0.0001 per share, having an aggregate…
  3. HUMAHumacyte, Inc.424B3Prospecto suplementario o de reventaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…Stock Purchase Agreement will not be sufficient to fund our operations, as currently planned, for more than one year beyond the filing date of this registration statement, we have determined that there is substantial doubt regarding our ability to continue as a going concern. If we do not raise sufficient funds through one or more offerings under this prospectus or through other means, then in connection with the future filing of our Annual Report on Form 10-K for the year…
  4. SABSSAB Biotherapeutics, Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…December 31, 2024, have been audited by EisnerAmper LLP, independent registered public accounting firm, as set forth in their report (which report includes an explanatory paragraph regarding the existence of substantial doubt about our ability to continue as a going concern), and have been incorporated herein by reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing. WHERE YOU CAN FIND MORE INFORMATION This prospectus…
  5. MBXMBX Biosciences, Inc.S-1Capacidad de emisión registradaEDGAR
  6. ORKAOruka Therapeutics, Inc.424B3Prospecto suplementario o de reventaEDGAR
  7. TLPHTALPHERA, INC.S-3Capacidad de emisión registradaEDGAR

Participaciones y control

  1. CDTCDT Equity Inc.SC 13D/ACambio en participación significativaEDGAR
  2. LENZLENZ Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  3. XCUREXICURE, INC.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. ALLRAllarity Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  2. BNTCBenitec Biopharma Inc.8-KResultadosEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; the impact of, and our ability to remediate, the identified material weakness in our internal controls over financial reporting; the impact of local, regional, and national and international economic conditions and events; and other risks detailed from time to time in the Company…
  3. CYTKCYTOKINETICS INC8-KVenta de acciones no registrada (colocación privada)EDGAR
  4. MBXMBX Biosciences, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸EX-99.1 2 mbx-ex99_1.htm EX-99.1 Exhibit 99.1 MBX Biosciences Announces Once-Weekly Canvuparatide Achieved Primary Endpoint in Phase 2 Trial with 63% Responder Rate at 12 Weeks; 79% Responder Rate at 6 Months in Open-Label Extension Statistically significant responder rate achieved at 12 weeks with zero contribution from rescue…
    En el documentoDesignación de medicamento huérfanotexto original ▸…designed to provide convenient, once-weekly administration and a continuous, infusion-like PTH exposure with lower daily peak-to-trough ratios than observed with daily PTH dosing regimens. Canvuparatide received orphan drug designation from the U.S. Food and Drug Administration for the treatment of HP. About MBX Biosciences MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide…
  5. ORKAOruka Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  6. ACXPAcurx Pharmaceuticals, Inc.8-KCambio de estatutosEDGAR
  7. ALLRAllarity Therapeutics, Inc.8-KOtros hechos relevantesEDGAR

    Allarity Therapeutics anunció que su CEO, Thomas Jensen, ha sido invitado a presentar en la conferencia Biomarkers & Precision Medicine 2025 en Londres, organizada por Oxford Global.

    Original en inglés · traducción automáticatoday announced that its CEO, Thomas Jensen, has been invited to present at the upcoming Biomarkers & Precision Medicine 2025 conference in London, organized by Oxford Global. In addition to his presentation, Mr.

    Traducción automática (claude-sonnet-5-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

  8. AVTXAvalo Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
  9. BCABBioAtla, Inc.8-KOtros hechos relevantesEDGAR
  10. BCDABioCardia, Inc.8-KOtros hechos relevantesEDGAR
  11. BNTCBenitec Biopharma Inc.10-KInforme anualEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…may also contain statements expressing substantial doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, if at all. Risks Related to the Product Development and Regulatory Approval…
    En el documentoContrasplit de accionestexto original ▸…Contents Our common stock began trading on The Nasdaq Capital Market, or Nasdaq, at the start of trading on the Implementation Date under the symbol “BNTC.” Reverse Stock Split On July 26, 2023, the Company effected a 1-for-17 reverse stock split (the “Reverse Stock Split”) of its common stock. In accordance with the Reverse Stock Split, 17 pre-split shares of the Company’s common stock were automatically converted into one issued and outstanding…
    En el documentoDebilidad material en el control internotexto original ▸…connection with the restatement, management has re-evaluated the effectiveness of the Company’s internal controls over financial reporting. The Audit Committee of the Board, with concurrence of management, has concluded that, in light of the errors described above, a material weakness exists in the Company’s internal control over financial reporting as of June 30, 2025. Management is actively taking steps to remediate the material weakness in the Company’s internal control over financial…
  12. CCCCC4 Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  13. IONSIONIS PHARMACEUTICALS INC8-KOtros hechos relevantesEDGAR

    Ionis anunció resultados topline positivos del estudio pivotal de zilganersen en niños y adultos con enfermedad de Alexander, donde la dosis de 50 mg mostró una estabilización estadísticamente significativa en la velocidad de marcha en la semana 61 frente a control, con una… Sigue en la ficha

    Original en inglés · traducción automáticaZilganersen 50 mg demonstrated statistically significant and clinically meaningful stabilization on the primary endpoint of gait speed as assessed by the 10-Meter Walk Test (10MWT) compared to control at week 61 (mean difference 33.3%, p=0.0412) with favorable safety and tolerability.

    Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

    En 2020 la FDA concedió a zilganersen las designaciones de medicamento huérfano y pediátrica rara.

    Original en inglés · traducción automáticaIn 2020, the U.S. Food and Drug Administration (FDA) granted zilganersen Orphan Drug designation and Rare Pediatric designation.

    Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

  14. MIRAMIRA PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
  15. ONCOOnconetix, Inc.8-KNuevo acuerdo materialEDGAR
  16. PTNPALATIN TECHNOLOGIES INC8-KOtros hechos relevantesEDGAR
  17. RNTXRein Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  18. SHPHShuttle Pharmaceuticals Holdings, Inc.8-KNuevo acuerdo materialEDGAR
  19. SNYRSynergy CHC Corp.8-KCambio en el consejo o la direcciónEDGAR

Juntas de accionistas

  1. REVBREVELATION BIOSCIENCES, INC.DEF 14AConvocatoria de junta de accionistasEDGAR

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