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Lunes 12 oct 2026SEC · NASDAQ biomédico

Portada›Miércoles 3 de diciembre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 3 de diciembre de 2025

Los 24 documentos que 22 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

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. ASBPAspire-Lakewood Holdings, Inc.S-1Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…going concern considerations in accordance with Financial Accounting Standard Board’s (“FASB”) ASC Subtopic 205-40, “Going Concern,” management has determined that the Company’s liquidity condition raises substantial doubt about the Company’s ability to continue as a going concern through twelve months from the date these condensed consolidated financial statements are available to be issued. These condensed consolidated financial statements do not include any adjustments relating…
  2. CMNDClearmind Medicine Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…covering the October 31, 2024 consolidated financial statements contains an explanatory paragraph that states that the Company’s recurring losses from operations and lack of sufficient resources raise substantial doubt about the entity’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of that uncertainty. Such financial statements are incorporated in this prospectus supplement by…
  3. ELABPMGC Holdings Inc.424B3Prospecto suplementario o de reventaEDGAR
    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 share of common stock. On March 10, 2025, the Company completed a second reverse stock split on a ratio of seven…
    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. 47 ● 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…
  4. ELABPMGC Holdings Inc.424B3Prospecto suplementario o de reventaEDGAR
    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 share of common stock. On March 10, 2025, the Company completed a second reverse stock split on a ratio of seven…
    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. 54 ● 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…
  5. LNAILunai Bioworks Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…424B5 Prospectus Supplement Filed pursuant to Rule 424(b)(5) (To Prospectus dated November 6, 2024) Registration Statement No. 333-282898 Lunai Bioworks Inc. Up to $11,702,826 of Common Stock We have entered into an ATM Sales Agreement (the “Sales Agreement”) with Dawson James Securities, Inc. (“Dawson James”) relating to shares of our common stock, par value $0.0001 per share, (the “Common Stock”) offered by this prospectus supplement…
  6. RANIRani Therapeutics Holdings, Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…audited our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024 (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), as set forth in their report, which is incorporated by reference in this prospectus and elsewhere in the registration statement. Our financial…
  7. ALLRAllarity Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR

Participaciones y control

  1. HOWLWerewolf Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. CAPRCAPRICOR THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…Therapeutics Announces Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy ​ ● Pivotal Phase 3 randomized, double-blind, placebo-controlled study (n=106) met the primary endpoint (PUL v2.0) and the key secondary cardiac endpoint (LVEF), both achieving statistical significance (p=0.03 and p=0.04, respectively) ● Statistical significance was achieved in all type 1 error controlled…
    En el documentoDesignación de medicamento huérfanotexto original ▸…pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials. Deramiocel has received Orphan Drug Designation for the treatment of Duchenne Muscular Dystrophy (DMD) from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation…
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…trials. Deramiocel has received Orphan Drug Designation for the treatment of Duchenne Muscular Dystrophy (DMD) from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA, which may qualify Capricor for a Priority Review Voucher…
  2. STROSUTRO BIOPHARMA, INC.8-KCambio de estatutosEDGAR
    En el documentoContrasplit de accionestexto original ▸…Sutro or the Company) (NASDAQ: STRO), a clinical stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that its Board of Directors (Board) has approved a reverse stock split of the Company’s outstanding shares of common stock at a ratio of 1-for-10. The reverse stock split will become effective at 12:01 a.m. Eastern Time on December 3, 2025. Sutro’s common stock will begin…
  3. ALNYALNYLAM PHARMACEUTICALS, INC.8-KCambio en el consejo o la direcciónEDGAR
  4. BCDABioCardia, Inc.8-KCambio en el consejo o la direcciónEDGAR
  5. BCRXBIOCRYST PHARMACEUTICALS INC8-KOtros hechos relevantesEDGAR
  6. BDTXBlack Diamond Therapeutics, Inc.8-KResultadosEDGAR
  7. BIAFbioAffinity Technologies, Inc.8-KOtros hechos relevantesEDGAR
  8. CLNNClene Inc.8-KOtros hechos relevantesEDGAR
  9. FLNAFILANA THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
  10. INMBInmune Bio, Inc.8-KCambio en el consejo o la direcciónEDGAR
  11. IXHLIncannex Healthcare Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸EX-99.1 2 ea026814501ex99-1_incannex.htm PRESS RELEASE OF INCANNEX HEALTHCARE INC., DATED DECEMBER 3, 2025 Exhibit 99.1 Incannex Granted FDA Fast Track Designation for IHL-42X in Obstructive Sleep Apnea (OSA) MELBOURNE, Australia and NEW YORK, USA — December 3, 2025 — Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing…
  12. LNAILunai Bioworks Inc.8-KNuevo acuerdo materialEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 1.01 Entry into a Material Definitive Agreement. On December 2, 2025, Lunai Bioworks, Inc. (the “Company”) entered into an At-the-Market Sales Agreement (the “Sales Agreement”) with Dawson James Securities, Inc. (the “Sales Agent”), pursuant to which the Company may offer and sell (the “Offering”) shares of its common stock, par value $0.0001 per share…
  13. REVBREVELATION BIOSCIENCES, INC.8-KOtros hechos relevantesEDGAR
  14. TARAProtara Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  15. VTGNVistagen Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…of Maryland, College Park, Robert H. Smith School of Business. Except as disclosed herein, there are no arrangements or understandings between Mr. Tressler and any other person pursuant to which he was appointed as the Company’s Chief Financial Officer, Treasurer and principal financial and accounting officer, and Mr. Tressler is not a participant in any related party transaction required to be reported pursuant to Item 404(a) of Regulation S-K. As…

Juntas de accionistas

  1. MBIOMUSTANG BIO, INC.DEF 14AConvocatoria de junta de accionistasEDGAR

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