Portada›Viernes 12 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, viernes 12 de septiembre de 2025

Los 33 documentos que 28 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← jueves 11 de septiembre de 2025 · lunes 15 de septiembre de 2025 →

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Emisiones y dilución

1. CDIOCardio Diagnostics Holdings, Inc.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025. Reverse Stock Split The Company held its annual meeting of stockholders on November 15, 2024, where the Company’s stockholders approved a reverse stock split at a ratio within a range of 1-for-5 and 1-for-40 and granted the Company’s Board of Directors the discretion to determine the timing and ratio of the split within such range. On April 10, 2025, the Company…
2. CLNNClene Inc.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …the 2024 SSCP Notes, we are required to maintain unrestricted cash and cash equivalents of at least $2.0 million to avoid acceleration of the full balance of the 2024 SSCP Notes. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. 7 To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as…

   En el documentoContrasplit de accionestexto original ▸

   …wholly-owned subsidiary of Chelsea Worldwide Inc. On the Closing Date, Chelsea Worldwide Inc. changed its name to Clene Inc. and listed its shares of common stock on Nasdaq under the symbol “CLNN.” We effected a 1-for-20 reverse stock split of our common stock beginning with the opening of trading on July 11, 2024 (the “Reverse Stock Split”). As a result, every 20 shares of common stock issued and outstanding were automatically combined…
3. GNPXGenprex, Inc.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …reference, our independent registered public accounting firm, in its audit report to the financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, expressed substantial doubt about our ability to continue as a going concern. See also our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025, as incorporated by reference into this prospectus, including the discussion therein under “Management’s Discussion…

   En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

   …organization collaborators presented a poster on a non-viral lipid nanoparticle delivery system that would allow a patient to receive multiple treatments. 4 Recent Developments ATM Sales On December 13, 2023, we entered into an At The Market (“ATM”) Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, serving as agent (the “Agent”) with respect to an ATM offering program under which we may offer and sell through the Agent, from time to…
4. HUMAHumacyte, Inc.S-3Capacidad de emisión registradaEDGAR
   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…
5. LBRXLB PHARMACEUTICALS INC424B4Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …future and may never achieve or maintain profitability. • As a result of our history of losses and negative cash flows from operations, our consolidated financial statements contain a statement regarding a substantial doubt about our ability to continue as a going concern. • We will require substantial additional financing in addition to the proceeds of this offering to achieve our goals, and failure to obtain additional capital when needed, or on acceptable terms to us…
6. SLXNSilexion Therapeutics Corp424B4Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …any committed source of financing to meet those needs, there may be substantial doubt raised about our ability to continue as a “going concern.” Please see the explanatory paragraph under the heading “Substantial Doubt about the Company’s Ability to Continue as a Going Concern” in our independent auditors’ report on our financial statements that appear in this prospectus. Those financial statements do not include any adjustments that might result from our inability to continue…
7. BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
8. BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
9. BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
10. COCPCocrystal Pharma, Inc.424B3Prospecto suplementario o de reventaEDGAR
11. OABIOmniAb, Inc.S-3Capacidad de emisión registradaEDGAR

Participaciones y control

1. CRMDCorMedix Inc.SC 13DCambio en participación significativaEDGAR
2. CTORCITIUS ONCOLOGY, INC.SC 13D/ACambio en participación significativaEDGAR
3. SVASINOVAC BIOTECH LTDSC 13D/ACambio en participación significativaEDGAR
4. VORVor Biopharma Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. ALNYALNYLAM PHARMACEUTICALS, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
2. BNTCBenitec Biopharma Inc.8-KCuentas anteriores declaradas no fiablesEDGAR
3. YARWYarrow Bioscience, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
4. ALKSAlkermes plc.8-KCambio en el consejo o la direcciónEDGAR
5. ALKSAlkermes plc.8-KNuevo acuerdo materialEDGAR
6. ALXOALX ONCOLOGY HOLDINGS INC8-KCambio en el consejo o la direcciónEDGAR
   En el documentoCambio en la dirección de la empresatexto original ▸

   …September 4, 2025, the closing bid price of the Company’s common stock had been at $1.00 per share or greater. Management Updates On September 11, 2025, Alan Sandler, M.D., informed the Company of his resignation as Chief Medical Officer of the Company, effective September 26, 2025, in order to pursue other professional opportunities. As noted above, Dr. Sandler will return to his role as a director of the Company and remain heavily involved…
7. ARWRARROWHEAD PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
   En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

   …Ionis sought FDA approval for a new ApoCIII-inhibitor, called olezarsen, to treat people with FCS in the United States. In recognition of the importance of olezarsen to treat people with FCS, the FDA granted olezarsen both Fast Track designation and Breakthrough Therapy designation, and also expedited review of its New Drug Application. The FDA granted olezarsen approval in December 2024. As the FDA explained, “[t]his is a first-in-class approval, meaning [olezarsen] uses a new…

   En el documentoDesignación de vía rápida (Fast Track)texto original ▸

   …Ionis sought FDA approval for a new ApoCIII-inhibitor, called olezarsen, to treat people with FCS in the United States. In recognition of the importance of olezarsen to treat people with FCS, the FDA granted olezarsen both Fast Track designation and Breakthrough Therapy designation, and also expedited review of its New Drug Application. The FDA granted olezarsen approval in December 2024. As the FDA explained, “[t]his is a first-in-class approval…
8. CURXCuranex Pharmaceuticals Inc8-KOtros hechos relevantesEDGAR
9. HROWHARROW, INC.8-KNuevo acuerdo materialEDGAR
10. LBRXLB PHARMACEUTICALS INC8-KCambio de estatutosEDGAR
11. MDCXMedicus Pharma Ltd.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Chief Financial Officer of the Company, will be taking a medical leave of absence from the Company commencing on such date. In connection with Mr. Quinlan's medical leave of absence, Carolyn Bonner was appointed as acting Chief Financial Officer ("Acting CFO") of the Company. Ms. Bonner, 41, will also continue to serve as President of the Company, a role she has held since September 2023. Ms. Bonner will not receive any additional compensation…
12. MTEXMANNATECH INC8-KNuevo acuerdo materialEDGAR
13. NRXPNRX Pharmaceuticals, Inc.8-KCompra o venta de activos completadaEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

    …ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal Ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application…

    En el documentoDesignación de vía rápida (Fast Track)texto original ▸

    …disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal Ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has…
14. PLURPluri Inc.8-KOtros hechos relevantesEDGAR
15. RKTORocket One Inc.8-KOtros hechos relevantesEDGAR
16. SLXNSilexion Therapeutics Corp8-KNuevo acuerdo materialEDGAR
17. TRAWTraws Pharma, Inc.8-KNuevo acuerdo materialEDGAR

Juntas de accionistas

1. NEOGNEOGEN CORPDEF 14AConvocatoria de junta de accionistasEDGAR

← jueves 11 de septiembre de 2025 · lunes 15 de septiembre de 2025 →

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