Portada›Lunes 6 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 6 de octubre de 2025

Los 36 documentos que 35 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← viernes 3 de octubre de 2025 · martes 7 de octubre de 2025 →

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Emisiones y dilución

1. BIVIBIOVIE INC.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company‘s recurring losses from operations and negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern. Management’s plans regarding these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion…

   En el documentoContrasplit de accionestexto original ▸

   …held by our investors, might have an adverse effect on any trading market for our Common Stock and could impair our ability to raise capital in the future through the sale of equity securities. 33 We effected a reverse stock split on July 7, 2025, and such reverse stock split has caused and could further cause our stock price to decline relative to its value before the reverse stock split and decrease the liquidity of shares of…
2. BMEABiomea Fusion, Inc.424B5Nueva emisión de acciones con precioEDGAR
3. ISPCiSpecimen Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …profitability in subsequent periods. Our prior losses and expected future losses have had and will continue to have adverse effects on our stockholders’ equity (deficit) and working capital. There is substantial doubt about our ability to continue as a going concern. Our audited financial statements included in this Annual Report include an explanatory paragraph that indicates that they were prepared assuming that we would continue as a going concern. We have suffered…

   En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸

   …Agreement. In connection with the ATM Offering, we incurred offering costs of approximately $255,000, resulting in net proceeds of approximately $1,239,000. 38 Reverse Stock Split On October 9, 2023, we received a notification from Nasdaq that our Common Stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by the Listing Rules of The Nasdaq Stock Market. On July 19, 2024, our stockholders approved a proposal to amend our Fourth Amended…

   En el documentoContrasplit de accionestexto original ▸

   …our issued and outstanding shares of common stock, as well as any shares of common stock held by the Company in treasury, at a ratio in the range from 1-for-10 to 1-for-20. On August 19, 2024, the Board approved a one-for-twenty (1:20) reverse stock split of our issued and outstanding shares of common stock. On September 13, 2024, we filed with the Secretary of State of the State of Delaware a Certificate of Amendment to our Certificate of Incorporation…

   En el documentoDebilidad material en el control internotexto original ▸

   …recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. During the year ended December 31, 2024, we identified a material weakness in our internal control over financial reporting that may cause us to fail to meet our reporting obligations or result in material misstatements of our financial statements. If we fail to remediate this…

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

   …exercisable for an aggregate of up to 65,625 shares of common stock, all of which were repurchased by us on February 13, 2024, and are no longer outstanding. At the Market Offering On March 5, 2024, we entered into an At the Market Offering Agreement (the “ATM Agreement”) with Rodman & Renshaw LLC as agent (the “Sales Agent”) pursuant to which we may issue and sell shares of our common stock, having an aggregate offering price of up to…
4. MPLTMapLight Therapeutics, Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …acceptable terms, could cause us to delay, limit, reduce or terminate our product development or future commercialization efforts. • Our recurring losses from operations and financial condition raise substantial doubt about our ability to continue as a going concern. • If we are unable to successfully identify, develop and commercialize any product candidates or experience significant delays in doing so, our business, financial condition, results of operations and…
5. CRMDCorMedix Inc.S-3ASRCapacidad de emisión registradaEDGAR
6. IMMXImmix Biopharma, Inc.S-3Capacidad de emisión registradaEDGAR
7. SCNIScinai Immunotherapeutics Ltd.424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

1. VORVor Biopharma Inc.SC 13D/ACambio en participación significativaEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …Reporting Person (See Instructions) OO Comment for Type of Reporting Person: The number of shares set forth rows 8, 10 and 11 reflect the 1-for-20 reverse stock split of Vor Biopharma Inc. Common Stock effected September 18, 2025 (the "Reverse Stock Split"). SCHEDULE 13D CUSIP No. 929033108 1 Name of reporting person Reid Hoffman 2 Check the appropriate box if a member of a Group (See Instructions) (a) (b) 3 SEC use only 4 Source of funds (See Instructions…
2. AMRXAmneal Pharmaceuticals, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. EQEquillium, Inc.8-KCambio en el consejo o la direcciónEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered significant operating losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty…
2. HOWLWerewolf Therapeutics, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
3. ARVNARVINAS, INC.8-KOtros hechos relevantesEDGAR
4. BMEABiomea Fusion, Inc.8-KOtros hechos relevantesEDGAR
5. CLRBCellectar Biosciences, Inc.8-KOtros hechos relevantesEDGAR
6. CORTCORCEPT THERAPEUTICS INC8-KCambio en el consejo o la direcciónEDGAR
7. CYPHCYPHERPUNK TECHNOLOGIES INC.8-KOtros hechos relevantesEDGAR
8. DCOYDecoy Therapeutics Inc.8-KOtros hechos relevantesEDGAR
9. GANXGain Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
10. HALOHALOZYME THERAPEUTICS, INC.8-KCambio en el consejo o la direcciónEDGAR
11. HROWHARROW, INC.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 ImprimisRx Announces Leadership Changes Frank Mullery Appointed Chief Executive Officer of ImprimisRx Bridseida Cruz Appointed Head of Quality of ImprimisRx NASHVILLE, Tenn., October 6, 2025 – Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America…
12. IRONDisc Medicine, Inc.8-KCambio en el consejo o la direcciónEDGAR
13. IVVDInvivyd, Inc.8-KOtros hechos relevantesEDGAR
14. LIMNLiminatus Pharma, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

    …of going concern considerations in accordance with Financial Accounting Standards Board (“FASB”) ASC 205-40, Presentation of Financial Statements—Going Concern, management has concluded that there is substantial doubt about its ability to continue as a going concern within one year after the date that the accompanying unaudited condensed consolidated financial statements are issued. The Company’s unaudited condensed consolidated financial statements do not include…
15. MAZEMaze Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
16. MRKRMarker Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
17. ORMPORAMED PHARMACEUTICALS INC.8-KOtros hechos relevantesEDGAR
18. PHATPhathom Pharmaceuticals, Inc.8-KCambio en el consejo o la direcciónEDGAR
19. QCLSQ/C TECHNOLOGIES, INC.8-K/ACambio en el consejo o la direcciónEDGAR
20. REGNREGENERON PHARMACEUTICALS, INC.8-KResultadosEDGAR
21. SCNXScienture Holdings, Inc.8-KCambio de estatutosEDGAR
22. STOKStoke Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Smith holds a B.A. with honors in accounting and finance from Manchester Metropolitan (UK). There are no arrangements or understandings between Mr. Smith and any other persons, pursuant to which he was appointed as Chief Executive Officer and principal executive officer, there are no family relationships among any of the Company’s directors or executive officers and Mr. Smith, and he has no direct or indirect material interest in any transaction…
23. TELOTelomir Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
24. TRAWTraws Pharma, Inc.8-KCambio en el consejo o la direcciónEDGAR

Juntas de accionistas

1. HINDVyome Holdings, IncDEF 14AConvocatoria de junta de accionistasEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …disclaimer of opinion, and were not qualified or modified as to uncertainty, audit scope, or accounting principles, except that such reports contained a separate emphasis of matter paragraph related to substantial doubt about the Company’s ability to continue as a going concern. RSM was appointed by the Board of Directors on July 15, 2022, as the Company’s independent registered public accounting firm, and served as the Company’s auditor from that date through April 8, 2024…
2. IBIOiBio, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
   En el documentoDebilidad material en el control internotexto original ▸

   …CohnReznick to make reference thereto in its reports; and (ii) no reportable events within the meaning of Item 304(a)(1)(v) of Regulation S-K, except that during the quarter ended March 31, 2023, the Company identified a material weakness in its controls relating to accounting for stock-based compensation expense relating to the vesting of severed employees’ awards, which the Company fully remediated for the year ended June 30, 2023, as…
3. PMCBPharmaCyte Biotech, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

← viernes 3 de octubre de 2025 · martes 7 de octubre de 2025 →

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