Portada›Jueves 18 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, jueves 18 de septiembre de 2025

Los 33 documentos que 29 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← miércoles 17 de septiembre de 2025 · viernes 19 de septiembre de 2025 →

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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. HURATuHURA Biosciences, Inc./NVS-1/ACapacidad de emisión registrada (enmienda)EDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …ownership interest. A decline in the value of TuHURA could also cause you to lose all or part of your investment. 6 Table of Contents TuHURA’s recurring losses from operations and financial condition raise substantial doubt about its ability to continue as a going concern. TuHURA’s recurring losses from operations and financial condition raise substantial doubt about its ability to continue as a going concern. In TuHURA’s financial statements for the six months ended June…

   En el documentoContrasplit de accionestexto original ▸

   …Merger Sub merged with and into TuHURA, with TuHURA surviving the Merger and becoming direct, wholly owned subsidiary of the Company. Effective at 12:01 a.m. Eastern Time on October 18, 2024, the Company effected the Reverse Stock Split, whereby every 35 shares of issued and outstanding common stock were converted into one share of common stock. Any fractional shares of common stock resulting from the Reverse Stock Split were rounded…
3. JSPRJasper Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …June 30, 2025, we had an accumulated deficit of $288.8 million. Given our recurring losses from operations and negative cash flows, and based on our current operating plan, we concluded that there is substantial doubt about our ability to continue as a going concern within one year from August 13, 2025, the date we filed our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. Implications of Being a Smaller Reporting Company We are a “smaller reporting…
4. XFORX4 Pharmaceuticals, Inc424B3Prospecto suplementario o de reventaEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …completed the business combination with X4 Therapeutics, Inc. (formerly X4 Pharmaceuticals, Inc.) and we completed our corporate rebranding, changing our name to X4 Pharmaceuticals, Inc. On April 28, 2025, we effected a 1-for-30 reverse stock split of our Common Stock (the “Reverse Stock Split”). All references to common stock share and per share amounts in this prospectus are presented on a post-Reverse Stock Split basis. Our principal executive…
5. BIAFbioAffinity Technologies, Inc.424B3Prospecto suplementario o de reventaEDGAR
6. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
7. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
8. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
9. STTKShattuck Labs, Inc.S-3Capacidad de emisión registradaEDGAR

Participaciones y control

1. CGONCG Oncology, Inc.SC 13DCambio en participación significativaEDGAR
2. CGONCG Oncology, Inc.SC 13DCambio en participación significativaEDGAR
3. RAPPRapport Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. ENVBEnveric Biosciences, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
2. GRCEGrace Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored…

   En el documentoDesignación de medicamento huérfanotexto original ▸

   …which provide patent protection to 2037. The new patent on the I.V. dosing regimen for GTx-104 strengthens the Company’s intellectual property position and extends protection to 2043. Grace has also been granted Orphan Drug Designation from the FDA, which provides GTx-104 seven years of marketing exclusivity in United States upon FDA approval of the Company’s New Drug Application (NDA). “We conducted extensive clinical work with our…
3. MDCXMedicus Pharma Ltd.8-KNuevo acuerdo materialEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than 90% probability of castration levels of testosterone suppression (97.5%) but the secondary endpoint of maintaining this rate above 90% was not met with the probability dropping to 82.5…
4. NKTRNEKTAR THERAPEUTICS8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …66.0%) 71 (68.3%) 45 (61.6%) ≥1.25, n (%) 8 REZOLVE - AD: Baseline Demographics Dose Dependent % EASI Reduction, Clear Separation from Placebo at All Timepoints for Study Treatment Arms All dose arms met primary endpoint with statistical significance p - value <0.001 ***p - value<0.001 0 20 40 60 80 110 53% 106 104 73 31% Week 16 *** 61% % EASI Improvement *** 58% *** LS Mean At Week 16 0 2 4 6 8 10 12 14 16 - 80 - 60…
5. NXTSNexentis Technologies Inc.8-KOtros hechos relevantesEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …N2OFF, Inc.\ (NASDAQ: NITO) (FSE:80W) (“N2OFF” or the “Company”), a clean tech company engaged in sustainable solutions for the energy and agri-tech industries, announced that its Board of Directors has approved a one-for-thirty-five (1-for-35) reverse stock split of its common stock that is scheduled to become effective for Nasdaq purposes on September 22, 2025. Beginning on September 22, 2025, the Company’s common stock will trade on the Nasdaq Capital Market…
6. OCGNOcugen, Inc.8-KFin de acuerdo materialEDGAR
7. AMPHAmphastar Pharmaceuticals, Inc.8-KNuevo acuerdo materialEDGAR
8. CTNMContineum Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
9. DBVTDBV Technologies S.A.8-KCambio en el consejo o la direcciónEDGAR
10. DCOYDecoy Therapeutics Inc.8-KNuevo acuerdo materialEDGAR
11. HUMAHumacyte, Inc.8-KNuevo acuerdo materialEDGAR
12. KALAKALA BIO, Inc.8-KOtros hechos relevantesEDGAR
13. PALIPALISADE BIO, INC.8-KOtros hechos relevantesEDGAR
14. PASGPassage BIO, Inc.8-KCambio en el consejo o la direcciónEDGAR
15. PDSBPDS Biotechnology Corp8-KOtros hechos relevantesEDGAR
16. RADXRadiopharm Theranostics Ltd20-FInforme anual (emisor extranjero)EDGAR
17. REPLReplimune Group, Inc.8-KOtros hechos relevantesEDGAR
18. SHPHShuttle Pharmaceuticals Holdings, Inc.8-KCambio en el consejo o la direcciónEDGAR
19. TELOTelomir Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
20. TNXPTonix Pharmaceuticals Holding Corp.8-KOtros hechos relevantesEDGAR

Juntas de accionistas

1. LFCRLIFECORE BIOMEDICAL, INC. \DE\DEF 14AConvocatoria de junta de accionistasEDGAR
   En el documentoDebilidad material en el control internotexto original ▸

   …certain monitoring activities that were responsive to timely identification and remediation of control deficiencies; and •Control Activities – as a result of the material weaknesses in the COSO components identified above, the control activities were ineffective and represent a material weakness. The material weaknesses identified above relate to matters such as the accounting for and classification of certain non-standard transactions, inventory valuation, the capitalization of interest on assets…

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