Portada›Martes 2 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, martes 2 de septiembre de 2025

Los 40 documentos que 35 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

miércoles 3 de septiembre de 2025 →

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Emisiones y dilución

1. ACTUACTUATE THERAPEUTICS, INC.S-3Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …objectives of management for future operations, future results of anticipated product development efforts, and our ability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continue as a going concern and we will require substantial additional capital to finance our operations, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may…
2. CTORCITIUS ONCOLOGY, INC.S-3Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …addition, such statements could be affected by risks and uncertainties related to: ● our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern; ● the Company’s need for substantial additional funds, even after completion of this offering, and its ability to raise those funds; ● the ability of the Company to commercialize LYMPHIR, including covering…
3. INDPIndaptus Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …have been incorporated by reference herein in reliance upon the report of Haskell & White LLP, independent registered public accounting firm, which report includes an explanatory paragraph expressing substantial doubt regarding the Company’s ability to continue as a going concern, and upon the authority of said firm as experts in accounting and auditing. S-13 WHERE YOU CAN FIND MORE INFORMATION This prospectus supplement constitutes a part of a registration statement on Form S…

   En el documentoContrasplit de accionestexto original ▸

   …shares of common stock at an exercise price per share equal to $8.302. The placement agent warrants are immediately exercisable and expire five years from the date of issuance. Reverse Stock Split We implemented a 1-for-28 reverse stock split of our outstanding common stock, which became effective on June 26, 2025, with the shares beginning trading on a post-split basis on the Nasdaq Capital Market on June 27, 2025. As a result of the reverse…

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

   …As Filed Pursuant to Rule 424(b)(5) Registration No. 333-289573 PROSPECTUS SUPPLEMENT (To Prospectus dated August 20, 2025) INDAPTUS THERAPEUTICS, INC. Up to $2,340,000 Shares of Common Stock We have entered into an at-the-market offering agreement, or the Offering Agreement, dated June 1, 2022, as amended, with H.C. Wainwright & Co., LLC, or the Sales Agent or Wainwright, as sales agent relating to the shares of our common stock, par…
4. INDPIndaptus Therapeutics, Inc.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …have been incorporated by reference herein in reliance upon the report of Haskell & White LLP, independent registered public accounting firm, which report includes an explanatory paragraph expressing substantial doubt regarding the Company’s ability to continue as a going concern, and upon the authority of said firm as experts in accounting and auditing. incorporation of CERTAIN information by reference The SEC allows us to “incorporate by reference” the information we have filed…

   En el documentoContrasplit de accionestexto original ▸

   …shares of common stock at an exercise price per share equal to $8.302. The placement agent warrants are immediately exercisable and expire five years from the date of issuance. Reverse Stock Split We implemented a 1-for-28 reverse stock split of our outstanding common stock, which became effective on June 26, 2025, with the shares beginning trading on a post-split basis on the Nasdaq Capital Market on June 27, 2025. As a result of the reverse…
5. MLYSMineralys Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

   …stock, for 60 days after the date of this prospectus without first obtaining the written consent of the representatives, subject to specified exceptions, including sales pursuant to existing trading plans established under Rule 10b5-1 under the Exchange Act and sales of shares sold in “at-the-market” offerings pursuant to the Sales Agreement. Specifically, we and these other persons have agreed not to directly or indirectly: •offer, pledge, sell or contract to sell any common stock, •sell any option or contract to purchase any common stock…
6. RPRXRoyalty Pharma plc424B2Nueva emisión de acciones con precioEDGAR
7. SABSSAB Biotherapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
   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…
8. TTRXTurn Therapeutics Inc.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …development. We expect to incur additional losses for the foreseeable future, and it is possible we may never achieve or maintain profitability. Our consolidated financial statements therefore express substantial doubt about our ability to continue as a going concern. ​ • We have a limited operating history and there are inherent uncertainties and risks in pharmaceutical and medical device product development and commercialization. ​ • If we fail to obtain or generate…

   En el documentoDebilidad material en el control internotexto original ▸

   …that competes against large, well-established companies with long-standing relationships, extensive clinical data, and recognized brands, as well as against new companies with innovative products. ​ • We identified a material weakness in our internal control over the accuracy of our financial reporting. Any failure to maintain an effective control over financial reporting may result in material misstatements of our consolidated financial…
9. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
10. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR
11. MDCXMedicus Pharma Ltd.424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

1. SNTISenti Biosciences Holdings, Inc.SC 13D/ACambio en participación significativaEDGAR
2. STTKShattuck Labs, Inc.SC 13DCambio en participación significativaEDGAR

Informes y hechos relevantes

1. CNTXContext Therapeutics Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
   En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸

   …(the “Minimum Bid Price Rule”). The Extension Letter has no immediate effect on the Nasdaq listing or trading of the Company’s common stock. As previously disclosed, on February 27, 2025, the Company received written notice from Nasdaq stating that the Company was not in compliance with the Minimum Bid Price Rule because the Company’s common stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. The Company intends to actively monitor the closing bid price…
2. CRMDCorMedix Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoCambio en la dirección de la empresatexto original ▸

   …Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. The Company announced today that Susan Blum, Elizabeth Hurlburt and Matthew David (each, an “Executive”)have been appointed to serve as the Company’s Chief Financial Officer, Chief Operating Officer and Chief Business Officer, respectively, each effective as of the Closing Date. In their previous roles, Ms. Blum served as the Chief Financial Officer of Melinta, Ms. Hurlburt…
3. HINDVyome Holdings, Inc8-KOtros hechos relevantesEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …markets. There is no assurance that such financing can be completed. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Management is implementing plans to reduce expenses and seek additional financing. However, there can be no assurance that these plans will be successful. The financial statements do not include any…

   En el documentoContrasplit de accionestexto original ▸

   …Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) promulgated by the Financial Accounting Standards Board (“FASB”). In August 2025, the Board of Directors of the Company approved a 5,000 – 1 reverse stock split. All share and per share numbers have been updated to reflect such a reverse stock split. b) Segments The Company organized its operations into two operating segments. The segments reflect the way the…
4. IONSIONIS PHARMACEUTICALS INC8-KOtros hechos relevantesEDGAR

   Ionis Pharmaceuticals anunció el 2 de septiembre de 2025 resultados positivos preliminares de los estudios de Fase 3 CORE y CORE2 de olezarsen en personas con hipertrigliceridemia severa.

   Original en inglés · traducción automática

   CARLSBAD, Calif., Sept. 2, 2025 -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive topline results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with severe hypertriglyceridemia (sHTG).

   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.

   Olezarsen cumplió el criterio principal del estudio, mostrando una reducción estadísticamente significativa de los niveles de triglicéridos en ayunas a los seis meses, además de todos los criterios secundarios clave.

   Original en inglés · traducción automática

   Olezarsen met the primary endpoint, demonstrating a statistically significant reduction in fasting triglyceride levels at six months, and all key secondary endpoints.

   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.

5. MDCXMedicus Pharma Ltd.8-KVenta de acciones no registrada (colocación privada)EDGAR
   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…
6. OTLKOutlook Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …primary efficacy endpoint in NORSE EIGHT, it is recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010. Additionally, the FDA reiterated that NORSE TWO met its primary endpoint for effectiveness. “While we are very disappointed with this outcome, we intend to meet with the FDA to receive additional clarity on their requirements to potentially approve the first on-label bevacizumab…
7. QCLSQ/C TECHNOLOGIES, INC.8-KFin de acuerdo materialEDGAR
8. UPBUpstream Bio, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …99.1 Upstream Bio Reports Positive Top-Line Results from the Phase 2 VIBRANT Trial of Verekitug for the Treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) – In this 24-week study, VIBRANT met its primary endpoint, with verekitug dosed every 12 weeks leading to a statistically significant and clinically meaningful reduction from baseline in placebo-adjusted endoscopic nasal polyp score (NPS) of -1.8 (p<0.0001)…
9. ZYMEZymeworks Inc.8-KOtros hechos relevantesEDGAR
   En el documentoAprobación acelerada de la FDAtexto original ▸

   …BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab has received accelerated approval from the U.S. FDA, conditional approval from the NMPA in China, and conditional marketing authorization from the European Commission for the treatment of adults with previously treated, unresectable or…
10. ARWRARROWHEAD PHARMACEUTICALS, INC.8-KNuevo acuerdo materialEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸

    EX-99.1 2 arwr-202509028kex991.htm EX-99.1 EXHIBIT 99.1 PRESS RELEASE September. 2, 2025 Arrowhead Pharmaceuticals and Novartis Enter into a Global License and Collaboration Agreement –Upon closing, Arrowhead will receive an upfront payment of $200 million –Novartis will receive an exclusive worldwide license to ARO-SNCA, Arrowhead’s preclinical stage siRNA therapy for the treatment of synucleinopathies, such as Parkinson’s Disease…
11. BIAFbioAffinity Technologies, Inc.8-KNuevo acuerdo materialEDGAR
12. COYACoya Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
13. CYTKCYTOKINETICS INC8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

    …symptoms in patients with HCM. Aficamten was evaluated in SEQUOIA-HCM, a positive pivotal Phase 3 clinical trial in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic HCM from the U.S. Food & Drug Administration (FDA) and for the treatment of symptomatic obstructive HCM from the National Medical Products Administration (NMPA) in China…

    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …investigational drug candidate currently under regulatory review in the U.S; the Food and Drug Administration (FDA) is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. Results of MAPLE-HCM The primary endpoint in MAPLE-HCM was the mean change from baseline in pVO2 for aficamten compared to metoprolol after 24 weeks of treatment. For aficamten, the mean change in pVO2…
14. DTILPRECISION BIOSCIENCES INC8-KCambio en el consejo o la direcciónEDGAR
15. EDITEditas Medicine, Inc.8-KOtros hechos relevantesEDGAR
16. ENVBEnveric Biosciences, Inc.8-KOtros hechos relevantesEDGAR
17. IDYAIDEAYA Biosciences, Inc.8-KNuevo acuerdo materialEDGAR
18. IRDOpus Genetics, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On August 29, 2025, Opus Genetics, Inc., a Delaware corporation (the “Company”), appointed Robert Gagnon as the Company’s Chief Financial Officer and principal accounting officer, effective September 2, 2025 (the “Effective Date”). In connection with his appointment, on August 29, 2025, Mr. Gagnon entered into an employment agreement (the “Employment…
19. KALAKALA BIO, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On August 29, 2025, KALA BIO, Inc. (the “Company”) appointed Todd Bazemore as the Chief Executive Officer of the Company, effective immediately (the “Effective Date”). As of the Effective Date, Mr. Bazemore also continued to serve as President of the Company and ceased serving as Chief Operating Officer of…
20. KYNBKYNTRA BIO, INC.8-KOtros hechos relevantesEDGAR
21. MAZEMaze Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On September 2, 2025, Maze Therapeutics, Inc. (the “Company”) announced that the Board of Directors of the Company (the “Board”) appointed Misbah Tahir as the Company’s Chief Financial Officer and “principal financial officer,” effective as of September 2, 2025 (the “Appointment Date”). Before joining the Company, Mr. Tahir served as the Chief Financial Officer of IGM Biosciences, Inc. from…
22. MLYSMineralys Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
23. OLMAOlema Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
24. RGENREPLIGEN CORP8-KCambio en el consejo o la direcciónEDGAR
25. UTHRUNITED THERAPEUTICS Corp8-KOtros hechos relevantesEDGAR
26. VTVTvTv Therapeutics Inc.8-KNuevo acuerdo materialEDGAR
27. ZBIOZenas BioPharma, Inc.8-KNuevo acuerdo materialEDGAR

miércoles 3 de septiembre de 2025 →

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