Portada›Miércoles 8 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 8 de octubre de 2025

Los 21 documentos que 19 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← martes 7 de octubre de 2025 · jueves 9 de octubre de 2025 →

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Emisiones y dilución

1. APGEApogee Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
2. TTRXTurn Therapeutics Inc.424B4Nueva emisión de acciones con precioEDGAR
   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 ▸

   …large, well-established companies with long-standing relationships, extensive clinical data, and recognized brands, as well as against new companies with innovative products. ​ ​ 15 TABLE OF CONTENTS • 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…
3. LITSLite Strategy, Inc.S-3Capacidad de emisión registradaEDGAR
4. ZBIOZenas BioPharma, Inc.S-3ASRCapacidad de emisión registradaEDGAR

Participaciones y control

1. JBIOJade Biosciences, Inc.SC 13D/ACambio en participación significativaEDGAR
2. VORVor Biopharma Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. KPTIKaryopharm Therapeutics Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …the applicable agreement and the potential future financial implications of such agreement; Karyopharm’s ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; substantial doubt exists regarding Karyopharm’s ability to continue as a going concern; development or regulatory approval of drug candidates by Karyopharm’s competitors for products or product candidates in which Karyopharm is currently commercializing or developing; the direct or indirect…
2. NXTSNexentis Technologies Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
   En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸

   …regained compliance with the Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share for the Company’s common stock. As previously reported, on March 28, 2025, the Company received notice from Nasdaq that it was not in compliance with the minimum bid price requirement. The Notification states that for 10 consecutive business days from September 22, 2025 through October 3, 2025, the closing bid price of the Company’s common stock was at least $1.00 per share…
3. RNAZTranscode Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoCambio en la dirección de la empresatexto original ▸

   …Holdings) Inc. (“CK Life Sciences”) to be used primarily to advance clinical development of TransCode’s lead microRNA asset, TTX-MC138, into a Phase 2 clinical trial. Philippe Calais, PharmD, PhD, has been appointed as TransCode’s Chief Executive Officer and remains Chairman of the Board of Directors, but has stepped down from his positions on the Board’s Audit Committee and Compensation Committee. Tom Fitzgerald steps down as Interim Chief Executive…
4. SPRBSPRUCE BIOSCIENCES, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
5. ZBIOZenas BioPharma, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoAcuerdo de licencia o colaboracióntexto original ▸

   …transition of ongoing Phase 3 global trials for orelabrutinib in MS. A joint steering committee will oversee development and regulatory activities related to orelabrutinib. Term and Termination The InnoCare License Agreement will remain in effect on a product-by-product and country-by-country basis until expiration of the applicable royalty term, unless earlier terminated. Each party has customary termination rights, including for uncured material breach, insolvency, patent challenge, or, in the case of Zenas, for convenience. The foregoing…
6. AQSTAquestive Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

   …is the first sublingual epinephrine film, offering a device-free, patient- friendly alternative, if approved by the United States Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm is scheduled for January 31, 2026. About Anaphylm™ (dibutepinephrine) Sublingual Film Anaphylm (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage…
7. BMRABIOMERICA INC8-KCambio en el consejo o la direcciónEDGAR
8. CRVOCervoMed Inc.8-KOtros hechos relevantesEDGAR
9. KRROKorro Bio, Inc.8-KCambio en el consejo o la direcciónEDGAR
   En el documentoCambio en la dirección de la empresatexto original ▸

   …pursuant to Section 13(a) of the Exchange Act. ☐ Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. Departure of Chief Financial Officer On October 7, 2025, Vineet Agarwal announced his intention to resign from his position of Chief Financial Officer of Korro Bio, Inc., or Korro, effective October 17, 2025 to pursue another opportunity…
10. LENZLENZ Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
11. LSTALISATA THERAPEUTICS, INC.8-KNuevo acuerdo materialEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸

    …ADC platform. Under the Agreement, Catalent will assume full responsibility for research, development, and commercialization costs. Financial Terms. In connection with entering into the Non-Exclusive License Agreement, the Company is eligible to receive pre-determined development milestone payments of up to $10.5 million in the aggregate. The Company is also eligible to receive tiered revenue sharing on future sales and/or partnerships, subject to specified royalty reductions as set forth…
12. RNACCartesian Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
13. RNAZTranscode Therapeutics, Inc.8-K/ANuevo acuerdo materialEDGAR
14. TELOTelomir Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR

Juntas de accionistas

1. TRAWTraws Pharma, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

← martes 7 de octubre de 2025 · jueves 9 de octubre de 2025 →

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