Portada›Lunes 3 de noviembre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 3 de noviembre de 2025

Los 67 documentos que 48 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← viernes 31 de octubre de 2025 · martes 4 de noviembre de 2025 →

Va en color lo que cambia el capital o avisa de un riesgo: las emisiones con precio (424B1, 424B2, 424B4 y 424B5), los 8-K con item 1.02, 1.03, 2.04, 3.01, 3.02 y 4.02, y cualquier documento en el que haya aparecido una frase vigilada, que va citada debajo. Lo demás va en tinta normal. Una cita marcada «por primera vez» es una frase que no estaba en el informe previo del mismo tipo de esa empresa. La etiqueta del formulario lleva a su explicación.

Emisiones y dilución

1. CRBPCorbus Pharmaceuticals Holdings, Inc.424B5Nueva emisión de acciones con precioEDGAR
2. INTSINTENSITY THERAPEUTICS, INC.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …audited by EisnerAmper LLP, independent registered public accounting firm, as stated in their report which is incorporated by reference, which report includes an explanatory paragraph about the existence of substantial doubt concerning the Company's ability to continue as a going concern. Such financial statements have been incorporated by reference in reliance on the report of such firm given upon their authority as experts in accounting and auditing. WHERE YOU CAN FIND MORE INFORMATION…
3. KPTIKaryopharm Therapeutics Inc.S-3Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …2024, have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements) appearing elsewhere herein, included therein, and incorporated herein by reference. Such consolidated financial statements are incorporated…
4. KPTIKaryopharm Therapeutics Inc.S-3Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …2024, have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements) appearing elsewhere herein, included therein, and incorporated herein by reference. Such consolidated financial statements are incorporated…
5. PBMPSYENCE BIOMEDICAL LTD.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …Common Shares sold to White Lion under the White Lion Purchase Agreement and are subject to the further limitations set forth in the White Lion Purchase Agreement. Effective November 26, 2024, the Company implemented a 75-to-1 share consolidation (reverse stock split) of its Common Shares. The Share Consolidation was approved by the Company’s shareholders and its board of directors. Effective May 5, 2025, the Company implemented a second share consolidation (reverse…
6. ARDXARDELYX, INC.S-3ASRCapacidad de emisión registradaEDGAR
7. AXSMAxsome Therapeutics, Inc.S-3ASRCapacidad de emisión registradaEDGAR
8. BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
9. BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
10. BDRXBiodexa Pharmaceuticals Plc424B3Prospecto suplementario o de reventaEDGAR
11. CAMPCamp4 Therapeutics CorpS-3Capacidad de emisión registradaEDGAR
12. HURATuHURA Biosciences, Inc./NVS-3Capacidad de emisión registradaEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

    …these securities in any state where the offer or sale is not permitted. SUBJECT TO COMPLETION, DATED NOVEMBER 3, 2025 PROSPECTUS SUPPLEMENT (To Prospectus Dated , 2025) $50,000,000 Common Stock We have entered into an At the Market Offering Agreement (the “Sales Agreement”), dated November 3, 2025, with H.C. Wainwright & Co., LLC (the “Sales Agent”), relating to the shares of our common stock, par value $0.001 per share (the “Common Stock…

Participaciones y control

1. ORGOOrganogenesis Holdings Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. BNTCBenitec Biopharma Inc.8-KCambio en el consejo o la direcciónEDGAR
   En el documentoDesignación de vía rápida (Fast Track)texto original ▸

   …Mates to the Board on November 3, 2025, a copy of which is attached hereto as Exhibit 99.1. Item 7.01 Regulation FD Disclosure. On November 3, 2025, Company issued a press release announcing that the FDA granted Fast Track Designation to BB-301 for the treatment of Oculopharyngeal Muscular Dystrophy ("OPMD"), a chronic, life-threatening genetic disorder. In addition, the press release announced that the Company would host a live webcast…

   En el documentoDebilidad material en el control internotexto original ▸

   …sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; the impact of, and our ability to remediate, the identified material weakness in our internal controls over financial reporting, the impact of local, regional, and national and international economic conditions and events; and other risks detailed from time to time in the Company…
2. HURATuHURA Biosciences, Inc./NV8-KOtros hechos relevantesEDGAR
   En el documentoAprobación acelerada de la FDAtexto original ▸

   …When VSIR, the gene that encodes for VISTA is silenced, an immune response is observed and survival is enhanced in murine models of mutNPM1 AML Recently, several new drugs called menin inhibitors have received accelerated approval in patients with relapsed and refractory mutNPM1. Menin is the “carrier” protein that exerts the proliferative effect on leukemic blasts. While the response rates of 25% to 30% that are seen following…
3. KPTIKaryopharm Therapeutics Inc.8-KResultadosEDGAR
   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…
4. SRPTSarepta Therapeutics, Inc.8-KResultadosEDGAR
   En el documentoEl ensayo NO alcanzó su objetivo principaltexto original ▸

   …fulfill the primary postmarketing requirement. Additionally, results from ESSENCE will be shared at future medical meetings, and publication will be pursued in a medical journal. “While the ESSENCE study did not meet statistical significance on its primary endpoint, we believe the results demonstrated a clear treatment effect, showing clinically meaningful functional outcomes for people with Duchenne who have mutations amenable to skipping exons 45 or 53. These…

   En el documentoRecorte de plantilla o reestructuracióntexto original ▸

   …September 30, 2024, with no similar activity for the three months ended September 30, 2025, as well as a decrease in compensation, other personnel, and stock-based compensation expenses as a result of our restructuring plan announced during the three months ended September 30, 2025. This decrease was partially offset by a $100.0 million increase in up-front and milestone expenses due to our milestone payment to Arrowhead…
5. ABVCABVC BIOPHARMA, INC.10-QInforme trimestralEDGAR
   En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸

   …took effect on July 25, 2023. Series A Convertible Preferred Stock As of September 30, 2025, no Series A Convertible Preferred Stock has been issued by the Company. NASDAQ Listing On May 24, 2023, we received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is not currently in compliance with the minimum stockholders’ equity…

   En el documentoContrasplit de accionestexto original ▸

   …Amendment to its Articles of Incorporation authorizing a 1-for-10 reverse stock split of the issued and outstanding shares of its common stock (the “2023 Split”). The Company’s stockholders previously approved the Reverse Stock Split at the Company’s Special Shareholder Meeting held on July 7, 2023. The Reverse Stock Split was effected to reduce the number of issued and outstanding shares and to increase the per share trading value…
6. ABVCABVC BIOPHARMA, INC.8-KResultadosEDGAR
7. ACADACADIA PHARMACEUTICALS INC8-KCambio en el consejo o la direcciónEDGAR
8. AXSMAxsome Therapeutics, Inc.8-KResultadosEDGAR
   En el documentoDesignación de medicamento huérfanotexto original ▸

   …is Axsome’s novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy. • Narcolepsy: Axsome plans to submit an NDA to the FDA for AXS-12 for the treatment of cataplexy in narcolepsy in the fourth quarter of 2025. AXS-14 AXS-14 (esreboxetine) is Axsome’s novel…

   En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

   …D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted FDA Breakthrough Therapy designation for AD agitation. • Alzheimer’s Disease Agitation: Axsome has submitted a supplemental NDA (sNDA) to the FDA for AXS-05 in Alzheimer’s disease agitation. The Company plans to announce the FDA’s decision…
9. AXSMAxsome Therapeutics, Inc.10-QInforme trimestralEDGAR
10. BCRXBIOCRYST PHARMACEUTICALS INC8-KResultadosEDGAR
11. CGEMCullinan Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
12. COGTCogent Biosciences, Inc.8-KResultadosEDGAR
13. CRBPCorbus Pharmaceuticals Holdings, Inc.8-KNuevo acuerdo materialEDGAR
14. CRBUCaribou Biosciences, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸

    …cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL. About the ANTLER phase 1 clinical trial The ANTLER clinical trial is a multicenter, open-label phase 1 trial evaluating vispacabtagene regedleucel…

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

    …therapy (“RMAT”) designation for relapsed or refractory large B cell lymphoma (“r/r LBCL”) as well as fast track designation for r/r B-NHL from the U.S. Food and Drug Administration (“FDA”); CB-011 has received fast track designation for r/r MM from the FDA. The Company’s CAR-T cell therapy product candidate pipeline is shown below: ANTLER Clinical Trial Results On November 3, 2025, the Company announced results from its ongoing ANTLER…
15. DNTHDianthus Therapeutics, Inc. /DE/8-KOtros hechos relevantesEDGAR
16. DTILPRECISION BIOSCIENCES INC10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸

    …than 1-for-30, with such ratio and the implementation and timing of such reverse stock split to be determined by our board of directors in its sole discretion. On February 6, 2024, our board of directors approved a 1-for-30 reverse stock split of our issued and outstanding common stock, and on February 13, 2024, we filed with the Secretary of State of the State of Delaware a certificate of amendment to our amended and restated certificate of…
17. DTILPRECISION BIOSCIENCES INC8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

    …integrated HBV DNA. The ELIMINATE-B trial is investigating PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients with chronic Hepatitis B. PBGENE-HBV has been granted Breakthrough Therapy designation by the FDA. About PBGENE-DMD, A Muscle-Targeted Excision Program PBGENE-DMD is Precision’s development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin…
18. HALOHALOZYME THERAPEUTICS, INC.8-KResultadosEDGAR
19. HALOHALOZYME THERAPEUTICS, INC.10-QInforme trimestralEDGAR
20. IDXXIDEXX LABORATORIES INC /DE10-QInforme trimestralEDGAR
21. IDXXIDEXX LABORATORIES INC /DE8-KResultadosEDGAR
22. IONSIONIS PHARMACEUTICALS INC8-K/ANuevo acuerdo materialEDGAR
23. KLRSKalaris Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On October 28, 2025, the Board of Directors (the “Board”) of Kalaris Therapeutics, Inc. (the “Company”) appointed Matthew Gall as Chief Financial Officer and Treasurer of the Company, effective as of November 3, 2025 (the “Effective Date”). In addition, Mr. Gall will serve as the Company’s principal financial officer. Prior to his appointment as Chief…
24. KPTIKaryopharm Therapeutics Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

    …availability of additional funding or other strategic alternatives and considering our debt service obligations, and the financial covenant to maintain minimum liquidity,we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying condensed consolidated financial statements are issued. We plan to address the conditions that raise substantial doubt regarding our ability to continue…

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

    …Nasdaq Stock Market (“Nasdaq”) informing us that we were not in compliance with certain continued listing requirements of the Nasdaq Global Select Market. As previously disclosed, on September 16, 2024, we received a deficiency letter from the Listing Qualifications Department (the “Staff”) of Nasdaq notifying us that, for the prior 32 consecutive business days, the bid price of our common stock had closed below the minimum $1.00 per…

    En el documentoContrasplit de accionestexto original ▸

    …footnotes included in our Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the Securities and Exchange Commission on February 19, 2025 (“Annual Report”). On February 25, 2025, we effected a 1-for-15 reverse stock split of our common stock (the “Reverse Stock Split”). All share and per share amounts in these condensed consolidated financial statements and notes thereto, including the conversion rates of convertible debt…
25. KRYSKrystal Biotech, Inc.10-QInforme trimestralEDGAR
26. KRYSKrystal Biotech, Inc.8-KResultadosEDGAR
27. KYTXKyverna Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
28. LQDALiquidia Corp8-KResultadosEDGAR
29. LQDALiquidia Corp10-QInforme trimestralEDGAR
30. LYELLyell Immunopharma, Inc.8-KCambio en el consejo o la direcciónEDGAR
31. MYGNMYRIAD GENETICS INC8-KResultadosEDGAR
32. OTLKOutlook Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
33. PHIOPhio Pharmaceuticals Corp.8-KOtros hechos relevantesEDGAR
34. PYXSPyxis Oncology, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸

    …pembrolizumab). Pyxis Oncology is focused on advancing MICVO, with the goal of improving outcomes for patients living with R/M HNSCC and contributing to meaningful progress in cancer treatment. MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy…
35. PYXSPyxis Oncology, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

    …cash equivalents and short-term investments, will not be sufficient to fund the Company's operations over the next 12 months from the date of this Quarterly Report on Form 10-Q. This condition raises substantial doubt about the Company’s ability to continue as a going concern for one year from the date these unaudited condensed consolidated financial statements are issued. The Company plans to continue to fund its losses from operations and capital funding needs through public…
36. QUREuniQure N.V.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸

    …unclear. ​ uniQure expects to receive final minutes within 30 days of the meeting and plans to urgently interact with the FDA to find a path forward for the timely accelerated approval of AMT-130. ​ The FDA granted AMT-130 Breakthrough Therapy designation based upon data from the Phase I/II studies compared to external controls in April 2025 and Regenerative Medicines Advanced Therapy (RMAT) designation in May 2024. ​ “We are surprised by the FDA’s feedback…
37. RNTXRein Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …indications. Rein’s lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 has received Orphan Drug Designation in the U.S. Rein’s second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan…
38. SLDBSolid Biosciences Inc.8-KResultadosEDGAR
39. SLDBSolid Biosciences Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

    …common stock through public offerings, including our IPO and follow-on public offerings, private placements, the ATM Sales Agreement, and pursuant to the stock purchase agreements. On March 13, 2019, we entered into the ATM Sales Agreement, which was amended and restated in March 2024, under which we may offer and sell, from time to time, shares of our common stock through Jefferies as sales agent. Any such sales being made by any method…
40. SNDXSyndax Pharmaceuticals Inc8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML. Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation…

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

    …granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult…
41. SNDXSyndax Pharmaceuticals Inc10-QInforme trimestralEDGAR
42. TCRXTScan Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸

    …study design for TSC-101 Dosed first solid tumor patients with multiplex TCR-T therapy; paused further enrollment to prioritize heme development; reiterates planned data readout in Q1 2026 Enacted ~30% workforce reduction to focus clinical development on heme program and initiate pre-clinical development of in vivo-engineered TCR-T for solid tumors Strategic prioritization extends cash runway into H2 2027 Conference call…
43. TGTXTG THERAPEUTICS, INC.8-KResultadosEDGAR
44. VORVor Biopharma Inc.8-KCambio en el consejo o la direcciónEDGAR
45. VRTXVERTEX PHARMACEUTICALS INC / MA8-KResultadosEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸

    …enrollment in the Phase 1/2/3 study of zimislecel in people with T1D. Vertex has temporarily postponed completion of dosing in the study, pending an internal manufacturing analysis. •Zimislecel has been granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration, Priority Medicines (PRIME) designation from the EMA, and has secured an Innovation Passport under the Innovative Licensing…

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

    …approval in the U.S. Vertex has now also completed full enrollment of the Phase 3 study in IgAN. •Vertex recently initiated the Phase 2/3 pivotal study of povetacicept in patients with pMN. The FDA recently granted Fast Track designation for povetacicept in pMN. •Vertex will have an oral presentation of updated Phase 1/2 data on povetacicept in IgAN and pMN at the American Society of Nephrology (ASN) Kidney Week. Vertex will host an in…
46. XENEXenon Pharmaceuticals Inc.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …out early 2026 with patient randomization complete – Phase 3 X-NOVA2 and X-NOVA3 studies in MDD & Phase 3 X-CEED study in BPD continuing to recruit – Phase 1 Nav1.7 & Kv7 studies underway – Tucker Kelly appointed as Chief Financial Officer, bringing extensive strategic commercial finance experience in anticipation of the azetukalner launch – Conference call at 4:30 pm ET today VANCOUVER, BC and BOSTON, MA, November 3, 2025 – Xenon Pharmaceuticals…
47. XENEXenon Pharmaceuticals Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

    …capital. Until such time as we can generate substantial product revenue, if ever, we expect to finance our cash needs through a combination of collaboration agreements and equity or debt financings. We entered into an “at-the-market” equity offering sales agreement in August 2020, amended as of March 2022, with Jefferies LLC and Stifel, Nicolaus & Company, Incorporated, or the ATM Program, and a new prospectus supplement was filed with the SEC on…

Juntas de accionistas

1. BCDABioCardia, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
2. CYPHCYPHERPUNK TECHNOLOGIES INC.DEF 14AConvocatoria de junta de accionistasEDGAR
   En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸

   …volume in our Common Stock and facilitate future financings by the Company. Nasdaq Listing Requirements Minimum Bid Requirement — Continued Listing As previously reported, on March 12, 2025, the Company received a notification letter (the “Closing Bid Price Deficiency Letter”) from the Listing Qualifications staff of The Nasdaq Stock Market LLC 15 TABLE OF CONTENTS notifying the Company that, based on the previous 30 consecutive business days, the closing bid price for the…
3. GLSIGreenwich LifeSciences, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
4. INMInMed Pharmaceuticals Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
5. NXTSNexentis Technologies Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
6. TXMDTherapeuticsMD, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
7. VIVSVivoSim Labs, INC.DEF 14AConvocatoria de junta de accionistasEDGAR

← viernes 31 de octubre de 2025 · martes 4 de noviembre de 2025 →

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