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[FWP] Goldman Sachs Group Inc. Free Writing Prospectus

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Rhea-AI Filing Summary

Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) disclosed that the U.S. FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of UX111 (ABO-102), its AAV gene therapy for Sanfilippo syndrome type A. The agency is requesting additional chemistry, manufacturing and controls (CMC) information and remediation of observations from recent facility inspections. The CRL does not cite deficiencies in the clinical data package; the FDA characterized neurodevelopmental and biomarker data as robust and asked only for updated data in the resubmission.

The company believes the cited issues are facility- and process-related and “readily addressable.” Management plans to engage the FDA over the coming months, then resubmit the BLA, which would trigger a new review period of up to six months. No timeline for resubmission was provided, but the disclosure implies at least a several-month delay to potential approval and launch.

Investor takeaway: Receipt of a CRL materially delays potential commercialization and revenue generation from UX111, introduces additional regulatory risk, and may elevate operating costs as manufacturing processes are refined. Mitigating factors include the absence of clinical concerns and the company’s confidence that CMC issues can be resolved.

Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) ha comunicato che la FDA statunitense ha emesso una Complete Response Letter (CRL) riguardante la Biologics License Application (BLA) per UX111 (ABO-102), la sua terapia genica AAV per la sindrome di Sanfilippo tipo A. L'agenzia richiede ulteriori informazioni sulla chimica, produzione e controlli (CMC) e la risoluzione delle osservazioni emerse durante recenti ispezioni degli impianti. La CRL non evidenzia carenze nei dati clinici; la FDA ha definito robusti i dati neuroevolutivi e biomarcatori, richiedendo solo dati aggiornati nella nuova presentazione.

L'azienda ritiene che le problematiche siano legate agli impianti e ai processi, e siano “facilmente risolvibili.” La direzione intende collaborare con la FDA nei prossimi mesi per poi ripresentare la BLA, il che attiverebbe un nuovo periodo di revisione fino a sei mesi. Non è stata fornita una tempistica per la ripresentazione, ma la comunicazione implica un ritardo di diversi mesi rispetto all'approvazione e al lancio potenziali.

Indicazioni per gli investitori: La ricezione della CRL ritarda significativamente la possibile commercializzazione e generazione di ricavi da UX111, introduce rischi regolatori aggiuntivi e potrebbe aumentare i costi operativi durante la messa a punto dei processi produttivi. Fattori mitiganti sono l'assenza di preoccupazioni cliniche e la fiducia dell'azienda nella risoluzione delle problematiche CMC.

Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) informó que la FDA de EE. UU. emitió una Carta de Respuesta Completa (CRL) para la Solicitud de Licencia Biológica (BLA) de UX111 (ABO-102), su terapia génica AAV para el síndrome de Sanfilippo tipo A. La agencia solicita información adicional sobre química, fabricación y controles (CMC) y la corrección de observaciones derivadas de inspecciones recientes de las instalaciones. La CRL no señala deficiencias en el paquete de datos clínicos; la FDA calificó los datos neurodesarrollativos y de biomarcadores como sólidos y solo pidió datos actualizados en la nueva presentación.

La compañía considera que los problemas señalados están relacionados con las instalaciones y los procesos, y son “fácilmente solucionables.” La dirección planea interactuar con la FDA en los próximos meses para luego volver a presentar la BLA, lo que desencadenaría un nuevo periodo de revisión de hasta seis meses. No se proporcionó un plazo para la nueva presentación, pero la divulgación implica un retraso de varios meses en la posible aprobación y lanzamiento.

Conclusión para inversores: La recepción de la CRL retrasa significativamente la posible comercialización y generación de ingresos de UX111, introduce riesgos regulatorios adicionales y podría aumentar los costos operativos mientras se perfeccionan los procesos de fabricación. Factores mitigantes incluyen la ausencia de preocupaciones clínicas y la confianza de la compañía en resolver los problemas CMC.

Ultragenyx Pharmaceutical Inc. (나스닥: RARE)는 미국 FDA가 산필리포 증후군 A형에 대한 자사의 AAV 유전자 치료제 UX111 (ABO-102)의 생물학적 제제 허가 신청서(BLA)에 대해 완전응답서한(CRL)을 발행했다고 밝혔습니다. FDA는 추가적인 화학, 제조 및 관리(CMC) 정보와 최근 시설 점검에서 발견된 문제점의 수정 조치를 요구하고 있습니다. CRL은 임상 데이터 패키지에 결함이 없음을 명시하고; FDA는 신경발달 및 바이오마커 데이터를 견고하다고 평가했으며 재제출 시 최신 데이터만 요구했습니다.

회사는 지적된 문제들이 시설 및 공정과 관련된 것이며 “쉽게 해결 가능”하다고 보고 있습니다. 경영진은 향후 몇 달간 FDA와 협의한 후 BLA를 재제출할 계획이며, 이는 최대 6개월의 신규 심사 기간을 촉발할 것입니다. 재제출 일정은 제공되지 않았으나, 이번 공시는 승인 및 출시가 몇 달 이상 지연될 가능성을 시사합니다.

투자자 참고사항: CRL 수령은 UX111의 잠재적 상업화 및 수익 창출을 실질적으로 지연시키고, 추가적인 규제 위험을 도입하며, 제조 공정 개선 과정에서 운영 비용이 증가할 수 있습니다. 완화 요인으로는 임상적 우려가 없고 회사가 CMC 문제를 해결할 수 있다는 자신감이 포함됩니다.

Ultragenyx Pharmaceutical Inc. (Nasdaq : RARE) a annoncé que la FDA américaine a émis une lettre de réponse complète (CRL) concernant la demande d'autorisation biologique (BLA) pour UX111 (ABO-102), sa thérapie génique AAV pour le syndrome de Sanfilippo de type A. L'agence demande des informations supplémentaires sur la chimie, la fabrication et les contrôles (CMC) ainsi que la correction des observations issues des inspections récentes des installations. La CRL ne relève aucune insuffisance dans le dossier clinique ; la FDA a qualifié les données neurodéveloppementales et les biomarqueurs de robustes et a seulement demandé des données mises à jour lors de la nouvelle soumission.

L'entreprise estime que les problèmes cités sont liés aux installations et aux procédés, et « facilement résolvables ». La direction prévoit d'échanger avec la FDA dans les prochains mois, puis de soumettre à nouveau la BLA, ce qui déclencherait une nouvelle période d'examen pouvant aller jusqu'à six mois. Aucun calendrier de resoumission n'a été communiqué, mais la divulgation implique un retard de plusieurs mois avant une éventuelle approbation et commercialisation.

À retenir pour les investisseurs : La réception de la CRL retarde considérablement la commercialisation potentielle et la génération de revenus liés à UX111, introduit un risque réglementaire supplémentaire et pourrait augmenter les coûts opérationnels lors de l'amélioration des processus de fabrication. Les facteurs atténuants incluent l'absence de préoccupations cliniques et la confiance de l'entreprise dans la résolution des problèmes CMC.

Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) gab bekannt, dass die US-amerikanische FDA einen Complete Response Letter (CRL) für den Biologics License Application (BLA) von UX111 (ABO-102), ihrer AAV-Gentherapie für das Sanfilippo-Syndrom Typ A, ausgestellt hat. Die Behörde fordert zusätzliche Informationen zu Chemie, Herstellung und Kontrollen (CMC) sowie die Behebung von Beanstandungen aus kürzlichen Anlageninspektionen. Der CRL führt keine Mängel im klinischen Datenpaket auf; die FDA bewertete die neuroentwicklungsbezogenen und Biomarkerdaten als robust und forderte lediglich aktualisierte Daten bei der erneuten Einreichung.

Das Unternehmen ist der Ansicht, dass die beanstandeten Punkte an den Anlagen und Prozessen liegen und „leicht zu beheben“ sind. Das Management plant, in den kommenden Monaten mit der FDA in Kontakt zu treten und dann die BLA erneut einzureichen, was eine neue Prüfungsfrist von bis zu sechs Monaten auslösen würde. Ein Zeitplan für die erneute Einreichung wurde nicht genannt, jedoch deutet die Mitteilung auf eine Verzögerung von mehreren Monaten bis zur möglichen Zulassung und Markteinführung hin.

Fazit für Investoren: Der Erhalt des CRL verzögert die potenzielle Kommerzialisierung und Umsatzerzielung von UX111 erheblich, bringt zusätzliche regulatorische Risiken mit sich und könnte die Betriebskosten während der Optimierung der Herstellungsprozesse erhöhen. Mildernde Faktoren sind das Fehlen klinischer Bedenken und das Vertrauen des Unternehmens, die CMC-Probleme lösen zu können.

Positive
  • No clinical deficiencies cited; FDA deems neurodevelopmental and biomarker data robust.
  • Issues confined to CMC and facilities, which management believes are addressable.
  • FDA invites swift resubmission; review clock expected to be six months once filed.
Negative
  • Complete Response Letter materially delays potential UX111 approval and commercialization.
  • Additional CMC work and facility remediation will increase costs and execution risk.
  • Timeline for resubmission is uncertain, extending regulatory overhang for investors.

Insights

TL;DR: FDA CRL delays UX111 approval due to CMC and facility issues; clinical data intact.

The FDA’s Complete Response Letter shifts the regulatory pathway from imminent approval to an undefined remediation phase. CMC and facility observations typically require documentary fixes, supplemental validation runs, or re-inspections—all time-consuming and resource-intensive. Although the absence of clinical deficiencies protects the underlying therapeutic rationale, gene therapies face heightened scrutiny on manufacturing consistency, and repeat AAV batches can be costly. Resubmission triggers a new up-to-6-month review clock, so earliest approval now likely slips into 2H 2026. Given UX111 targets an ultra-rare population with limited alternatives, delay erodes potential first-mover advantage and postpones rare-disease priority review vouchers or anticipated cash flows.

TL;DR: Negative near-term catalyst; manageable if CMC fixes succeed; cash burn may rise.

The CRL removes a near-term approval catalyst investors had embedded in valuation models. Consensus peak-sales timelines must shift, impacting discounted cash-flow calculations. Management’s assertion that issues are ‘readily addressable’ offers some relief, but execution risk remains, especially given Ultragenyx’s limited in-house manufacturing track record. Additional spending on remediation and possible re-inspection could expand operating loss in FY25-26. Balance-sheet sufficiency is not discussed in the filing, leaving open questions on runway. Nonetheless, the FDA’s positive view of efficacy data preserves long-term value of the asset, keeping competitive dynamics unchanged. Overall impact: moderately negative until clarity on resubmission timing emerges.

Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) ha comunicato che la FDA statunitense ha emesso una Complete Response Letter (CRL) riguardante la Biologics License Application (BLA) per UX111 (ABO-102), la sua terapia genica AAV per la sindrome di Sanfilippo tipo A. L'agenzia richiede ulteriori informazioni sulla chimica, produzione e controlli (CMC) e la risoluzione delle osservazioni emerse durante recenti ispezioni degli impianti. La CRL non evidenzia carenze nei dati clinici; la FDA ha definito robusti i dati neuroevolutivi e biomarcatori, richiedendo solo dati aggiornati nella nuova presentazione.

L'azienda ritiene che le problematiche siano legate agli impianti e ai processi, e siano “facilmente risolvibili.” La direzione intende collaborare con la FDA nei prossimi mesi per poi ripresentare la BLA, il che attiverebbe un nuovo periodo di revisione fino a sei mesi. Non è stata fornita una tempistica per la ripresentazione, ma la comunicazione implica un ritardo di diversi mesi rispetto all'approvazione e al lancio potenziali.

Indicazioni per gli investitori: La ricezione della CRL ritarda significativamente la possibile commercializzazione e generazione di ricavi da UX111, introduce rischi regolatori aggiuntivi e potrebbe aumentare i costi operativi durante la messa a punto dei processi produttivi. Fattori mitiganti sono l'assenza di preoccupazioni cliniche e la fiducia dell'azienda nella risoluzione delle problematiche CMC.

Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) informó que la FDA de EE. UU. emitió una Carta de Respuesta Completa (CRL) para la Solicitud de Licencia Biológica (BLA) de UX111 (ABO-102), su terapia génica AAV para el síndrome de Sanfilippo tipo A. La agencia solicita información adicional sobre química, fabricación y controles (CMC) y la corrección de observaciones derivadas de inspecciones recientes de las instalaciones. La CRL no señala deficiencias en el paquete de datos clínicos; la FDA calificó los datos neurodesarrollativos y de biomarcadores como sólidos y solo pidió datos actualizados en la nueva presentación.

La compañía considera que los problemas señalados están relacionados con las instalaciones y los procesos, y son “fácilmente solucionables.” La dirección planea interactuar con la FDA en los próximos meses para luego volver a presentar la BLA, lo que desencadenaría un nuevo periodo de revisión de hasta seis meses. No se proporcionó un plazo para la nueva presentación, pero la divulgación implica un retraso de varios meses en la posible aprobación y lanzamiento.

Conclusión para inversores: La recepción de la CRL retrasa significativamente la posible comercialización y generación de ingresos de UX111, introduce riesgos regulatorios adicionales y podría aumentar los costos operativos mientras se perfeccionan los procesos de fabricación. Factores mitigantes incluyen la ausencia de preocupaciones clínicas y la confianza de la compañía en resolver los problemas CMC.

Ultragenyx Pharmaceutical Inc. (나스닥: RARE)는 미국 FDA가 산필리포 증후군 A형에 대한 자사의 AAV 유전자 치료제 UX111 (ABO-102)의 생물학적 제제 허가 신청서(BLA)에 대해 완전응답서한(CRL)을 발행했다고 밝혔습니다. FDA는 추가적인 화학, 제조 및 관리(CMC) 정보와 최근 시설 점검에서 발견된 문제점의 수정 조치를 요구하고 있습니다. CRL은 임상 데이터 패키지에 결함이 없음을 명시하고; FDA는 신경발달 및 바이오마커 데이터를 견고하다고 평가했으며 재제출 시 최신 데이터만 요구했습니다.

회사는 지적된 문제들이 시설 및 공정과 관련된 것이며 “쉽게 해결 가능”하다고 보고 있습니다. 경영진은 향후 몇 달간 FDA와 협의한 후 BLA를 재제출할 계획이며, 이는 최대 6개월의 신규 심사 기간을 촉발할 것입니다. 재제출 일정은 제공되지 않았으나, 이번 공시는 승인 및 출시가 몇 달 이상 지연될 가능성을 시사합니다.

투자자 참고사항: CRL 수령은 UX111의 잠재적 상업화 및 수익 창출을 실질적으로 지연시키고, 추가적인 규제 위험을 도입하며, 제조 공정 개선 과정에서 운영 비용이 증가할 수 있습니다. 완화 요인으로는 임상적 우려가 없고 회사가 CMC 문제를 해결할 수 있다는 자신감이 포함됩니다.

Ultragenyx Pharmaceutical Inc. (Nasdaq : RARE) a annoncé que la FDA américaine a émis une lettre de réponse complète (CRL) concernant la demande d'autorisation biologique (BLA) pour UX111 (ABO-102), sa thérapie génique AAV pour le syndrome de Sanfilippo de type A. L'agence demande des informations supplémentaires sur la chimie, la fabrication et les contrôles (CMC) ainsi que la correction des observations issues des inspections récentes des installations. La CRL ne relève aucune insuffisance dans le dossier clinique ; la FDA a qualifié les données neurodéveloppementales et les biomarqueurs de robustes et a seulement demandé des données mises à jour lors de la nouvelle soumission.

L'entreprise estime que les problèmes cités sont liés aux installations et aux procédés, et « facilement résolvables ». La direction prévoit d'échanger avec la FDA dans les prochains mois, puis de soumettre à nouveau la BLA, ce qui déclencherait une nouvelle période d'examen pouvant aller jusqu'à six mois. Aucun calendrier de resoumission n'a été communiqué, mais la divulgation implique un retard de plusieurs mois avant une éventuelle approbation et commercialisation.

À retenir pour les investisseurs : La réception de la CRL retarde considérablement la commercialisation potentielle et la génération de revenus liés à UX111, introduit un risque réglementaire supplémentaire et pourrait augmenter les coûts opérationnels lors de l'amélioration des processus de fabrication. Les facteurs atténuants incluent l'absence de préoccupations cliniques et la confiance de l'entreprise dans la résolution des problèmes CMC.

Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) gab bekannt, dass die US-amerikanische FDA einen Complete Response Letter (CRL) für den Biologics License Application (BLA) von UX111 (ABO-102), ihrer AAV-Gentherapie für das Sanfilippo-Syndrom Typ A, ausgestellt hat. Die Behörde fordert zusätzliche Informationen zu Chemie, Herstellung und Kontrollen (CMC) sowie die Behebung von Beanstandungen aus kürzlichen Anlageninspektionen. Der CRL führt keine Mängel im klinischen Datenpaket auf; die FDA bewertete die neuroentwicklungsbezogenen und Biomarkerdaten als robust und forderte lediglich aktualisierte Daten bei der erneuten Einreichung.

Das Unternehmen ist der Ansicht, dass die beanstandeten Punkte an den Anlagen und Prozessen liegen und „leicht zu beheben“ sind. Das Management plant, in den kommenden Monaten mit der FDA in Kontakt zu treten und dann die BLA erneut einzureichen, was eine neue Prüfungsfrist von bis zu sechs Monaten auslösen würde. Ein Zeitplan für die erneute Einreichung wurde nicht genannt, jedoch deutet die Mitteilung auf eine Verzögerung von mehreren Monaten bis zur möglichen Zulassung und Markteinführung hin.

Fazit für Investoren: Der Erhalt des CRL verzögert die potenzielle Kommerzialisierung und Umsatzerzielung von UX111 erheblich, bringt zusätzliche regulatorische Risiken mit sich und könnte die Betriebskosten während der Optimierung der Herstellungsprozesse erhöhen. Mildernde Faktoren sind das Fehlen klinischer Bedenken und das Vertrauen des Unternehmens, die CMC-Probleme lösen zu können.

Free Writing Prospectus pursuant to Rule 433 dated July 11, 2025

Registration Statement No. 333-284538

 

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Market Linked Securities — Autocallable with Contingent Coupon and Contingent Downside

Principal at Risk Securities Linked to the Class A Common Stock of Robinhood Markets, Inc. due July 22, 2026

 

Summary of Terms

 

 

Company (Issuer) and Guarantor:

GS Finance Corp. (issuer) and The Goldman Sachs Group, Inc. (guarantor)

 

Hypothetical Payout Profile (Maturity Payment Amount)

 

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If the securities are not automatically called prior to stated maturity and the ending price is less than the downside threshold price, you will lose more than 40%, and possibly all, of the face amount of your securities at stated maturity.

Any return on the securities will be limited to the sum of your contingent coupon payments, if any. You will not participate in any appreciation of the underlying stock, but you will have full downside exposure to the underlying stock if the ending price is less than the downside threshold price.

You should read the accompanying preliminary pricing supplement dated July 11, 2025, which we refer to herein as the accompanying preliminary pricing supplement, to better understand the terms and risks of your investment, including the credit risk of GS Finance Corp. and The Goldman Sachs Group, Inc.

The securities are part of the Medium-Term Notes, Series F program of GS Finance Corp. and are fully and unconditionally guaranteed by The Goldman Sachs Group, Inc. This document should be read in conjunction with the following:

Preliminary pricing supplement dated July 11, 2025
WFS product supplement no. 5 dated February 14, 2025
Prospectus supplement dated February 14, 2025
Prospectus dated February 14, 2025

 

Market Measure (the “underlying stock”):

the Class A common stock of Robinhood Markets, Inc. (current Bloomberg ticker: “HOOD UW”)

 

Pricing date:

expected to be July 17, 2025

 

Issue date:

expected to be July 22, 2025

 

Final calculation day:

expected to be July 17, 2026

 

Stated maturity date:

expected to be July 22, 2026

 

Starting price:

the stock closing price of the underlying stock on the pricing date

 

Ending price:

the stock closing price of the underlying stock on the final calculation day

 

Performance factor:

the ending price divided by the starting price (expressed as a percentage)

 

Automatic call:

If the stock closing price of the underlying stock on any call date is greater than or equal to the starting price, the securities will be automatically called, and on the related call settlement date you will be entitled to receive a cash payment per security in U.S. dollars equal to the face amount plus a final contingent coupon payment. The securities will not be subject to automatic call until the January 2026 calculation day.

 

Downside threshold price:

60% of the starting price

 

Contingent coupon payment:

Subject to the automatic call, on each contingent coupon payment date, for each $1,000 of the outstanding face amount, you will receive a contingent coupon payment equal to at least $21.667 (equivalent to a contingent coupon rate of at least approximately 26.00% per annum) (set on the pricing date) if, and only if, the stock closing price of the underlying stock on the related calculation day is greater than or equal to the coupon threshold price.

 

Coupon threshold price:

60% of the starting price

 

Call dates:

each calculation day commencing in January 2026 and ending in June 2026

 

Call settlement date:

the contingent coupon payment date immediately following the applicable call date

 

Calculation days:

monthly, on the 17th day of each month, commencing in August 2025 and ending in June 2026, and the final calculation day

 

Contingent coupon payment dates:

monthly, on the third business day following each calculation day; provided that the contingent coupon payment date with respect to the final calculation day will be the stated maturity date

 

Maturity payment amount (for each $1,000 face amount of your securities):

if the ending price is greater than or equal to the downside threshold price: $1,000; or
if the ending price is less than the downside threshold price: $1,000 × performance factor

 

The estimated value of your securities at the time the terms of your securities are set on the pricing date is expected to be between $925 and $955 per $1,000 face amount. See the accompanying preliminary pricing supplement for a further discussion of the estimated value of your securities.

Underwriting discount:

up to 1.075% of the face amount*; Wells Fargo Securities, LLC (“WFS”) is the agent for the distribution of the securities. WFS will receive the underwriting discount of up to 1.075% of the aggregate face amount of the securities sold. The agent may resell the securities to Wells Fargo Advisors (“WFA”) at the original issue price of the securities less a concession of 0.50% of the aggregate face amount of the securities. In addition to the selling concession received by WFA, WFS advises that WFA may also receive out of the underwriting discount a distribution expense fee of 0.075% for each $1,000 face amount of a security WFA sells.

 

 

CUSIP:

40058JNT8

 

 

Tax consequences:

See “Supplemental Discussion of U.S. Federal Income Tax Considerations” in the accompanying preliminary pricing supplement

 

 

* In addition, in respect of certain securities sold in this offering, GS&Co. may pay a fee of up to 0.20% of the aggregate face amount of the securities sold to selected securities dealers in consideration for marketing and other services in connection with the distribution of the securities to other securities dealers.

 

 

 

The securities have more complex features than conventional debt securities and involve risks not associated with conventional debt securities. See “Risk Factors” in this term sheet and in the accompanying preliminary pricing supplement. This document does not provide all of the information that an investor should consider prior to making an investment decision. You should not invest in the securities without reading the accompanying preliminary pricing supplement and related documents for a more detailed description of the underlying stock, the terms of the securities and certain risks.

 


 

About Your Securities

GS Finance Corp. and The Goldman Sachs Group, Inc. have filed a registration statement (including a prospectus, as supplemented by the prospectus supplement, WFS product supplement no. 5 and preliminary pricing supplement listed below) with the Securities and Exchange Commission (SEC) for the offering to which this communication relates. Before you invest, you should read the prospectus, prospectus supplement, WFS product supplement no. 5 and preliminary pricing supplement, and any other documents relating to this offering that GS Finance Corp. and The Goldman Sachs Group, Inc. have filed with the SEC for more complete information about us and this offering. You may get these documents without cost by visiting EDGAR on the SEC web site at sec.gov. Alternatively, we will arrange to send you the prospectus, prospectus supplement, WFS product supplement no. 5 and preliminary pricing supplement if you so request by calling (212) 357-4612.

Risk Factors

An investment in the securities is subject to risks. Many of the risks are described in the accompanying preliminary pricing supplement, accompanying WFS product supplement no. 5, accompanying prospectus supplement and accompanying prospectus. Below we have provided a list of risk factors discussed in the accompanying preliminary pricing supplement (but not those discussed in the accompanying WFS product supplement no. 5, accompanying prospectus supplement and accompanying prospectus). In addition to the below, you should read in full “Selected Risk Considerations” in the accompanying preliminary pricing supplement, “Risk Factors” in the accompanying WFS product supplement no. 5, as well as the risks and considerations described in the accompanying prospectus supplement and accompanying prospectus.

The following risk factors are discussed in greater detail in the accompanying preliminary pricing supplement:

 

Risks Related to Structure, Valuation and Secondary Market Sales

The Estimated Value of Your Securities At the Time the Terms of Your Securities Are Set On the Pricing Date (as Determined By Reference to Pricing Models Used By GS&Co.) Is Less Than the Original Offering Price Of Your Securities
The Securities Are Subject to the Credit Risk of the Issuer and the Guarantor
You May Lose Your Entire Investment in the Securities
The Return on Your Securities May Change Significantly Despite Only a Small Change in the Price of the Underlying Stock
You May Not Receive a Contingent Coupon on Any Contingent Coupon Payment Date
A Higher Contingent Coupon, a Lower Coupon Threshold Price and/or a Lower Downside Threshold Price May Reflect Greater Expected Volatility of the Underlying Stock, and Greater Expected Volatility Generally Indicates An Increased Risk of Declines in the Price of the Underlying Stock and, Potentially, a Significant Loss at Maturity

 

Your Securities Are Subject to Automatic Redemption
The Contingent Coupon Does Not Reflect the Actual Performance of the Underlying Stock from the Pricing Date to Any Calculation Day or from Calculation Day to Calculation Day
The Market Value of Your Securities May Be Influenced by Many Unpredictable Factors
We Will Not Hold Shares of the Underlying Stock for Your Benefit
You Have No Shareholder Rights or Rights to Receive the Underlying Stock

Additional Risks Related to the Underlying Stock

The Underlying Stock Has a Very Limited Trading History

Risks Related to Tax

Certain Considerations for Insurance Companies and Employee Benefit Plans
The Tax Consequences of an Investment in Your Securities Are Uncertain
Foreign Account Tax Compliance Act (FATCA) Withholding May Apply to Payments on Your Securities, Including as a Result of the Failure of the Bank or Broker Through Which You Hold the Securities to Provide Information to Tax Authorities

 

Wells Fargo Advisors is a trade name used by Wells Fargo Clearing Services, LLC and Wells Fargo Advisors Financial Network, LLC, members SIPC, separate registered broker-dealers and non-bank affiliates of Wells Fargo & Company.

This document does not provide all of the information that an investor should consider prior to making an investment decision. You should not invest in the securities without reading the accompanying preliminary pricing supplement and related documents for a more detailed description of the underlying stock, the terms of the securities and certain risks.


FAQ

Why did the FDA issue a CRL to Ultragenyx (RARE) for UX111?

The FDA requested additional CMC information and remediation of facility inspection observations; no clinical data issues were cited.

Does the CRL affect the clinical efficacy of UX111?

No. The FDA acknowledged that neurodevelopmental outcome data are robust and requested only updated data for resubmission.

How long could UX111 approval be delayed?

Ultragenyx must first address CMC issues, then resubmit the BLA. The FDA review period after resubmission could take up to six months.

What is the financial impact of the FDA CRL on Ultragenyx?

The delay postpones potential revenue from UX111 and may increase manufacturing and compliance costs.

What are the next steps for Ultragenyx following the CRL?

The company will work with the FDA over the coming months to resolve observations and aims to resubmit the BLA once completed.
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