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    Orion Makes Disclosure Under Chapter 9 Section 10 Securities

    21 Mar 2025

    // GLOBENEWSWIRE

    Orion Corp: Disclosure Under Chapter 9 Section 10 Securities Mark

    20 Mar 2025

    // GLOBENEWSWIRE

    Orion Corp: Disclosure Under Chapter 9 Section 10 Securities Mark

    12 Mar 2025

    // GLOBENEWSWIRE

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    Orion is a globally operating Finnish pharmaceutical company - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are neurological disorders, oncology and respiratory diseases for which Orion develops inhaled pulmonary medication. Orion's customers are mainly healthcare service providers and professionals such as specialist and general practitioners, veterinarians, pharmacies, hospitals, healthcare centres, clinics, etc.

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    Orion CorporationFinland Flag
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    Head officeOrion CorporationOrionintie 1A, FI-02200 Espoo, FinlandP.O.Box 65, ...
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    +358 10 4261
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    fermionSales@fermion.fi
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    DATA COMPILATION #PharmaFlow

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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    21 Nov 2024
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    NEWS #PharmaBuzz

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    Orion Makes Disclosure Under Chapter 9 Section 10 Securities
    Orion Makes Disclosure Under Chapter 9 Section 10 Securities

    21 Mar 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/03/21/3047072/0/en/Orion-Corporation-Disclosure-Under-Chapter-9-Section-10-of-the-Securities-Market-Act-BlackRock-Inc.html

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    21 Mar 2025
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    Orion Corp: Disclosure Under Chapter 9 Section 10 Securities Mark
    Orion Corp: Disclosure Under Chapter 9 Section 10 Securities Mark

    20 Mar 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/03/20/3046320/0/en/Orion-Corporation-Disclosure-Under-Chapter-9-Section-10-of-the-Securities-Market-Act-BlackRock-Inc.html

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    20 Mar 2025
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    Orion Corp: Disclosure Under Chapter 9 Section 10 Securities Mark
    Orion Corp: Disclosure Under Chapter 9 Section 10 Securities Mark

    12 Mar 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/03/12/3041511/0/en/Orion-Corporation-Disclosure-Under-Chapter-9-Section-10-of-the-Securities-Market-Act-BlackRock-Inc.html

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    12 Mar 2025
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    Orion To Open Biologics R&D Centre In Cambridge In 2025
    Orion To Open Biologics R&D Centre In Cambridge In 2025

    10 Mar 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/03/10/3039501/0/en/Orion-to-open-new-Biologics-R-D-Centre-in-Cambridge-UK-in-2025-to-support-global-growth-strategy-considers-reorganizing-some-work-in-Turku.html

    GLOBENEWSWIRE
    10 Mar 2025
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    Orion Corporation: Transfer of 191,911 B shares on 10 March 2025
    Orion Corporation: Transfer of 191,911 B shares on 10 March 2025

    10 Mar 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/03/10/3040014/0/en/Orion-Corporation-Transfer-of-191-911-own-B-shares-on-10-March-2025.html

    GLOBENEWSWIRE
    10 Mar 2025
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    Orion Corp: Disclosure Under Chapter 9 Section 10 Securities Mark
    Orion Corp: Disclosure Under Chapter 9 Section 10 Securities Mark

    10 Mar 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/03/10/3039915/0/en/Orion-Corporation-Disclosure-Under-Chapter-9-Section-10-of-the-Securities-Market-Act-BlackRock-Inc.html

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    10 Mar 2025
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    Drugs in Development

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    Orion, Invenra Sign Deal for Bispecific Antibody Cancer Therapeutics

    Details:

    Under the terms of the agreements, Invenra will leverage its B-Body bispecific antibody platform from monoclonal antibody discovery to treat cancer.


    Lead Product(s): Undisclosed

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Discovery PlatformProduct Type: Antibody

    Sponsor: Invenra

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement January 30, 2025

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Oncology

    Highest Development Status : Discovery Platform

    Partner/Sponsor/Collaborator : Invenra

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Orion, Invenra Sign Deal for Bispecific Antibody Cancer Therapeutics

    Details : Under the terms of the agreements, Invenra will leverage its B-Body bispecific antibody platform from monoclonal antibody discovery to treat cancer.

    Product Name : Undisclosed

    Product Type : Antibody

    Upfront Cash : Undisclosed

    January 30, 2025

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    Orion's Partner Bayer Submits Darolutamide Application in China for Third Indication

    Details:

    Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.


    Lead Product(s): Darolutamide

    Therapeutic Area: Brand Name: Nubeqa

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Bayer AG

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 07, 2025

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    Lead Product(s) : Darolutamide

    Therapeutic Area :

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Bayer AG

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Orion's Partner Bayer Submits Darolutamide Application in China for Third Indication

    Details : Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.

    Product Name : Nubeqa

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 07, 2025

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    Orion and Marinus Terminate Agreement for Ganaxolone in Europe

    Details:

    under the termination agreement, Marinus regains Ztalmy (ganaxolone) rights in Europe. It is approved for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder.


    Lead Product(s): Ganaxolone

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Marinus Pharmaceuticals

    Deal Size: $1.5 million Upfront Cash: Undisclosed

    Deal Type: Termination December 30, 2024

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    Lead Product(s) : Ganaxolone

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Marinus Pharmaceuticals

    Deal Size : $1.5 million

    Deal Type : Termination

    DEALS_DEV arrow-down

    Orion and Marinus Terminate Agreement for Ganaxolone in Europe

    Details : under the termination agreement, Marinus regains Ztalmy (ganaxolone) rights in Europe. It is approved for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    December 30, 2024

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    Orion, Abilita Collaborate on Antibody Therapeutics With Licensing Options

    Details:

    The collaboration combines Abilita's strength in discovering breakthrough antibody therapeutics for challenging membrane protein targets with Orion's proven expertise in oncology, pain.


    Lead Product(s): Antibody

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: DiscoveryProduct Type: Large molecule

    Recipient: Abilita Therapeutics

    Deal Size: $785.0 million Upfront Cash: Undisclosed

    Deal Type: Collaboration December 18, 2024

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    Lead Product(s) : Antibody

    Therapeutic Area : Oncology

    Highest Development Status : Discovery

    Recipient : Abilita Therapeutics

    Deal Size : $785.0 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Orion, Abilita Collaborate on Antibody Therapeutics With Licensing Options

    Details : The collaboration combines Abilita's strength in discovering breakthrough antibody therapeutics for challenging membrane protein targets with Orion's proven expertise in oncology, pain.

    Product Name : Undisclosed

    Product Type : Large molecule

    Upfront Cash : Undisclosed

    December 18, 2024

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    Orion and Evariste Collaborate to Design Inhibitors for Undisclosed Target

    Details:

    The collaboration will allow Evariste to utilize its innovative Frobenius Discovery platform to design small-molecule inhibitors for a target selected by Orion.


    Lead Product(s): Undisclosed

    Therapeutic Area: Technology Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Small molecule

    Sponsor: Evariste

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration December 10, 2024

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Technology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Evariste

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Orion and Evariste Collaborate to Design Inhibitors for Undisclosed Target

    Details : The collaboration will allow Evariste to utilize its innovative Frobenius Discovery platform to design small-molecule inhibitors for a target selected by Orion.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    December 10, 2024

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    Orion and Alligator Bioscience Amend their Agreement Concerning Two Bispecific Antibodies

    Details:

    Orion will continue to developtwo bispecific antibodies, which are currently in late-stage pre-clinical development, successfully developed using Alligator’s RUBY bispecific format.


    Lead Product(s): Bispecific Antibody

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Large molecule

    Recipient: Alligator Bioscience

    Deal Size: $3.6 million Upfront Cash: Undisclosed

    Deal Type: Collaboration November 19, 2024

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    Lead Product(s) : Bispecific Antibody

    Therapeutic Area : Oncology

    Highest Development Status : Preclinical

    Recipient : Alligator Bioscience

    Deal Size : $3.6 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Orion and Alligator Bioscience Amend their Agreement Concerning Two Bispecific Antibodies

    Details : Orion will continue to developtwo bispecific antibodies, which are currently in late-stage pre-clinical development, successfully developed using Alligator’s RUBY bispecific format.

    Product Name : Undisclosed

    Product Type : Large molecule

    Upfront Cash : Undisclosed

    November 19, 2024

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    Orion Terminates ODM-111 Program Due To Narrow Therapeutic Window Challenges

    Details:

    ODM-111 is NaV. 1.8 blocker was being evaluated in the early-stage clinical trial studies with the patients for the treatment of acute and chronic pain.


    Lead Product(s): ODM-111

    Therapeutic Area: Neurology Brand Name: ODM-111

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 24, 2024

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    Lead Product(s) : ODM-111

    Therapeutic Area : Neurology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Orion Terminates ODM-111 Program Due To Narrow Therapeutic Window Challenges

    Details : ODM-111 is NaV. 1.8 blocker was being evaluated in the early-stage clinical trial studies with the patients for the treatment of acute and chronic pain.

    Product Name : ODM-111

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    October 24, 2024

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    Orion's Partner Bayer Submits Darolutamide Application in EU for Third Indication

    Details:

    Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.


    Lead Product(s): Darolutamide

    Therapeutic Area: Brand Name: Nubeqa

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Bayer AG

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 14, 2024

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    Lead Product(s) : Darolutamide

    Therapeutic Area :

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Bayer AG

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Orion's Partner Bayer Submits Darolutamide Application in EU for Third Indication

    Details : Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.

    Product Name : Nubeqa

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 14, 2024

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    Bayer Submits Third EU Indication Application for Darolutamide via Orion Collaboration

    Details:

    Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.


    Lead Product(s): Darolutamide,Undisclosed

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: Phase IIIProduct Type: HPAPI

    Recipient: Bayer AG

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 14, 2024

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    Lead Product(s) : Darolutamide,Undisclosed

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Recipient : Bayer AG

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bayer Submits Third EU Indication Application for Darolutamide via Orion Collaboration

    Details : Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.

    Product Name : Nubeqa

    Product Type : HPAPI

    Upfront Cash : Inapplicable

    October 14, 2024

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    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

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    Bayer Seeks U.S. FDA Nod for Third Indication of Orion-Originated Darolutamide

    Details:

    Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.


    Lead Product(s): Darolutamide

    Therapeutic Area: Brand Name: Nubeqa

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Bayer AG

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 26, 2024

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    Orion Corporation

    Finland
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    Lead Product(s) : Darolutamide

    Therapeutic Area :

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Bayer AG

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bayer Seeks U.S. FDA Nod for Third Indication of Orion-Originated Darolutamide

    Details : Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.

    Product Name : Nubeqa

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    September 26, 2024

    Fermion Orion Company Banner

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

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