Immunology | Phase II Developments

ARS Pharmaceuticals

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Neurelis Announces That ARS Pharmaceuticals' Intranasal Epinephrine Product, Demonstrates Bioequivalent Exposure To Epinephrine Injectors

Lead Product(s): Epinephrine

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2020

Details:

The presentation will highlight promising results for ARS Pharmaceuticals' lead asset, ARS-1 which results in bioequivalent exposure to epinephrine injection given once and twice.

AFYX Therapeutics

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AFYX Therapeutics Achieves Primary Endpoint in Phase 2b Trial of Rivelin-CLO in Patients with Oral Lichen Planus

Lead Product(s): Clobetasol Propionate

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 22, 2020

Details:

Study conducted in OLP patients with the 20?g dose of Rivelin-CLO demonstrated a statistically significant improvement in ulcer area, and continued to show improvement through the end of 4 weeks.

Immunovant

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Immunovant Announces Closing of $139.4 Million Public Offering

Lead Product(s): IMVT-1401

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: SVB Leerink

Deal Size: $139.4 million Upfront Cash: Undisclosed

Deal Type: Public Offering April 16, 2020

Details:

Company closed its previously announced underwritten public offering of 9,613,365 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 1,253,917.

RemeGen

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CHINA China

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FDA Grants Fast Track Designation to RemeGen's Telitacicept as a Treatment for Systemic Lupus Erythematosus

Lead Product(s): Telitacicept

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 15, 2020

Details:

US FDA granted Fast Track designation for RC18, for the treatment of systemic lupus erythematosus (SLE). RC18 shows statistically significant improvement for patients at multiple doses.

Kadmon

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Kadmon Announces Receipt of Final Meeting Minutes from FDA Following Pre-NDA Meeting for KD025 for the Treatment of Cgvhd

Lead Product(s): Belumodsil

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 14, 2020

Details:

Based on the feedback from the FDA, the Company believes the proposed data package will be sufficient to support a submission of KD025 for the treatment of patients with cGVHD.

OSE Immunotherapeutics SA

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FRANCE France

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OSE Immunotherapeutics and Servier Amend the Global Licensing Option Agreement

Lead Product(s): OSE-127

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Laboratoires Servier

Deal Size: $21.4 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement March 17, 2020

Details:

In December 2016, OSE Immunotherapeutics granted Servier a two-step option agreement to acquire the exclusive worldwide license to develop and commercialize OSE-127.

Kadmon

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Kadmon Announces Expanded Results of Interim Analysis of Pivotal Trial of KD025 in cGVHD

Lead Product(s): Belumodsil

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 23, 2020

Details:

KD025 has been well tolerated and has already demonstrated high response rates in patients with severe and complex cGVHD after a median of five months of follow-up.

Salzman Group

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Kalytera Announces New Payments Agreement with the Salzman Group

Lead Product(s): Cannabidiol

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Kalytera Therapeutics

Deal Size: $0.3 million Upfront Cash: Undisclosed

Deal Type: Agreement February 07, 2020

Details:

Salzman Group has provided certain services in connection with the Kalytera's programs for the development of cannabidiol for treatment of graft versus host disease.

MaaT Pharma

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FRANCE France

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MaaT Pharma Announces €18 Million Series B Financing

Lead Product(s): MaaT013

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Symbiosis Pharmaceutical Services LTD

Deal Size: $19.5 million Upfront Cash: Undisclosed

Deal Type: Series B Financing February 05, 2020

Details:

The funding will continue the clinical development of the company's current pipeline as well as the extension to other indications in oncology.

Kezar Life Sciences

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Kezar Announces Closing of $56.8 Million Public Offering

Lead Product(s): KZR-616

Therapeutic Area: Immunology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Cowen

Deal Size: $56.8 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 04, 2020

Details:

Kezar intends to use the net proceeds from the offering primarily to fund the research and development of its product candidates, acquire or license products or technologies.

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ARS Pharmaceuticals

Neurelis Announces That ARS Pharmaceuticals' Intranasal Epinephrine Product, Demonstrates Bioequivalent Exposure To Epinephrine Injectors

AFYX Therapeutics

AFYX Therapeutics Achieves Primary Endpoint in Phase 2b Trial of Rivelin-CLO in Patients with Oral Lichen Planus

Immunovant

Immunovant Announces Closing of $139.4 Million Public Offering

RemeGen

FDA Grants Fast Track Designation to RemeGen's Telitacicept as a Treatment for Systemic Lupus Erythematosus

Kadmon

Kadmon Announces Receipt of Final Meeting Minutes from FDA Following Pre-NDA Meeting for KD025 for the Treatment of Cgvhd

OSE Immunotherapeutics SA

OSE Immunotherapeutics and Servier Amend the Global Licensing Option Agreement

Kadmon

Kadmon Announces Expanded Results of Interim Analysis of Pivotal Trial of KD025 in cGVHD

Salzman Group

Kalytera Announces New Payments Agreement with the Salzman Group

MaaT Pharma

MaaT Pharma Announces €18 Million Series B Financing

Kezar Life Sciences

Kezar Announces Closing of $56.8 Million Public Offering