Athena Pharmaceutiques Oral Dispersible Tablets

Athena Pharmaceutiques Oral Dispersible Tablets

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Rani Therapeutics

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Celltrion and Rani Therapeutics Partner on Development of Oral Monoclonal Antibody Treatment

Details:

Rani is granted an exclusive license to use CT-P43 in the development and commercialization of RT-111, an orally administered ustekinumab biosimilar and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-111 following a Phase 1 clinical trial.

Lead Product(s): Ustekinumab

Therapeutic Area: Dermatology Product Name: RT-111

Highest Development Status: Preclinical Product Type: Large molecule

Partner/Sponsor/Collaborator: Celltrion

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership January 09, 2023

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Rani Therapeutics Receives Feedback from Pre-IND Meeting with FDA; Provides Pipeline Update

Details:

RT-102 (Parathyroid Hormone) is being developed for the treatment of osteoporosis. The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering drug with high reliability to participants via the RaniPill™ GO.

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: RT-102

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 05, 2023

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Rani Therapeutics Announces Repeat-Dose Topline Results from RT-102 Phase 1 Study

Details:

The study achieved all of its endpoints, with repeat doses of RT-102 (parathyroid hormone) being generally well tolerated and delivering drug with high reliability to participants via the RaniPill™ GO.

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: RT-102

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 06, 2022

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Rani Therapeutics Announces New RT-111 Development Program and Provides Corporate Update

Details:

RT-111, a RaniPill GO capsule containing a biosimilar of STELARA® (ustekinumab) is an interleukin-12 and interleukin-23 antagonist for the potential treatment of psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis.

Lead Product(s): Ustekinumab

Therapeutic Area: Endocrinology Product Name: RT-111

Highest Development Status: Preclinical Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 24, 2022

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Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of RT-102 in Osteoporosis

Details:

RT-102, RaniPill capsule containing proprietary formulation of human PTH analog PTH (1-34) for potential treatment of osteoporosis achieved all of its endpoints, with RT-102 being generally well-tolerated and demonstrating high oral bioavailability of Rani’s PTH analog.

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: RT-102

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 10, 2022

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Rani Therapeutics Enters into $45 Million Loan Agreement to Support Ongoing RaniPill® Platform Advancement and Clinical Pipeline Development

Details:

The financing agreement is expected to support the continued advancement of the RaniPill platform and ongoing clinical development of the Company’s drug pipeline including RT-102.

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: RT-102

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: Avenue Venture Opportunities Fund

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement August 08, 2022

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Rani Therapeutics Announces Initiation of Phase 1 Study of RT-102 Oral PTH for Osteoporosis

Details:

In preclinical studies, RT-102, an oral formulation of the human parathyroid hormone delivered via RaniPill™ capsule demonstrated a pharmacokinetic profile comparable to published data of PTH(1-34) injections for the treatment of osteoporosis.

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: RT-102

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 23, 2022

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Robotic Pill Developer Rani Therapeutics Nets $73M IPO

Details:

RaniPill or RT-101 is being evaluated for acromegaly, and Rani expects to run trials for neuroendocrine tumor of the gastrointestinal tract as well as carcinoid syndrome.

Lead Product(s): Octreotide Acetate

Therapeutic Area: Oncology Product Name: RT-101

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: BofA Securities

Deal Size: $73.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering July 26, 2021

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Rani Therapeutics Raises $69 Million Series E To Advance Clinical Trials And Manufacturing Of Robotic Pill

Details:

Rani Therapeutics platform technology converts injectable drugs like PTH and adalimumab into pills. Rani has conducted early human studies with adalimumab and exenatide to confirm high bioavailability with the Rani delivery approach.

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: RT-102

Highest Development Status: Preclinical Product Type: Peptide

Partner/Sponsor/Collaborator: BofA Securities

Deal Size: $69.0 million Upfront Cash: Undisclosed

Deal Type: Series E Financing December 10, 2020

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Rani Therapeutics Announces Positive Phase I Study Results of Oral Octreotide using RaniPill™

Details:

The Phase I study successfully achieved both its primary and secondary endpoints, demonstrating the safety and tolerability of Octreotide-RP.

Lead Product(s): Octreotide Acetate

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 30, 2020

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