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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Long-Term Safety and Efficacy Data Presented with Paltusotine in Participants Living with Acromegaly","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Crinetics Pharmaceuticals"},{"company":"Oramed Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Oramed Reports Positive Top-Line Results from Phase 2 NASH Trial with its ORMD-0801, Oral Insulin Candidate","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Peptide","graph2":"Oramed Pharmaceuticals"}]
Details:
The 12-week trial enrolled 32 patients (with 30 patients completing) and demonstrated that ORMD-0801 (insulin) was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.
Lead Product(s):
Insulin
Therapeutic Area: Endocrinology
Product Name: ORMD-0801
Highest Development Status: Phase III
Product Type: Peptide
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 13, 2022
Details:
The results show that CRN00808 (paltusotine), an investigational compound, lowered and maintained insulin-like growth factor-1 (IGF-1) at levels comparable to prior injected SRL therapy for up to 103 weeks in participants living with acromegaly.
Lead Product(s):
Paltusotine
Therapeutic Area: Endocrinology
Product Name: CRN00808
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 06, 2022
Details:
CRN00808 (paltusotine) is an investigational, orally available nonpeptide agonist that designed to be selective for somatostatin receptor type 2. It was designed by Crinetics discovery team to provide oral option for patients with acromegaly and neuroendocrine tumors.
Lead Product(s):
Paltusotine
Therapeutic Area: Endocrinology
Product Name: CRN00808
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 02, 2022
Details:
Primary endpoint of trial is to compare efficacy of ORMD-0801 (Insulin) to placebo in improving glycemic control by A1c over a 26-week treatment period, with a secondary endpoint of comparing ORMD-0801 to placebo in maintaining glycemic control over a 52-week treatment period.
Lead Product(s):
Insulin
Therapeutic Area: Endocrinology
Product Name: ORMD-0801
Highest Development Status: Phase III
Product Type: Peptide
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 26, 2022
Details:
ANJ900 (Metformin) is a gut-targeted formulation designed to lower glucose with reduced systemic exposure of metformin, so that patients who cannot take currently available formulations of metformin may achieve better glucose control.
Lead Product(s):
Metformin
Therapeutic Area: Endocrinology
Product Name: ANJ900
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 02, 2022
Details:
Crinetics intends to use the net proceeds from the offering to fund the development of paltusotine, CRN04777, CRN04894 and its other research and development programs, and for working capital and general corporate purposes.
Lead Product(s):
Paltusotine
Therapeutic Area: Endocrinology
Product Name: CRN00808
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
SVB Leerink
Deal Size: $125.0 million
Upfront Cash: Undisclosed
Deal Type: Public Offering
April 18, 2022
Details:
Crinetics intends to use the net proceeds from the proposed offering to fund the development of paltusotine (CRN00808), CRN04777, CRN04894 and its other research and development programs, and for working capital and general corporate purposes.
Lead Product(s):
Paltusotine
Therapeutic Area: Endocrinology
Product Name: CRN00808
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
SVB Leerink
Deal Size: $125.0 million
Upfront Cash: Undisclosed
Deal Type: Public Offering
April 12, 2022
Details:
Teplizumab, an investigational anti-CD3 mAb developed for delay of clinical type 1 diabetes at-risk individuals, company resubmitted BLA for teplizumab has been considered a complete, class 2 response by USFDA.
Lead Product(s):
Teplizumab
Therapeutic Area: Endocrinology
Product Name: PRV-031
Highest Development Status: Phase III
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 21, 2022
Details:
Paltusotine is Crinetics’ investigational, orally available nonpeptide somatostatin receptor type 2 (SST2) agonist being evaluated as a treatment for acromegaly and neuroendocrine tumors (NETs), including NETs complicated by carcinoid syndrome.
Lead Product(s):
Paltusotine
Therapeutic Area: Endocrinology
Product Name: CRN00808
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Sanwa Kagaku Kenkyusho
Deal Size: Undisclosed
Upfront Cash: $13.0 million
Deal Type: Licensing Agreement
February 28, 2022
Details:
CHMP’s positive opinion of PF-06836922 (somatrogon) is based on the results from Phase 3, the study demonstrated that treatment improved the mean overall life interference total score after 12 weeks.
Lead Product(s):
Somatrogon
Therapeutic Area: Endocrinology
Product Name: PF-06836922
Highest Development Status: Phase III
Product Type: Peptide
Partner/Sponsor/Collaborator:
OPKO Health
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 17, 2021
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