Sequoyah

Crinetics Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, August 8, 2023
ENDO, TSH, Maintenance, KOL, Endocrinology, Carcinoid syndrome, Sequoyah, Glomus tumor, NDA, Congenital adrenal hyperplasia, Holocene, History, Octreotide, Graves' ophthalmopathy, Acromegaly, Entrepreneurship, Investment, PTH1R, SAN, PHPT, Primary hyperparathyroidism, Hospital, Research, FDA, Conference, Massachusetts General Hospital, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Congenital hyperinsulinism, Pharmaceutical industry, Cryptocurrency

SAN DIEGO, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • SAN DIEGO, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the second quarter ended June 30, 2023.
  • Enrollment in our Phase 3 PATHFNDR-2 study is also now complete and we anticipate topline results in the first quarter of 2024,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics.
  • “Unfortunately, we also suffered a setback with our CRN04777 program and made the difficult decision to wind down its development.
  • PATHFNDR-1 is a placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly switching from standard-of-care peptide depots.

Crinetics Hosting Key Opinion Leader Webinar to Discuss the Current Treatment Landscape and Unmet Need in Acromegaly

Retrieved on: 
Monday, July 31, 2023
KOL, MGH, Metabolism, Pituitary gland, Sequoyah, Clinical trial, Saint Andrew's Society, Medicine, Research, BSN, Harvard Medical School, Acromegaly, American Association of Clinical Endocrinologists, Patient, SAN, European Society of Endocrinology, Endocrine Society, Diagnosis, Hospital, Massachusetts General Hospital, Pharmaceutical industry, Adult, Endocrinology

(Nasdaq: CRNX) today announced that it will host a Key Opinion Leader (KOL) webinar on August 8, 2023 at 12:00 pm Eastern Time, featuring presentations by KOLs Beverly MK Biller M.D.

Key Points: 
  • (Nasdaq: CRNX) today announced that it will host a Key Opinion Leader (KOL) webinar on August 8, 2023 at 12:00 pm Eastern Time, featuring presentations by KOLs Beverly MK Biller M.D.
  • and Karen JP Liebert, R.N., BSN, both of Massachusetts General Hospital, who will discuss the current landscape and unmet medical need in acromegaly, as well as the treatment burden associated with standard-of-care injectable somatostatin receptor ligands (SRLs).
  • Karen JP Liebert, R.N., B.S.N., is a research nurse / study coordinator in the Neuroendocrine Department at Massachusetts General Hospital (MGH).
  • She is a member of the Endocrine Nursing Society and has co-authored numerous peer-reviewed publications.

New Data Demonstrating Stable Biochemical and Symptom Levels with Two-Years of Oral Paltusotine Administration Presented at ENDO 2023

Retrieved on: 
Wednesday, June 21, 2023
ENDO, Rat, FISU World University Games, Pain, Graves' ophthalmopathy, A1C, Patient, Hypercalcaemia, Primary hyperparathyroidism, SST2, Health, Hyperthyroidism, Memory, PTH1R, Fatigue, Thyroid, Camp, PRO, Weakness, HHM, Acromegaly, Headache, Safety, Growth hormone, Cancer, Medicine, Biomarker, History, Calcium, ASD, Swelling, Autoimmune disease, Endocrine Society, Perspiration, Medical school, Human, Blood pressure, Exophthalmos, TSH, Malignancy, Osteoporosis, Endocrine system, Arthralgia, Sequoyah, Saint Andrew's Society, PHPT, Poster, TSHR, TED, Pharmaceutical industry, Entrepreneurship, Endocrinology

SAN DIEGO, June 21, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) presented efficacy, safety and patient-reported outcome (PRO) data at ENDO 2023 for paltusotine, an experimental, once-daily, oral, small molecule somatostatin receptor type 2 (SST2) agonist in Phase 3 clinical development for the treatment of acromegaly. The Endocrine Society’s annual meeting, ENDO 2023, was held June 15-18, 2023, in Chicago, Illinois.

Key Points: 
  • The Endocrine Society’s annual meeting, ENDO 2023 , was held June 15-18, 2023, in Chicago, Illinois.
  • The ASD score was a composite representing participants’ daily impressions of common acromegaly symptoms including headache, joint pain, sweating, fatigue, weakness, swelling, and numbness/tingling.
  • Approximately 90% of participants said they preferred once-daily, oral paltusotine over current standard of care of injected SRLs when asked after one year of treatment.
  • The data presented in a poster at ENDO on June 17th show Crinetics’ PTH1R antagonist suppressing PTH-stimulated increases in ionized calcium, urinary cAMP, and bone resorption biomarkers in rats.

Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 28, 2023
Momentum, Hyperparathyroidism, Diabetes, Safety, SRL, Innovation, Volunteering, Octreotide, Congenital hyperinsulinism, Research, Clinical trial, FDA, Investment, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NDA, Trial of the century, MAD, MHRA, ACTH, Glomus tumor, Congenital adrenal hyperplasia, Sequoyah, SAN, Polycystic kidney disease, Medicines and Healthcare products Regulatory Agency, MAA, Pharmacodynamics, Graves' ophthalmopathy, Adrenocorticotropic hormone, Food, DSM-IV codes, Carcinoid syndrome, Acromegaly, Health care, Risk management, Pharmaceutical industry, Cryptocurrency, Pharmacokinetics

Pending a successful outcome from the PATHFNDR studies, an NDA submission in acromegaly is expected in 2024

Key Points: 
  • Pending a successful outcome from the PATHFNDR studies, an NDA submission in acromegaly is expected in 2024
    SAN DIEGO, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the fourth quarter and year ended December 31, 2022.
  • PATHFNDR-2 is the second placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly.
  • Enrollment is ongoing in the study and the company is aggressively navigating prolonged pandemic-related and geopolitical disruptions in certain key study regions.
  • In April 2022, Crinetics successfully completed an underwritten follow-on offering of its common stock, raising gross proceeds of approximately $125 million.

Crinetics Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 14, 2022
Marketing, Acromegaly, Clinical trial, ACTH, MHRA, Safety, Form 10-K, Carcinoid syndrome, SST2, Plasma, Investment, Pharmacovigilance, MAA, Congenital adrenal hyperplasia, CAH, Health care, Degenerative disease, Research, Intellectual property, COVID-19, Congenital hyperinsulinism, FDA, United Kingdom, Sequoyah, Drug Quality and Security Act, Annual report, Maintenance, Adrenocorticotropic hormone, Wilms' tumor, Therapy, Drug discovery, International Congress on Tuberculosis, Innovation, SRL, SAN, Endocrinology, Patient, Renewable energy, Pharmaceutical industry, Lease, Neuroendocrinology

SAN DIEGO, Nov. 14, 2022 (GLOBE NEWSWIRE) --  Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the third quarter ended September 30, 2022.

Key Points: 
  • SAN DIEGO, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the third quarter ended September 30, 2022.
  • PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of paltusotine in acromegaly patients.
  • Topline data from PATHFNDR-1 are expected in the third quarter of 2023 and topline data from paltusotines second Phase 3 trial, PATHFNDR-2, are expected in the fourth quarter of 2023.
  • Additional information on risks facing Crinetics can be found under the heading Risk Factors in Crinetics periodic reports, including its annual report on Form 10-K for the year ended December 31, 2021.

Amryt to Present Data from MPOWERED Phase 3 Trial of Mycapssa® (oral octreotide) at ENEA 2022

Retrieved on: 
Wednesday, September 7, 2022
Acromegaly, SRL, Patient, ENEA, Degenerative disease, Neurosurgery, Northwestern Health Sciences University, Poster, Oregon Health & Science University, Physician, Union, RCT, Sequoyah, European, Adult, Oregon Health Plan, Lead, Congress, FACE, Capsule, Pharmaceutical industry, MD

Dr. Tracy Cunningham, Chief Medical Officer of Amryt,commented: These data provide important information for physicians when switching patients from injectable SRLs to Mycapssa.

Key Points: 
  • Dr. Tracy Cunningham, Chief Medical Officer of Amryt,commented: These data provide important information for physicians when switching patients from injectable SRLs to Mycapssa.
  • These patients were then followed for an additional nine months in the randomized controlled treatment (RCT) phase.
  • At the end of the RCT phase patients were provided the option to continue into an open label phase and receive Mycapssa.
  • Response was defined as the time-weighted average of IGF-1

New Long-Term Safety and Efficacy Data Presented with Paltusotine in Participants Living with Acromegaly

Retrieved on: 
Tuesday, September 6, 2022
Carpal tunnel syndrome, COVID-19, Fatigue, ENEA, Pain, Securities Act of 1933, Research, Liver, SAN, Medication, Evolve, Drug Quality and Security Act, Injection, Carcinoid syndrome, Hormone, GLOBE, Metabolism, Degenerative disease, Patient, Time, Glucose, Adenoma, SEC, Universiade, Arthritis, FDA, Growth hormone, Drug discovery, Intellectual property, Sleep apnea, Annual report, Arthralgia, Congenital hyperinsulinism, SRL, SST2, Securities Exchange Act of 1934, Form 10-K, Lipid metabolism, Pituitary adenoma, Sequoyah, Vocal cords, GH, Marketing, Needle, Congenital adrenal hyperplasia, Doctor of Philosophy, Advance, Wilms' tumor, Heart, ACTH, Human, Medical school, Therapy, Clinical trial, OLE, Pharmaceutical industry, Endocrinology, Acromegaly, MD

SAN DIEGO, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals (Nasdaq: CRNX) today announced that Monica R. Gadelha, MD, PhD, professor of endocrinology at the Medical School of the Universidade Federal do Rio de Janeiro and a principal investigator in the Phase 2 ACROBAT program, presented new data from the planned two-year interim analysis of the ACROBAT Advance open label extension (OLE) study at the 35th Brazilian Congress of Endocrinology and Metabolism (CBEM).

Key Points: 
  • This preliminary data, combined with the preference participants had for oral paltusotine over the injected standard-of-care, speaks to the potential paltusotine may have as a long-term therapy for acromegaly.
  • Dr. Gadelha will present an additional poster of the Advance OLE data at the European Neuroendocrine Association (ENEA) meeting.
  • That presentation, titled Long-Term Treatment with Oral Paltusotine for Acromegaly: Results from the ACROBAT Advance study will be made on September 9th.
  • In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily paltusotine.

New Long-Term Safety and Efficacy Data for Investigational Compound Paltusotine to be Presented at the Brazilian Congress of Endocrinology and Metabolism

Retrieved on: 
Friday, September 2, 2022
Acromegaly, Congenital hyperinsulinism, Carpal tunnel syndrome, Needle, SRL, Fatigue, Pain, SST2, Lipid metabolism, Liver, Pituitary adenoma, Congenital adrenal hyperplasia, SAN, Doctor of Philosophy, Advance, Wilms' tumor, Medication, Glucose, Heart, ACTH, Adenoma, Injection, Carcinoid syndrome, Hormone, Universiade, OLE, Sequoyah, Human, GLOBE, Medical school, Arthritis, Metabolism, Therapy, Degenerative disease, Growth hormone, Vocal cords, Drug discovery, Sleep apnea, Patient, Arthralgia, Pharmaceutical industry, MD, Endocrinology

Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone.

Key Points: 
  • Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone.
  • Paltusotine is an investigational, orally available nonpeptide agonist that is designed to be highly selective for the somatostatin receptor type 2 (SST2).
  • In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily paltusotine.
  • All of the companys drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts.

Crinetics Pharmaceuticals and Sanwa Kagaku Kenkyusho Enter into Exclusive Licensing Agreement for the Development and Commercialization of Paltusotine in Japan

Retrieved on: 
Monday, February 28, 2022
Annual report, Glucose, Congenital adrenal hyperplasia, Securities Exchange Act of 1934, Diabetes, NETS, Acromegaly, Liver, Nasdaq, Degenerative disease, Form 10-K, Lipid metabolism, Research, Therapy, Partnership, ACTH, Human, Wilms' tumor, Diarrhea, Sleep apnea, Hormone, Safety, Disease, SST2, Endocrinology, Securities Act of 1933, SAN, Fatigue, Drug discovery, Carcinoid syndrome, Quality of life, Drug Quality and Security Act, Pain, Needle, Growth hormone, Sequoyah, Dialysis, Patient, Arthritis, GLOBE, Lung, Pituitary adenoma, Gastrointestinal tract, Vocal cords, Congenital hyperinsulinism, Achievement, Carpal tunnel syndrome, Arthralgia, Medication, Adenoma, Medicine, Injection, Heart, Flushing, Marketing, SEC, Pharmaceutical industry

In addition, upon market approval of paltusotine in Japan, Crinetics will be eligible to receive tiered royalties based on net product sales.

Key Points: 
  • In addition, upon market approval of paltusotine in Japan, Crinetics will be eligible to receive tiered royalties based on net product sales.
  • Sanwa will have an exclusive right to develop and commercialize the product in Japan and will be responsible for leading the development and commercialization of paltusotine for acromegaly and NETs in Japan.
  • Crinetics retains all rights to develop and commercialize paltusotine outside Japan.
  • In Japan, Sanwa expects to initiate Phase 1 development with paltusotine in 2022.

Crinetics Pharmaceuticals Presenting New Data from Open Label Extension Trial of Paltusotine in Acromegaly at the Society for Endocrinology BES Congress

Retrieved on: 
Monday, November 8, 2021
Carcinoid syndrome, Endocrinology, Arthritis, ACTH, Securities Exchange Act of 1934, Congenital hyperinsulinism, Serum, Annual report, Pain, Therapy, Drug Quality and Security Act, Safety, Vocal cords, ULN, GH, Form 10-K, Acromegaly, Needle, SAN, Securities Act of 1933, Injection, Congress, GLOBE, Arthralgia, Degenerative disease, Patient, Congenital adrenal hyperplasia, Sequoyah, OLE, Heart, Liver, Society, Fatigue, Growth hormone, Glucose, SEC, Drug discovery, Adenoma, Lipid metabolism, Wilms' tumor, SST2, Hormone, Observation, Pituitary adenoma, SRL, Medication, Carpal tunnel syndrome, Human, Sleep apnea, Nasdaq, Pharmaceutical industry

This was true for patients with controlled or uncontrolled IGF-1 at baseline while treated with injected SRLs.

Key Points: 
  • This was true for patients with controlled or uncontrolled IGF-1 at baseline while treated with injected SRLs.
  • It was designed by the Crinetics discovery team to provide a once-daily option for patients with acromegaly and neuroendocrine tumors.
  • In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily oral paltusotine.
  • Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors.