Somatostatin

Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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Wednesday, February 28, 2024

SAN DIEGO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • ET Today
    SAN DIEGO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the fourth quarter and full year ended December 31, 2023.
  • We also expect full results from our Phase 2 study in carcinoid syndrome in the first half of this year.
  • In December 2023, Crinetics reported an initial analysis of data from a subset of 27 patients.
  • Earlier today, February 28, 2024, Crinetics announced a private placement equity financing for gross proceeds of approximately $350 million.

Lantheus Announces Acceptance of its First-to-File ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate)

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Thursday, January 11, 2024

LUTATHERA® is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Key Points: 
  • LUTATHERA® is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
  • Based on the most recent update to the FDA’s online paragraph IV database listings,1 Lantheus believes it is the first applicant to have filed a substantially complete ANDA for Lutetium Lu 177 Dotatate containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act.
  • Should its ANDA be approved by the FDA, Lantheus believes it will be eligible for 180 days of generic marketing exclusivity in the U.S.
    Lantheus licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2003 from POINT Biopharma Global, Inc. in December of 2022.
  • To read the press release announcing that licensing transaction, please click here .

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

Retrieved on: 
Tuesday, November 7, 2023

SAN DIEGO, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • SAN DIEGO, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the third quarter ended September 30, 2023.
  • We are enthusiastic about these upcoming key milestones for the paltusotine franchise.”
    Third Quarter 2023 and Operating Highlights:
    Phase 3 PATHFNDR-1 study met primary and all secondary endpoints.
  • In September 2023, Crinetics announced the pricing of an upsized underwritten public offering of 11,441,648 shares of its common stock at $30.59 per share.
  • Unrestricted cash, cash equivalents, and investments totaled $554.7 million as of September 30, 2023, compared to $334.4 million as of December 31, 2022.

Global Peptide Drug Conjugates Market Expected to Reach $4.21 Billion by 2030, Driven by Rising Cancer Cases - ResearchAndMarkets.com

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Tuesday, October 24, 2023

The global peptide drug conjugates market is poised for significant growth, with an expected value of USD 4.21 billion by 2030, registering a remarkable Compound Annual Growth Rate (CAGR) of 28.58% during the forecast period.

Key Points: 
  • The global peptide drug conjugates market is poised for significant growth, with an expected value of USD 4.21 billion by 2030, registering a remarkable Compound Annual Growth Rate (CAGR) of 28.58% during the forecast period.
  • Rising Cancer Cases: The market's growth is driven by the global surge in cancer cases and related mortality.
  • The increasing demand for novel treatments like peptide drug conjugates (PDCs) to target uncontrolled cell growth is expected to fuel market growth.
  • For instance, in December 2021, Coherent Biopharma and WuXi STA announced a strategic partnership agreement to develop their current and future therapeutic drugs, including peptide drug conjugates.

Ariceum Therapeutics' targeted radiopharmaceutical 177Lu-satoreotide exhibits promising clinical response and good tolerability profile in patients with advanced neuroendocrine tumours

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Thursday, September 28, 2023

This international study was conducted in 7 countries - Australia, Austria, Canada, Denmark, France, Switzerland, and the UK - and enrolled 40 patients with advanced, SSTR2-positive NETs.

Key Points: 
  • This international study was conducted in 7 countries - Australia, Austria, Canada, Denmark, France, Switzerland, and the UK - and enrolled 40 patients with advanced, SSTR2-positive NETs.
  • The primary tumours of the patients included progressive, grade 1 and 2 (≈60%) gastroenteropancreatic (GEP), and (a)typical lung NETs, paraganglioma, and pheochromocytoma.
  • Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "These exciting new data demonstrate the great potential of our targeted radiopharmaceutical, satoreotide, for treating patients with advanced neuroendocrine tumours.
  • A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours.

Ariceum Therapeutics' targeted radiopharmaceutical 177Lu-satoreotide exhibits promising clinical response and good tolerability profile in patients with advanced neuroendocrine tumours

Retrieved on: 
Thursday, September 28, 2023

This international study was conducted in 7 countries - Australia, Austria, Canada, Denmark, France, Switzerland, and the UK - and enrolled 40 patients with advanced, SSTR2-positive NETs.

Key Points: 
  • This international study was conducted in 7 countries - Australia, Austria, Canada, Denmark, France, Switzerland, and the UK - and enrolled 40 patients with advanced, SSTR2-positive NETs.
  • The primary tumours of the patients included progressive, grade 1 and 2 (≈60%) gastroenteropancreatic (GEP), and (a)typical lung NETs, paraganglioma, and pheochromocytoma.
  • Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "These exciting new data demonstrate the great potential of our targeted radiopharmaceutical, satoreotide, for treating patients with advanced neuroendocrine tumours.
  • A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours.

RayzeBio to Present at Upcoming Medical Conferences

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Monday, May 22, 2023

RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs.

Key Points: 
  • RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs.
  • 2023 American Society for Clinical Oncology (ASCO) annual meeting: June 2 - 6 in Chicago, IL
    Title: ACTION-1 phase 1b/3 trial of RYZ101 in somatostatin receptor subtype 2–expressing (SSTR2+) gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Initial safety analysis.
  • Australian and New Zealand Society of Nuclear Medicine (ANZSNM): May 26 - 28 in Adelaide, Australia
    Title: Anti-tumor activity of RYZ101 in somatostatin receptor-expressing preclinical models of small-cell lung cancer.
  • Title: Novel peptide binder to Glypican-3 for targeted radiopharmaceutical therapy of hepatocellular carcinoma.

RadioMedix and Orano Med Complete Patient Enrolment in Phase II Trial of Targeted Alpha-Emitter AlphaMedix in Neuroendocrine Cancers

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Tuesday, May 16, 2023

RadioMedix and Orano Med, two clinical stage radiopharmaceutical companies, today announced that the last patient has been dosed in the Phase II trial of the targeted alpha emitter therapy, 212Pb-DOTAMTATE (AlphaMedix™).

Key Points: 
  • RadioMedix and Orano Med, two clinical stage radiopharmaceutical companies, today announced that the last patient has been dosed in the Phase II trial of the targeted alpha emitter therapy, 212Pb-DOTAMTATE (AlphaMedix™).
  • “Previous studies have shown targeted alpha therapy (TAT) with AlphaMedix™ is well-tolerated.
  • Julien Dodet, President, and Chief Executive Officer of Orano Med, noted: “Completing this Phase II trial enrolment on schedule is a great achievement everyone involved and confirms the strong interest of the medical community for targeted alphatherapies with lead-212.
  • This reinforces Orano Med’s commitment to make innovative lead-212-based therapies available to the medical community and patients worldwide.”

Successful Results Using Sernova’s Cell Pouch System™ with Evotec’s iPSC-Derived Islet-like Clusters for Type 1 Diabetes Presented at the 4th IPITA / HSCI / JDRF Summit

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Monday, April 24, 2023

The objective of the partnership is to produce an off-the-shelf, commercially scalable cell therapy treatment, with human testing anticipated to begin in 2024.

Key Points: 
  • The objective of the partnership is to produce an off-the-shelf, commercially scalable cell therapy treatment, with human testing anticipated to begin in 2024.
  • The presentation included an introduction to Evotec’s proprietary GMP process for manufacturing iPSC-derived ILCs for use in Sernova’s Cell Pouch, as well as encouraging results from multiple studies using a standard mouse model of T1D.
  • ILCs implanted into Sernova’s Cell Pouch demonstrated rapid normalization of glycemic control in the streptozotocin (STZ)-induced diabetic NSG (NOD.SCID.IL-2Rgammanull) mouse model.
  • “These results demonstrate that Evotec’s ILCs in the Cell Pouch can become fully functional endocrine islets following implantation, with potency equivalent to human islets.

ProterixBio Announces Commercial Offering of Quantitative Soluble ST2 Assay

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Friday, February 10, 2023

BILLERICA, Mass., Feb. 10, 2023 /PRNewswire/ -- ProterixBio, Inc. today announced the offering of the Presage® ST2 Assay as a testing service through ProterixBio's high-complexity CLIA laboratory.

Key Points: 
  • BILLERICA, Mass., Feb. 10, 2023 /PRNewswire/ -- ProterixBio, Inc. today announced the offering of the Presage® ST2 Assay as a testing service through ProterixBio's high-complexity CLIA laboratory.
  • The protein ST2 (suppressor of tumorigenicity 2) is a member of the interleukin-1 receptor family.
  • The Presage® ST2 assay provided by ProterixBio is a 510(k) cleared device 5 providing a quantitative measure of soluble ST2 in serum or plasma (K3EDTA and Heparin).
  • We utilize sST2 as a complement to proBNP — Soluble ST2 provides appreciation of the chronicity of the underlying disease state.