Zealand Pharma

Entera Bio Announces Robust Pharmacokinetic Data for First-in-Class Oral GLP-2 Peptide Tablet Treatment for Patients with Short Bowel Syndrome

Retrieved on: 
Wednesday, March 20, 2024
Zealand Pharma, Plasma, Rat, LC-MS/MS, Short bowel syndrome, Half-life, Inflammation, Patient, Tablet, Teduglutide, POC, OPKO Health, Injection, Entera, Pharmaceutical industry

The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.

Key Points: 
  • The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.
  • Currently, the only approved GLP-2 agonist, which is marketed under the name Gattex® (teduglutide), requires daily sub-cutaneous injections.
  • Entera and OPKO completed a proof of concept (PoC) single dose pharmacokinetic study in rodents as the first validation for oral administration of the GLP-2 treatment.
  • This data is consistent with previously reported PK data relating to OPKO’s GLP-2 peptide’s long acting profile, which had initially been developed as a weekly subcutaneous injection.

Zealand Pharma Announces Financial Results for the Full Year 2023

Retrieved on: 
Tuesday, February 27, 2024
DREAM, F2, F1, Overweight, Obesity, Weight loss, Part, F3, Human, Boehringer Ingelheim, BMI, NASH, Fatty liver disease, Zealand Pharma

In parallel, Zealand is planning a Phase 2b trial of petrelintide planned for initiation in the second half of 2024.

Key Points: 
  • In parallel, Zealand is planning a Phase 2b trial of petrelintide planned for initiation in the second half of 2024.
  • In February 2024, Boehringer Ingelheim and Zealand Pharma announced positive results from the Phase 2 trial of survodutide in metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH).
  • In December 2023, Zealand submitted an NDA to the U.S. FDA for the treatment of adult patients with SBS dependent on parenteral support.
  • A recording of the event will be available following the call on the Investor section of Zealand’s website at https://www.zealandpharma.com/events/ .

Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis

Retrieved on: 
Monday, February 26, 2024
Fibrosis, Obesity, MASH, Boehringer Ingelheim, Zealand Pharma, Pharma, Liver disease, Fine chemical

The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring).

Key Points: 
  • The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring).
  • Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis.
  • The double-blind, placebo-controlled Phase 2 trial studied three doses of survodutide at 2.4 mg, 4.8 mg, and 6.0 mg. Top-line results demonstrated an improvement in MASH, at all doses explored in the trial.
  • Treatment with survodutide did not show unexpected safety or tolerability issues, including at the higher dose of 6.0 mg.

Zealand Pharma major shareholder announcement: J O Hambro Capital Management

Retrieved on: 
Friday, January 19, 2024
Zealand Pharma, Perpetual Limited, Fine chemical

Zealand Pharma major shareholder announcement: J O Hambro Capital Management

Key Points: 
  • Zealand Pharma major shareholder announcement: J O Hambro Capital Management
    Copenhagen, Denmark, 19 January 2024 – Zealand Pharma A/S (“Zealand”) (Nasdaq: ZEAL) (CVR-no.
  • 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announces the receipt on 18 January 2024 of notification pursuant to Section 38 of the Danish Capital Markets Act from J O Hambro Capital Management:
    As of 17 January 2024, Perpetual Limited (the parent company of J O Hambro Capital Management) holds nominally 3,095,511 shares (each share carrying one vote) in Zealand Pharma A/S, corresponding to 4.952% of the total share capital and total voting rights in Zealand Pharma A/S.
  • Please see further details in the attached notification form.

Zealand Pharma major shareholder announcement: J O Hambro Capital Management

Retrieved on: 
Wednesday, January 17, 2024
Zealand Pharma, Perpetual Limited, Fine chemical

Zealand Pharma major shareholder announcement: J O Hambro Capital Management

Key Points: 
  • Zealand Pharma major shareholder announcement: J O Hambro Capital Management
    Copenhagen, Denmark, 17 January 2024 – Zealand Pharma A/S (“Zealand”) (Nasdaq: ZEAL) (CVR-no.
  • 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announces the receipt on 17 January 2024 of notification pursuant to Section 38 of the Danish Capital Markets Act from J O Hambro Capital Management:
    As of 11 January 2024, Perpetual Limited (the parent company of J O Hambro Capital Management) holds nominally 3,128,162 shares (each share carrying one vote) in Zealand Pharma A/S, corresponding to 5.004% of the total share capital and total voting rights in Zealand Pharma A/S.
  • Please see further details in the attached notification form.

Zealand Pharma major shareholder announcement: Avoro Capital Advisors LLC

Retrieved on: 
Wednesday, January 10, 2024
Nasdaq Copenhagen, Zealand Pharma

Zealand Pharma major shareholder announcement: Avoro Capital Advisors LLC

Key Points: 
  • Zealand Pharma major shareholder announcement: Avoro Capital Advisors LLC
    Copenhagen, Denmark, 10 January 2024 – Zealand Pharma A/S (“Zealand”) (Nasdaq: ZEAL) (CVR-no.
  • 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announces the receipt on 9 January 2024 of notification pursuant to Section 38 of the Danish Capital Markets Act from Avoro Capital Advisors LLC.
  • 1 / 2024, Avoro Life Sciences Fund LLC now holds nominally 3,438,184 shares in Zealand Pharma A/S, corresponding to 5.50% of the total share capital in Zealand Pharma A/S.
  • Avoro Capital Advisors LLC holds the corresponding number of voting rights to the shares.

Zealand Pharma to highlight obesity pipeline at R&D Event on December 5

Retrieved on: 
Monday, December 4, 2023
Obesity, Zealand Pharma, CMO, Prevalence, Overweight

Copenhagen, Denmark, December 4, 2023 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL) (CVR-no.

Key Points: 
  • Copenhagen, Denmark, December 4, 2023 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL) (CVR-no.
  • Speakers at the event will include members of Zealand Pharma’s management team: Adam Steensberg, President and CEO; and David Kendall, CMO and Head of R&D.
  • At Zealand Pharma, our robust and differentiated pipeline of drug candidates offers the potential to shape the future management of obesity,” said Adam Steensberg, President and CEO at Zealand Pharma.
  • The Obesity R&D Event will also be webcast live on December 5, 2023, at 1:30 pm GMT.

Zealand Pharma Announces Financial Results for the First Nine Months of 2023

Retrieved on: 
Thursday, November 9, 2023
DREAM, Short bowel syndrome, FDA, PDUFA, Congenital hyperinsulinism, BMI, Alexion, S&M, Obesity, GIP, Weight loss, KCNA3, G&A, CMC, RCF, MAD, SBS, Zealand Pharma, Chronic kidney disease, CGM, Danske Bank, Hypoglycemia, NASH, Boehringer Ingelheim, Risk, Partnership, EUR, Credit, Part, NDA, Overweight, Patient, Human, Cardiovascular disease, Pharmaceutical industry, Birth control, Fine chemical, CHI, Sanofi

Milestone payments from existing partnerships were recognized in the third quarter of 2023, with cash inflow expected in the fourth quarter of 2023, contributing to the company’s solid financial position.

Key Points: 
  • Milestone payments from existing partnerships were recognized in the third quarter of 2023, with cash inflow expected in the fourth quarter of 2023, contributing to the company’s solid financial position.
  • Boehringer Ingelheim and Zealand Pharma expect to report topline results from the Phase 2 trial with survodutide in NASH in the first half of 2024.
  • In the second half of 2024, Zealand expects topline results from the 13-week dose titration trial.
  • Zealand has completed pre-clinical activities for the Kv1.3 ion channel blocker to support potential first-in-human clinical trials in 2024.

Zealand Pharma presents data for amylin analog ZP8396 at ObesityWeek

Retrieved on: 
Tuesday, October 17, 2023
BMI, Obesity, Weight loss, Weight, MD, Human, MAD, Overweight, Clinical trial, Safety, Pharmaceutical industry, Birth control, Tolerability, Zealand Pharma

Copenhagen, Denmark, October 17, 2023 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no.

Key Points: 
  • Copenhagen, Denmark, October 17, 2023 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no.
  • 20045078) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced presentations of clinical and non-clinical results for Zealand’s amylin analog ZP8396 at the Obesity Society Annual Meeting (ObesityWeek) being held in Dallas, Texas from October 14-17, 2023.
  • Topline results from the 6-week multiple ascending dose (MAD) clinical trial were previously reported in Company Announcement No.
  • “The clinical results for amylin analog ZP8396 presented at ObesityWeek support its potential as a next generation treatment for overweight and obesity that could provide weight loss comparable with GLP-1 based therapies with improved tolerability,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma.

Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease

Retrieved on: 
Thursday, October 5, 2023
Cardiovascular disease, III, BMI, Type 2 diabetes, European Association for the Study of Diabetes, Hypertension, Obesity, Prevalence, A1C, Disease, Overweight, Principal, Conditional sentence, EASD, Phase, Appetite, Dyslipidemia, Chronic kidney disease, Obstructive sleep apnea, BI, Zealand Pharma, Boehringer Ingelheim, University college, Risk, Pharmaceutical industry, Electric motor, Dietary supplement, Diabetes

Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease

Key Points: 
  • Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease
    SYNCHRONIZE-1 and SYNCHRONIZE-2 are global Phase III studies of survodutide (BI 456906) in people living with obesity and overweight without and with type 2 diabetes, respectively
    A third study, SYNCHRONIZE-CVOT, is a global, long-term cardiovascular safety study of survodutide in people living with obesity and overweight with cardiovascular disease, chronic kidney disease or with risk factors for cardiovascular disease
    Boehringer Ingelheim and Zealand Pharma A/S (NASDAQ: ZEAL) announced the initiation of three Phase III trials investigating survodutide (also known as BI 456906) for people living with overweight or obesity.
  • The trial design builds upon learnings from Phase II, in which people living with overweight or obesity achieved up to 19 percent weight loss.1 The Phase III trials will soon open for recruitment.
  • SYNCHRONIZE-1 will enrol people without type 2 diabetes (A1C
  • The third study, SYNCHRONIZE-CVOT, is a Phase III trial that will enrol people with overweight or obesity with cardiovascular disease, chronic kidney disease, or risk factors for cardiovascular disease.