Company announcement – No. 48 / 2024 Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for dasiglucagon in CHI for up to three weeks of dosing due to the timing of a third-party manufacturing facility reinspectionThe reinspection of the facility was completed in August/September 2024 for which a new inspection classification is pendingZealand remains committed to working with the FDA and the third-party manufacturer to bring dasiglucagon to patients in the U.S. as soon as possible Copenhagen, Denmark, October 9, 2024 – Zealand Pharma A/S (NASDAQ:ZEAL) (CVR-no. 200

Company announcement – No. 47 / 2024 Zealand Pharma announces that Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two Phase III trials in MASH for survodutide The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis, based on survodutide's groundbreaking results from Phase II study  Boehringer launches two Phase III studies of survodutide, LIVERAGE in adults with MASH and moderate or advanced fibrosis (stages 2 or 3), and LIVERAGE-Cirrhosis in those with MASH and cirrhosis (stage 4) Copenhagen, Denmark, October 8, 2024 –

Company announcement – No. 46 / 2024 Total number of shares and voting rights in Zealand Pharma A/S on September 30, 2024 Copenhagen, Denmark, September 30, 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, in accordance with section 32 of the Danish Capital Markets Act, announces the total number of shares and voting rights in the Company at the end of a calendar month during which there have been changes to its share capital.  In Company announcement No. 45/2024 from September 12, 2024, Zealand announced an increase in share capital relating t

Press Release – No. 9 / 2024 Zealand Pharma to participate in the 2024 Cantor Global Healthcare Conference on September 18th Copenhagen, Denmark, September 13, 2024 – Zealand Pharma A/S (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced that Chief Medical Officer, David Kendall, MD, will participate in a fireside chat at the 2024 Cantor Global Healthcare Conference at 9:10 a.m. ET (3:10 p.m. CET) on Wednesday, September 18, 2024. A live audio webcast of the fireside chat will be available at https://wsw.com/webcast/cantor22/zeal/2081412 and accessible through the company's website at https

Company announcement – No. 45 / 2024 Zealand Pharma Increases its Share Capital as a Consequence of Exercise of Employee Warrants Copenhagen, Denmark, September 12, 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, has increased its share capital by a nominal amount of DKK 10,110 divided into 10,110 new shares with a nominal value of DKK 1 each. The increase is a consequence of the exercise of warrants granted under several of Zealand Pharma's employee warrant programs. The increase is a consequence of the exercise of warrants granted under two o

Company announcement – No. 44 / 2024 Zealand Pharma announces positive topline results from 13-week Phase 1b multiple ascending dose clinical trial with GLP-1/GLP-2 receptor dual agonist dapiglutide Placebo-adjusted reductions in body weight of up to a mean of 8.3% with dapiglutide after 13 weekly dosesDapiglutide treatment with doses up to 13 mg was assessed to be safe and well-tolerated with gastrointestinal adverse events consistent with the profile reported with other incretin-based therapies Higher doses up to 26 mg over a 28-week treatment period are being evaluated in the ongoing Part 2 of the trial with topline results expected in the first half of 2025 Copenhagen, Denmark,

Company announcement – No. 41 / 2024 Zealand Pharma Increases its Share Capital as a Consequence of Exercise of Employee Warrants Copenhagen, Denmark, August 22, 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, has increased its share capital by a nominal amount of DKK 13,000 divided into 13,000 new shares with a nominal value of DKK 1 each. The increase is a consequence of the exercise of warrants granted under two of Zealand Pharma's employee warrant programs. Employee warrant programs are part of Zealand Pharma's incentive scheme

Company announcement - No. 39 / 2024 Zealand Pharma Announces Financial Results for the First Half of 2024 Very strong progress across R&D pipeline followed by substantial capital raise enabling further investments to accelerate the development programs for wholly owned obesity assets.   Extremely encouraging weight loss and tolerability data announced with long-acting amylin analog petrelintide from MAD Part 2 (16-week trial)Impressive data from Boehringer Ingelheim's Phase 2 clinical trial with survodutide in MASH presented at the EASL congress in Milan, ItalySignificant strengthening of the balance sheet with completion of upsized equity offering raising gross proceeds of DKK 7 bill

Company announcement – No. 35 / 2024 Zealand Pharma announces completion of an upsized equity offering of 8.35 million new ordinary shares raising gross proceeds of USD 1 billion / DKK 7 billion NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA, EXCEPT AS PERMITTED BY APPLICABLE LAW. THIS ANNOUNCEMENT DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY SECURITIES IN THE UNITED STATES AND THE SECURITIES REFERRED TO HEREIN MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES ABSENT REGISTRATION EXCEPT PURSUANT TO AN APPLICABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT

Company announcement – No. 34 / 2024 Zealand Pharma announces upsizing of previously announced equity offering from approximately USD 900 million / DKK 6.257 billion to USD 1 billion / DKK 7 billion NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA, EXCEPT AS PERMITTED BY APPLICABLE LAW. THIS ANNOUNCEMENT DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY SECURITIES IN THE UNITED STATES AND THE SECURITIES REFERRED TO HEREIN MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES ABSENT REGISTRATION EXCEPT PURSUANT TO AN APPLICABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJEC

Berenberg initiated coverage of Zealand Pharma with a rating of Buy

Morgan Stanley resumed coverage of Zealand Pharma with a rating of Equal-Weight

Morgan Stanley downgraded Zealand Pharma from Overweight to Equal-Weight

Jefferies upgraded Zealand Pharma from Hold to Buy

Company announcement – No. 40 / 2023 Zealand Pharma appoints Enrique Conterno and Elaine Sullivan as board observers Copenhagen, Denmark, November 30, 2023 – a Zealand Pharma A/S (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced the appointment of pharmaceutical industry veterans Enrique Conterno and Elaine Sullivan as observers to the company's board of directors. It is expected that Enrique Conterno and Elaine Sullivan will stand for election to Zealand Pharma's board of directors at the company's 2024 Annual General Meeting. "As board observes, Enrique and Elaine collectively bring decades

COMPANY ANNOUNCEMENT – NO. 36 / 2022 Copenhagen, DK and Boston, MA, August 24, 2022 – Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the appointment of Henriette Wennicke as Zealand's Chief Financial Officer starting November 1, 2022. Henriette Wennicke comes to Zealand with broad finance and business experience at large organizations, including in healthcare, where she has led financial planning and R&D portfolio management. She is currently the Vice President and Head of Investor Relations and Treasury at GN Store Nord, a global leader in inte

Press Release - No. 2/2022 Zealand Pharma Announces Appointment of David M. Kendall, M.D., as Chief Medical Officer David Kendall named Zealand Pharma CMOFollows Zealand Pharma's appointment of Adam Steensberg as CEO and decision to refocus strategyKendall has over 35 years of diabetes and metabolic disease experience including nearly two decades in the pharma industry Copenhagen, DK and Boston, MA, U.S. June 2, 2022 – Zealand Pharma A/S (NASDAQ:ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the appointment of David M. Kendall, M.D., as Chief Medical Officer. Dr. Kendall most recently

Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines AgencyCopenhagen, Denmark, May 31, 2024 – Zealand Pharma A/S (NASDAQ:ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.

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 Phase 1a results for ZP8396, the company's amylin analogue. The first-in-human study was designed to assess safety, pharmacokinetic (PK) and pharmacodynamic effects of ZP8396 in healthy lean and overweight people. Dose-dependent body weight reductions of up to a mean of 4.2% from baseline (4.8% placebo corrected) following a single dose of ZP8396 In development as a non-incretin peptide therapy for the potential management of overweight and obesity

Company announcement – No. 43 / 2022 Zealand Pharma announces directed issue and private placement of approximately 4.5m new shares NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA, EXCEPT AS PERMITTED BY APPLICABLE LAW. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE IN THE UNITED STATES AND THE SECURITIES REFERRED TO HEREIN MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES ABSENT REGISTRATION EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT; ANY PUBLIC OFFERING OF SUCH SECURITIES TO BE MADE IN THE UNITED STATES WI

Novo Nordisk A/S (NYSE:NVO) has completed posting topline results across its six Phase 3a clinical trials in the ONWARDS program of once-weekly insulin icodec in people with diabetes. In ONWARDS 5 study, once-weekly insulin icodec was found to be non-inferior to once-daily basal insulin in reducing HbA1c. With that, the 52-week open-label trial met its primary endpoint at the end of the study. Novo’s icodec led to a reduction of -1.68% points on HbA1c, compared to -1.31% for the once-daily control. The study comprised 1,085 insulin-naive people with type 2 diabetes. Patients on icodec also used an app to guide their dosing. The news adds to ONWARDS trial readouts dating back to April.

Zealand Pharma Announces Positive Results from Phase 3 Trial of Glepaglutide in Patients with Short Bowel Syndrome (EASE 1) Glepaglutide treatment met the primary endpoint with twice weekly dosing achieving a statistically significant reduction in weekly parenteral support volume by 5.13 Liters/week from baseline at 24 weeks 66% of patients in the twice weekly group had a clinically meaningful response (>20% reduction in parenteral support volume) In total 9 patients treated with glepaglutide were weaned off parenteral support, while no placebo treated patients were able to wean off parenteral support Glepaglutide treatment was assessed as safe and was well-tolerated in the trial Conf

Press release – No. 6 / 2022 Zealand Pharma Announces Oral Presentation of Phase 2 Data for BI 456906 at the 58th Annual Meeting of the European Association for the Study of Diabetes (EASD) BI 456906 effectively lowered HbA1c up to -1.88% at week 16 in patients with type 2 diabetes in the Phase 2 clinical trial Preclinical pharmacology of BI 456906 supports ongoing Phase 2 studies in obesity or non-alcoholic steatohepatitis Copenhagen, Denmark and Boston MA, U.S. September 21, 2022  – Zealand Pharma A/S (CVR-no. 20045078) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the presentation of data from the Boehringer

Zealand Pharma A/S (NASDAQ:ZEAL) has entered into a global license and development agreement with Novo Nordisk A/S (NYSE:NVO) to commercialize Zegalogue (dasiglucagon) for injection. FDA approved Zegalogue for severe hypoglycemia in pediatric and adult patients with diabetes aged six and above. Under the terms of the agreement, Zealand will receive an upfront payment of DKK 25 million and is eligible to receive up to DKK 45 million in near-term development, regulatory, and manufacturing-based milestones.  Related: Zealand Pharma's Dasiglucagon Aces Late-Stage Study In Pediatric Patients, Shares Move Higher. Zealand is also eligible to receive up to DKK 220 million in sales-based milest

Zealand Pharma A/S (NASDAQ:ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced it has entered into a global license and development agreement with Novo Nordisk A/S to commercialize ZEGALOGUE® (dasiglucagon) for injection. ZEGALOGUE® is approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 and above. Under the terms of the agreement, Zealand will receive an upfront payment of DKK 25 million and is eligible to receive up to DKK 45 million in near-term development, regulatory and manufacturing-based milest

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