On August 30, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, AUG 30, 2021, View Source [SID1234587027]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 4 August 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021.

Since the announcement 23 August 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 18,897,886 B shares of DKK 0.20 as treasury shares, corresponding to 0.8% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 27 August 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 20,091,414 B shares at an average share price of DKK 486.93 per B share equal to a transaction value of DKK 9,783,088,903.

On August 30, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has entered into a sponsored research collaboration with Dana-Farber Cancer Institute (Dana-Farber) (Press release, SpringWorks Therapeutics, AUG 30, 2021, View Source [SID1234587025]). The collaboration is designed to further investigate nirogacestat, SpringWorks’ investigational gamma secretase inhibitor (GSI), with anti-B-cell maturation antigen (BCMA) agents in a variety of preclinical multiple myeloma models. Constantine Mitsiades, M.D., Ph.D., Assistant Professor of Medicine at Dana-Farber and Harvard Medical School, will serve as the Principal Investigator for the research, which will utilize preclinical in vivo models from the Mitsiades Lab to simulate the multiple myeloma tumor microenvironment. In addition, the research will also deploy functional genomics approaches to explore determinants of response and mechanisms of resistance to GSI + BCMA combination therapy.

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Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of multiple myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies.1 To date, SpringWorks has entered into clinical collaborations with six industry partners to evaluate nirogacestat in combination with BCMA therapies across modalities.

"SpringWorks has demonstrated its commitment to understanding the science and advancing the clinical exploration of GSI + BCMA combination therapies," said Dr. Mitsiades. "I am pleased to collaborate with them towards the goal of improving clinical outcomes for patients with multiple myeloma while simultaneously enabling the advancement of the underlying science."

"We are delighted to be collaborating with the Mitsiades Lab at Dana-Farber to expand our understanding of nirogacestat’s mechanism of action when combined with BCMA therapies," said Badreddin Edris, Ph.D., Chief Operating Officer of SpringWorks. "Dr. Mitsiades and his colleagues have been at the forefront of developing cutting-edge translational models of multiple myeloma and we believe that this collaboration has the potential to yield novel insights that can help us to further refine our approach to improving outcomes for these patients."

Under the terms of the sponsored research agreement, SpringWorks will be responsible for funding the work and will retain an option to exclusively license any new intellectual property emerging from the research collaboration.

About Nirogacestat

Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has six collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, two bispecific antibodies and a monoclonal antibody. SpringWorks has also formed research collaborations with Fred Hutchinson Cancer Research Center and Dana-Farber Cancer Institute to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA therapies using a variety of preclinical multiple myeloma models.

Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

On August 30, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, reported that it has been awarded $37 million in cooperative agreement funds with the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) as part of an industry outreach initiative to establish reliable domestic molybdenum-99 (Mo-99) production without the use of highly enriched uranium (HEU) (Press release, NorthStar Medical Radiostopes, AUG 30, 2021, View Source [SID1234587024]). NorthStar will use funds from the award to complete its neutron capture technology program and continue development and expansion of its accelerator production program. Both projects support non-uranium based, environmentally friendly production of the important medical radioisotope Mo-99. DOE/NNSA will provide $16.3M in funding for the neutron capture project and $20.7M for the accelerator project. NorthStar will also be required to provide an equal amount of matching funds. The awards will also be used in continuing development of enhancements for the FDA-approved and commercially available RadioGenix System (technetium Tc-99m generator). The RadioGenix System uses reliable, domestic, non-uranium based Mo-99 to supply physicians and patients with technetium-99m (Tc-99m). Mo-99 is the parent radioisotope of Tc-99m, the most widely used medical imaging radioisotope, which is used to inform healthcare decisions for 40,000 U.S. patients daily.

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"NorthStar deeply appreciates these new cooperative agreement awards and this financial and technical support provided by DOE/NNSA."

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"NorthStar deeply appreciates these new cooperative agreement awards and this financial and technical support provided by DOE/NNSA," said Stephen Merrick, President and Chief Executive Officer. "NorthStar is the only commercialized U.S. producer of Mo-99, having provided reliable Mo-99/Tc-99m supply to the nation for nearly three years. We are proud to be the first and only company to achieve commercialized Mo-99 production through collaboration with DOE/NNSA to date. We are working aggressively to ensure sustainable domestic Mo-99 supply through dual production and processing hubs for additional capacity and scheduling flexibility. Funds from these cooperative agreements will be used for completion of our neutron capture technology program and Isotope Processing facility, for completing Phase 1 of our accelerator technology program and first Accelerator Production facility and progressing Phase 2 of the accelerator program. The funds will also support enhancements to the RadioGenix System to continue optimizing its utility with new technologies."

Mr. Merrick continued, "Previous DOE/NNSA awards to NorthStar have been instrumental to our successful efforts to provide the nuclear medicine community and the patients it serves with a reliable domestic supply of Mo-99 produced without highly enriched uranium. They have supported our development and approval of U.S.-produced, non-uranium Mo-99 and the RadioGenix System as well as the development of FDA-approved concentrated Mo-98 (cMo-98), which has enabled a near four-fold increase in our Mo-99 production capacity. Equipment for two facility expansions has been partially funded with DOE/NNSA cooperative awards to date. They include our Isotope Processing facility, which is near completion and which will more than double production capacity for Mo-99, and our first-of-its-kind Accelerator Production facility, which has been completed, and is now being fitted out with advanced production equipment. I also want to recognize the work that our partners at the University of Missouri Research Reactor (MURR) have done to help ensure that Mo-99/Tc-99m is available for radiopharmacies, healthcare providers, and, most importantly, patients."

DOE/NNSA supports the establishment of a reliable domestic supply of Mo-99 produced in the United States without the use of HEU, and with support from Congress, is providing several cooperative agreement awards under a recent Funding Opportunity Announcement. As with all DOE/NNSA cooperative agreements for domestic Mo-99 partners, DOE/NNSA matches NorthStar funding dollar for dollar. NorthStar was selected by DOE/NNSA based on the evaluations and recommendations of an independent Merit Review Panel. With inclusion of the current and past awards, NorthStar has been awarded a total of over $100 million in cooperative agreement funds by DOE/NNSA.

NorthStar has a strategic, multi-pronged approach to increasing Mo-99 radioisotope production capacity across several platforms," stated James T. Harvey, PhD, Senior Vice President and Chief Science Officer at NorthStar. "It includes our commercially utilized cMo-98 neutron capture process, and programs that are underway for addition of the use of electron beam accelerators, which is one of the most effective methods of producing Mo-99. Accelerator production will use commercially proven electron beam accelerators to "knock-off" a neutron from concentrated molybdenum-100 (Mo-100) to produce medically useful Mo-99. Like all of our Mo-99 processes, NorthStar’s Mo-99 accelerator production process is non-uranium based and environmentally friendly."

About DOE/NNSA

Established by Congress in 2000, NNSA is a semi-autonomous agency within the U.S. Department of Energy responsible for enhancing national security through the military application of nuclear science. NNSA maintains and enhances the safety, security, and effectiveness of the U.S. nuclear weapons stockpile without nuclear explosive testing; works to reduce the global danger from weapons of mass destruction; provides the U.S. Navy with safe and effective nuclear propulsion; and responds to nuclear and radiological emergencies in the U.S. and abroad. Visit energy.gov/nnsa for more information.

About the RadioGenix System (Technetium Tc- 99m Generator)

The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium based molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration (FDA) in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix System and Sodium Pertechnetate Tc 99m Injection USP

The RadioGenix System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in

Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION

Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
Sodium Pertechnetate Tc 99m Injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Use the lowest dose of Sodium Pertechnetate Tc 99m Injection necessary for imaging and ensure safe handling and preparation to protect the patient and health care worker from unintentional radiation exposure. Encourage patients to drink fluids and void as frequently as possible after intravenous or intravesicular administration. Advise patients to blow their nose and wash their eyes with water after ophthalmic administration.
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 24 hour expiration time from elution is reached, whichever occurs earlier. Follow step-by-step instructions for use provided in the Operator’s Guide, RadioGenix System 1.2.

On August 30, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in investor conferences in September 2021 (Press release, Ideaya Biosciences, AUG 30, 2021, View Source [SID1234587022]).

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Citi’s 16th Annual BioPharma Virtual Conference
Yujiro Hata, Chief Executive Officer, will participate in a panel discussion entitled "Aiming for the Bull’s Eye – Latest Advances in Targeted Oncology" on Friday, September 10, 2021 at 9:45am ET. The panel discussion will be hosted by Yigal Nochomovitz, Ph.D. Director, Equity Research. The panelists include:

– Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences
– Terry Rosen, Chief Executive Officer, Arcus Biosciences
– Jacob Chacko, Chief Executive Officer, ORIC Pharmaceuticals
– Avanish Vellanki, Chief Executive Officer, Rain Therapeutics
– Briggs Morrison, Chief Executive Officer, Syndax Pharmaceuticals

H.C. Wainwright 23rd Annual Global Investment Conference
Paul Stone, Chief Financial Officer, will present on Monday, September 13, 2021 at 7:00am ET

R. W. Baird 2021 Virtual Global Healthcare Conference
Fireside chat with Yujiro Hata, Chief Executive Officer hosted by Joel Beatty, M.D. C.F.A., Senior Research Analyst
Wednesday, September 15, 2021 at 4:20pm ET

2021 Cantor Virtual Global Healthcare Conference
Paul Stone, Chief Financial Officer, will present on Thursday, September 30, 2021 at 11:20am ET

A live audio webcast of each event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

On August 30, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported its participation in the following conferences in September (Press release, I-Mab Biopharma, AUG 30, 2021, View Source [SID1234587021]). Details of the conferences and management presentations are as follows:

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Jefferies Asia Forum (Virtual)

One-on-one and small group meetings: September 9, 2021

Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, Mr. Tianyi Zhang, Executive Director Investor Relations, Mr. Tyler Ehler, Senior Director Investor Relations and Phoebe Peng, Associate Director Investor Relations

For more information, please contact your Jefferies representative.

H. C. Wainwright 23rd Annual Global Investment Conference (Virtual)

Presentation: Monday, September 13, 2021 at 7:00 a.m. ET
Presenter: Mr. Jielun Zhu, Director and Chief Financial Officer

Webcast link: View Source The webcast will also be available under "Event Calendar" on IMAB’s IR website at View Source

One-on-one and small group meetings: September 13-15, 2021
Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, Mr. Tianyi Zhang, Executive Director Investor Relations, Mr. Tyler Ehler, Senior Director Investor Relations and Phoebe Peng, Associate Director Investor Relations

For more information, please contact your H. C. Wainwright representative.

ICA China Biotech Corporate Access Day (Virtual)

One-on-one and small group meetings: September 23, 2021

Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, Mr. Tianyi Zhang, Executive Director Investor Relations, Mr. Tyler Ehler, Senior Director Investor Relations and Phoebe Peng, Associate Director Investor Relations

For more information, please contact your ICA representative.

2021 Cantor Fitzgerald Global Healthcare Conference (Virtual)

Presentation: Monday, September 27, 2021 at 8:40 a.m. ET
Presenter: Mr. Jielun Zhu, Director and Chief Financial Officer

Webcast link: View Source The webcast will also be available under "Event Calendar" on IMAB’s IR website at View Source

One-on-one meetings: September 27-30, 2021
Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, Mr. Tianyi Zhang, Executive Director Investor Relations, Mr. Tyler Ehler, Senior Director Investor Relations and Phoebe Peng, Associate Director Investor Relations

For more information, please contact your Cantor Fitzgerald representative.