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Omeros Corporation to Announce Second Quarter Financial Results on August 9, 2021

On August 3, 2021 Omeros Corporation (NASDAQ: OMER), reported that the company will issue its second quarter financial results for the period ended June 30, 2021, on Monday, August 9, 2021, after the market closes (Press release, Omeros, AUG 3, 2021, View Source [SID1234585642]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

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Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 4195376. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 4195376.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at View Source

NorthStar Medical Radioisotopes and GE Healthcare Sign Exclusive U.S. Manufacturing and Distribution Agreement

On August 3 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, and GE Healthcare reported the signing of an exclusive agreement for the manufacturing and distribution of iodine-123 (I-123) capsules in the United States (Press release, NorthStar Medical Radiostopes, AUG 3, 2021, View Source [SID1234585641]). Under the contract terms, GE Healthcare’s Pharmaceutical Diagnostics unit will manufacture and supply NorthStar with I-123 capsules under the NorthStar label using a new, state-of-the-art production system at its facility in Arlington Heights, Ill. Upon receipt of the required regulatory approvals, NorthStar will retain exclusive U.S. marketing and distribution rights for these I-123 capsules, which will be available in 100µCi and 200µCi formulations.

Iodide I-123 (as sodium iodide I-123) is a radioisotope of iodine, a staple product in radiopharmacies that is used routinely in nuclear medicine as the proven standard for the diagnosis of physiological abnormalities in the thyroid, including thyroid cancer. The American Cancer Society estimates that approximately 44,280 Americans will be diagnosed with thyroid cancer in 2021.

"This exclusive sales and manufacturing agreement marks NorthStar’s strong and growing relationship with GE Healthcare, and we look forward to working with the company in meeting the needs of radiopharmacy customers and the patients we all serve," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "NorthStar is strongly committed to the future of nuclear medicine. The ability to provide I-123 further expands our diagnostic imaging portfolio, which includes domestically produced, non-uranium Mo-99/technetium-99m and FibroScint, a novel fibrin-specific diagnostic imaging agent with potential clinical utility in cardiovascular care."

"We are pleased to sign this agreement and look forward to working with NorthStar in providing patients across the United States with I-123 capsules," said Chris Vessell, U.S. Nuclear Medicine Supply Chain Leader, GE Healthcare Pharmaceutical Diagnostics. "NorthStar has proven itself a leader in successfully driving technology development to produce innovative, real-world solutions for radioisotope production to meet healthcare needs, and we anticipate a productive relationship with the company."

GE Healthcare Pharmaceutical Diagnostics imaging agents support three patient procedures every second worldwide across MRI, X-ray/CT, ultrasound and nuclear medicine imaging.

Ambrx Announces First Patient Dosed in a Phase 1 Trial for ARX517, an ADC in Development to Treat PSMA Expressing Tumors

On August 3, 2021 Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported the first patient has been dosed in a Phase 1, multicenter, open-label, dose-escalation, and dose expansion study to evaluate the safety, pharmacokinetics (PK), and anti-tumor activity of ARX517 in subjects with prostate specific membrane antigen (PSMA) expressing tumors found in prostate, pancreatic, lung and ovarian cancers (Press release, Ambrx, AUG 3, 2021, View Source [SID1234585640]).

ARX517 is an anti-PSMA antibody drug conjugate (ADC) that demonstrated activity in both enzalutamide sensitive and resistant preclinical models for prostate cancer while demonstrating favorable PK and toxicity profiles in IND-enabling GLP toxicity studies.

"I am excited to announce that we dosed our first patient in our Phase 1 trial, and thus have taken the first steps in evaluating the potential clinical benefit of ARX517 in cancer patients with tumors overexpressing PSMA," said Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "ARX517 is the second ADC in our internal pipeline to enter the clinic, which I believe speaks to the broad applicability and productivity of our technology platform. I look forward to updating you on the progression of this trial."

The Phase 1 trial will be a multi-center, open-label, dose escalation and dose expansion study. This trial, referred to as APEX-01, is designed to assess the safety, tolerability and PK profile, as well as the anti-tumor activity, of ARX517 as a monotherapy. The trial will enroll up to 76 patients with advanced solid tumors whose diseases have failed prior standard therapies.

About PSMA, prostate cancer and other solid tumors

PSMA has been found highly expressed in prostate cancer, particularly in metastatic castration-resistant prostate cancer (mCRPC). Additionally, PSMA has been found in a variety of other solid tumors. Prostate cancer represents a significant unmet need and sizable market opportunity. There were 1.3 million new cases of prostate cancer with five-year survival rates of approximately 27% and 359,000 associated deaths worldwide in 2018. For men, prostate cancer is the second most frequent cancer and the fifth leading cause of cancer death. The global market for prostate cancer therapies was estimated to be $9.3 billion in 2018 and is forecast to grow to $12.8 billion by 2028. While non-ADC therapies are available to treat mCRPC, there is no approved therapy specifically targeting PSMA to treat prostate cancer.

10-Q – Quarterly report [Sections 13 or 15(d)]

Jazz Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Silverback Therapeutics to Participate in the 2021 Wedbush PacGrow Healthcare Conference

On August 3, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that the Company will participate in the 2021 Wedbush PacGrow Healthcare Conference from August 10-11, 2021 (Press release, Silverback Therapeutics, AUG 3, 2021, View Source [SID1234585639]).

Laura Shawver, Ph.D., Silverback’s Chief Executive Officer, will participate in the "Heavenly (anti)Bodies" panel on Tuesday, August 10, 2021 at 1:10 p.m. ET (10:10 a.m. PT). Members of the Silverback management team will also host investor meetings during the conference.