On July 25, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report financial and business results for the second quarter of 2022 after the market closes on Thursday, August 4, 2022 (Press release, Supernus, JUL 25, 2022, View Source [SID1234616907]).

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Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to present the second quarter 2022 financial and business results on Thursday, August 4, 2022 at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be accessible in the Events & Presentation section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

On July 25, 2022 OPKO Health, Inc. (NASDAQ: OPK) reported that operating and financial results for the three and six months ended June 30, 2022 after the close of the U.S. financial markets on Thursday, August 4, 2022 (Press release, Opko Health, JUL 25, 2022, View Source [SID1234616906]). OPKO’s senior management will provide a business update and discuss financial results as well as financial guidance during a conference call and live audio webcast on August 4th beginning at 4:30 p.m. Eastern time.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using this link. Callers who pre-register will be given a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (833) 630-0584 (U.S.) or (412) 317-1815 (International). A webcast of the call may also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until August 11, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 5775821. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

On July 25, 2022 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the second quarter of 2022 after the market closes on Monday, August 8, 2022 (Press release, MacroGenics, JUL 25, 2022, View Source [SID1234616905]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Monday, August 8, 2022, at 4:30 pm ET.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference Call Information

To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On July 25, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported that it has received U.S. Food and Drug Administration (FDA) acceptance of its Investigational New Drug (IND) application for HB-300, a novel arenaviral immunotherapy for the treatment of metastatic castration-resistant prostate cancer (Press release, Hookipa Pharma, JUL 25, 2022, View Source [SID1234616904]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"FDA acceptance of our IND application for HB-300 is a key milestone as we expand and diversify our oncology pipeline and arenavirus platform from viral antigens to self-antigens," said Joern Aldag, Chief Executive Officer at HOOKIPA. "With the concurrent acceptance of the Drug Master File, we have reduced cycle time between completion of preclinical studies and clinical entry of our pipeline projects."

About HB-300
HB-300 is an alternating, 2-vector replicating arenaviral immunotherapy for metastatic castration-resistant prostate cancer. It uses the Lymphocytic Choriomeningitis Virus and Pichinde Virus as arenaviral backbones, with each expressing two well-defined antigens of prostate cancer, PAP and PSA. Subsequent clinical development may include addition of arenaviral therapeutics expressing a third antigen, PSMA. HOOKIPA’s approach is designed to focus the immune response against the target antigens. The technology has demonstrated the ability to induce potent antigen-specific T cell responses and anti-tumor activity in preclinical tumor models.

About the Drug Master File
A Drug Master File (DMF) is a voluntary submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The information contained in the DMF may be used to support additional INDs and other submissions. The FDA accepted HOOKIPA’s submission of a Type II Master File to the FDA’s Center for Biologics Evaluation and Research to present data specific to HOOKIPA’s proprietary replicating arenavirus platform.

About prostate cancer
Prostate cancer is the most diagnosed cancer and fifth leading cause of death from cancer in men. There are several stages of prostate cancer, and prostate cancer cells usually need androgen hormones, such as testosterone, to grow. Treatment for early-stage prostate cancer often aims to lower testosterone levels to stop or slow growth. Metastatic castration-resistant prostate cancer is when the cancer has spread, or metastasized, to other parts of the body including the lymph nodes, bones, rectum, liver and lungs. Metastatic castration-resistant prostate cancer does not respond to hormone therapy. Currently, there are limited treatment options for people with metastatic castration-resistant prostate cancer and only 30 percent will survive beyond five years.

On July 25, 2022 Guardant Health, a leading precision oncology company, reported that applauds Congresswoman Anna Eshoo (D-CA) and Energy and Commerce Chairman Frank Pallone (D-NJ) for raising important questions in a letter to U.S. Health and Human Services (HHS) Secretary Xavier Becerra on how the United States Preventive Services Task Force (USPSTF) process can be improved to increase patient access to essential preventive services such as early cancer screening tests (Press release, Guardant Health, JUL 25, 2022, View Source [SID1234616903]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The USPSTF is an independent, volunteer advisory board that issues evidence-based recommendations on which clinical preventative services Americans should receive.1 Services that receive an "A" or "B" grade from the Task Force are covered with $0 cost-sharing for insured patients.2 Under its current structure, the USPSTF aims to review and update existing recommendations every five years, though multi-year delays are common.3,4

"The Task Force guidelines play a key role in ensuring people have access to preventative services like early cancer screening however, the current USPSTF five-year update cycle doesn’t reflect today’s pace of innovation," said AmirAli Talasaz, Guardant Health co-CEO. "We thank Reps. Eshoo and Pallone for their action, and hope that HHS leadership will take the necessary steps to improve the USPSFT process so that innovative technologies like blood-based cancer screening tests can be accessible to patients upon FDA approval."

The Congressional letter outlines how a new blood test to screen asymptomatic, average-risk patients for colorectal cancer (CRC) may not be accessible to patients right away under the current USPSTF process. The most recent USPSTF review of CRC screening was completed in May 20215 and the next recommendation is not expected until 2026. Therefore, should FDA approval be granted for CRC blood-based screening tests, it may still be years until the USPSTF releases its next recommendation to include blood tests.

The inability to provide access to the latest innovations in cancer screening technology has far-reaching implications. More than 75% of people who die from CRC today are not up to date with recommended screening.6 Blood tests have the potential to overcome many of the access barriers associated with current CRC screening methods by incorporating these tests into routine medical care. Timely access to innovative new cancer screening technologies like blood tests can lead to improved compliance, early detection and diagnosis.

For more information on how Guardant Health is advocating for access to modern cancer screenings visit View Source