On May 6, 2019 Omeros Corporation (NASDAQ: OMER), reported that the company will issue its first quarter 2019 financial results for the period ended March 31, 2019, on Thursday, May 9, 2019, after the market closes (Press release, Omeros, MAY 6, 2019, View Source [SID1234535840]). 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 4095776. 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 4095776.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at www.omeros.com and select "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On May 6, 2019 Sierra Oncology, Inc. (SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that members of its senior management team will be attending the SunTrust Robinson Humphrey 5th Annual Life Sciences Conference in New York on May 8th, and the Oppenheimer Oncology Insight Summit in New York on May 16th (Press release, Sierra Oncology, MAY 6, 2019, View Source [SID1234535737]).

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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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Sun Trust Robinson Humphrey 5th Annual Life Sciences Summit
Date: May 8
Format: One-on-one sessions

Oppenheimer Oncology Insight Summit
Date: May 16
Format: One-on-one sessions

On May 6, 2019 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing novel drugs to address treatment resistance, and Almac Diagnostic Services, a global stratified medicine company, reported approval by the U.S. Food and Drug Administration (FDA) of an investigational device exemption (IDE) for the diagnostic assay that will be used in Turning Point’s registrational phase 2 clinical study (Press release, Turning Point Therapeutics, MAY 6, 2019, View Source [SID1234535761]).

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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 next-generation sequencing (NGS) assay is intended for use in identifying patients with ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors. Clinical investigators will use the diagnostic test to determine molecular eligibility for enrollment into Turning Point’s registrational Phase 2 portion of the global TRIDENT-1 clinical study.

"We are pleased to achieve this important milestone with our partner Almac, moving us closer to the start of our pivotal study for repotrectinib in the second half of 2019," said Athena Countouriotis, M.D., president and chief executive officer. "With a clear unmet medical need for therapies that target genomic alterations in different cancers, the diagnostic assay will provide clinical investigators with timely information to confirm the presence of the oncogenic drivers we continue to study in patients with advanced solid tumors."

Almac has been developing the NGS diagnostic based on Archer Dx’s Anchored Multiplex PCR (AMP) chemistry, with the intent of submitting it for regulatory approval in the United States and using it initially at Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.

"We are very pleased to have been granted IDE approval by the FDA for the development and validation of this complex NGS diagnostic assay for its intended use as a clinical trial assay," said Paul Harkin, president and managing director, Almac Diagnostic Services. "We are delighted to assist Turning Point Therapeutics with this important upcoming clinical study, and furthering our partnership to progress such a promising investigational therapy as repotrectinib."

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is much smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.

Turning Point Therapeutics’ TRIDENT-1 Phase 2 open-label, multi-cohort study is planned for initiation in the second half of 2019.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests. Almac partners with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. Almac also facilitates biomarker clinical trial management and clinical test delivery from its CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials. For more information visit: www.almacgroup.com/diagnostics

On May 6, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentations at two upcoming investor conferences (Press release, Jazz Pharmaceuticals, MAY 6, 2019, View Source [SID1234535779]).

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Bank of America Merrill Lynch Healthcare Conference in Las Vegas on Tuesday, May 14, 2019 at 8:00 a.m. PDT / 4:00 p.m. IST. Dan Swisher, president and chief operating officer, will provide an overview of the company and a business and financial update.
RBC Capital Markets Global Healthcare Conference in New York on Tuesday, May 21, 2019 at 9:00 a.m. EDT / 2:00 p.m. IST. Matt Young, executive vice president and chief financial officer, will provide an overview of the company and a business and financial update.
A live audio webcast of each presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of each presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of each webcast will be available for at least one week following each presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

On May 6, 2019 Lidds reported the preliminary data from a voluntary open label extension (OLE) study indicates that the time to re-treatment with Liproca Depot in prostate cancer patients is potentially longer than anticipated (Press release, Lidds, MAY 6, 2019, View Source [SID1234555914]). This information comes from the OLE phase of the Phase IIb study, LPC-004. Data from the main study is currently being collected according to plan. Preliminary study results will be available during the third quarter of this year.

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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 voluntary open label extension (OLE) study involves a number of patients who participated in the Liproca Depot Phase IIb clinical study. In the OLE phase, a second injection of Liproca Depot was administered once the patient’s PSA level (a biomarker for prostate cancer) had returned to its pre-treatment level.

-Preliminary information from the OLE study looks promising as it indicates a longer than expected anti-androgen effect from Liproca Depot treatment, says Monica Wallter, CEO of LIDDS.

Earlier Phase II studies have shown that Liproca Depot can be an effective anti-androgen treatment without the resulting hormonal side effects associated with current treatments that have a physical and psychological impact on patients.

– Patients who have participated in the voluntary open label extension study so far say they would be prepared to be treated with Liproca Depot again, says Monica Wallter.

Liproca Depot is based on LIDDS proprietary NanoZolid technology that allows active anti-cancer drugs to be injected directly into a tumor and for the drugs to be released over an extended period of time. Liproca Depot is currently in the final stage of a Phase IIb study at clinics in Canada, Finland and Lithuania.

One in every six men is diagnosed with prostate cancer and there is currently no standard drug treatment for prostate cancer patients at low risk of progression. The global drug market for prostate cancer is expected to grow to more than USD 8 billion by 2022.

Facts about the open label extension (OLE) study:
The voluntary OLE study involves patients who participated in the Liproca Depot Phase IIb clinical study. A second injection of Liproca Depot was administered once the patient’s PSA level (a biomarker for prostate cancer) had returned to its pre-treatment level.
The rationale for conducting the OLE study is to understand the long-term anti-androgen efficacy of Liproca Depot and to follow these patients for a further year to assess safety and quality of life parameters after a repeated Liproca Depot injection.