On March 1, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will present at the following investor conferences in March (Press release, UroGen Pharma, MAR 1, 2023, View Source [SID1234627993]).

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Cowen 43rd Annual Health Care Conference — March 7-9, 2023

Panel Presentation Date: Tuesday, March 7th from 12:50-1:50pm ET
Webcast Link: https://wsw.com/webcast/cowen132/panel12/2317014
Oppenheimer 33rd Annual Healthcare Conference — March 13-15, 2023

Presentation Date: Tuesday, March 14th from 10:40-11:10am ET
Webcast Link: View Source
Webcasts for both the Cowen and Oppenheimer presentations will be available via the Investors section of UroGen’s website, www.urogen.com. A replay of each webcast will be available on the Company’s website for approximately 30 days.

On March 1, 2023 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 Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat, as well as host investor meetings, at the Cowen 43rd Annual Health Care Conference on Tuesday, March 7, 2023, at 9:50 a.m. ET (Press release, Supernus, MAR 1, 2023, https://ir.supernus.com/news-releases/news-release-details/supernus-present-cowen-43rd-annual-health-care-conference [SID1234627992]).

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The conference will take place March 6-8, 2023, at Boston Marriott Copley Place in Boston, Mass. Investors interested in arranging a meeting with company management should contact the Cowen conference coordinator. A live audio webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.

On March 1, 2023 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported that it has commenced an underwritten public offering to sell up to $300 million of shares of its common stock (Press release, Revolution Medicines, MAR 1, 2023, View Source [SID1234627990]). All of the shares of common stock are being offered by Revolution Medicines. In addition, Revolution Medicines intends to grant the underwriters a 30-day option to purchase up to an additional $45 million of shares of common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan, TD Cowen, SVB Securities and Guggenheim Securities are acting as joint book-running managers for the proposed offering. UBS Investment Bank is acting as lead manager.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission (SEC) on March 2, 2021, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; SVB Securities LLC, 53 State Street, 40th Floor, Boston, MA 02109, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 1, 2023 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of the new QIAseq Platform Partnership program and the first partnership with medical data-analysis provider SOPHiA GENETICSTM (Nasdaq: SOPH) that will bring together its QIAseq reagent technology for next-generation sequencing (NGS) with the SOPHiA DDMTM digital analytics platform (Press release, Qiagen, MAR 1, 2023, View Source [SID1234627989]).

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Building on its own offering integrated with QIAGEN Digital Insights, the bioinformatics business of QIAGEN, the QIAseq Platform Partnership program aims to enhance the utilization and compatibility of its best-selling NGS kits to support secondary analysis and tertiary interpretation workflows offered by other digital data-sharing and analytics companies. These kits are designed for use with any sequencer. The goal is to provide research customers even wider access to the fast-growing area of precision diagnostics that is producing new insights in genetics.

As a first step in the new Platform Partnership program, customers can now order QIAseq panels combined with SOPHiA DDM a cloud-based platform that analyzes data from various sources to enable entirely new research perspectives. The partnership will initially support somatic variant detection (an alteration in DNA that occurs after birth) using QIAseq Targeted DNA Pro panels for homologous recombination repair (HRR), a special type of biomarker test to find tumors that have certain mutations that may make them sensitive to PARP inhibitors.

The partnership with SOPHiA GENETICS is planned to be expanded to other areas of analysis, including the use of QIAseq panels custom-made solutions.

"Our Platform Partnership Program will enable more customers to benefit from the high quality of the QIAGEN NGS preparation kits through the use of a wider range of analytics solutions to address their unique analysis and interpretation needs," said Thomas Schweins, Senior Vice President of the Life Sciences Business Area at QIAGEN. "SOPHiA GENETICS is our first partner thanks to their unique expertise and reputation. We look forward to offering our customers a leading combination and expanding our collaboration."

"SOPHiA’s mission is to democratize data-driven medicine. To get there, we are partnering with reagent manufacturers so that our deep expertise in genomic analysis complements their solutions," said Kevin Puylaert, Vice President Business Development at SOPHiA GENETICS. "We have a strong and longstanding relationship with QIAGEN and have used their products as part of our ‘bundle solution’ for years. QIAGEN’s amplicon-targeted NGS technology has an outstanding reputation to be among the best. We are taking full advantage of the performance of both solutions in this collaboration and are very optimistic about the positive impact on medicine and research."

The applications of SOPHiA DDM are planned to be expanded to eventually support a wide range of applications using QIAGEN kits. The goal is to allow customers to use SOPHiA’s Set-Up Program, an efficient and reliable process that establishes and demonstrates the analytical performance of any test prior to it being carried out. This will enable customers to better and more efficiently design new workflows using QIAseq technologies.

Some four million samples have been processed by QIAGEN’s growing range of NGS panels. With leading products like QIAseq Targeted DNA Pro and QIAseq Pan-cancer Multimodal panels, QIAGEN has built a portfolio of universal NGS solutions that have enabled customers to test for somatic cancer variants, tumor mutational burden, minimal residual disease, and now with this partnership homologous recombination repair deficiency.

Disclaimer: Unless specified otherwise, SOPHiA GENETICS products are for research use only (RUO) and not for use in diagnostic procedures. QIAseq Targeted DNA Panels are intended for molecular biology applications. These products are not intended for the clinical diagnosis, prevention or treatment of any disease.

On March 1, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported the first subject has been treated in Italy in the Company’s Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106) (Press release, Moleculin, MAR 1, 2023, View Source [SID1234627988]).

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"We continue to be highly encouraged by the data demonstrated from the successfully concluded Annamycin single agent trials and the no evidence of cardiotoxicity seen to date. We remain very optimistic in Annamycin’s potential to be an important treatment for refractory or relapsed AML in combination with Cytarabine. We are pleased to commence subject dosing in Italy and are continuing our efforts to bring additional sites online and build momentum in enrollment. We are committed to driving the development of Annamycin for the treatment of AML and look forward to continuing our evaluations of Annamycin in combination with Ara-C," commented Walter Klemp, Chairman and CEO of Moleculin.

Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory AML and STS lung metastases and the Company believes it may have the potential to treat additional indications.

The Phase 1/2 MB-106 trial is an open label trial that builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials, MB-104 and MB-105, conducted in the U.S. and Europe, respectively. Highlights from the final data demonstrated in the MB-105 study include:

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MB-105 demonstrated 80% overall response rate (ORR) in final cohort for treatment of relapsed/refractory acute myeloid leukemia (R/R AML).

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Final reported results showed one CRi (complete response with incomplete recovery of peripheral blood count) and three PRs (Partial Response).

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The responses in the MB-105 trial were seen in subjects 62-73 years of age and the CRi was from a subject 65 years of age.

The clinical study report for MB-105 has been finalized and the Company expects to publish detailed data in a paper or publication in the near future.

Data so far have resulted from treatment with Annamycin as a single agent, however, additional preclinical animal data from sponsored research demonstrated Annamycin in combination with Cytarabine had a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone.1

Annamycin currently has Fast Track Status and Orphan Drug Designation from the US Food and Drug Administration (FDA) for the treatment of STS lung metastases and the treatment of relapsed or refractory AML. For more information about the MB-106 Phase 1/2 trial, visit clinicaltrialsregister.eu and reference EudraCT 2020-005493-10 or clinicaltrials.gov and reference NCT05319587.

1 Zal T, Zielinski R, Grela K, Cardenas-Zuniga R, Skora S, Fokt I, Zal A, Andreeff M, Gil L Shephard R, Priebe W, High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-Null AML Mouse Model, Blood (2020) 136 (Supplement 1): 6-7. View Source