1stOncology™: Cancer Intelligence Service – Page 12069 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

IMMUNOMEDICS ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK

On April 27, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates, reported it has commenced an underwritten public offering of $350,000,000 of shares of its common stock (Press release, Immunomedics, APR 27, 2020, View Source [SID1234556912]). In addition, Immunomedics expects to grant the underwriters a 30-day option to purchase up to an aggregate of an additional $52,500,000 of shares of common stock sold in connection with the offering at the public offering price.

Schedule your 30 min Free 1stOncology Demo!
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

Schedule Your 30 min Free Demo!

Immunomedics intends to use the net proceeds from this offering primarily to support the commercial launch of Trodelvy in the United States in metastatic triple-negative breast cancer, continue to expand the clinical development programs for Trodelvy, invest in the broader clinical development of the platform (including IMMU-130 and IMMU-140), continued scale-up of manufacturing and manufacturing process improvements, as well as for working capital and general corporate purposes.

Cowen, BofA Securities, Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. The offering is subject to market 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.

The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 that Immunomedics filed with the Securities and Exchange Commission on June 11, 2018 and that became effective upon filing. A preliminary prospectus supplement and the accompanying prospectus relating to this offering are being filed with the SEC and will be available at the SEC’s website located at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, Attention: Prospectus Department, or by telephone at (800) 747-3924 or by email at [email protected].

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

BIOGEN PRICES $3.0 BILLION OF SENIOR UNSECURED NOTES

On April 27, 2020 Biogen Inc. (Nasdaq: BIIB) reported the pricing of two series of senior unsecured notes for an aggregate principal amount of $3.0 billion (Press release, Biogen, APR 27, 2020, View Source [SID1234556700]). The notes will mature as follows:

$1.5 billion will mature on May 1, 2030 and will bear interest at an annual rate of 2.25%

$1.5 billion will mature on May 1, 2050 and will bear interest at an annual rate of 3.15%
The offering is expected to close on April 30, 2020, subject to customary closing conditions.

Biogen intends to use the net proceeds from the sale of the notes to redeem in full $1.5 billion in aggregate principal amount of its outstanding 2.90% Senior Notes due September 15, 2020, and all accrued and unpaid interest thereon, to fund, together with cash on hand, repurchases of its common stock under its share repurchase plans and for working capital and other general corporate purposes.

Goldman Sachs & Co. LLC, BofA Securities, Inc. and J.P. Morgan Securities LLC are acting as joint book-running managers and representatives of the several underwriters. A copy of the preliminary prospectus supplement and the accompanying base prospectus, which is filed as part of Biogen’s effective shelf registration statement on Form S-3 filed on April 24, 2020 (File No. 333-237819), may be obtained from any of the representatives by calling Goldman Sachs & Co. LLC toll-free at 1 (866) 471-2526, BofA Securities, Inc. toll-free at 1 (800) 294-1322 or J.P. Morgan Securities LLC at 1 (212) 834-4533.

An electronic copy of the preliminary prospectus supplement and the accompanying base prospectus may also be obtained at no charge at the Securities and Exchange Commission’s website at www.sec.gov.

This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any state or other jurisdiction where such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction, where the offer, solicitation or sale of these securities would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering of the notes may be made only by means of a prospectus supplement and the accompanying base prospectus.

Iovance Biotherapeutics to Host First Quarter 2020 Financial Results Conference Call and Webcast on Tuesday, May 5, 2020

On April 27, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its first quarter 2020 financial results on Tuesday, May 5, 2020 (Press release, Iovance Biotherapeutics, APR 27, 2020, View Source [SID1234556699]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. EDT.

To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 4564469. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will also be available for one year in the Investors section at www.iovance.com.

Personal Genome Diagnostics Receives FDA Clearance for PGDx elio™ tissue complete, the First Comprehensive Genomic Profiling Diagnostic Kit for Oncology

On April 27, 2020 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner (Press release, Personal Genome Diagnostics, APR 27, 2020, View Source [SID1234556662]). By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

"Nearly 80% of patients aren’t getting the clinical insights they need to inform their treatment path, or they aren’t being tested in a window of time that makes a difference in determining their care," said Megan Bailey, Chief Executive Officer, PGDx. "PGDx elio tissue complete responds to this unmet need by bringing genomic cancer testing of the highest quality directly to healthcare providers. Since the founding of our company we have been united in our mission to empower the fight against cancer, and an integral part of that is establishing standardized testing as a core element of patient care. Today is an incredible milestone for us, but more importantly for the millions of people living with cancer."

PGDx elio tissue complete detects single nucleotide variants (SNVs) and small insertions and deletions (indels) in 500+ genes, select amplifications and translocations, and genomic signatures including microsatellite instability (MSI) and tumor mutation burden (TMB). Collectively, the information from this diagnostic kit is intended for use by healthcare professionals to help tailor clinical management for patients based on their tumor’s unique genomic profile in accordance with professional guidelines. The broad genomic profiling assay includes biomarkers to help inform the use of targeted cancer therapies and immunotherapies and can help oncologists identify patients for clinical trial participation. This FDA clearance was supported by a magnitude of data that demonstrates robustness and consistency of performance across multiple lab sites, and accuracy data across all variant classes in clinical samples from 35 tumor types.

"There has not, until this point, been one standardized test for all kinds of cancer that any lab across the country can perform," said Dr. Pranil Chandra, Chief Medical Officer of Genomic and Clinical Pathology Services, PathGroup, an early collaborator for PGDx elio tissue complete. "With this clearance, labs across the country will for the first time have an option for a regulated, standardized test that examines a broad view of cancer pathways and genomic signatures across advanced cancers. PGDx elio testing features automated bioinformatics that ensures consistent results and quality of testing, resulting in fast and reliable clinical insights to enable oncologists to match patients with the best therapies to fight their cancer."

"Personal Genome Diagnostics is pioneering an integrated healthcare ecosystem that furthers the availability and opportunities of precision medicine," said Dr. Michael Hanbury, Chief Operating Officer, PathGroup. "Developing insights into genomic drivers of cancer can provide physicians expanded understanding of patient-specific tumor genetics and improve targeted therapies to save lives and improve outcomes. This clearance demonstrates the benefits of focused collaborative efforts between medical device manufacturers and pathologists to advance the diagnosis and treatment for thousands of patients with advanced tumors. We are pleased to partner with PGDx and offer this new test to our community of clients, physicians and patients."

PGDx elio tissue complete

PGDx elio tissue complete is an FDA-cleared diagnostic kit and accompanying software for molecular labs that provides comprehensive genomic profiles of all solid tumors. PGDx elio tissue complete detects single nucleotide variants (SNVs) and small insertions and deletions (indels) in 500+ genes, select amplifications and translocations, and genomic signatures including microsatellite instability (MSI), and tumor mutation burden (TMB). Designed to be used locally at the lab of choice, PGDx elio testing and automated bioinformatics ensures both consistency and quality of testing regardless of location.

CARsgen Therapeutics Receives Positive EMA Opinion on Orphan Drug Designation for Fully Human Anti-BCMA CAR-T Cells (CT053) for the Treatment of Multiple Myeloma

On April 27, 2020 CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, reported the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted a positive opinion on CARsgen’s application for orphan designation of its investigational CT053 CAR T-cell therapy, fully human anti-BCMA (B cell maturation antigen) autologous chimeric antigen receptor (CAR) T cells for the treatment of multiple myeloma (Press release, Carsgen Therapeutics, APR 27, 2020, View Source [SID1234556661]). CT053 was previously granted orphan drug designation by the US Food and Drug Administration in August 2019.

"The COMP’s adoption of a positive opinion for CT053 orphan drug designation is another important recognition of CARsgen’s commitment to the development of its potential best-in-class CAR T cell therapy for the treatment of multiple myeloma," said Zonghai Li, M.D., Ph.D., Chief Executive Officer of CARsgen. "We look forward to working closely with the EMA under the recently granted PRIME eligibility and continuing the clinical development of CT053 in Europe."

The positive opinion issued by COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days. EMA orphan drug designation helps support the development of new treatments for rare conditions, those affecting not more than five in 10,000 people in the EU, that are life-threatening or chronically debilitating. Medicines that meet the EMA’s orphan designation criteria qualify for incentives to encourage advancement of drug development.