PDL BioPharma Completes Spin-Off of LENSAR

On October 2, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that it has completed the previously announced spin-off of its femtosecond laser system business, LENSAR, Inc. (Nasdaq: LNSR) ("LENSAR") (Press release, PDL BioPharma, OCT 2, 2020, View Source [SID1234567971]).

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PDL stockholders received 0.075879 shares of LENSAR common stock for every one share of PDL common stock outstanding at 5:00 p.m. Eastern Time on September 22, 2020, the record date for the spin-off. Stockholders of PDL who have acquired shares of PDL common stock in the "regular way" market since shortly before the record date and through October 1, 2020 acquired such shares with an entitlement to receive shares of LENSAR common stock in connection with the distribution. Stockholders of PDL who acquired their shares of PDL common stock ex-distribution during that time did so without an entitlement to receive shares of LENSAR common stock in connection with the distribution. LENSAR shares will begin "regular way" trading on the NASDAQ Stock Market on October 2, 2020.

International Lung Cancer Association Selects Medscape Oncology for Virtual 2020 Conferences

On October 2, 2020 Medscape reported that The International Association for the Study of Lung Cancer (IASLC) has selected Medscape Oncology as its partner to host and manage these IASLC virtual conferences in 2020 (Press release, Medscape, OCT 2, 2020, View Source [SID1234567992]):

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– IASLC 2020 Hot Topic Meeting: Liquid Biopsy: A worldwide virtual event scheduled for
October 2-3, 2020
– IASLC 2020 North America Conference on Lung Cancer (NACLC): A worldwide virtual event scheduled for October 16-17, 2020

In collaboration with the IASLC, Medscape Oncology and MedscapeLIVE! will offer an immersive and engaging conference learning environment reaching the members of the thoracic oncology community including physicians, nurses, other clinicians, researchers and scientists as well as patients, survivors and advocates in the field of lung cancer.

The two conferences will include interactive educational sessions, late-breaking research, live chats with industry and e-poster presenters, interactive breakout sessions, networking opportunities and Virtual Exhibit Halls with product theaters.

"We are pleased to partner with Medscape in the delivery of the IASLC’s remaining 2020 meetings. The MedscapeLIVE! virtual conference platform and production services allow us to accomplish our mission of using all available means to deliver quality education to eliminate lung cancer and other thoracic malignancies. This partnership allows us to share important information with a global audience through live stream and on-demand content—while allowing us to protect the health of our members and their respective communities," said Dave Mesko, IASLC Chief Executive Officer.

The IASLC’s Mission

To embrace the study of the etiology, epidemiology, prevention, diagnosis, treatment and all other aspects of lung cancer and other thoracic malignancies.
To provide education and information about lung cancer and other thoracic malignancies to IASLC members, to the medical community at large, and to the public.
To use all available means to eliminate lung cancer and other thoracic malignancies as a health threat for the individual patient and throughout the world.
"We are honored to partner with the IASLC to offer comprehensive and immersive virtual meetings. As we are during a time of great change, it is more important than ever that healthcare providers across the world have access to digital education that aids in their ability to stay current with the latest changes in their field. We are excited to be working with the IASLC to deliver this critical information and impact provider practices and patient care," said Rejéan Rochette, Group General Manager, Medscape Education.

To learn more about the IASLC’s upcoming meetings, visit View Source

About the International Association for the Study of Lung Cancer

The International Association for the Study of Lung Cancer (IASLC) is the only global network dedicated to the study and eradication of lung cancer and other thoracic malignancies. Since its founding in 1974, the association’s membership has grown to more than 8,000 lung and thoracic cancer specialists from all disciplines in more than 100 countries.

By hosting global conferences, funding cutting-edge research and educating the health care community and the public about thoracic cancers, the IASLC works to alleviate the burden lung cancer places on patients, families and communities.

Each year, the IASLC hosts the World Conference on Lung Cancer (WCLC), the world’s largest meeting dedicated solely to thoracic cancers. The WCLC attracts more than 7,500 lung cancer specialists from across the world and offers attendees networking opportunities while providing a podium for practice-changing research.

In keeping with their commitment to education, the IASLC publishes the Journal of Thoracic Oncology (JTO), a primary source for thoracic malignancy prevention, detection, diagnosis and treatment information. The JTO serves as an authoritative resource in the field, with its impact factor increased from 12.460 in 2018 to 13.357 in 2019. Additionally, at the beginning of 2020, the IASLC launched a gold open-access publication to accompany the JTO entitled JTO Clinical and Research Reports.

SH-110 Successful FDA Pre-IND Meeting

On October 2, 2020 Shorla Pharma reported that have completed a successful pre-IND meeting with the US Health Authority, the Food and Drug Administration (‘FDA’) on our third oncology drug SH-110 (Press release, Shorla Pharma, OCT 2, 2020, View Source;utm_medium=rss&utm_campaign=sh-110-successful-fda-pre-ind-meeting [SID1234567976]). This proprietary product will have a significant benefit to patients suffering from brain cancer ultimately reducing treatment burden and providing a palatable age appropriate treatment. With this positive outcome we will progress our development programme for this much needed drug.

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Benitec Biopharma Announces Pricing of $10.0 Million Public Offering

On October 2, 2020 Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "the Company"), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on the proprietary DNA-directed RNA interference ("ddRNAi") platform, reported the pricing of an underwritten public offering of 3,225,806 shares of its common stock (or common stock equivalents in lieu thereof) at a price to the public of $3.10 per share (Press release, Benitec Biopharma, OCT 2, 2020, View Source [SID1234567994]). The Company expects to receive aggregate gross proceeds of approximately $10.0 million from the offering. The offering is expected to close on or about October 6, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company has also granted the underwriter a 30-day option to purchase up to 483,870 additional shares of its common stock, at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any.

The Company intends to use the net proceeds from the offering for the continued advancement of development activities for its product pipeline, general corporate purposes, and strategic growth opportunities.

A registration statement on Form S-1 (File No. 333-246314) relating to these securities was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on October 2, 2020. This offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

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.

Zionexa US Corp. secures pass-through payment status and assignment of temporary C-code for Cerianna

On October 2, 2020 Zionexa US Corp., a wholly owned subsidiary of Zionexa SAS, specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, reported that the Center for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and reimbursement through a C-code for Cerianna (fluoroestradiol F-18) injection (Press release, Zionexa, OCT 2, 2020, View Source [SID1234567977]).

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Cerianna (fluoroestradiol F-18) injection is a new molecular imaging agent approved by the Food and Drug Administration (FDA) indicated for use in positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer (MBC). Cerianna (fluoroestradiol F-18) is the first FDA-approved F-18 PET imaging agent specifically indicated for use in patients with recurrent or metastatic breast cancer. The temporary code, C9060, is effective since October 1, 2020. The permanent code will be expected in January 2021.

"Receiving the pass-through status and the C-code for Cerianna is a very important step in our process to get our new molecule commercialized in the United-States and provide physicians access to a non-invasive and qualitative way to find the optimal treatment for the patient with MBC. MBC is a real health issue with more than 40,000 MBC-related deaths expected in the U.S. in 2019," said Peter Webner, CEO of Zionexa USA. "Our team continues to organize and optimize on our commercial and production strategy and we expect a launch at the end of 2020."

About Metastatic Breast Cancer

Metastatic breast cancer is the most advanced stage of breast cancer. Also called stage IV or advanced breast cancer, MBC means that the cancer has spread beyond the breast to other parts of the body. MBC affects more than 168,000[1] patients in the United-States.

[1] Mariotto et al, 2017

INDICATION

CERIANNA is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

Limitations of Use
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).

IMPORTANT SAFETY INFORMATION

Adverse Reactions – Reported adverse reactions include: injection site pain and dysgeusia.

Radiation Risks – Ensure safe drug handling and patient preparation procedures to protect patients and health care providers from unintentional radiation exposure.

Risk of Misdiagnosis – Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer.

Contraindications – None.

Use in Specific Populations – Lactation: Interrupt breastfeeding.