On October 18, 2021 ViewRay, Inc. (Nasdaq: VRAY) reported that the company will host a Virtual Clinical Data Event for Investors and Analysts on Thursday, October 28, 2021. The event will begin at 8:30 am ET / 5:30 am PT (Press release, ViewRay, OCT 18, 2021, View Source [SID1234591476]).

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The Virtual Clinical Data Event will be hosted by the ViewRay leadership team and will feature the clinical work of Dr. Michael Chuong MD, FACRO, Medical & Clinical Research Director, Dept of Radiation Oncology, Miami Cancer Institute, GI Service Lead, Department of Radiation Oncology, Miami Cancer Institute, Associate Professor, Vice Chair of Research and Education, Florida International University, and Dr. Himanshu Nagar, MD, radiation oncologist Assistant Professor, Weill Cornell Medicine, New York-Presbyterian.

Guests must register to participate in the event on the company’s website beginning on October 21, 2021. A replay of the event will be available on the company’s website following the event.

On October 18, 2021 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported the closing on October 18, 2021 of its initial public offering (the "Offering") of 5,000,000 shares of common stock at a price to the public of $14.00 per share for total gross proceeds of $70,000,000 before deducting underwriting discounts and commissions and estimated offering expenses (Press release, Lucid Diagnostics, OCT 18, 2021, View Source [SID1234591472]).

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In addition, Lucid has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock from Lucid at the initial public offering price less underwriting discounts and commissions.

Cantor and Canaccord Genuity are acting as joint book-running managers for the offering. BTIG and Needham & Company are acting as co-lead managers for the offering.

A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission ("SEC") on October 13, 2021. This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification or publication of an offering prospectus under the securities laws of any such state or jurisdiction.

The offering is being made only by means of a written prospectus. Copies of the prospectus related to the offering can be accessed by visiting the SEC website at View Source Alternatively, copies of the prospectus relating to the offering can be obtained from either of the following:

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

On October 18, 2021 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, reported a clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology (Nasdaq: PBYI), a biopharmaceutical company, to conduct a Phase 2 clinical trial (Press release, Celcuity, OCT 18, 2021, View Source [SID1234591471]).

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This open-label Phase 2 trial will evaluate the efficacy and safety of Puma’s drug, NERLYNX (neratinib), and Xeloda (capecitabine), a Genentech/Roche drug, in previously treated patients selected with Celcuity’s CELsignia HER2 Activity Test who have metastatic HER2-negative breast cancer. Under the agreement, The University of Rochester Wilmot Cancer Center will serve as the sponsor and Ajay Dhakal, M.D., a medical oncologist at the University of Rochester Medical Center, will serve as the principal investigator of this study. The University of Rochester Wilmot Cancer Center is one of the 51 NCI-Designated Comprehensive Cancer Centers in the U.S. tasked with developing new approaches to diagnosing and treating cancer.

"This clinical trial could play a key role in creating a new treatment paradigm for metastatic HER2-negative breast cancer patients with brain metastases," said Dr. Dhakal. "We are eager to begin working with Celcuity’s cutting-edge CELsignia technology to identify a new subset of patients who may respond to NERLYNX."

Puma will supply NERLYNX, its pan-HER inhibitor currently approved by the U.S. Food and Drug Administration (FDA) for early and late-stage HER2-positive breast cancer. Celcuity will provide its CELsignia HER2 Activity Test to select HER2-negative metastatic breast cancer patients with brain metastases who have hyperactive HER2-driven signaling pathways for the trial and will fund the patient-related trial costs. Based on its estimates of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after initiation of the trial followed by the final results 12 to 15 months later. Celcuity expects enrollment to begin by early to mid-2022.

The goal of the trial is to demonstrate that previously treated HER2-negative metastatic breast cancer patients with brain metastases who have hyperactive HER2 signaling tumors, as identified by the CELsignia test, respond to treatment with NERLYNX in combination with XELODA, a chemotherapy commonly used in metastatic breast cancer patients. Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for metastatic HER2- negative breast cancer patients with brain metastases.

"We are excited about the opportunity to collaborate with Dr. Dhakal, The University of Rochester Wilmot Cancer Center, and Puma Biotechnology on this important clinical trial," said Brian Sullivan, CEO and co-founder of Celcuity. "This will be our first collaboration to study metastatic breast cancer patients with brain metastases selected for treatment using our CELsignia HER2 Activity Test. Patients with HER2-negative breast cancer who have brain metastases have few good options today. Approximately 20% of the 280,000 HER2-negative breast cancer patients receiving drug treatment annually have tumors with hyperactive HER2 signaling.1 For these patients, this trial represents a critical step towards a potential new therapeutic option."

On October 18, 2021 Phase Genomics, Inc., a biotech company leading advancements in next-generation sequencing (NGS) solutions for genome assembly and analysis, reported the launch of the beta version of its new platform for next generation cytogenomic applications in the reproductive genetics and oncology spaces (Press release, Phase Genomics, OCT 18, 2021, View Source [SID1234591470]).

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The platform enables rapid, efficient sample processing and does not require culturing of live, dividing cells nor high-molecular-weight DNA extraction. "This is a fast and inexpensive platform that is capable of providing tremendous benefit towards answering complex genomic questions that existing methods are unable to fully resolve,” said Shawn Sullivan, Co-founder and CTO of Phase Genomics. "The flexibility of this method allows us to use a low starting volume of cells from fresh and frozen material and, most notably, paraffin-embedded tissue. We can deliver an invaluable compendium of genetic information from a single sample without having to wait for results from multiple tests. With our robust chemistry and the machine learning underpinnings of our analytic technology, our platform offers the potential to complement or replace incumbent technologies like cytogenetics, FISH, and CMA in both solid and liquid cancers and in reproductive health."

While the platform can be broadly applied to constitutional genetics, Phase Genomics sees the immediate utility that it can bring to the prenatal market. According to Sullivan, the platform can help provide answers to the study of patient populations faced with infertility or unexplained repeated pregnancy loss. "For example, our platform can detect cryptic rearrangements potentially causing a couple’s fertility issues, it can uncover novel structural and copy-number changes essential to fetal development in non-viable or paraffin-embedded POC tissue samples and, most importantly, help fuel the translation of these discoveries into clinical tools that will remove emotional, financial and other burdens borne by patients working through these heartbreaking conditions."

Many of the same challenges exist in oncology. Unlocking and maximizing the use of the genetic information contained in unculturable and paraffin-embedded cancer samples is a unique property of the Phase Genomics platform. Phase Genomics’ Co-founder and CEO Dr. Ivan Liachko stated, "The Phase Genomics ultra-long-range sequencing method and machine learning-enabled analytical platform arm clinical researchers, and eventually, healthcare providers, with a cost-effective, high-throughput, sequencing-based method that delivers actionable information. This information provides insights that can be used in the development of new diagnostic and treatment options for cancer and genetic disease, ultimately leading to improved patient care and outcomes."

Today’s announcement opens RUO platform access to early beta participants. Phase Genomics is engaged in a number of active partnerships with research and commercial entities and is presenting early results in a poster at the American Society of Human Genetics Conference. The Phase Genomics platform is for research use only and is not for use in diagnostic procedures. More information on the platform is available here.

Join Phase Genomics for a webinar on Tuesday, November 30th to learn more about this technology and follow Phase Genomics on Twitter for the latest news and information.

On October 18, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported that October 19, 2021 has been set as the record date for the dividend of shares of common stock of 2seventy to be distributed to bluebird stockholders in order to effect the separation of bluebird bio and 2seventy bio, Inc. into two independent, publicly traded companies (Press release, bluebird bio, OCT 18, 2021, View Source [SID1234591469]).

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Each bluebird bio stockholder of record as of the close of business on October 19, 2021 will receive, on the distribution date, one share of 2seventy common stock for every three shares of bluebird common stock held. The share dividend is expected to be distributed to bluebird stockholders on or about November 4, 2021. Following the separation, bluebird stockholders will also receive cash in lieu of any fractional shares of 2seventy common stock that those holders would have received after application of the 3:1 distribution ratio. No action is required by bluebird stockholders in order to receive the shares of 2seventy common stock in the dividend distribution.

Additionally, on October 18, 2021 the Securities and Exchange Commission declared 2seventy’s Registration Statement on Form 10 (the "Form 10") effective. This Form 10 contains further information regarding bluebird bio’s plans for a tax-free spin-off of its oncology programs and portfolio into 2seventy bio as a publicly traded company, including the conditions to completion of the separation.

"When-issued" trading for 2seventy common stock and "ex-distribution" trading for bluebird common stock is expected to commence on October 18, 2021 under the stock ticker symbols "TSVTV" and "BLUEV", respectively. A description of these expected trading markets is included in the Form 10. After the separation, 2seventy common stock is expected to trade on the Nasdaq Global Select Market under the stock ticker symbol "TSVT" and bluebird will continue to trade on Nasdaq Global Select Market under the stock ticker symbol "BLUE."