Pacira BioSciences Reports Preliminary Net Product Sales of $116.9 Million for the Third Quarter of 2020

On October 7, 2020 Pacira BioSciences, Inc. (Nasdaq: PCRX), the leading provider of innovative non-opioid pain management options, reported preliminary unaudited net product sales of EXPAREL (bupivacaine liposome injectable suspension) and iovera° of $113.7 million and $2.7 million, respectively, for the third quarter of 2020 (Press release, Pacira Pharmaceuticals, OCT 7, 2020, View Source [SID1234568185]). The company also reported preliminary unaudited net product sales of EXPAREL and iovera° of $39.5 million and $1.1 million, respectively, for the month of September 2020. EXPAREL average daily sales were 109 percent, 111 percent, and 110 percent of prior year levels for the months of July, August, and September, respectively.

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"We are very encouraged with our strong performance as revenue and claims data show EXPAREL weekly growth rates exceeding those of the elective surgery market due to its expanding role in shifting a variety of complex surgical procedures to the 23-hour stay environment and broadening utilization in non-elective procedures, such as cesarean sections, cardiothoracic and oncology surgeries. When the elective surgery market recovers to its normal pace, we expect EXPAREL revenue to experience further growth," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Demand for training around nerve and field blocks continues to grow and we remain on track to launch our state-of-the-art Innovation and Training Center in Tampa later this month. This facility will advance interactive, hands-on instruction around best practice field block techniques while improving patient care and enabling patient migration to the 23-hour stay environment."

During the second quarter of 2020, the company’s product sales were negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the third quarter or full year 2020.

Kura Oncology Announces Preliminary Data for Menin Inhibitor KO-539 Accepted for Oral Presentation at ASH

On October 7, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that an abstract reporting preliminary data from KOMET-001, an ongoing clinical trial of the Company’s oral, potent and selective menin inhibitor, KO-539, has been accepted for oral presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Kura Oncology, OCT 7, 2020, View Source [SID1234568184]).

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The following abstract will be posted on the ASH (Free ASH Whitepaper) website at 9:00 a.m. ET on November 5, 2020. Updated data will be presented at the meeting.

Title: Preliminary Data on a Phase 1/2A First in Human Study of the Menin-KMT2A (MLL) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Publication Number: 115
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel promising therapies for relapsed/refractory AML
Session Date: Saturday, December 5, 2020
Session Time: 9:30 AM – 11:00 AM
Presentation Time: 10:30 AM

About KOMET-001

KOMET-001 (Kura Oncology Menin Inhibitor Trial) is a Phase 1/2A study to determine the safety, tolerability and recommended Phase 2 dose of KO-539 in patients with refractory or relapsed acute myeloid leukemia (AML). A planned expansion phase in specific genetic subgroups, including NPM1 mutant AML and KMT2A rearranged AML, is expected to further evaluate anti-leukemic activity and tolerability of KO-539. Additional information about the Phase 1/2A study of KO-539 can be found at kuraoncology.com/clinical-trials-komet.

About KO-539

KO-539, an oral investigational drug candidate, is a novel compound targeting the menin-KMT2A (MLL) interaction for treatment of genetically defined AML patients with high unmet need. In preclinical models, KO-539 inhibits the KMT2A (MLL) protein complex and has downstream effects on HOXA9/MEIS1 expression. KO-539 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML.

Genprex to Present at Zooming with LD Micro on October 14, 2020

On October 7, 2020 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it will be presenting virtually at the upcoming Zooming with LD Micro event on Wednesday, October 14 at 11 a.m. ET (Press release, Genprex, OCT 7, 2020, View Source [SID1234568183]). Genprex’s President and Chief Executive Officer, Rodney Varner, will be delivering the company’s corporate presentation followed by a Q&A session with participants.

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Event: Zooming with LD Micro

Date: Wednesday, October 14, 2020

Time: 11 a.m. ET

Registration Link: https://bit.ly/34v3Sk3

Investors and other individuals may access the virtual presentation by registering for the event.

Oncolytics Biotech® to Participate in BIO Investor Forum Digital

On October 7, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the Company will be participating in the BIO Investor Forum Digital, which is taking place virtually from October 13-15, 2020 (Press release, Oncolytics Biotech, OCT 7, 2020, View Source [SID1234568182]).

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The Company’s profile for the forum is available here. Registered attendees will be able to view an on-demand corporate overview provided by President and Chief Executive Officer Dr. Matt Coffey. Company management will also be participating in one-on-one investor meetings at the forum. To schedule a meeting, please submit a meeting request on the forum website, or email [email protected].

Exact Sciences and Pfizer Extend and Amend Cologuard® Promotion Agreement

On October 7, 2020 Exact Sciences Corp. (Nasdaq: EXAS) and Pfizer Inc. (NYSE: PFE) reported an extension and amendment of their agreement to promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer (Press release, Exact Sciences, OCT 7, 2020, View Source [SID1234568180]). Under terms of the nationwide agreement, Pfizer will continue to provide marketing and related support for Cologuard and join Exact Sciences’ efforts to educate patients, physicians, and health systems about Cologuard.

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The COVID-19 pandemic has highlighted the need for convenient, accurate cancer testing options. Outcomes can be dramatically improved if colorectal cancer is caught in early stages, and with more than an estimated one million screening colonoscopies missed this year, there is an urgent need to increase screening rates.1 Cologuard is an accurate, at-home colon cancer screening option and is uniquely positioned to support screening during this time and after the pandemic abates.

"We’re thrilled to continue working with Pfizer to increase screening rates with Cologuard, especially during this critical time," said Kevin Conroy, chairman and CEO of Exact Sciences. "Over the past two years, Pfizer has shown incredible commitment to Exact Sciences’ goal of eradicating colorectal cancer by helping detect the disease at its earliest, most treatable stages. The talented Exact Sciences team is excited to continue joining forces with Pfizer to help improve screening rates among the 46 million unscreened Americans."

In the two years since the partnership began, more than 3 million people were screened with Cologuard and more than 90,000 healthcare providers ordered Cologuard for the first time. The combined teams have also introduced several new direct-to-consumer marketing campaigns and worked with dozens of large health systems to improve colorectal cancer screening rates.

"Now more than ever, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on an even greater urgency. This partnership is a testament to that purpose, and Pfizer is incredibly proud of the work we have done with Exact Sciences to raise colorectal cancer screening rates," said Mike Gladstone, Global President of Internal Medicine at Pfizer.

Under the terms of the amended agreement, Pfizer will provide sales and marketing support through the end of 2022 and health system support through the end of 2021. Exact Sciences will compensate Pfizer based on the amount of services provided, along with additional fixed and performance-related fees set forth in the agreement. Exact Sciences will maintain responsibility for all aspects of manufacturing and laboratory operations of Cologuard.

More information about the agreement is available here, in a form 8-K that Exact Sciences has filed with the Securities and Exchange Commission.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.