MedX Health Corp. provides update on the release of its Annual Financial Statements and related Disclosures for fiscal 2019 and postponement of release of its First Quarter 2020 Interim Financial Statements and related Disclosures

On May 27, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V: MDX) reported an update on the filing of its Annual Financial Statements and related Disclosures (the "Annual Disclosures") for the year ended December 31, 2019, following the earlier announcement in its Press Release dated April 28, 2020, that filing of the Annual Disclosures would be delayed due to COVID-19 related delays (Press release, MedX Health, MAY 27, 2020, View Source [SID1234558579]). The Company is continuing to work diligently and expeditiously with its auditors, and anticipates that the Annual Disclosures will be filed by June 12, 2020, as previously indicated.

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The Company further announces that filing of the Interim Financial Statements and related Disclosures for the three-month period ended March 31, 2020, the First Quarter of fiscal 2020 (the "Interim Disclosures") will also be delayed owing to COVID-19 related issues. The Company anticipates that the Interim Disclosures will be filed by July 13, 2020.

In relation to the delay in filing of the Annual Disclosures and the Interim Disclosures, MedX relies on the provisions of Ontario Instrument 51-502, Temporary Exemption from Certain Corporate Finance Requirements and corresponding Instruments in the other jurisdictions in which the Company is a reporting issuer.

MedX confirms that there have been no material business developments other than as disclosed in its Press Releases and previous filings, and further confirms that Management and other insiders of the Company have been, since April 28, 2020, and continue to be subject to a trading black-out policy that reflects the principles in section 9 of National Policy 11-207, Failure to-File Cease Trade Orders and Revocations in Multiple Jurisdictions, which will remain in effect until both the Annual Disclosures and the Interim Disclosures have been filed.

Arcus Biosciences, Inc. Announces Commencement of Underwritten Public Offering of Common Stock

On May 27, 2020 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer therapies, reported that it has commenced an underwritten public offering of its common stock (Press release, Arcus Biosciences, MAY 27, 2020, View Source [SID1234558578]). The company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. All of the shares in the offering will be sold by Arcus Biosciences. The offering is subject to market and other conditions, and there can be no assurances 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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Citigroup, SVB Leerink and Evercore Group LLC are acting as joint book running managers for the proposed offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) and is effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Copies of the prospectus related to the offering may be obtained, when available, from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at (800) 831-9146; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, 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 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.

Scholar Rock to Present at the Jefferies Virtual Global Healthcare Conference

On May 27, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will present at the Jefferies Virtual Global Healthcare Conference on Wednesday, June 3, 2020 at 8:30 am ET (Press release, Scholar Rock, MAY 27, 2020, View Source [SID1234558577]).

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A webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcasts will be available on the Company’s website for approximately 90 days following the presentation.

Maverick Therapeutics to Participate at 2020 Jefferies Virtual Healthcare Conference

On May 27, 2020 Maverick Therapeutics Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, reported it will share company and pipeline updates at the Jefferies Virtual Healthcare Conference being held from June 2 to June 4, 2020 (Press release, Maverick Therapeutics, MAY 27, 2020, View Source [SID1234558576]). Chief Executive Officer Jim Scibetta is scheduled to participate in a live presentation on June 3, 2020 at 3:30 p.m. Eastern Time.

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Following the conference, the presentation will be available on the events & presentations section of the Maverick website at: View Source

FDA Accepts for Review Fresenius Kabi’s BLA Submission for Pegfilgrastim Biosimilar

On May 27, 2020 Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, reported the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for MSB11455, the company’s pegfilgrastim biosimilar candidate for Neulasta (Press release, Fresenius Kabi Oncology, MAY 27, 2020, View Source [SID1234558575]).

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This is Fresenius Kabi’s first U.S. biosimilar regulatory submission. Pegfilgrastim is used to reduce the incidence of infection associated with febrile neutropenia, a serious side effect of chemotherapy. The drug works by stimulating the body’s own production of white blood cells to fight infection.

"Pegfilgrastim plays a vital role in oncology care, and this acceptance by FDA is an important step toward giving oncologists and their patients greater access by providing another option to help support the immune system following chemotherapy," said Seema Kumbhat, M.D., chief medical officer for Fresenius Kabi USA.

Fresenius Kabi has global expertise in the development, manufacturing and distribution of generic pharmaceuticals with a focus on quality, reliability of supply and responsive customer and patient support.

"The acceptance of Fresenius Kabi’s submission of pegfilgrastim marks a key milestone as we seek approval for our first biosimilar in the United States," said John Ducker, president and CEO of Fresenius Kabi USA. "Fresenius Kabi is well positioned to become a U.S. market leader in biosimilars. In the U.S., we offer oncologists the industry’s broadest portfolio of injectable medicines, and we look forward to bringing this experience to producing high-quality biosimilars."

Fresenius Kabi’s BLA submission for its pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data. The application includes the results of two pivotal clinical trials that showed equivalent pharmacokinetic and pharmacodynamic profiles to the originator Neulasta, as well as similar immunogenicity in healthy volunteers. The safety of MSB11455 was also comparable to Neulasta.

Fresenius Kabi is participating as an Enhanced Exhibitor at ASCO (Free ASCO Whitepaper)20 Virtual, a meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is taking place virtually May 29-31, 2020. #ASCO20 #biosimilars