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.

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.

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

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

On May 27, 2020 Kinnate Biopharma Inc., a precision oncology company focused on the discovery and development of novel kinase inhibitors, reported the appointment of Nima Farzan as Chief Executive Officer, and a member of the Board of Directors (Press release, Kinnate Biopharma, MAY 27, 2020, View Source [SID1234558574]). Farzan brings nearly two decades of executive leadership and commercial and development experience in the biopharmaceutical industry to the Kinnate team, most recently as president and CEO of PaxVax. Company co-founder and former CEO Stephen Kaldor, PhD, has been appointed Chairman.

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Kinnate is developing best- and first-in-class small molecule therapies targeting kinases for genetically defined and hard-to-treat cancers. The company’s current portfolio includes a RAF dimer inhibitor targeting Class II and III mutations and an FGFR2/3 inhibitor. The company is also advancing a number of other programs, including a CDK12 inhibitor, which is a potentially first-in-class candidate.

"Kinnate has built unparalleled strength in structure-based drug design coupled with a deep understanding of the genetic mutations driving cancer progression through its internal expertise and scientific collaborations," said Keith T. Flaherty, MD, Director of Clinical Research at the Massachusetts General Hospital Cancer Center, Professor of Medicine at Harvard Medical School and Kinnate Board member and Scientific Advisor. "Nima’s demonstrated leadership in building innovative science-focused commercial organizations will add invaluable experience to the Kinnate team as they continue to accelerate their portfolio of precision medicines towards clinical testing."

At PaxVax, Farzan successfully led a team of 250 people through a number of commercial product launches and negotiated the acquisition of the company by Emergent BioSolutions in 2018. Prior to PaxVax, he held a series of roles with increasing responsibility at Novartis AG, most recently as Vice President of US Marketing in the company’s Vaccines & Diagnostics division. Prior to Novartis, Farzan worked at DoubleTwist, a pioneering genomics company, and was a consultant with Boston Consulting Group. He is currently a member of the Keros Therapeutics (NASDAQ: KROS) Board of Directors. Farzan holds a BA in Human Biology from Stanford University and an MBA from the Harvard Business School.

"With less than 10 percent of cancer patients benefiting from precision therapies, there remains a huge unmet medical need for genetically targeted medicines," said Farzan. "It is a privilege to join a company of this caliber and work with such a seasoned group of drug discovery leaders and our world-class partners who, like us, are driven by the urgency of cancer patients who need more effective therapies."

Kinnate has also announced today the appointment of Mark Meltz as Chief Operating Officer and General Counsel. Meltz joins Kinnate from Audentes Therapeutics where he was Senior Vice President and General Counsel and helped lead the sale of the company to Astellas Pharma in January 2020. Prior, he was Executive Vice President and Chief Business Development and Legal Officer at PaxVax where he helped lead the sale of the company to Emergent BioSolutions, served as Associate General Counsel at Biogen and was Head of Legal for North America at Novartis in its Vaccines & Diagnostics division. He holds a BA with Departmental Honors in Psychology from Yale University and a JD, Magna Cum Laude, from Boston College Law School.

In December 2019, Kinnate announced a $74.5M Series B financing and the expansion of its Board of Directors which in addition to Farzan and Dr. Kaldor, includes Dr. Flaherty (Massachusetts General Hospital, Harvard Medical School), Carl Gordon, PhD (OrbiMed), Michael Rome, PhD (Foresite Capital), and Brett Zbar, MD (Foresite Capital).