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NuVasive to Present at the 31st Annual Piper Jaffray Healthcare Conference

On November 25, 2019 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported that management will present at the 31st Annual Piper Jaffray Healthcare Conference at the Lotte New York Palace in New York City on Wednesday, Dec. 4, 2019 at 1:00 p.m. EST / 10:00 a.m. PST (Press release, NuVasive, NOV 25, 2019, View Source [SID1234551668]).

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A live webcast of the presentation will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. A replay of the presentation will remain available on the website for 30 days after the live webcast.

Ardelyx and Kyowa Kirin Expand Partnership with Two Additional Agreements

On November 25, 2019 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases and Kyowa Kirin Co., Ltd., (TSE:4151, President and CEO: Masashi Miyamoto, Kyowa Kirin), a Japan-based Global Specialty Pharmaceutical Company, reported the expansion of their partnership with two new agreements (Press release, Ardelyx, NOV 25, 2019, View Source [SID1234551667]).

In the first agreement, the companies have established a two-year research collaboration, whereby Ardelyx will execute a research plan, in which Kyowa Kirin will also join, to advance two of Ardelyx’s ongoing research programs focused on the identification and design of compounds to two undisclosed targets. In return, Kyowa Kirin will pay Ardelyx $10 million ($5 million a year for two years) to support the ongoing research. Following the end of the research period, Kyowa Kirin will have the option to license any candidates nominated by the companies for further development and commercialization in certain specified territories, with additional commitments payable to Ardelyx of up to $10.5 million in upfronts and up to $500 million in development and sales milestones. The research collaboration will be governed by a joint research committee. Additional terms were not disclosed.

Under the second agreement, Kyowa Kirin has made a $20 million equity investment in Ardelyx at $6.96 for 2,873,563 shares.

"Kyowa Kirin is a leader in the development and commercialization of medicines for patients with cardiorenal disease and an important and highly collaborative partner for Ardelyx and we’re thrilled to expand our relationship with them," said Mike Raab, president and chief executive officer of Ardelyx. "The research collaboration will leverage our successful drug discovery platform, which includes tools and techniques for selectively modulating the exposure of drug leads, our human stem cell-based translational technology, and our extensive experience in developing disease models, expertise that has proven successful in our development and approval of tenapanor. Funding from this agreement and the equity investment serve as an important source of capital as we prepare for the potential launch and commercialization of tenapanor in hyperphosphatemia."

Takeyoshi Yamashita, Ph.D., Executive officer, Director of Corporate Strategy & Planning Department of Kyowa Kirin added, "We view Ardelyx’s ability selectively targeting key molecule to be well validated with the successful discovery and development of tenapanor, a novel, ground-breaking inhibitor of the sodium hydrogen exchanger 3 (NHE3). Through our newly established research and equity agreements, we look forward to a deeper, expanded collaboration with the Ardelyx team."

Ardelyx and Kyowa Kirin initially established a collaboration partnership in November 2017 through a license agreement that provided Kyowa Kirin with exclusive rights to develop and commercialize Ardelyx’s lead investigational product, tenapanor, for the treatment of cardiorenal diseases, including hyperphosphatemia, in Japan. Kyowa Kirin will have the exclusive rights to develop, market and commercialize tenapanor for cardiorenal diseases and conditions associated with them, including hyperphosphatemia, in Japan.

NanoString to Present at the Evercore ISI 2nd Annual HealthCONx Conference

On November 25, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for translational research and molecular diagnostic products, reported that the company’s management is scheduled to present at the Evercore ISI 2nd Annual HealthCONx Conference in Boston (Press release, NanoString Technologies, NOV 25, 2019, View Source [SID1234551666]).

Brad Gray, president and chief executive officer, is scheduled to present on Wednesday, December 4th, 2019 from 2:00-2:40pm ET. Interested parties can access the live webcast with accompanying slides from the investor section of the company’s website at www.nanostring.com. The webcast replay will be available one hour after the conclusion of the live presentation and archived for 60 days.

X4 Pharmaceuticals Announces Proposed Public Offering

On November 25, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics for the treatment of rare diseases, reported that it has commenced an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof) and Class B warrants to purchase its common stock (Press release, X4 Pharmaceuticals, NOV 25, 2019, View Source [SID1234551665]). All of the securities in the offering will be sold by X4. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

Cowen and Stifel are acting as joint book-running managers for the offering. Canaccord Genuity and Oppenheimer & Co. are acting as lead managers, and H.C. Wainwright & Co. and Roth Capital Partners are acting as managers for the offering.

The offering will be made only by means of a written prospectus and related prospectus supplement forming part of a shelf registration statement on Form S-3 that was originally filed with the Securities and Exchange Commission (SEC) on August 9, 2019 and declared effective by the SEC on August 29, 2019. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available at the SEC’s website located at www.sec.gov, copies of which may be obtained, when available, from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926, and from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, or by telephone at 415-364-2720 or by email at [email protected].

This press release shall 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 other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

EpicentRx Announces Positive Results From Phase 1 Trial of RRx-001 as First-line Treatment in Newly Diagnosed Glioblastoma

On November 25, 2019 EpicentRx, Inc., a clinical cancer immunotherapy company targeting both sides of the immune system to deliver cancer treatments with minimal toxicity, reported positive results from the Phase 1 G-FORCE trial of RRx-001 as first-line treatment in newly diagnosed glioblastoma (Press release, EpicentRx, NOV 25, 2019, View Source [SID1234551664]). The late-breaking data were presented by Nicholas Butowski, M.D., a principal investigator on the trial and Professor of Neurological Surgery at the University of California San Francisco Weill Institute for Neurosciences, on November 22 at the Society for Neuro-Oncology annual meeting in Phoenix.

Glioblastoma multiforme (GBM) represents 15-20% of all primary intracranial neoplasm, with death typically occurring within the first 15 months after diagnosis. The median age of diagnosis is 64 years old. Since agents from various drug classes have failed in clinical trials, there is an urgent need for a more effective and less toxic GBM therapy.

RRx-001, EpicentRx’s lead program, is a small molecule immunotherapy targeting the CD47 – SIRPα axis and has been evaluated in multiple clinical studies.

In the G-FORCE trial, 18 patients with histologically verified glioblastoma received RRx-001 plus radiotherapy and temozolomide. After a six-week break, patients in cohorts 1-3 received temozolomide maintenance therapy, while patients in cohorts 4-6 received temozolomide plus RRx-001 maintenance therapy.

RRx-001 combination therapy led to an overall survival (OS) of 21.9 months, compared with historical OS data of 15-20 months. The RRx-001 combo also led to a progression-free survival (PFS) of 13 months, compared with historical PFS data of 6-7 months.

The combination therapy was well tolerated, with no serious adverse events considered related to treatment with RRx-001.

"Patients diagnosed with glioblastoma have poor prognosis and very limited treatment options," said Corey A. Carter, M.D., President & CEO of EpicentRx.

"The results from this Phase 1 G-FORCE study and our ongoing Phase 3 REPLATINUM trial in small cell lung cancer (SCLC) validate RRx-001 as a viable therapy for multiple cancer types. We plan to begin a Phase 0 trial of RRx-001 for GBM in the near future to gain further insight into the mechanism of action in brain tumors before starting Phase 3 studies," added Dr. Carter.

"I am very excited to begin the Phase 0 trial," said Howard Fine, M.D., Director of Neuro-oncology at Weill Cornell Medical Center and principal investigator for the upcoming Phase 0 trial. "This is a high priority project and collaboration for both Weill Cornell and EpicentRx, and an important step in our efforts to bring safe, effective and minimally toxic therapeutics to GBM patients," Dr. Fine said.

RRx-001 has Orphan Drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma, and from EMA for SCLC.

About RRx-001

RRx-001 is a next generation small molecule immunotherapy being developed by EpicentRx. The therapy targets the CD47 – SIRPα axis and repolarizes tumor associated macrophages (TAMs) and other immunosuppressive cells in the tumor microenvironment to an immunostimulatory phenotype. RRx-001 stimulates the immune system and can be used as monotherapy or in combination with chemotherapy, immunotherapy, radiation and targeted agents, giving the therapy the potential to convert "treatment-resistant" tumors into "treatment-sensitive" tumors. RRx-001 is currently in the Phase 3 REPLATINUM trial for the treatment of third-line and beyond small cell lung cancer (SCLC). RRx-001 is also in the Phase 2 QUADRUPLE THREAT trial for the treatment of SCLC, non-small cell lung cancer, neuroendocrine tumors, ovarian and prostate cancer, and the Phase 2 PREVLAR trial for the prevention of oral mucositis. Clinical studies for the drug have also been conducted for the treatment of colorectal cancer, brain metastases and glioblastoma.