Fusion Pharma to Present at the EANM 2018 Congress and BIO Investor Forum 2018

On November 15, 2018 Fusion Pharmaceuticals, a biopharmaceutical company focused on radiotherapeutics (specifically, targeted alpha therapeutics), reported that it will present at two separate conferences this week (Press release, Fusion Pharmaceuticals, OCT 15, 2018, View Source [SID1234531595]).

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On Tuesday, October 16, 2018, Fusion will present scientific data on its lead program FPI-1434 at the European Association of Nuclear Medicine (EANM) 2018 Congress. The meeting is behind held in the CCD, Congress Center Dusseldorf, in Dusseldorf, Germany.

On Thursday, October 18, 2018, at 10:00am PT, Fusion will present at the BIO Investor Forum 2018. The event is being held at the Westin St. Francis Hotel in San Francisco, California.

Virogin Awarded 2018 Ernst & Young Fudan China’s Most Promising Enterprise

Shanghai, China – Virogin Biotech Ltd. ("Virogin") has been named 2018 Ernst & Young Fudan China’s Most Promising Enterprise, recognized within the ‘Health Reimagined’ category (Press release, Virogin Biotech, OCT 15, 2018, View Source [SID1234532328]).

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Hosted by global professional services firm Ernst & Young and Fudan University’s School of Management, these 8th annual awards identified prominent companies and future industry leaders that exhibit a commitment to innovation, sustained high growth, and potential to strengthen the economic development of China. At the industry awards ceremony, Virogin was recognized for their leadership in bio-innovative drug research and development.

As stated by the Ernst & Young Fudan China Most Potential Enterprise Selection Jury, "the award-winning companies represent a creative, entrepreneurial, diversified and inclusive corporate paradigm in today’s highly disruptive business world".

Virogin’s CEO and co-founder, Chris Huang says: "For Virogin, this award is testament to the work of our core team, all whom possess extensive experience and deep background in technology development, clinical advancement and business operations. At present, the company has three independent R&D projects and ongoing cooperative research and development projects. Our clinical product VG161 will enter clinical phase in the first half of 2019. We look forward to continuing our R&D work, and strengthening relations with our strategic partners to advance our SynerlyticTM platform."

Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292 for the Treatment of RET Fusion-Positive Thyroid Cancer

On October 15, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options (Press release, Loxo Oncology, OCT 15, 2018, View Source [SID1234529908]). This designation supplements the two LOXO-292 Breakthrough Therapy Designations granted in September 2018. The Breakthrough Therapy Designation announced today was also based on data from the ongoing global Phase 1/2 LIBRETTO-001 clinical trial.

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The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

About LOXO-292
LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 has been granted Breakthrough Therapy Designation by the U.S. FDA.

LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

Allogene Therapeutics Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On October 15, 2018 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported the closing of its previously announced initial public offering of 20,700,000 shares of its common stock, which includes 2,700,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $18.00 per share (Press release, Allogene, OCT 15, 2018, View Source [SID1234530319]). Including the option exercise, the gross proceeds to Allogene Therapeutics from the offering, before deducting the underwriting discounts and commissions and offering expenses, were $372.6 million.

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Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies LLC acted as the joint book-running managers for the offering.

The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from:

Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or via telephone: 1-866-471-2526, or via email: [email protected]; or

J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or via telephone: 1-866-803-9204; or

Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or via email: [email protected]; or

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or via telephone: 1-877-547-6340, or via email: [email protected].

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 10, 2018. 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 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.

Neurocrine Biosciences Announces Conference Call and Webcast of Third Quarter 2018 Financial Results

On October 15, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report third quarter financial results after the Nasdaq market closes on Monday, Nov. 5, 2018 (Press release, Neurocrine Biosciences, OCT 15, 2018, View Source;p=RssLanding&cat=news&id=2371705 [SID1234530025]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9176 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.