On October 26, 2018 Gamida Cell Ltd., a leading cellular and immune therapeutics company, reported the pricing of its initial public offering of 6,250,000 ordinary shares at a public offering price of $8.00 per share for aggregate gross proceeds of $50.0 million (Press release, Gamida Cell, OCT 26, 2018, View Source [SID1234530214]). All of the shares in the offering are being offered by Gamida Cell. In addition, Gamida Cell granted the underwriters a 30-day option to purchase up to 937,500 additional ordinary shares at the initial offering price, less underwriting discounts and commissions. Gamida Cell’s ordinary shares are expected to begin trading on the Nasdaq Global Market on October 26, 2018, under the ticker symbol "GMDA." The offering is expected to close on or about October 30, 2018, subject to customary closing conditions.

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BMO Capital Markets and RBC Capital Markets are acting as joint book-running managers for this offering. Needham & Company and Oppenheimer & Co. are acting as co-lead managers for this offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on October 26, 2018. This offering will be made only by means of a prospectus. Copies of the final prospectus related to this offering may be obtained, when available, from: BMO Capital Markets, 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, Telephone: (800) 414-3627, Email: [email protected]; or RBC Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, Attention: Equity Syndicate Department, Telephone: (877) 822-4089, Email: [email protected].

This press release shall not constitute an offer to sell or the 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 October 26, 2018 Fresenius Kabi reported the immediate availability in the United States of Arsenic Trioxide Injection in a 10 mg per 10 mL vial presentation (Press release, Fresenius, OCT 26, 2018, View Source [SID1234530213]).

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The product is the first-to-market generic of TRISENOX indicated for relapsed or refractory acute promyelocytic leukemia.

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company is a leading developer, manufacturer and provider of injected and infused medicines in the United States with expertise in producing affordable generic alternatives to more expensive brand-name drugs.

"With the introduction of Arsenic Trioxide Injection, Fresenius Kabi is pleased to continue to expand its broad oncology portfolio, providing patients and clinicians with access to affordable generic alternatives of vital medicines," said John Ducker, president and CEO of Fresenius Kabi USA. "We’re also pleased to bring back the 10 mg per 10 mL (1mg per mL) presentation of Arsenic Trioxide Injection – now in a vial – to provide a familiar alternative to clinicians."

About Arsenic Trioxide Injection

Arsenic Trioxide Injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the translocation or PML/RAR-alpha gene expression.

Important Safety Information

WARNING: DIFFERENTIATION SYNDROME AND CARDIAC CONDUCTION ABNORMALITIES

See full prescribing information for complete boxed warning.

Patients treated with Arsenic Trioxide Injection may develop differentiation syndrome, which can be fatal. If symptoms occur, initiate high-dose steroids immediately and monitor hemodynamics.
Arsenic Trioxide Injection can cause QT interval prolongation and ventricular arrhythmia, which can be fatal. Before administering Arsenic Trioxide Injection, assess the QT interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QT interval. Do not administer Arsenic Trioxide Injection to patients with ventricular arrhythmia or prolonged QTcF.
Arsenic Trioxide injection is contraindicated in patients with hypersensitivity to arsenic.

Hepatotoxicity: Monitor hepatic function tests at least twice weekly during arsenic trioxide injection therapy.

Carcinogenesis: Arsenic trioxide is a human carcinogen. Monitor patients for the development of second primary malignancies.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.

Serious adverse reactions reported include: Differentiation Syndrome, cardiac conduction abnormalities, hepatotoxicity, carcinogenesis, and embryo-fetal toxicity. The most common adverse reactions (greater than 30%) were leukocytosis, neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain, hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia, QTc prolongation, edema, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia and dizziness.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use Arsenic Trioxide Injection safely and effectively. Please see accompanying full prescribing information (View Source) for ARSENIC TRIOXIDE INJECTION, including BOXED WARNING. Full prescribing information is also available at www.fresenius-kabi.co/us.

On October 26, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it will host a conference call and webcast to provide a corporate update and report its third-quarter 2018 financial results on Friday, November 2, 2018, at 8:30 a.m. ET (Press release, GlycoMimetics, OCT 26, 2018, View Source [SID1234530211]).

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The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 9176334. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

On October 26, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the Company will host a business update call on Friday, November 2, 2018 (Press release, Advaxis, OCT 26, 2018, View Source [SID1234530210]).

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Advaxis’ senior management will host a conference call to provide a business update and pipeline discussion. The conference call and live audio webcast will begin at 11:00 a.m. Eastern time on Friday, November 2, 2018.

Conference Call & Webcast Information
WHEN: Friday, November 2, 2018 at 11:00 a.m. Eastern time
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 1538717
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning November 2, 2018 two hours after the close of the conference call. To access the recording, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the operator with the conference ID: 1538717. In addition, an audio webcast will be archived on the Company’s website for a period of time at www.advaxis.com.

On October 26, 2018 Senior Director of Corporate Development at Immunomic Therapeutics Inc. Sia Anagnostou will speak at the Precision Lung Cancer World R&D Summit in Boston (Press release, Immunomic Therapeutics, OCT 26, 2018, View Source [SID1234530209]). Anagnostou’s presentation, titled "UNITE Technology as Nucleic Acid & Cell Based Immunotherapy: TERT – LAMP Case Study," will highlight Immunomic’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology. Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response, including antibody production, cytokine release and critical immunological memory, a method that could put UNITE at the crossroads of immunotherapies in a number of illnesses, including cancer. The investigational UNITE technology is currently being applied as a cancer immunotherapy in a Phase II clinical trial targeting glioblastoma multiforme (GBM). Anagnostou’s presentation will explore the broader potential of UNITE through discussion of the LAMP-based immunotherapy technology, AST-VAC2 (VAC2). VAC2 is an allogeneic cancer immunotherapy being developed by Asterias Biotherapeutics, Inc. in collaboration with Cancer Research UK and is currently in a Phase 1 clinical trial for treatment of non-small cell lung cancer.

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Who: Sia Anagnostou, Senior Director of Corporate Development at Immunomic Therapeutics, Inc.

What: Presentation on Activating Immune Responses in Cancer

When: Monday, October 29 at 4:00 p.m. EDT

Where: Wyndam Boston Beacon Hill, 5 Blossom St., Boston, MA 02114

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.