On June 4, 2020 TVAX Biomedical reported that receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the use of its vaccine-enhanced adoptive T cell therapy (VACT) for treatment of glioblastoma multiforme, a deadly form of brain cancer (Press release, TVAX Biomedical, JUN 4, 2020, View Source [SID1234560853]).

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"We are very pleased to receive Fast Track Designation by the FDA for glioblastoma multiforme (GBM)," stated Dr. Wayne Carter, Chief Executive Officer. "Glioblastoma is a devastating disease for which there are limited treatment options."

FDA Fast Track Designation is designed to accelerate marketing approval of therapies aimed at treating serious and life-threatening diseases. The Designation creates an opportunity for close and regular communication between TVAX Biomedical and the FDA in order to improve the efficiency of product development. Additionally, it provides a pathway for accelerated approval and rolling review of completed Biological Licensing Application sections by the FDA.

TVAX Biomedical has completed Phase 1 and 2a studies in multiple cancers, including GBM. Significant benefit was demonstrated in GBM patients using TVAX’s patented VACT in those studies. TVAX’s currently planned studies will evaluate VACT in newly diagnosed GBM patients who have healthy immune systems and minimal disease at a time when VACT would be anticipated to generate maximal efficacy.

On June 4, 2020 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat at the 41st Annual Goldman Sachs Global Healthcare Conference on Thursday, June 11, 2020 at 9:40 a.m. ET (2:40 p.m. BST) (Press release, Alkermes, JUN 4, 2020, View Source [SID1234560852]). The webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On June 4, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference Webcast at 9:40 a.m. ET on Thursday, June 11, 2020 (Press release, Neurocrine Biosciences, JUN 4, 2020, View Source [SID1234560851]). Kevin Gorman, Chief Executive Officer, Eiry Roberts, Chief Medical Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On June 4, 2020 NuVasive, Inc. (NASDAQ: NUVA) reported that it closed the issuance of an additional $50.0 million in aggregate principal amount of the 1.00% Convertible Senior Notes due 2023 (the "Convertible Notes"), pursuant to the exercise in full of the initial purchasers’ option to purchase such additional notes (the "Option Notes") in connection with the previously announced Convertible Notes offering that closed on June 1, 2020 (Press release, NuVasive, JUN 4, 2020, View Source;301070982.html [SID1234560850]).

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The Option Notes have the same terms as the Convertible Notes. The Option Notes were issued under the same Indenture as the Convertible Notes dated as of June 1, 2020 between the Company and Wilmington Trust, National Association, as trustee, which terms are described in the Company’s Current Report on Form 8-K filed on June 1, 2020.

The sale of the Option Notes to the initial purchasers settled on June 4, 2020, subject to customary closing conditions, and resulted in approximately $48.6 million in net proceeds to NuVasive (in addition to the previously announced net proceeds of $387.5 million from the initial closing of the offering of the Convertible Notes on June 1, 2020) after deducting fees and estimated offering expenses payable by NuVasive.

In addition, in connection with the issuance of the Option Notes, NuVasive entered into privately negotiated additional convertible note hedge transactions and additional warrant transactions with certain dealers, including affiliates of certain of the initial purchasers of the Convertible Notes and other financial institutions (the "Option Counterparties"). The additional convertible note hedge transactions and the additional warrant transactions are on substantially similar terms as the base convertible note hedge transactions and base warrant transactions entered into on May 27, 2020 with the Option Counterparties.

NuVasive intends to use approximately $2.5 million of the net proceeds from the offering of the Option Notes to pay the cost of the additional convertible note hedge transactions (after such cost is partially offset by the proceeds to NuVasive from the additional warrant transactions). NuVasive intends to use the remaining net proceeds for working capital and other general corporate purposes, which may include potential mergers and acquisitions, to refinance indebtedness and for repurchases of outstanding Convertible Senior Notes due 2021 (the "2021 Notes"). Any repurchase of the 2021 Notes could have the effect of raising or maintaining the market price of NuVasive’s common stock above levels that would otherwise have prevailed, or preventing or retarding a decline in the market price of NuVasive’s common stock, and thereby impacting the trading price of the Convertible Notes.

The offering of the Option Notes is only being made to qualified institutional buyers pursuant to Rule 144A under the Securities Act. Neither the Option Notes nor any shares of NuVasive’s common stock issuable upon conversion of the Option Notes have been or are expected to be registered under the Securities Act or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

On June 4, 2020 DLA Piper reported Iovance Biotherapeutics, a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), in a US$603.7 million underwritten public offering of 19,475,806 shares of its common stock at a public offering price of $31.00 per share, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance (Press release, Iovance Biotherapeutics, JUN 4, 2020, View Source [SID1234560849]). The shares of common stock issued and sold in the offering include 2,540,322 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less the underwriting discounts and commissions.

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Iovance plans to use the proceeds from the offering to fund the expansion of its organization to support the potential commercial launch of lifileucel for advanced melanoma and LN-145 for advanced cervical cancer, to initiate a program directed at registration of its tumor-infiltrating lymphocyte therapies in non-small cell lung cancer, to continue support of ongoing commercial manufacturing activities, and for the development of its IL-2 analog, IOV-3001, and for other general corporate purposes. Additional indications or TIL products may be explored with the use of proceeds.

"We are proud to have partnered with Iovance to complete this offering, applying our extensive experience advising life sciences, biotechnology and pharmaceutical clients in complex capital markets transactions. Over the last month, our East Coast life sciences team has closed public offerings for biotech companies in excess of $1 billion, and we are pleased to continue to support our clients’ expansion and ongoing success," said Emilio Ragosa, the DLA Piper partner who led the firm’s deal team.

In addition to Ragosa (Short Hills), the DLA Piper team advising Iovance included partners Patrick O’Malley and Neil Balmert (both of San Diego), as well as partners Rebecca McKnight (Austin) and Christopher Mikson (Philadelphia), and associates Oliver Newman, Dylan Caplan, David Pennant (all of Philadelphia), H. Thomas Felix, Nika Antonikova (both of San Diego) and Sarah Thompson Schick (Austin).

DLA Piper’s global capital markets team represents issuers and underwriters in registered and unregistered equity, equity-linked and debt capital markets transactions, including initial public offerings, follow-on equity offerings, equity-linked securities offerings, and offerings of investments grade and high-yield debt securities.

DLA Piper advises on all aspects of the life sciences sector, combining subject matter experience with considerable knowledge of the scientific, medical, regulatory, commercial and enforcement environments facing biopharmaceutical, medical device, research and diagnostics clients. Recognizing that clients’ needs vary, the firm rapidly organizes and customizes client service teams, whether for a large pharmaceutical company, a mid-sized medical device client or a development-stage biotech company.