On January 6, 2023 bluebird bio, Inc. (NASDAQ: BLUE) ("bluebird bio" or the "Company") reported that it has entered into a definitive agreement to sell its second Rare Pediatric Disease Priority Review Voucher (PRV) for $95 million (Press release, bluebird bio, JAN 6, 2023, View Source [SID1234625960]).

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bluebird bio was granted two PRVs upon the US Food and Drug Administration (FDA) approvals of ZYNTEGLO (betibeglogene autotemcel) for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusions and SKYSONA (elivaldogene autotemcel) for the treatment of early, active cerebral adrenoleukodystrophy, on August 17, 2022 and September 16, 2022 respectively. On December 29, 2022, bluebird closed the sale of its first PRV for $102 million.

"The sale of our second priority review voucher further bolsters our financial position and provides an important source of non-dilutive funding for the company," said Chris Krawtschuk, chief financial officer, bluebird bio. "Strengthening the company’s balance sheet – as we have continued to do through demonstrated fiscal discipline and the sale of both PRVs – ensures we enter 2023 with significant momentum behind the commercial launches of our two FDA-approved gene therapies, and the opportunity ahead in sickle cell disease."

bluebird received a payment of $95 million upon closing of the transaction, which occurred simultaneously with the parties entering into the agreement. Jefferies LLC acted as the exclusive financial advisor to bluebird for this transaction.

About the Rare Pediatric Disease Priority Review Voucher Program

The Rare Pediatric Disease Priority Review Voucher Program is intended to encourage development of new drug and biological products for the prevention and treatment of certain rare pediatric diseases. Under this program, upon approval, the US Food and Drug Administration awards priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. The voucher can be redeemed to receive priority review of a subsequent marketing application for a different product. PRVs may be sold or transferred, and there is no limit on the number of times a PRV can be transferred.

On January 6, 2023 AVEO Oncology ("AVEO") (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, reported that at a special meeting of stockholders (the "Special Meeting") held today, AVEO stockholders approved the adoption of the Agreement and Plan of Merger among LG Chem, Ltd. ("LG Chem"), a subsidiary of LG Chem and AVEO (the "merger agreement") (Press release, AVEO, JAN 6, 2023, View Source [SID1234625959]). As previously announced, under the terms of the merger agreement, AVEO stockholders will receive $15.00 per share in cash upon the closing of the transaction.

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"Today’s approval is a significant step toward the completion of AVEO’s transaction with LG Chem, and I thank our stockholders for their strong support," said Michael Bailey, President and Chief Executive Officer of AVEO. "As the U.S. late stage development and commercial foundation for LG Chem Life Sciences’ oncology segment, we believe AVEO will be well positioned to advance its mission of passionately pursuing a better life for patients with cancer."

The final voting results will be reported in a Current Report on Form 8-K to be filed by AVEO with the Securities and Exchange Commission after certification by AVEO’s inspector of elections. The stockholders also approved a non-binding, advisory proposal relating to certain compensation that may be paid or become payable to certain of AVEO’s executive officers that is based on or otherwise relates to the merger between AVEO and LG Chem.

Completion of the transaction remains subject to certain customary closing conditions, including clearance of the transaction by the Committee on Foreign Investment in the United States, and the transaction is expected to close in early 2023.

Advisors

BofA Securities is serving as exclusive financial advisor to LG Chem, and Latham & Watkins LLP is serving as LG Chem’s legal counsel. Moelis & Company LLC is serving as exclusive financial advisor to AVEO, and WilmerHale LLP is serving as AVEO’s legal counsel.

On January 6, 2023 Aura Biosciences presented its corporate presentation (Presentation, Aura Biosciences, JAN 6, 2023, View Source [SID1234625958]).

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On January 6, 2023 Aptose Biosciences presented its corporate presentation (Presentation, Aptose Biosciences, JAN 6, 2023, View Source [SID1234625957]).

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On January 6, 2023 Agilent Technologies, Inc. (NYSE: A) reported a partnership with Akoya Biosciences, Inc. (Nasdaq: AKYA), The Spatial Biology Company, to develop multiplex-immunohistochemistry diagnostic solutions for tissue analysis and to commercialize workflow solutions for multiplex assays in the clinical research market (Press release, Akoya Biosciences, JAN 6, 2023, View Source [SID1234625955]). Integrating Agilent’s Dako Omnis (autostaining instrument) and Akoya’s PhenoImager HT (imaging platform) for multiplex chromogenic immunohistochemistry (mIHC) and immunofluorescent (mIF) assays will create a singular end-to-end commercial workflow, including reagents, staining, imaging, and analysis.

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Agilent and Akoya will partner to develop chromogenic and immunofluorescent multiplex assays that include spatial analysis for biopharma companies developing precision cancer therapeutics. These assay solutions will enable researchers and medical professionals to address patient selection needs of novel therapeutics and rapidly translate their discoveries into clinical testing. Spatial phenotyping using multiplex imaging provides the advantages of single-cell analysis while preserving spatial relationships between the cells. This offers an invaluable tool for uncovering novel insights into cellular organization in the tumor microenvironment and therapeutic response.

This agreement will deliver an end-to-end multiplex solution for biomarker clinical research enabled by digital pathology, providing capabilities across the pharma value chain. Combining Agilent’s companion diagnostic and IHC workflow expertise, the large install base of Dako Omnis instruments, and a strong network of pharma partners; with Akoya’s install base of imagers, spatial analysis expertise, and CLIA lab capabilities will further empower biopharma partners to leverage this integrated workflow solution for their biomarker discovery and validation needs, helping drive better patient stratification. Under a separate Value-Added Reseller agreement, Akoya Biosciences will distribute and resell Dako Omnis as a part of the end-to-end multiplex solution.

"We are delighted to be partnering with Akoya to create industry-leading products and services for multiplex chromogenic and immunofluorescence tissue assays," said Sam Raha, president of Agilent’s Diagnostic and Genomics Group. "This partnership enables an ecosystem that assists the development of novel precision cancer therapeutics and offers a streamlined workflow to our joint customers in the clinical research market to meet the needs of future clinical diagnostics," Raha added.

"Multiplex tissue analysis has the potential to transform the field of cancer therapeutics and usher in a new era of precision pathology," said Brian McKelligon, CEO of Akoya Biosciences. "This partnership and the combined strength of both organizations will catalyze the development and deployment of multiplex tissue-based biomarkers for the benefit of our biopharma and CRO partners and, ultimately, patients."