MammaPrint is an FDA-cleared microarray-based test that uses expression levels of the 70 MammaPrint genes to assess distant recurrence risk in early-stage breast cancer. The prospective RASTER study proved that MammaPrint Low Risk patients can safely forgo chemotherapy, which is further subject of the prospective randomized MINDACT trial. While MammaPrint diagnostic results are obtained from mini-arrays, clinical trials may be performed on whole-genome arrays. Here we demonstrate the equivalence and reproducibility of the MammaPrint test. MammaPrint indices were collected for breast cancer samples: (i) on both customized certified array types (n = 1,897 sample pairs), (ii) with matched fresh and FFPE tissues (n = 552 sample pairs), iii) for control samples replicated over a period of 10 years (n = 11,333), and iv) repeated measurements (n = 280). The array type indicated a near perfect Pearson correlation of 0.99 (95 % CI: 0.989-0.991). Paired fresh and FFPE samples showed an excellent Pearson correlation of 0.93 (95 % CI 0.92-0.94), in spite of the variability introduced by intratumoral tissue heterogeneity. Control samples showed high consistency over 10 year’s time (overall reproducibility of 97.4 %). Precision and repeatability are overall 98.2 and 98.3 %, respectively. Results confirm that the combination of the near perfect correlation between array types, excellent equivalence between tissue types, and a very high stability, precision, and repeatability demonstrate that results from clinical trials (such as MINDACT and I-SPY 2) are equivalent to current MammaPrint FFPE and fresh diagnostics, and can be used interchangeably.

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On May 23, 2016 Arbor Pharmaceuticals, LLC (Arbor) and XenoPort, Inc. (XenoPort) (NASDAQ:XNPT) announced today that they have signed a definitive agreement under which Arbor will acquire XenoPort for $7.03 per share in cash, or a total equity value of approximately $467 million (Press release, Arbor Pharmaceuticals, MAR 23, 2016, View Source [SID1234523639]). The purchase price per share represents a 60 percent premium to the closing price of XenoPort shares on May 20, 2016.

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"We are pleased to be adding HORIZANT and the XenoPort pipeline to the growing portfolio of Arbor products," said Ed Schutter, President and Chief Executive Officer of Arbor. "We believe that XenoPort’s lead product HORIZANT offers patients and physicians a valuable treatment option for moderate-to-severe primary restless legs syndrome and postherpetic neuralgia. The XenoPort sales team has done an excellent job of growing HORIZANT, and we look forward to supporting them to continue this significant momentum."

Vincent J. Angotti, Chief Executive Officer of XenoPort, stated, "This transaction provides immediate and substantial value to our stockholders, and we believe that Arbor is well positioned to provide the proper resources for a more expanded commercialization effort of HORIZANT. We evaluated many potential options to maximize the value for stockholders and believe this transaction represents a great outcome for XenoPort stockholders."

Under the terms of the agreement, Arbor will commence a tender offer to purchase all of the outstanding shares of XenoPort for $7.03 per share. Following the closing of the tender offer, the agreement provides for the parties to effect, as promptly as practicable, a merger that would result in all shares not tendered in the tender offer being converted into the right to receive $7.03 per share in cash. The transaction, which has been unanimously approved by both the Arbor Board of Directors and the XenoPort Board of Directors, is expected to close in the third quarter of 2016.

Closing of the tender offer and merger is subject to certain customary conditions, including the tender of more than 50 percent of all outstanding shares of XenoPort. The transaction is also subject to review by the U.S. Government under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, as amended, and other customary closing conditions.

Centerview Partners is serving as exclusive financial advisor to XenoPort, and Weil, Gotshal & Manges LLP is serving as legal advisor to XenoPort. Deutsche Bank has provided sole committed debt financing to Arbor in support of the transaction. Alston & Bird, LLP and Simpson, Thacher & Bartlett LLP acted as legal advisors to Arbor.

On March 23, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported the closing of its previously announced underwritten public offering of 9,100,000 shares of its common stock and warrants to purchase up to an aggregate of 6,825,000 shares of its common stock at a combined public offering price of $0.75 per share and related warrant (Press release, Heat Biologics, MAR 23, 2016, View Source [SID:1234509847]). Each share of its common stock was sold together with a warrant to purchase 0.75 of a share of its common stock. The gross proceeds from this offering were approximately $6.8 million, before deducting the underwriting discount and estimated offering expenses payable by Heat, but excluding proceeds from the exercise of any warrants.

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Heat intends to use the net proceeds from the offering to complete its Phase 2 clinical trial evaluating HS-410 for the treatment of non-muscle invasive bladder cancer (NMIBC), which remains Heat’s primary focus. The remaining net proceeds are expected to be used to advance the current eight patients enrolled in Heat’s Phase 1b clinical trial evaluating HS-110 for the treatment of non-small cell lung cancer (NSCLC) through the reporting of topline data, as well as for licensing or acquisition of assets complementary to its existing programs and for general corporate and working capital purposes.

Roth Capital Partners and Aegis Capital Corp. acted as joint book-running managers and Noble Financial Capital Markets acted as co-manager for this offering.

The shares of common stock and warrants described above were offered pursuant to a registration statement on Form S-1 that was declared effective by the U.S. Securities and Exchange Commission on March 17, 2016 and a related automatically effective registration statement on Form S-1 filed pursuant to Rule 462(b) of the Securities Act of 1933, as amended.

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

On March 22, 2016 Eiger BioPharmaceuticals, Inc. (NASD: EIGR) reported completion of its merger with Celladon Corporation effective March 22, 2016 (Filing, 8-K, Celladon, MAR 23, 2016, View Source [SID:1234509850]). In connection with the merger, Celladon changed its name to Eiger BioPharmaceuticals, Inc. The combined company will commence trading as of the open of market March 23, 2016 on The NASDAQ Global Market under the symbol "EIGR."

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Prior to the merger, Eiger received gross proceeds of $39.5 million, including the conversion of $6.0 million in aggregate principal amount under, and all interest accrued on, convertible promissory notes of Eiger, in new investment from a combination of certain current and new investors in Eiger, including HBM Healthcare Investments, Vivo Capital, InterWest Partners, RA Capital Management, Sabby Management, Sphera Global Healthcare, Perceptive Advisors and Monashee Capital Partners. Together with approximately $26.1 million in available, pre-merger cash on Celladon’s balance sheet, the combined company has approximately $59 million in cash available before the payment of transaction and other fees.

"We are very pleased to complete this merger, which marks a significant milestone for Eiger. We are transitioning from a private company to a publicly-traded company through this merger, and significantly increasing our financial resources," said David Cory, President and CEO of Eiger. "These funds are expected to support operations and enable us to advance all four Phase 2 Orphan Disease programs."

Following the previously announced financing and merger and 1-for-15 reverse stock split of its outstanding common stock in connection with the merger, the combined company has approximately 7.0 million shares of common stock outstanding.
Jefferies LLC acted as lead placement agent, Piper Jaffray acted as placement agent and Oppenheimer acted as financial advisor on the financing. Additionally, Jefferies LLC acted as lead financial advisor and Piper Jaffray acted as financial advisor on the merger.

(Filing, Annual, Rosetta Genomics, 2015, MAR 23, 2016, View Source [SID:1234509916])

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