NEW YORK (GenomeWeb) – Myriad Genetics announced this week that it has signed a commercialization plan with Pfizer, under an existing companion diagnostic agreement in which Myriad is pursuing US Food and Drug Administration approval for its BRACAnalysis CDx to be used as a companion diagnostic with Pfizer's investigational PARP inhibitor talazoparib. Under the terms of the commercialization plan, each company will remain responsible for the commercialization of its respective product, but they will collaborate on certain commercial activities intended to support the use of the BRACAnalysis CDx in identifying patients for potential treatment with talazoparib following FDA approval.
Talazoparib and BRACAnalysis CDx currently are under FDA review based on results from the EMBRACA trial, which evaluated talazoparib versus physician's choice chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Myriad said it anticipates a regulatory decision from the FDA by December 2018.
Guardant Health said this week that it closed its initial public offering of approximately 14.4 million shares of its common stock at $19 per share, raising gross proceeds of about $273.1 million. The number of shares offered included the exercise in full of the underwriters’ option to purchase an additional 1.9 million shares of the company’s stock. JP Morgan and BofA Merrill Lynch were joint book-running managers for the offering. Cowen, Leerink, and William Blair were comanagers.
Personalis said this week that it has received an extension to its contract with the US Department of Veterans Affairs to sequence an additional 34,000 genomes for the VA's Million Veteran Program, bringing the total number of genomes sequenced by the company under the contract to almost 80,000. Personalis won its first contract with the VA MVP in 2012.
Premaitha Health this week reported that its revenues for the first half of 2018 rose 45 percent year over year to £3.9 million ($5.1 million). Premaitha will publish its full H1 results on or before Dec. 3.
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