Spark Therapeutics Inc. got the jump on what one analyst called "a defining year in gene therapy" with a deal that brought $20 million from Pfizer Inc. and includes the potential for as much as $260 million in milestone payments, as the pair strives for new therapies against hemophilia B.
With positive top-line phase IIa/b results disclosed last month and another phase II trial under way with its pain candidate, TRV130, Trevena Inc. priced a public offering for gross proceeds of about $45 million, selling about 11 million shares at $4 each in a deal expected to close Wednesday.
Aiming to cover the landscape of hyperoxaluria – overproduction of oxalate in the kidneys, which can lead not only to painful stones but also, in other forms, complications as serious as end-stage renal disease – Allena Pharmaceuticals Inc. raised $25 million in a series B financing.
Taking what CEO Adam Grossman called "a different spin on intravenous immunoglobulin [IVIG]" while "trying to provide a product that's very targeted, niche-focused, and is going to provide an advantage to a subset" of the patient population, Adma Biologics Inc. reported positive top-line phase III results in primary immune deficiency diseases (PIDD) with lead compound RI-002.
The takeout speculation prompted by Avanir Pharmaceuticals Inc.'s patent victory earlier in the year came to pass in the form of an agreement with Otsuka Pharmaceutical Co. Ltd. under which the Tokyo-based pharma will pay $17 per share in cash, or about $3.5 billion, in a deal expected to close in the first quarter of next year.
Though doubtless pleased with Nuedexta, Avanir Pharmaceuticals Inc.'s approved therapy for pseudobulbar affect (PBA), Otsuka Pharmaceutical Co. Ltd. may have been playing it safe with regard to chances in the lucrative Alzheimer's disease (AD) agitation market, offering $17 per share in cash, or $3.5 billion, in the buyout expected to close during the first quarter of next year.
As expected, the FDA hit Avanir Pharmaceuticals Inc. late Wednesday with a complete response letter (CRL) related to the new drug application (NDA) for AVP-825, a drug-device combination product consisting of low-dose sumatriptan powder, delivered intranasally with a breath-powered delivery technology for the acute treatment of migraine.
Half of the more than 100 firms targeted by a group of hackers out to intercept confidential data regarding potentially market-moving disclosures are biotech companies, according to a new report by the Milpitas, Calif.-based security firm FireEye.
The approval this fall of Merck & Co. Inc.'s lauded Keytruda (pembrolizumab) for melanoma – well ahead of its Oct. 28 PDUFA date – opened the door for the promising class of programmed cell death-1 (PD-1) inhibitors, and represented another stride in the steady march of immunotherapy in cancer.