Hyperion Therapeutics Inc. broadened its orphan disease pipeline in a big way by inking an agreement to acquire Andromeda Biotech Ltd., an Israel-based subsidiary of Clal Biotechnology Industries Ltd., in a carefully crafted deal that links much of the economics to back-end milestones.
Spectrum Pharmaceuticals Inc. looked toward another win in its late-stage pipeline as Captisol-enabled (propylene glycol-free) melphalan met the primary endpoints in a pivotal phase II safety and efficacy study. The company plans to file a new drug application (NDA) in the third quarter under the 505(b)(2) pathway for the high-dose intravenous formulation of CE melphalan as a conditioning treatment in autologous stem cell transplantation (ASCT) in multiple myeloma.
Evoke Pharma Inc. enrolled the first patient in the phase III trial of EVK-001, its intranasal formulation of metoclopramide, to treat symptoms associated with acute and recurrent diabetic gastroparesis in women. Founded in 2007, the Solana Beach, Calif.-based specialty pharma has remained laser-focused on the development of its only product, which the FDA agreed to review on the basis of a single pivotal trial.
Zafgen Inc. defied recent trends to downsize biotech initial public offerings (IPO) by filing with the SEC to seek a raise of up to $86.25 million, excluding overallotments. If the offering amount stands, Zafgen would slide into a tie with Radius Health Inc. for third place among 22 biotechs sitting in the IPO queue, according to BioWorld Snapshots, behind Alder Biopharmaceuticals Inc. and Intra-Cellular Therapies Inc., which filed to raise $115 million apiece.
In Greek mythology, Telephus was a son of Heracles who received a wound in battle that would not heal until he returned to the Greek warrior, Achilles, who had inflicted the injury. He was healed by the very spear that had pierced him.
The good news for Vital Therapies Inc. is that the company managed to eke out its initial public offering (IPO) despite the recent selloff in biotechnology stocks. The bad news is that Vital, like two other April graduates, slashed its price to get out the door. The San Diego-based firm raised $54 million, with most of the proceeds slated to fund late-stage trials of Elad, its human cell-based bio-artificial liver system.
Although the amounts are shrinking, biotechs are still seeking to squeeze through the initial public offering (IPO) window. After three filings last week in the hunt for a combined raise of $174 million, Angion Biomedica Corp. registered Monday with the SEC seeking up to $35 million, including overallotments.
Neostem Inc. set its sights on the hot cancer immunotherapy market with an agreement to acquire California Stem Cell Inc. (CSC) through a stock transaction. The New York-based cell therapy company, whose most advanced program, AMR-001, is a chemotactic hematopoetic stem cell product to treat damaged heart muscle following heart attack, moves melapuldencel-T, an autologous stem cell immune-based therapy, to the head of the class and takes on the challenge of a phase III trial with the CSC buy.
When investors think about funding investigative treatments for sleep apnea, the last thing they're likely to consider is a pill. But that's exactly what Galleon Pharmaceuticals Inc. is pursuing for the indication, which is estimated to affect up to 40 million individuals in the U.S. and 100 million worldwide.
Autism is on the rise, for reasons that continue to baffle researchers. The growing prevalence – an estimated one in 68 children is affected with autism spectrum disorder (ASD), according to recent data from the Centers for Disease Control and Prevention (CDC) – is all the more worrisome considering that most drug development efforts in autism have been dismal failures.
