Neurophage Pharmaceuticals Inc. moved one step closer to an investigational new drug filing and the initiation of human studies for lead candidate, NPT088, with the completion of a $17 million series D.
Since launching in Tokyo in 2006, followed by the establishment of a U.S. subsidiary a year later, Regimmune Corp. has endured both financial and natural disasters: the meltdown of the global capital markets and the Tōhoku earthquake and tsunami.
Versartis Inc. turned heads with its Wall Street debut, pricing its initial public offering (IPO) at $21 – the high end of a range expanded just two days earlier – to raise $126 million. But the IPO didn’t whet the appetite of investors.
History repeated itself for Agenus Inc. six months after Glaxosmithkline plc’s (GSK) phase III DERMA trial of its MAGE-A3 cancer immunotherapeutic, formulated with Agenus’ QS-21 Stimulon adjuvant, missed its primary endpoint of extending disease-free survival (DFS) in melanoma. This time, the culprit was non-small-cell lung cancer (NSCLC).
The bulls marched on as Alder Biopharmaceuticals Inc. joined the growing queue of biotechs seeking to prevail on the public markets. The Bothell, Wash.-based company filed a registration statement with the SEC seeking to raise up to $115 million in its initial public offering (IPO) to fund its ongoing clinical program for lead compound ALD403, a monoclonal antibody targeting calcitonin gene-related peptide, or CGRP, to prevent migraine headache.
No matter what the cause – cluster headaches, migraines, cancer, nerve damage, temporomandibular joint disorder, trigeminal neuralgia or another disorder – chronic head pain remains among the most vexing of medical conditions for patients and the most daunting of challenges for scientists. Over-the-counter remedies that may help acute conditions often are ineffective for chronic pain, and opioids that can relieve pain come with serious downsides.
Despite the mandate in section 907 of the FDA Safety and Innovation Act of 2012 (FDASIA) that the FDA seek the inclusion of demographic “subgroups” in clinical trials, both the agency and drugmakers have struggled to improve participation rates among historically underrepresented populations, especially African Americans and Hispanics.
Should investors run from a biotech stock that blows up, taking a one-day dive of 25 percent or more? Or should they add more shares? What about jumping aboard the biotech pop-ups – the companies that see a gain of 25 percent or more in a single day?
Despite pricing its initial public offering (IPO) at the bottom of the range, Achaogen Inc. enjoyed a strong debut Wednesday on the Nasdaq Global Market. Trading under the ticker AKAO, shares opened at $12.85 but quickly moved above the price range, hitting $14.48 by midday before closing at $14.31. Approximately 3.2 million shares changed hands.
Five months after an upsized follow-on offering brought in $120 million and in the midst of preparing its new drug application (NDA) to the FDA for ATX-101, Kythera Biopharmaceuticals Inc. pulled off a crafty reacquisition of global rights for the aesthetic candidate from Bayer Healthcare’s Consumer Care Division, a unit of Bayer AG, of Leverkusen, Germany.
