Bioblast Pharma Ltd. extended the 2014 initial public offering (IPO) window, filing an F-1 with the SEC seeking to raise up to $37.5 million and a listing on the Nasdaq Capital Market. The Tel Aviv firm filed as an emerging growth company under the Jumpstart Our Business Startups Act of 2012.
For nearly two decades, scientists have appreciated the healing power of nitric oxide (NO), a free radical that garnered researchers at three U.S. institutions the 1998 Nobel Prize in Physiology or Medicine for their discoveries involving NO as a signaling molecule in the cardiovascular system. Despite its promise, NO’s potential has been limited by the fact that the substance is gaseous and highly reactive, confounding the ability of drug developers to store and deliver it safely in the right amount, to the right location and at the right time.
Alcobra Ltd. didn’t set out to address attention deficit hyperactivity disorder (ADHD), an indication with a number of approved drugs – including Ritalin (methylphenidate, Novartis AG), Concerta (a different formulation of methylphenidate, Johnson & Johnson) and Adderall XR (d-amphetamine, Shire plc) – as well as spectacular failures. Instead, the company was formed in 2008 by several Israeli entrepreneurs to pursue a drug that would induce rapid sobriety for social drinkers by quickly reducing blood alcohol levels – thus, the mashup of “alcohol” and “sobriety” in its name.
As expected, Gilead Sciences Inc. reported robust revenues for the fourth quarter of 2013, up 21 percent to $3.12 billion from $2.59 billion for the same period a year earlier. Total revenues for the full year were $11.2 billion, up 15 percent compared to $9.7 billion a year earlier, on record product sales of $10.8 billion – a 15 percent year-over-year increase.
Less than a year into their drug development partnership, privately held Edison Pharmaceuticals Inc. and Japan’s Dainippon Sumitomo Pharma Co. Ltd. (DSP) bulked up the deal, inking a potential $4.295 billion strategic alliance that vastly expands their pursuit of drugs targeting cellular energy metabolism.
Anyone who thought Gilead Sciences Inc. had the hepatitis C virus (HCV) market sewn up with the December 2013 FDA approval of once-daily oral nucleotide analogue sofosbuvir, branded Sovaldi, isn’t taking the long view. Sovaldi is off to a roaring start but, as Leerink Partners LLC analyst Howard Liang observed in a recent HCV industry update, “by our count there are a total of 19 interferon (IFN)-free regimens for which some sustained virological response (SVR, viral cure) data are available.”
Shares of Kalobios Pharmaceuticals Inc. fell by as much as one-third Thursday morning, to a 52-week low of $3.15, after the company disclosed following Wednesday’s market close that its Phase II study of KB003 missed the primary endpoint of improving FEV1 in patients with severe asthma, compared to placebo.
Although Tunitas Therapeutics Inc. has its namesake in California’s Tunitas Creek, which meanders from the Santa Cruz Mountains to the Pacific Ocean, the company’s progress has been anything but a long and winding road.
Shares of Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) climbed steadily on Tuesday after the company disclosed that it plans to sell 16.4 million shares of common stock at $6.50 apiece to entities managed by the Baupost Group LLC. The hedge fund increased its stake in Idenix from 27 percent to approximately 35 percent of outstanding shares.
Nearly 18 months after its launch by the FDA, the breakthrough therapy designation (BTD) is showing the potential to meet the agency’s stated goal of speeding the development and review of drugs that show early evidence of offering substantial improvement over existing therapies on a clinically significant endpoint.