At the end of this week, congressional scrutiny was weighting down large cap biotech Gilead Sciences, Inc (NASDAQ: GILD) and dragging down much of the biotech sector, but there was still good news surrounding small cap biotech stocks like Endocyte, Inc (NASDAQ: ECYT), Aastrom Biosciences Inc (NASDAQ: ASTM) and TNI BioTech (OTCMKTS: TNIB) plus there were more biotech IPOs which debuted:
Congress Takes Aim at Gilead Sciences and the High Cost of Drugs. A letter from three Democrats on the House's Energy and Commerce Committee requesting a briefing with Gilead Sciences regarding its Sovaldi Hep C drug that the FDA approved back in February helped to send the stock down 4.57% today. The letter stated:
Our concern is that a treatment will not cure patients if they cannot afford it. Reports indicate that Gilead intends to sell Sovaldi at $84,000 per treatment. In cases where Sovaldi is prescribed with other treatments the costs could be even higher.
The letter ends by asking for a briefing no latter than April 3, 2014. However, the letter alone does not appear to be causing any panic among investors as some have apparently decided to trim some of their biotech positions in the wake of a strong run from the sector. The iShares NASDAQ Biotechnology Index ETF (NASDAQ: IBB) lost 4.74% while the SPDR S&P Biotech ETF (NYSEARCA: XBI) lost 4.18%.
26 Biotech IPOs for This Year and Counting. This week, Akebia Therapeutics, Inc (NASDAQ: AKBA) and MediWound (NASDAQ: MDWD) were the latest small cap IPOs to join the biotech IPO party by bringing in $170 million. Specifically, Akebia Therapeutics, which has AKB-6548 working through a Phase IIb trial in patients with anemia secondary to chronic kidney disease, raised $100 million by selling about 5.9 million shares at a top-of-the-range $17 each while Israel based MediWound raised $70 million at the low end of its range to fund Phase III trials for its topical burn treatment, NexoBrid. FierceBiotech noted that these two biotech IPOs make for 26 successful biotech IPOs in the first quarter alone after bullish investors welcomed nearly 40 life sciences companies onto the public markets in 2013.
Endocyte, Inc Surges 92.42%. This morning before the market opened, small cap Endocyte and its partner Merck announced that European Union regulators had said its drug Vynfinit should be approved as a treatment for ovarian cancer plus the company said the drug helped slow the progression of lung cancer. Merck and Endocyte had announced a partnership in April 2012 with the former paying the latter $120 million upfront plus ECYT could get more than $1 billion if Vynfinit is successfully developed as a treatment for multiple types of cancer. Moreover, Cowen and Co. analyst Simos Simeonidis said EU regulators should make a final decision on the drug within three months. He expects them to approve Vynfinit and said the drug should be launched a short time later. Endocyte is up 165.5% since the start of the year, up 186.6% over the past year and up 264.4% since February 2011.
Aastrom Biosciences Rises 70%+ in Two Days on No News. Small cap Aastrom Biosciences, which is developing patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases, surged 30.58% today after rising more than 25% on Thursday. There has been no apparent news but trading volume today was 5.39M verses a daily average of 199,704. The most recent news from Aastrom Biosciences was an earnings report late last week – meaning the big moves yesterday and today appear to be technical in nature. Otherwise, it should be noted that Nick Colangelo, the President and CEO of Aastrom Biosciences, will present at the 2014 Regen Med Investor Day on Wednesday, March 26 at 3:15 pm. Aastrom Biosciences is up 97.2% since the start of the year, down 74.6% over the past year and down 7.3% over the past five years.
TNI BioTech Reports a Couple of Pieces of News. Small cap biotech TNI BioTech, which is working to combat chronic, life-threatening diseases through the activation and modulation of the body's immune system using patented immunotherapy, has had a couple of recent announcements. To begin with, TNI BioTech has announced that the US Patent and Trademark Office (USPTO) has granted a key patent for IRT-101 (MENK) for inducing sustained immune response of T-Cells plus the The Brewer Group, Inc., a global investment advisory firm, announced a new strategic partnership with TNIB to provide tailored services including investment banking advisory as well as government, investor relations and marketing support. Finally, TNI BioTech announced the formation of a new subsidiary called Cytocom, Inc, for the purpose of developing Low Dose Naltrexone (LDN) and Met-enkephalin (MENK). This comes after TNI BioTech spent last year developing a manufacturing and distribution network for sale of LDN into emerging nations and had discussions with the FDA and EMA to begin clinical trials in the United States.
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