BiotechStocks.com issues the following market briefing: US private sector jobs numbers came in higher than expected on Thursday morning. Results from June’s jobs numbers were reported to have grown by 172,000, while economists polled by Reuters forecast an increase of 159,000. These helped fuel the continued bullish sentiment in the market specifically after riskier sectors boosted gains on Wednesday. Stocks in biotech, healthcare, and technology have logged the biggest gains so far in July. Here are several biotechnology stocks posting gains with pipelines of new therapies in or expected to initiate Phase trials ahead of Wall Street’s anticipated gains:
Pluristem Therapeutics Inc. (PSTI) has been highlighted in recent press for its novel use of placenta-based cell therapy products. At the end of June, PSTI reported positive data from preclinical studies of its PLX-PAD cells in the treatment of Duchenne muscular dystrophy. Shares of PSTI have seen a rebound in price after hitting lows of $1.21 on June 21, even moving as high as $1.45 during the last few weeks. Duchenne muscular dystrophy is the most common neuromuscular disorder, and affects roughly one in 3,500 boys that can result in severe disability and even death. With no current cure on the market to date, PSTI’s positive results from a Phase II clinical trial of PLX-PAD as a treatment for muscle injury could prove to be a large step in the direction for an effective therapy.
PSTI is utilizing regulatory programs in the EU and Japan that can actually allow the company accelerated pathways to more near-term commercialization. Using results from two successful Phase I trials in critical limb ischemia, Pluristem was accepted into both regulatory programs (and no other company in the world has been accepted into both programs).
These programs could allow the Company to bypass Phase III trials and tens of millions of dollars in development costs. The Company is slated to initiate pivotal trials in 2016, which could lead to commercialization authorization late 2018 or early 2019.
This month Stonegate Capital Partners initiated coverage on Pluristem and arrived at a valuation range of $5.51 – $6.27, with a midpoint of approximately $6. The combination of a pipeline of products that address large patient populations with critical unmet needs, positive data, strategic dealings with global regulatory agencies along with critical industry partnerships were key factors that lead Stonegate to arrive at this valuation.
OXIS International (OTCQB: OXIS) has been much more active during the last few weeks and is making for a volatile, intra-day mover. The company has made several key announcements that include having the company’s lead cancer therapy candidate OXS-1550 being issued a U.S. Patent. OXIS also released news that it has begun enrolling patients in a Phase 1/Phase 2 trial of its most promising cancer drug, OXS-1550. In addition OXIS received an “Editors’ Choice” Honor from Science Translational Medicine, which was announced at the end of June.
“Our ability to use these targeted immunotherapies allows us to create off-the-shelf drugs that are much more cost-effective than the CAR-T technologies and much less invasive on the patient,” OXIS CEO, Mr. Cataldo said in a recent announcement. “It will also serve a much larger audience at a reduced cost.”
In just a few weeks, OXIS has managed to climb from $0.3001 to $0.45. Yesterday OXIS saw a move past $0.40 during the morning Session. Continued expansion of its current therapies as well as further recognition by industry peers have helped put OXIS in front of a captive audience in the biotech arena.
Anavex Life Sciences Corp. (AVXL) is a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system diseases, pain and various types of cancer. Over more recent weeks this summer, the company has generated much more attention surrounding its lead candidate ANAVEX 2-73 for the treatment of patients suffering from infantile spasms.
The FDA has granted orphan drug status to ANAVEX 2-73 with major importance on the exclusivity that AVXL will have for the next few years. Usually the FDA grants orphan drug status to drug candidates whose treatment of rare diseases affect less than 200,000 patients in the U.S. This status will allow ANAVEX 2-73 to enjoy seven years of market exclusivity in the U.S. upon approval and possibly more importantly will allow the company to receive certain “development and commercial incentives”. This includes priority of consultation with the FDA on clinical studies as well as reduced regulatory fees. Since the beginning of June the stock has seen an aggressive rally in price. Shares of AVXL have managed to move from lows of $3.95 in mid-June to highs of $6.47 this week.
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