17 Jan 5 Promising Stocks In The Stroke Management Industry
An increase in the geriatric population, coupled with a rise in lifestyle diseases such as hypertension, diabetes and coronary cardiac diseases are driving the growth in the stroke diagnostics and therapeutics market not only in the US but in Europe and Asia as well.
The market is expected to attain a size of $36.7 billion by 2023 with a CAGR of 7.4% as per a report by KBV research titled Global Stroke Management Market (2017-2023). An encouraging regulatory environment, innovations in technology and a burgeoning demand for alternative treatment are some other factors that are propelling the growth in the US Ischemic Industry.
An Ischemic stroke occurs when the blood supply to the Brain is blocked due to factors such as Atherosclerosis, rupture of blood vessels etc. 87 % of strokes are Ischemic, making it the 5 largest cause of death in the Unites States. It causes 1 in 20 deaths according to data available on centre for disease control and prevention (CDC).
The treatment for Ischemic Strokes now is restricted to the use of Tissue Plasminogen Activator (TPA) used with Thrombolysis. The narrow therapeutic time window leads to low treatment rates thereby calling for alternative medications or treatment options.
Over 1,000 neuroprotective agents were studied in preclinical stroke research, many with promising results , and close to 200 neuroprotective clinical trials have been completed so far with very little success.
Three new neuroprotective agents (NA-1, BIIB093 and 3K3A-APC) and one stem cell based therapy (MultiStem) targeted at the post-stroke care scenario will be the major drivers of growth in the industry.
Prohibitive treatment costs, non-transparent reimbursement policies and need for innovation are acting as deterrents in realising the true growth potential in this field.
A major challenge is the lack of success in translating the positive results found in animal studies to humans, which gives birth to the view that: ‘everything works in animals but nothing works in humans’. Thousands of neuroprotective agents have proved successful in experimental studies, but none in phase III trials except for t-PA that was approved in 1996 by the FDA.
According to a report by GlobalData the sales of drugs in the AIS market were about $7.2B in 2017 in the 8 major markets. The US was the largest market, with sales of $3.4B, representing 47% of all sales. The highest-selling drug in the market was Roche’s Activase (alteplase), which generated sales of $1.2B in the 8MM in 2017.
With advances in technology, strategic collaborations and innovative approaches to achieving a breakthrough in stroke research, some companies are spearheading a positive change in the industry.
Here are our picks for stocks for emerging companies in the Stoke Management Industry that you should watch out for in 2019.
Diffusion Pharmaceuticals (NASDAQ: DFFN)
Market Cap: 7.66M; Current Share Price: 2.27 USD
Diffusion Pharmaceuticals is emerging as one of the most promising biotechnology companies on the horizon. With its lead drug trans sodium crocetinat ( or TSC) at the forefront of its innovative solutions to varied conditions associated with “Hypoxia” , it has received a shot in its arm as the FDA has recently approved a patent for a phase 2 protocol allowing in-ambulance use oftrans sodium crocetinate (NASDAQ:TSC), in conjunction with Tissue Plasminogen Activator (tPA) for the treatment of stroke, giving Diffusion Pharmaceuticals a potential opportunity to use this combination drug therapy to pioneer a new alternative that could generate $1 billion annually.
In addition, the company is enrolling candidates for its Phase 3 INTACT (Investigation of TSC against Cancerous Tumors) program for treatment of inoperable glioblastoma multiforme (GBM) brain cancer. The company also appointed a new Chief Financial Officer, Mr.William “Bill” Hornung, previously the company’s Chief Business Officer a consummate administrator with over 20 years of experience with companies originating out of University Research communities.
The company declared assets worth $ 23.6 million including cash and cash equivalents of $11.0 million.
In addition to stroke and cancer treatments, the company is also conducting pre-clinical trials for the use of TSC as a potential treatment for cardiac infractions, respiratory diseases and neurodegenerative diseases. Another pre-clinical testing phase for GBM involves the use of RES-529, the company’s PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes.
BioXyTran (OTCPK: BIXT)
Market Cap: 42.55M; Current Share Price: 0.50 USD
BioXyTran is another rising star in the biopharmaceutical industry. The company is dedicated to the development of anti-necrosis drugs using the company’s lead product candidate, BXT-25, used as a resuscitative agent to treat Cardiac CereboVascular Accidents. The company is also foraying into regenerative medicine markets by developing a drug candidate named BXT 252 that has a plethora of wound healing applications. It is actively engaged in addressing unmet medical needs in field of hypoxia induced complications.
It lead drug candidate BXT-25 , a haemoglobin based polymer, that is 5000 times smaller than a red blood cell, can penetrate a blood-clot and reach the brain within 3 minutes. Its FDA approved OXYSENSE Technology allows it to measure oxygen delivery to brain in real-time. BXT-251 , another drug candidate aims to prolong extracorporeal circulation in cases of organ donations that can help them preserve organs for days rather than hours.
The company is at present raising funds for its clinical trials and is looking to build a robust intellectual property portfolio of patent applications and trademarks.
Mr. David Platt, the CEO of BioXyTran, a medicinal and PhD chemist with over 40 years of experience expressed confidence that the company will be able to keep up the positive momentum in 2019 and will be focussed on value creating clinical investigations, forging business development collaborations and planning and initiating an Investigational new drug registration with the FDA according to a press release.
The company has also filed a prospectus for a “Best Efforts No Minimum “offering of 10 million shares of common stock at $1 per share in November 2018.
DiaMedica Therapeutics (NASDAQ: DMAC)
Market Cap: 43.77M; Current Share Price: 3.59 USD
A clinical-stage biopharmaceutical company focussed on unmet medical needs, DiaMedica Therapeutics is committed to the development of novel therapies in the field of neurological and kidney diseases.
Its key drug candidate is DM199 a recombinant (synthetic) human protein, that has been proven to be safe at the clinical trial stages, for treatment of a variety of disorders. DM199 also has potential for use in the treatment of diabetic nephropathy and Acute Ischemic Stroke (AIS).
The company received a FDA approval for its Investigational New Drug Application for initiation of a phase 1b clinical trial of DM199 in Type I and Type II Diabetics suffering from Chronic Kidney Disease (CKD).
It recently offered an IPO of 4,10,000 common shares at $ 4 per share in the US.
It has also entered into a license and collaboration agreement with Ahon pharmaceutical Co Ltd, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co.Ltd which is one of china’s largest pharmaceutical firms. The agreement gives Ahon Pharma exclusive rights to develop and commercialize DM199 for Acute Ischemic Strokes (AIS) in mainland China, Taiwan, Hong Kong, S.A.R and Macau S.A.R.
Biogen (NASDAQ: BIIB)
Market Cap: 66.58B; Current Share Price: 330.47 USD
A pioneer in the Neuroscience industry Biogen is one of the world’s first biotechnology companies spearheaded by a team which includes Nobel Prize winners Walter Gilbert and Phillip Sharp. It focus is on developing novel therapies for neurological and neurodegenerative diseases such as multiple sclerosis, Alzheimer’s, Parkinson’s to name a few. It has introduced the first and the only approved treatment for spinal muscular atrophy.
In its third quarter 2018 financial results, Biogen reported total revenues of $3.4 billion, a 12% increase versus the previous year. During the period, SPINRAZA revenues comprised $224 million in sales in the U.S. and $244 million in sales outside the U.S. The number of commercial patients receiving SPINRAZA grew approximately 11% in the U.S. and about 29% outside the U.S. versus the second quarter of 2018.
“Biogen performed well against our strategic and operational priorities in the most recent quarter,” said Michel Vounatsos, Biogen’s chief executive officer. “Reported revenues grew at a double-digit rate boosted by strong gains from SPINRAZA, our biosimilars business, and OCREVUS royalties versus a year ago. Net income and earnings per share both increased at double-digit rates supported by a lower tax rate and a lower share count. Our core MS business was relatively resilient during the quarter. For SPINRAZA, in the U.S. we saw increased new patient demand among adults. Outside of the U.S., SPINRAZA revenues benefitted from strong patient uptake across a number of geographies, as well as broadening approvals and solid reimbursement patterns.”
It has also entered into strategic partnerships with companies such as C4 therapeutics to investigate the C4T’s novel protein degradation platform to discover and develop potential new treatments for neurological conditions, and Skyhawk Therapeutics, Inc. through which the companies will leverage Skyhawk’s SkySTAR™ technology platform with the goal of discovering innovative small molecule treatments for patients with neurological diseases.
Akebia Therapeutics (NASDAQ: AKBA)
Market Cap: 730.55M; Current Share Price: 6.25 USD
Akebia Therapeutics Inc, merged with Keryx Bio pharmaceuticals, Inc. making it a fully integrated renal company focussed on finding innovative solutions for kidney diseases.
According to John P. Butler, President and Chief Executive Officer of Akebia, “With established renal development, manufacturing and commercial capabilities, strong cash position, a flexible balance sheet and experienced management team, our company is uniquely positioned to capitalize on the significant market opportunity by maximizing the growth of Auryxia® (ferric citrate) and build launch momentum for our Phase 3 product candidate, vadadustat, subject to approval by the U.S. Food and Drug Administration (FDA)”.
The company’s lead drug candidate Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) currently in global Phase 3 development for the treatment of anemia due to chronic kidney disease.
In its third quarter results released in November 2018, Akebia reported a net loss of $ 26.0 million. Collaboration revenue was $53.2 million during the period. It has collaboration agreements with Otsuka Pharmaceutical Co.Ltd related to Europe, China and certain other regions. It ended the 2018 third quarter with cash, cash equivalents and available for sale securities of $390.1 million. It plans to fund its current operating plan through the first quarter of 2020, by means of cost-share funding received as part of the collaboration agreement with Otsuka on a prepaid quarterly basis.
Mozzafarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al., on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation 2016;133(4):e38–360. For 87% stroke statistic.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.