Stock News Staff

Evoke Pharma Inc. (NASDAQ:EVOK) To Submit NDA Application

Evoke Pharma Inc. (NASDAQ:EVOK)

Evoke Pharma Inc. (NASDAQ:EVOK) traded lower after announcing positive top-line results from a comparative exposure pharmacokinetic (PK) study. Shares of the specialty pharmaceutical company fell 6.98% to end Monday’s trading session at $3.20 a share.

Evoke Pharma Inc. (NASDAQ:EVOK)

New Drug Application

The sell-off added fuel to a downtrend that has plagued the stock in recent trading sessions. Evoke Pharma Inc. (NASDAQ:EVOK) has struggled to close above the $4 a share mark on two attempts amidst concerns that an uptrend, which began in August, could be losing momentum. However, the stock has outperformed the overall industry and is up by more than 40% for the year.

The stock is currently rated as a “Strong Buy” by one analyst firm, a “Hold” by three firms, and a “Sell” by one firm, according to data compiled by Zack Investment research

The topline clinical results come from a trial that sought to demonstrate that the company’s proposed novel treatment for diabetic gastroparesis has similar systemic exposure to Reglan Tablets. Buoyed by the positive results, the company intends to submit a New Drug Application (NDA) with a selected dose of Gimoti to the U.S. Food and Drug Administration (FDA). Gimoti is Evoke Pharma Inc. (NASDAQ:EVOK) lead candidate drug for the treatment of symptoms associated with acute and recurrent diabetic gastroparesis. Last month, the company completed subject dosing as part of an ongoing pharmacokinetic study. Results are expected in the fourth quarter.

The company is preparing the NDA application in partnership with RHO, a well-established research organization that that has worked on other successful gastrointestinal NDA submissions

“In the first quarter of 2018, we will submit the NDA with these PK data, as well as safety and efficacy data from five prior Evoke clinical studies in healthy volunteers and patients with diabetic gastroparesis. We believe Gimoti has the potential to become the new standard of care for patients suffering from this debilitating disease,” said CEO David Gonyer.

Q2 Financial Results

Separately, Evoke Pharmaceuticals reported a net loss of (-$1.6) million for the second quarter, nearly half a net loss of (-$3) million reported last year. Net loss in the quarter was partially offset by $1.3 million associated with a change in the fair value of warrant liability.

Research and development expenses in the quarter came in at $2 million compared to $2.1 million reported in Q2, 2016. Evoke Pharma Inc. (NASDAQ:EVOK) had approximately $12.6 million in cash and cash equivalent as of June 30, 2017.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Imprimis Pharmaceuticals Inc (NASDAQ:IMMY)

Imprimis Pharmaceuticals Inc (NASDAQ:IMMY) Rockets on Open!

Imprimis Pharmaceuticals Inc (NASDAQ:IMMY)

Imprimis Pharmaceuticals Inc (NASDAQ:IMMY) shares are rocketing on the back of a press release by the biotechnology company that it is making compounded Cyclosporine-based formulations available for physicians to consider prescribing as customizable, and possibly lower-cost alternative, to Restasis® for sufferers of dry-eye disease. Within 30 minutes IMMY shares jumped over 80% on a volume figure that is over 230 times its daily average.

Imprimis Pharmaceuticals Inc (NASDAQ:IMMY)

Imprimis Pharmaceuticals Inc (NASDAQ:IMMY) is an ophthalmology-focused pharmaceutical company that produces and dispenses high quality innovative medications in all 50 states. The CEO of Imprimis Pharmaceuticals Inc (NASDAQ:IMMY), Mark L. Baum, stated “While there are an estimated 30 million Americans suffering from Dry Eye Disease, only a small fraction of these patients receive therapy. Topical Cyclosporine, which is an off-patent and inexpensive drug, can cost more than $5,000 per year when it is purchased in the commercially available form of Restasis®.”

IMMY Stock Performance

Sales posted by Imprimis Pharmaceuticals Inc (NASDAQ:IMMY) have increased each year since 2014 when it reported a figure of $1.7 million. Bu 2016 sales had improved to $19.9 million. Unfortunately, that uptrend in sales has not been duplicated in earnings. IMMY shareholders have been experiencing losses for the past five years. In 2015, IMMY stock lost (-$1.66) per share. For 2016, the company posted a per share loss of (-$1.50). Also troubling Imprimis investors is the continuing, value-destroying share dilution. In 2012, 4.49 million shares were outstanding. That number grew to 12.74 by 2016.

While IMMY stock is on fire today, the shares have not been doing well. Prior to today, IMMY shares lost over 50% and are down over 66% over the past six months. But the company does not appear to be in financial peril. According to recent reports the biotechnology company has a cash per share figure of $0.21. Analysts rate the shares a “Strong Buy” and assign it a $5.00 price target.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $IMMY and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Infinity Pharmaceuticals Inc. (NASDAQ:INFI)

Infinity Pharmaceuticals Inc. (NASDAQ:INFI) Explodes on Outperform Rating

Infinity Pharmaceuticals Inc. (NASDAQ:INFI)

Shares of Infinity Pharmaceuticals Inc. (NASDAQ:INFI) more than doubled in value after the biopharmaceutical company said it will make a key presentation at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The stock was also up by 123% after analysts at Wells Fargo upgraded the stock to an ‘outperform’.

Infinity Pharmaceuticals Inc. (NASDAQ:INFI)

Wells Fargo Upgrade

Thursday’s rally brought an end to a sell-off that has plagued the stock since April. The stock of Infinity Pharmaceuticals Inc. (NASDAQ:INFI) came under pressure after rising to $3.50 a share, resulting in a drop below $1 a share. Infinity stock is now up by more than 130% for the year, after closing above $3.50.

Analysts at Wells Fargo believe the stock has some room to run on the upside as infinity Pharmaceuticals moves to make a presentation on IPI-549, an orally administered immuno-oncology development candidate.

IPI-549 has the potential to treat a broad range of solid tumors. Wells Fargo analyst Jim Birchenough believes the cancer therapy has a high likelihood of proof of concept data.

” … With likely validation of tumor macrophage targeting in immuno-oncology and a unique mechanism of action, we see upside potential not reflected at current stock price,” Birchenough said.

The analyst has since increased his share price target on the stock from $1 to $5 a share.

Infinity Pharmaceuticals Inc. (NASDAQ:INFI) is to make a presentation on a Phase 1/1b clinical study which is evaluating the safety and activity of IPI-549. The company is investigating the candidate drug as a monotherapy and in combination with Opdivo for patients struggling with advanced tumors. Reports indicate that IPI-549 could be the only P13K-gamma inhibitor in clinical development.

Wider Than Expected Net Loss

Development of IPI-549 and the Wells Fargo update has helped renew investor interest in infinity Pharmaceutical after a wider than expected second-quarter net loss triggered a sell-off. The biopharmaceutical company reported a net loss of (-$0.34) cents a share wider than consensus estimates of a net loss of (-$0.22) cents a share.

Since Infinity Pharmaceuticals Inc. (NASDAQ:INFI) does not have any approved product in the market, it likely needs to get everything right on the development of IPI-549 if it is to continue trading at higher levels. The company did not generate any revenues in the recent quarter compared to collaboration revenues of $9.5 million reported last year – mostly from royalty, license and milestone payments.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $INFI and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Ardelyx Inc. (NASDAQ:ARDX) Drug Thrives In Trials

Ardelyx Inc. (NASDAQ:ARDX)

Shares of Ardelyx Inc. (NASDAQ:ARDX) gained 36.11% in after-hours of trading, after the late-stage company said its experimental drug for irritable bowel syndrome met its primary endpoint. According to the drug developer, Tenapanor met the main goal of reducing abdominal pain and increasing bowel improvements.

IBS-C Treatment Opportunity

The positive clinical trial results could have a significant impact on the stock, especially after the Chief Executive Officer, Mike Raab claimed the results are a game changer for patients with IBS-C. Shares of Ardelyx are in dire need of a catalyst after its price edge lower after coming under pressure in May.  The stock is already down by more than 50% as it continues to trade at multi-year lows.

Ardelyx Inc. (NASDAQ:ARDX)

Investors’ confidence on the stock has taken a hit this year. However, the positive Tenapanor clinical trial results could be the catalyst to renew interest, given that the condition affects more than 11 million people across the United States.

“Based on tenapanor unique mechanism of action, which relies upon the inhibition of sodium absorption, and the exciting data reported today, tenapanor has the potential to be an important advancement and a new treatment option for patients suffering from IBS-C,” said William Chey, M.D., University of Michigan.

The clinical trial results indicate that Tenapanor has significant potential which increases the chances of Ardelyx Inc. (NASDAQ:ARDX) finding the ideal partner to bring it to market. Buoyed by the positive results, Ardelyx plans to submit, in the second half of next year, a New Drug Application (NDA) with the U.S Food and Drug Administration (FDA) for the treatment of IBS-C.

Ardelyx Restructuring

Separately, Ardelyx Inc. (NASDAQ:ARDX) completed a strategic review of its operations in the second quarter as it sought to position itself for multiple opportunities with its late-stage portfolio. The review process has resulted in the prioritization of resources to focus on upcoming milestones for late stage programs.  The company has also reduced its workforce by 28%.

Thanks to cost-saving initiatives, Ardelyx Inc. (NASDAQ:ARDX) remains on track to extend its operating runaway to the end of 2018. During the quarter, the company reported a net loss of (-$25.7) million or (-$0.54) cents a share, compared to a net loss of (-$28.6) million reported a year earlier.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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Strongbridge Biopharma plc. (NASDAQ:SBBP) Rattles Investors

Strongbridge Biopharma plc. (NASDAQ:SBBP)

Strongbridge Biopharma plc. (NASDAQ:SBBP) shares fell 18.7% after the rare disease therapeutic developer announced the pricing of a share offering. The company has priced an underwritten public offering of 4 million ordinary shares at a price of $6.25 a share.

Strongbridge Biopharma plc. (NASDAQ:SBBP)

SBBP Share Offering

The commercial stage biopharmaceutical company has also granted underwriters a 30-day option to purchase an additional 600,000 ordinary shares. Strongbridge Biopharma plc. (NASDAQ:SBBP) expects gross proceeds of $25 million. The offerings should close on or about October 6, 2017, subject to satisfaction of customary closing conditions. Pricing of the offering $6.25 a share also did not go well with investors, as it represented a discount from the previous day closing price of $7.50 a share.

Wednesday’s sell-off pushed the stock to a key support level. However, Strongbridge Biopharma plc. (NASDAQ:SBBP) is still up by more than 100% for the year as it continues to trade in a strong uptrend.

Cash Burn Concerns

The price drop also came on growing concern over the company’s cash burn rate. Strongbridge Biopharma plc. began the year with $67 million in cash – of which it has already burned half. Investors fear that the company may be forced to offer more shares in the future in a bid to keep up with its spending.

Strongbridge Biopharma plc. (NASDAQ:SBBP) intends to use net proceeds from the underwritten public offering to expand commercial opportunities for Keveyis, its FDA approved product for primary periodic paralysis. Purchased from Taro Pharmaceuticals last year, the product generated $1.5 million in the second quarter.

Keveyis expansion could accelerate Strongbridge Biopharma plc. (NASDAQ:SBBP) cash burn over the next several quarters. The company has already indicated that it plans to spend part of the net proceeds from the offering for the development of Recorlev and veldoreotide. There are also plans to carry out acquisitions in addition to technologies that would accelerate topline growth.

Strongbridge Q2 Financial Results

Separately, Strongbridge Biopharma plc. (NASDAQ:SBBP) reported second quarter financial results that met Wall Street expectations. The company reported a net loss of (-$30.2) million or (-$0.34) a share which was in line with analyst’s expectations. Revenue in the quarter totaled $1.5 million compared to analysts’ expectations of $836,000.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $SBBP and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Globus Maritime Ltd (NASDAQ:GLBS)

Globus Maritime Ltd (NASDAQ:GLBS) Drops As Revenues Surge

Globus Maritime Ltd (NASDAQ:GLBS)

Globus Maritime Ltd (NASDAQ:GLBS) shares fell 7.55% after the dry bulk shipping company reported unaudited, consolidated operating and financial results for the first half of the year. Revenues in the first half increased 63% compared to last year.

Globus Maritime Ltd (NASDAQ:GLBS)

Improving Fundamentals

According to the Chief Executive Officer, Athanasios Feidakis, the revenue growth indicates that the company’s efforts are finally bearing fruit. However, it appears investors remain skeptical about the company’s growth prospects.

Globus Maritime Ltd (NASDAQ:GLBS) has underperformed the overall industry even after the recovery of benchmark dry-bulk rates. The stock is down by more than 70% for the year as it continues to trade in a strong downtrend.

However, the Chief Executive Officer remains bullish about the company’s prospects buoyed by the 63% increase in revenues. Globus Maritime Ltd (NASDAQ:GLBS) has also trimmed its debt by about 30%, a further indication of bottom-line growth. Recovery in benchmark dry-bulk rates has allowed Global Maritime to hire its vessels out at a much higher rate.

“We are hoping to see a further improvement of the market fundamentals in the medium term future. We remain cautiously optimistic, and are following the market closely in our undertaking to best serve our clients and shareholders,” said Mr. Feidakis

Globus Financial Results

For the three months ended June 30, 2017, Globus Maritime Ltd (NASDAQ:GLBS) generated a net loss of (-$1.4) million or (-$0.05) a share, less than half a net loss of (-$2.9) million reported last year. The company attributes the decrease in net loss to an 80% increase in voyage revenues that came in at $3.6 million. Vessel operating expenses were down by $0.1 million or 5%.

For the first six months of the year, net loss totaled (-$3.7) million or (-$0.17) a share, compared to a net loss of (-$4.6) million for the corresponding period last year. Voyage revenue over the period was up 66% to $6.3 million as vessel operating expenses remained flat at $4.3 million.

Separately, an investor holding warrants, originally issued under February 2017 private placement, has exercised their right to purchase 500,000 shares of the company’s common stock at a price of $1.60 a share.

“We are pleased to have strengthened our balance sheet by $800,000. We consider this evidence of our investors’ support for our relentless efforts to move forward,” said Mr. Feidakis.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $GLBS and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

Tantech Holdings Ltd (NASDAQ:TANH)

Tantech Holdings Ltd (NASDAQ:TANH) Issues Shares To Institutional Investors

Tantech Holdings Ltd (NASDAQ:TANH)

Chinese clean energy firm Tantech Holdings Ltd (NASDAQ:TANH) has disclosed that it has signed a securities acquisition deal with a number of institutional investors. Shares of Tantech Holdings consequently fell by 32.94%. Under terms of the deal, Tantech Holdings will receive $6.5 million in a direct placement. Each common share will be priced at $3.45 and investors will be issued 1,891,307 shares. Additionally, investors will also receive warrants which will allow them to acquire 945,655 common shares at $4.25 a share.

Tantech Holdings Ltd (NASDAQ:TANH)

Tantech Holdings Ltd (NASDAQ:TANH) will use the proceeds of the offering for general corporate purposes. It is expected that the placement could be completed on September 29, 2017 if customary closing conditions are met.

Electric vehicles

Tantech Holdings Ltd (NASDAQ:TANH)’s securities purchase agreement comes barely over a week since the Chinese clean energy firm announced that its motor vehicle subsidiary had obtained $20 million in sales contracts for electric buses and vans.

“This new sales contract, along with the recent MIIT approval of two of our EV models, laid a solid foundation for us to gain market share in the fast growing Chinese EV segment,” said the Chief Executive Officer and chairman of Tantech Holdings Ltd (NASDAQ:TANH), Zhengyu Wang.

The sales contracts are for the purchase of 10 electric buses and 450 electric. Tantech also revealed that the buyer had made a deposit in order to lock in the price. The buyer will also be required to pay about 30% of the sales price November 2, 2017. The balance is to be paid upon delivery which is expected before the end of this calendar year.

Leading market

Both the electric van and the electric bus have received the approval of the Chinese authorities. The van, suited for tourist uses and airport transportation, has a capacity of 34 passengers while the bus is suited for urban transportation and has a capacity of 46 passengers. Both the electric bus and the electric van possess a driving range of 155 miles or 250 kilometers on a single charge.

The Chinese motor vehicle market is enormous and growing at a fast rate. Last year more than 28 million automobiles were sold and this number is expected to rise to an annual figure of 40 million motor vehicles within three years. This rapid growth has led to massive air pollution that is associated with internal combustion engines and the government has been keen to respond by developing the electric car sector.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $TANH and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Versartis Inc.(NASDAQ:VSAR)

Why Versartis Inc.(NASDAQ:VSAR) Collapsed

Versartis Inc. (NASDAQ:VSAR)

Versartis Inc.(NASDAQ:VSAR) shed more than 87% of its market value after announcing that its novel treatment for growth hormone deficiency (GHD), did not meet primary endpoints in a Phase 3 trial.

Stock Performance

Versartis Inc. (NASDAQ:VSAR) is currently trading at multi-year lows after breaking a key support. Investor’s sentiments have turned sour following the disappointing clinical trial results seen by the stock registering a new 52-week low of $2.60 a share.

Versartis Inc.(NASDAQ:VSAR)
One month VSAR stock price chart

Investors had high hopes that Somavaratan would do better in the trials than existing treatment, Genotropin. However, the trial results indicate that the drug registered statistically significant inferiority thus the reason why Wall Street pushed the stock lower on huge volumes.

“We are very surprised and disappointed to learn the outcome of the VELOCITY trial. Somavaratan showed height velocity in the range we had hoped, but it was not sufficient to demonstrate non-inferiority in this trial,” stated Jay Shepard, President, and CEO of Versartis Inc. (NASDAQ:VSAR).

The disappointing results all but complicates the regulatory pathway for the novel treatment. However, the candidate drug was well tolerated with a much lower discontinuation rate than Genotropin. The trial did not register any safety concerns.

News of Versartis Inc. (NASDAQ:VSAR) disappointing trial results sent Ascendis Pharma A/S (NASDAQ:ASND) shares up by more than 20% as it is also developing a human growth hormone therapy for children. The pharmaceutical company is currently enrolling patients in a late-stage trial, ahead of two planned trials. Results from the proposed trials should be out in the second half of next year.

Versartis fate on Wall Street, following the disappointing growth hormone trial, hangs in the balance. Investors may have to wait a little bit longer as the company says it will issue a guidance later in the year in the wake of disappointing Somavaratan trial results.

Q2 Earnings

Versartis Inc. (NASDAQ:VSAR) has been under immense pressure in recent weeks especially after posting a wider than expected second-quarter net loss of (-$36.6) million compared to (-$22.1) million in Q2 2016. Operating expenses for the quarter, ended June 30, 2017, surged to $36.2 million from $22.3 million the prior year as research and development expenses nearly doubled to $28.6 million from $16.4 million posted last year.

Versartis exited Q2 with cash and cash equivalent of $143.4 million.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $VSAR and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Mediwound Ltd (NASDAQ:MDWD) Slumps 17%

Mediwound Ltd (NASDAQ:MDWD)

Shares of Mediwound Ltd (NASDAQ:MDWD) fell 17.36% after the Israeli-based company announced an underwritten public offering of 4.4 million shares, priced at $5 a share. The company has also granted underwriters warrants for the purchase of additional 660,000 shares.

Mediwound Ltd (NASDAQ:MDWD)
One month MDWD stock price chart

MediWound’s Sell-Off

Tuesday’s slump added fuel to a sell-off wave that started in June. The stock has already shed more than 30% in market value as it continues to trade in a downtrend. It is currently trading in a $4.95- $5.30 trading range, levels last seen at the start of the year.

Investors pushing the stock lower does not come as a surprise as it underscores growing concerns that the public offering will burden the company with more debt. Stock dilution with the issuance of additional shares is another concern that continues to affect Mediwound Ltd (NASDAQ:MDWD)’s Sentiments on Wall Street.

Mediwound Ltd (NASDAQ:MDWD)’s expects gross proceeds of $22 million from the underwritten public offering, before the deduction of underwriting discounts, commissions, and other expenses. The offerings should close on or about September 21, 2017.

Mediwound Q2 Financial Results

The biopharmaceutical company reported a second quarter net loss of (-$4.5) million, an improvement from a net loss of (-$7.5) million reported last year. The company attributes the improved performance to a decrease of $3 million in operating expenses.

Revenue in the quarter was up by 93% to $0.69 million compared to $0.36 million reported in Q2 2016. Gross profit in the quarter stood at $0.2 million compared to a gross loss of (-$0.2) million in Q2 2016. Mediwound Ltd (NASDAQ:MDWD) exited the first half of the year with cash and short term deposits of $20.9 million and a working capital of $20.9 million.

NexoBrid $132 Million Funding

During the quarter the U.S Biomedical Advanced Research and Development Authority reiterated its commitment to continue funding research and development of Mediwound Ltd (NASDAQ:MDWD) NexoBrid indications. NexoBrid is MediWound’s proprietary pharmaceutical product for the removal of deep-partial and full-thickness thermal burns.

“In our second quarter, we continued to make progress in our commercial and clinical programs for NexoBird and EscharEx. We are thrilled with BARDA’s increased commitment to NexoBrid. This non-dilutive funding, totaling up to $132 million, provides significant support for our clinical development and manufacturing programs for several years,” said CEO Gal Cohen.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $MDWD and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Pluristem Therapeutics Inc. (NASDAQ:PSTI) Granted Fast Track Designation

Pluristem Therapeutics Inc. (NASDAQ:PSTI)

Pluristem Therapeutics Inc. (NASDAQ:PSTI) shares jumped 5.97% after the U.S. Food and Drug Administration granted it Fast Track Designation for its novel treatment for Critical Limb Ischemia(CLI) PLX-PAD. The designation increases the chances of the company enjoying an expedited review process.

Pluristem Therapeutics Inc. (NASDAQ:PSTI)
One month PSTI stock price chart

Investors Reactions

News of the FDA designation had initially pushed the stock to highs of $1.60 a share before it dropped to end the day at $1.42 a share. The rally helped affirm a bullish run that began early in the month after the stock fell to $1.10 a share. The stock faces immediate resistance at the $1.45.

PLX-PAD Prospects

Investor sentiments on Pluristem Therapeutics Inc. (NASDAQ:PSTI) are entirely based on the PLX-PAD treatment which is currently undergoing Phase 3 CLI study in the US and Europe. The European Medicine Agency has already included the candidate drug on its Adaptive Pathway Program, a further testament to its growing credibility as a novel treatment for CLI.

Japan’s Pharmaceuticals and Medical Devices Agency has also accorded PLX-PAD accelerated regulatory pathway. The agency has designed a single study that if successful will lead to early conditional marketing approval and reimbursement.

“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease,” said CEO Yaky Yanay.

PLX-PAD is seen as an alternative treatment that will help solve the needs of up to 40% of CLI patients who are at a high risk of amputation within the first year of diagnosis. PLX-PAD is thus seen as a valuable asset for Pluristem given that the disease costs the US $25 billion in healthcare costs annually

Financial Update

Separately, Pluristem has provided an update for its fourth quarter and fiscal 2017 for the period ended June 30, 2017. The company says it made significant advancement on its clinical development pipeline in addition to receiving $19 million in non-dilutive funding during the period

Pluristem Therapeutics Inc. (NASDAQ:PSTI) exited the FY2017 with cash and cash equivalents of $26.7 million after having conducted a public offering that raised $15.7 million in net proceeds.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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