Pluristem (PSTI) gains on the treatment of first patient suffering from COVID-19 complications with its cell therapy.

News that Haifa, Israel-based Pluristem Therapeutics (PSTI) has seen some success treating COVID-19 patients with "PLacental eXpanded" (PLX) cells sparked a 9.5% stock rally on Wall Street Thursday, and prompted a positive note from investment bank H.C. Wainwright.As analyst Swayampakula Ramakanth stated in his "first take" note published Thursday, the bank is maintaining a "buy" rating and $15.50 price target on Pluristem stock following that company's publishing of an update on the progress of a handful of "compassionate use" coronavirus patients in the U.S. and Israel. But is the data from this study really good enough to justify a "buy" rating on this stock? Let's look at the details.Pluristem's update, also released Thursday, discusses the status of 18 patients who have been treated with Pluristem's PLX cells, and in particular, focuses on the progress of the eight of those patients (i.e. less than half) who have "so far have completed a 28-day follow up period."As Pluristem relates: * "The survival rate of the 8 patients treated with PLX cells was 87.5%. (Translation: One patient died; seven did not). * "75% were off mechanical ventilation." (Which is to say, six were able to be taken off ventilators, but two were not). * And "62.5% were discharged alive from the hospital." (That's five who got out of hospital. Three more are still in).Viewed in this context, you can see how extremely small this patient population is, and how easily a different outcome for just one or two patients would be enough to dramatically shift the success percentages that Pluristem boasts of. Nevertheless, the headline numbers at least look good, and they were good enough to get Dr. Swayampakula to double down on his endorsement of the company yesterday.Why? As Swayampakula noted, "according to recently published studies conducted in major referral hospital networks in New York City, the survival rate was merely 12% among ventilator-dependent COVID-19 patients, and only 9% ventilator-dependent COVID-19 patients were able to come off ventilator support." Furthermore, as Pluristem itself points out, just "in data published in the NY area during March-April 2020 ... [only] 3.3% (38 out of 1151 patients) ... [of] patients requiring mechanical ventilation [were ultimately] discharged alive."And viewed in that context, it may not really matter how statistically significant Pluristem's results have been so far. The mere chance that Pluristem's treatment will improve upon that 3.3% survivability figure should be enough to allow the company's treatment to advance to Phase II clinical trials -- and keep the stock trending up even in the absence of revenues for Pluristem.Speaking of which, this is precisely what seems about to happen. As Pluristem confirms, the FDA has cleared the company to proceed to Phase II testing. And as Swayampakula clarifies, this next study should be much more comprehensive and statistically significant. As many as "140 ventilator-dependent COVID-19 patients" will take PLX at "three different dose levels," and their progress will be compared to that of other patients in a "randomized, double-blind, placebo-controlled trial," in which patient progress will be tracked for as long as 52 weeks after treatment.Let's cross our fingers and hope that PLX will show just as promising results under this much more stringent testing.Overall, in terms of other analyst activity, it has been relatively quiet. 2 Buy ratings assigned in the last three months add up to a ‘Moderate Buy’ analyst consensus. Meanwhile, the $13.75 average price target puts the upside potential at ~39%. (See Pluristem stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that the European Investment Bank (“EIB”)  has approved a €50 million non-dilutive financing for the Company (the “Approved Financing”). This Approved Financing, once received, will support Pluristem’s research and development in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19.

The Zacks Analyst Blog Highlights: Pluristem Therapeutics, Mesoblast, Gilead Sciences, Pfizer and Regeneron

Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, cordially invites investors, the media, and the public to join a signing ceremony and analyst & investor call on Thursday, April 30, 2020.

How far are we from a viable COVID-19 treatment? Worldwide, over 178,000 people have died so far, with confirmed cases numbering more than 2,500,000. More than 150 drugs are being researched as possible treatments, by companies big and small.Pluristem Therapeutics (PSTI) falls squarely into the latter category. The micro-cap pharma company has been grabbing some attention with its potential COVID-19 treatment.Following a virtual fireside chat with Pluristem’s President and CEO Yaky Yanay, H.C. Wainwright’s Swayampakula Ramakanth noted, “In our view, with the ongoing pandemic affecting nearly every country and stressing healthcare systems around the world, there is an urgent need for new and effective treatments, and this represents a significant market opportunity for Pluristem.” According to Yanay, the analyst said, "The company’s current centralized manufacturing facility in Israel is capable of producing sufficient doses to treat thousands of patients, and more capacity could be allocated to treat COVID-19 as needed.”In March, Pluristem’s PLX-PAD cell therapy, which uses allogeneic mesenchymal-like cells with immunomodulatory properties, was approved by the Israeli Ministry of Health to treat severe COVID-19 patients. Following which, Pluristem initiated a compassionate use program for the treatment of patients with acute respiratory failure and inflammatory complications resulting from COVID-19.A week following the treatment, all seven patients are alive, indicating 100% survival rate. 3 out of the 7 have shown improvement in respiratory parameters and have started to come off ventilator support.Pluristem has now filed for an IND with the FDA and in the near future expects to begin a multi-national clinical study in treating COVID-19 associated ARDS (acute respiratory distress syndrome).Additionally, Pluristem has in place fully developed logistic chains, both in the US and the EU, to support the clinical studies and enable them to get treatments to hospitals in a matter of hours.Ramakanth concluded, “In light of the medical urgency and Pluristem’s readiness to deliver on this promising treatment, we believe the company could complete the initial studies and report results before the end of 2020, with the potential to launch PLX-PAD for the treatment of COVID-19 as early as 1H21.”As a result, Ramakanth reiterates a Buy rating on Pluristem shares, along with a $15.50 price target, which implies nearly 50% upside from current levels. (To watch Ramakanth’s track record, click here)Overall, there is not much activity on the Street regarding the small biotech. Over the past 3 months, only one other analyst has chipped in with a view on Pluristem’s prospects. The additional Buy provides PSTI with a Moderate Buy consensus rating. With an average price target of $13.75, the upside is a healthy 33%. (See Pluristem stock analysis on TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. More recent articles from Smarter Analyst: * These 3 Biotech Stocks Could More Than Double by 2021, Says Wedbush * American Airlines: Warren Buffett Is Not Always Right * Moderna Pops 15% On FDA Approval For Phase 2 Covid-19 Vaccine Trial * Sarepta Reports Earnings Miss; But Key SRP-9001 Data Still On Track

Does Pluristem (PSTI) have what it takes to be a top stock pick for momentum investors? Let's find out.

Boeing Back to Work? Could Boeing (NYSE:BA) be going back to work? It says so, by April 20th, to resume producing commercial airplanes, which doesn’t seem to be such a smart idea considering that demand for commercial flights has plummeted and the price of flights is in freefall. Commercial airplanes under such conditions aren’t likely […]The post Market Morning: Boeing Going On, Unemployment Confusion, Gilead Treatment, China Barely Contracts appeared first on Market Exclusive.

Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase II study of its PLX cells in the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome (ARDS). The study, titled “A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19” will treat 140 adult patients that are intubated and mechanically ventilated and are suffering from respiratory failure and ARDS due to COVID-19.

Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks hitting 52-week highs April 23.) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) * Chembio Diagnostics Inc (NASDAQ: CEMI) * Cue Biopharma Inc (NASDAQ: CUE) * Eli Lilly And Co (NYSE: LLY) (reported strong Q1 results) * Exelixis, Inc. (NASDAQ: EXEL) * GenMark Diagnostics, Inc (NASDAQ: GNMK) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) * Immunomedics, Inc. (NASDAQ: IMMU) (announced FDA nod for its ADC to treat triple-negative breast cancer) * Incyte Corporation (NASDAQ: INCY) (announced publication of positive data for Jakafi in acute graft-versus-host disease) * Iovance Biotherapeutics Inc (NASDAQ: IOVA) * Johnson & Johnson (NYSE: JNJ) * Novo Nordisk A/S (NYSE: NVO) * OraSure Technologies, Inc. (NASDAQ: OSUR) * Pluristem Therapeutics Inc. (NASDAQ: PSTI) (announced advancement of its placental cells to modulate cytokine storm) * Quidel Corporation (NASDAQ: QDEL) (filed with the FDA EUA for its SARS-CoV-2 virus assay for direct sampling) * Repligen Corporation (NASDAQ: RGEN) * Seattle Genetics, Inc. (NASDAQ: SGEN) * Verastem Inc (NASDAQ: VSTM) * Vermillion, Inc. (NASDAQ: VRML) * Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) * West Pharmaceutical Services Inc. (NYSE: WST) (reacted to its first-quarter results) * Zai Lab Ltd (NASDAQ: ZLAB) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)Down In The Dumps (Biotech stocks hitting 52-week lows April 23.) * NanoVibronix Inc (NASDAQ: NAOV)Stocks In Focus GlaxoSmithKline Anti-PD-1 Monoclonal Antibody Shows Efficacy Against Endometrial Cancer In Early Stage Study GlaxoSmithKline plc (NYSE: GSK) released data from an updated analysis of the Phase 1 GARNET study that showed that dostarlimab, an investigational anti-PD-1monoclonal antibody, provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient endometrial cancer who progressed on or after a platinum-based regimen.The patients were administered 500mg of dostarlimab once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression.Lilly, Innovent Announces Acceptance Of Regulatory Filing For Expanded Indication Of Cancer Drug In China Eli Lilly And Co (NYSE: LLY) and Innovent Biologics announced the National Medical Products Administration of China has accepted the sNDA for Tyvyt sintilimab injection in combination with Alimta and platinum as first-line therapy in non-squamous non-small cell lung cancer.Tyvyt was officially approved by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin's lymphoma after at least two lines of systemic chemotherapy.FDA Approves Sanofi's Meningococcal Vaccine Sanofi SA (NASDAQ: SNY) announced FDA approval for MenQuadfi -- Meningococcal Conjugate Vaccine -- for the prevention of invasive meningococcal disease in persons 2 years and older.The stock was trading 0.76% higher at $48.74 in Friday's premarket session. See also: Some Biogen Analysts Unimpressed By Explanation For Aducanumab Filing DelayPluristem Secures $53.92M To Advance Pipeline Asset For COVID-19 Treatment Pluristem Therapeutics Inc. (NASDAQ: PSTI) said the European Investment Bank has approved 50 million euros ($53.92 million) in non-dilutive financing for supporting its R&D in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19.The funds will be disbursed in three tranches, with the first tranche consisting of 20 million euros, according to the company. In premarket trading Friday, Pluristem shares were climbing 17.28% to $12.15.Earnings Edwards Lifesciences Corp's (NYSE: EW) first-quarter sales rose 14% to $1.1 billion and adjusted EPS climbed 14% to $1.51, ahead of the $1.33-per-share consensus estimate.View more earnings on IBBCiting the impact from the COVID-19 pandemic, the company lowered its 2020 sales guidance from a range of $4.6 billion-$5 billion to $4 billion-$4.5 billion. The adjusted EPS guidance was lowered from $6.15-$6.40 to $4.75-$5.25.The stock was up 6.99% at $236.50 in Friday's premarket session. Merit Medical Systems, Inc. (NASDAQ: MMSI) reported first-quarter worldwide revenue of $243.5 million, up 2.2%, and non-GAAP EPS of 38 cents. Analysts estimated EPS of 26 cents. The company withdrew its 2020 guidance, citing the uncertainty associated with the COVID-19 pandemic.The stock rose 1.88% to $38.57 in after-hours trading.Takeda Divests Non-Core OTC, Prescription Drugs In Europe For Up To $670M Takeda Pharmaceutical Co Ltd (NYSE: TAK) said it has entered into an agreement to divest a portfolio of select non-core OTC and prescription pharmaceutical products sold in Europe and two manufacturing sites located in Denmark and Poland to Danish pharma company Orifarm Group for up to $670 million.Takeda said the portfolio to be divested fetched sales of $230 million in fiscal year 2018, driven by strong sales of cough/cold and vitamin OTC brands as well as prescription products Warfarin and Levaxin.On The Radar IPO Oric pharma, a clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, priced its upsized IPO of 7.5 million shares at $16 per share, the upper end of the previously estimated price range of $14-$16.The company's shares will be listed on the Nasdaq under the ticker symbol "ORIC."Related Link: Moderna Gains More Than 40% This Week: What You Should Know See more from Benzinga * The Daily Biotech Pulse: FDA Nod For Immunomedics, Lilly's Solid Q1 Beat, Predictive Oncology Restructures Debt * The Daily Biotech Pulse: Immunic To Develop COVID Treatment, Gilead Strikes IO Partnership * The Daily Biotech Pulse: Applied DNA Begins Validating COVID-19 Test, Cara's Positive Readout, Novan Explores Strategic Alternatives(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that it has treated its first patient suffering from COVID-19 complications in the United States under the U.S. Food and Drug Administration’s (FDA) Single Patient Expanded Access Program, also called a compassionate use program, which is part of the U.S. Coronavirus Treatment Acceleration Program (CTAP), an emergency program for possible therapies that uses every available method to move new treatments to patients as quickly as possible. In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, as well as expanding treatment under compassionate use in other countries.

Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that it has entered into definitive agreements with two institutional investors in connection with a registered direct offering, providing for the issuance of an aggregate of 1,587,302 shares of its common stock at a price of $9.45 per share. The net proceeds from the offering are expected to be approximately $15,000,000. Pluristem intends to use the net proceeds from the offering for working capital, including funding towards its Phase II study of PLX cell therapy in the treatment of complications arising from COVID-19 and other clinical trial activities, investment in capital equipment and other general corporate purposes.

Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today reported an update on the status of COVID-19 infected patients treated with PLX cells under a compassionate use program in Israel and the FDA Single Patient Expanded Access Program in the U.S. All treated patients were in Intensive Care Units (ICU), on invasive mechanical ventilation and suffered from Acute Respiratory Distress Syndrome (ARDS) at the time of treatment. As of today, a total of 18 patients were treated in Israel and in the U.S., of which 8 (1 in the U.S. and 7 in Israel) so far have completed a 28-day follow up period.

With the coronavirus outbreak gaining steam worldwide, pharma/biotech companies are evaluating every possible therapy to combat the spread.

Micro-cap biotech? Check. Up by over 40% in one trading session? Check. Possible COVID-19 treatment? Check. All the ingredients for a familiar narrative in these coronavirus driven times are present. We’re talking about Pluristem Therapeutics (PSTI), a small Israeli biotech with promising preliminary data regarding a possible COVID-19 treatment.Last week, Pluristem released initial results from its compassionate use program for the treatment of patients with acute respiratory failure and inflammatory complications resulting from COVID-19. Specifically, all seven ICU patients with acute respiratory distress syndrome (ARDS) treated so far with Pluristem’s PLX cell therapy have survived, with 6 out of 7 having completed the seven-day follow-up (one is still within the period). 4 out of the 6 (66%) patients displayed improvement in respiratory parameters, and 3 of the 6 (50%) patients are in late stages of weaning from ventilators.Next up, the company will apply to commence a multinational clinical study to further explore the potential use of PLX cells in the treatment of patients suffering from complications linked to COVID-19. PLX cells are allogeneic mesenchymal-like cells with immunomodulatory properties and can possibly suppress or reverse the risky over-activation of the immune system.H.C. Wainwright’s Swayampakula Ramakanth is “very encouraged” by the results and believes “the use of PLX cells for the treatment of COVID-19 could become a significant upside for the company.”The analyst added, “In our view, with the ongoing pandemic affecting nearly every country and stressing healthcare systems around the world, new, effective treatments are urgently needed. Therefore, we believe that both the FDA and the EMA may expedite the approval for clinical studies and simply the regulatory paths going forward. With regulatory expediency and patients only needing a 28-day follow-up, we believe the company could complete the initial studies and report results in 2H20.”Ramakanth reiterated a Buy on Pluristem shares along with a $15.50 price target. The implication for investors? Upside of an impressive 83%. (To watch Ramakanth’s track record, click here)Only one other analyst has published a review on the small biotech’s prospects, also recommending the stock a Buy. Therefore, Pluristem has a Moderate Buy consensus rating. The average price target is $13.75 and set to provide investors with returns of 63%, should the target be met over the coming months. (See Pluristem stock analysis on TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Is (PSTI) Outperforming Other Medical Stocks This Year?

Is (PSTI) Outperforming Other Medical Stocks This Year?

HAIFA, Israel, April 30, 2020 --  European Investment Bank (EIB) backs Pluristem with €50 million of financing, which will help the company to advance the clinical.

Promising results from a very small study caused shares of stem cell stocks to soar, but investors shouldn't get too carried away just yet.

Pluristem Therapeutics Inc. (PSTI) (PSTI) (the “Company”), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today provided a summary of an Investor & Analyst Call (the “Call”) conducted on April 30, 2020, in conjunction with the European Investment Bank (“EIB”) and kENUP Foundation. The purpose of the Call was to discuss the €50 million venture loan financing (the “Financing”) to Pluristem by the EIB and followed a signing ceremony of the Financing contract on Innovation Cell Therapies (EGFF) between the parties. Speakers on the Call included Pluristem’s CEO and President, Yaky Yanay, and the Company’s, CFO, Chen Franco-Yehuda; the kENUP Foundation’s Chairman Holm Keller; and the EIB’s Investment Officer, Anna Stodolkiewicz.