Tue, Mar. 24, 8:17 AM
- Based on positive data from three independent preclinical studies as well as those done by the U.S. National Institutes of Health (NIH) and others that suggest its second cell product, PLX-R18 is safe, Pluristem Therapeutics (NASDAQ:PSTI) decides to advance the product candidate in two indications in parallel.
- This year, the firm expects to submit an application to the FDA to conduct a clinical trial to assess PLX-R18 for the treatment of insufficient engraftment of transplanted hematopoietic cells, a procedure commonly used to in certain types of blood cancers and immune-related damage to bone marrow.
- Concurrently, it will continue its work with the NIH in developing PLX-R18 as a potential treatment of acute radiation syndrome (ARS). In the coming months, the company expects to receive FDA guidance on the additional animal studies needed to approve PLX-R18 for use in ARS under the Animal Rule regulatory pathway.
- Pluristem's first cell product, PLX-PAD, is currently being evaluated in a Phase 2 study in intermittent claudication (leg pain and discomfort) and a Phase 1 in pulmonary arterial hypertension (in partnership with United Therapeutics). It intends to initiate advanced trials in critical limb ischemia via accelerated regulatory pathways in Japan and Europe.
Tue, Feb. 17, 9:14 AM
Tue, Feb. 3, 12:47 PM
Mon, Feb. 2, 12:49 PM
Mon, Feb. 2, 10:54 AM
- Pluristem Therapeutics (PSTI -16.4%) reports results from a Phase 1/2 trial evaluating the safety and efficacy of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury after hip replacement (total hip arthroplasty). Twenty patients in the study were randomized into three treatment groups. The first group (n=7) received 150M PLX-PAD cells, the second group received 300M PLX-PAD cells (n=6) and the third received placebo (n=7). Each patient received injections in the gluteal muscle that had been traumatized during surgery.
- Patients receiving 150M PLX-PAD cells demonstrated a statistically significant improvement (p=0.0067) in maximal voluntary isometric contraction force of the gluteal muscle in the operated leg six months after total hip replacement (31.1 Nm versus 5.4 Nm). The company also reports that patients in this group also demonstrated a statistically significant improvement (p=0.0114) in muscle force in the contralateral (non-operated) gluteal muscle (19.4 Nm versus 0.5 Nm) compared to placebo, but no explanation as to why the numbers are different for the placebo group (5.4 Nm vs 0.5 Nm).
- Patients treated with 300M PLX-PAD cells failed to achieve a statistically significant improvement in muscle force (p=0.227).
- The development of PLX-PAD is ongoing.
Mon, Feb. 2, 9:12 AM
Mon, Feb. 2, 7:37 AM
- Last Wednesday, a bullish research report on thinly-traded micro cap Pluristem Therapeutics (NASDAQ:PSTI) propelled the stock almost 33% in two days.The report, by Acceleron Equity Research, stated a price target of $21, a seven-bagger from the then-current price of ~$3.
- It appears, though, that Acceleron is just a website. Neither the site or the report identify the authors, but the press release listed a contact under the name of M. Morhamus. According to the website developer, M.E.Garza, Acceleron was started by two former contributors to his biotech news site, BioMedReports, Michael Morhamus and A.J. Deniken. When contacted by reporters, however, Mr. Deniken stated that he was not an owner of Acceleron and didn't profit from the rise in PSTI's stock price. Mr. Mohamus did not respond to requests for comment sent via Twitter.
- Migdal Capital Markets senior biomedical analyst Steven Tepper says that investors don't have enough information about Acceleron to judge its credibility. "It would be irresponsible to make investment decisions on a research report that has no analyst name standing behind it. We need to know who owns this research company, who are the managers, what is its business model. A disclaimer means nothing if there's no analyst name written on the report."
- PSTI is down 12% premarket on mediocre volume.
- Previously: Pluristem surges on bullish research report (Jan. 28)
Thu, Jan. 29, 9:12 AM
Wed, Jan. 28, 12:44 PM
Wed, Jan. 28, 9:14 AM
Wed, Jan. 28, 9:02 AM
- Thinly-traded micro cap Pluristem Therapeutics (NASDAQ:PSTI) is up 11% premarket on robust volume in apparent response to a bullish report from Acceleron equity research with a price target of $21. It estimates EPS of $0.40 in 2017 and $1.25 in 2018.
- Acceleron believes the company will make significant progress this year in its clinical pipeline including shortening the time to market for its first product, PLX cells for critical limb ischemia, currently in Phase 2 in Europe. New Adaptive Licensing legislation in the European Union allows for limited commercialization of cell therapies after a successful Phase 2 study. Pluristem has yet to disclose a timeline for approval, however.
- As with any investment opportunity, retail investors should complete their own thorough due diligence before considering taking action.
Dec. 31, 2014, 10:25 AM
- Thinly-traded nano cap Brainstorm Cell Therapeutics (BCLI +22.7%) jumps on a 6x surge in volume in response to CEO Tony Fiorino's positive comments about the final results from the Phase 2a study of NurOwn in ALS patients.
- Management will host a conference call on January 5 at 8:30 am ET to discuss the data.
- Previously: BrainStorm to start Phase 2 ALS trial (April 28)
- Stem cell-related tickers: (CUR +3.8%)(STEM)(NBS +0.5%)(OTCQB:ISCO +1.4%)(PSTI +2.2%)(OTCQB:NVIV -1.5%)(FCSC +1.6%)
Oct. 14, 2014, 4:57 PM
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Oct. 7, 2014, 7:34 AM
- Pluristem Therapeutics (NASDAQ:PSTI) fends off a challenge from an unnamed cell therapy company to its European patent No. EP2200622 titled, "Adherent Cells From Adipose Or Placenta Tissues And Use Thereof In Therapy."
- The European Patent Office concluded that the company's patent, whose claims cover the treatment of ischemia with adherent placental cells which are propagated using a 3D culture, is valid.
Oct. 7, 2014, 3:18 AM
- European patent office upholds Pluristem's (NASDAQ:PSTI) patent claim covering treatment of ischemia with adherent placental cells which are propagated using a 3D culture.
- Pluristem's patent went through Opposition Proceedings before the Opposition Division of the European Patent Office as a result of a challenge from a cell therapy company.
- PSTI says case proves it is determined to defend its IP portfolio of 30 issued patents and 120 pending patents.
- Source: press release
PSTI vs. ETF Alternatives
Pluristem Therapeutics Inc is a bio-therapeutics company. It is engaged in developing off-the-shelf allogeneic cell therapy products for treatment of ischemic & inflammatory, cardiovascular, orthopedic, pulmonary, hematological, & women's health diseases.
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