Friday, April 26, 2019

Genprex (GNPX)

Poised to Emerge as a Leader in Cancer Gene Therapy.

Genprex Inc is a US-based clinical stage gene therapy company. It is engaged in developing a new approach to treating cancer, based upon its novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy.

Cosme Ordoñez, M.D., Ph. D. , Life Sciences Analyst, Noble Capital Markets, Inc.

Refer to full report for price target, fundamental analysis and rating. 

• Coverage
  Initiation. We are initiating coverage of Genprex, Inc. with an
  Outperform Rating and a $5.00 target price.
• Unique Gene
  Therapy Technology. We believe that Genprex will emerge as a leader in the area
  of gene therapy for the treatment of cancer. The Company is developing a unique
  platform technology consisting on the use of lipid nano…
  

  
  
  
  
  

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NOTE: investment decisions should not be based upon the content of
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making any investment decision. 

Monday, April 15, 2019

Dyadic International (DYAI)

The Importance Behind The Nasdaq Up-Listing.

Dyadic International Inc. is a biotechnology company developing a proprietary expression platform to manufacture of biologic products. The company is employing C1 technology, part of a fungi expression system, to produce variety of modalities of biologic products, including vaccines, oncolytic viruses, monoclonal and bispecific antibodies, as well as biosimilars. 

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to full report for price target, fundamental analysis and rating. 

• Important Milestone Accomplishment. Dyadic has announced the up-listing of its common stock on The Nasdaq
  Capital Market Exchange under stock symbol “DYAI”. The company has
  maintained the stock price requirement, for Nasdaq, following its SEC filing on
  February 2019. Trading will commence as early as 
  April 17, 2019. We believe this
  is an important milestone for the company and its current and future investors. 
• Why is this important?  The company has accomplished key
  milestones as guided, including the SEC filing and the Nasdaq up-listing. The
  stock has gained +112% YTD 2019. We believe the biggest potential benefit from
  the up-listing is increased visibility and tran…
  

  
  
  
  
  

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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Wednesday, April 3, 2019

Trovagene Inc. (TROV)

Updated early prostate cancer data demonstrates sustained PSA levels.

TrovaGene Inc is a US-based life science company which focuses on the development and commercialization of a proprietary molecular genetic detection technology for use in pharmaceutical development, clinical research and medical testing across a variety of clinical disciplines, including oncology and virology. 

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to full report for price target, fundamental analysis and rating. 

• AACR
  Presentation. The company had the second presentation from a Phase 2 study
  of onvansertib in combination with Zytiga/prednisone in patients with metastatic
  castration-resistant prostate cancer (mCRPC), at the American Association for
  Cancer Research (AACR) annual meeting today, following the update from the
  acute myeloid leukemia (AML) trial (refer to the note published on April 2nd,
  2019).
• Data Update in
  Prostate Cancer.  Onvansertib in combination with Zytiga/prednisone treatment
  achieved a reduction of prostate specific antigen (PSA) levels in 2 out of
  6 mCRPC patients. The previous data reported at
  the Genitourinary Cancers Symposium (ASCO-GU, on February) showed
  reduced PSA levels, however levels were relapsed. The company plans to
  comm… 

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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Tuesday, April 2, 2019

Trovagene Inc. (TROV)

Improved and updated data from AML patients.

TrovaGene Inc is a US-based life science company which focuses on the development and commercialization of a proprietary molecular genetic detection technology for use in pharmaceutical development, clinical research and medical testing across a variety of clinical disciplines, including oncology and virology. 

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to full report for price target, fundamental analysis and rating.  

• AACR Data
  Presentation.  The company presented data from a Phase 1b clinical trial of
  onvansertib in patients with acute myeloid leukemia (AML) at the American
  Association for Cancer Research (AACR) annual meeting on April 1st, 2019. The
  anti-leukemic activity improved with an increased number of patients treated.
  The disease control rate (DCR) rose to 89% (17/19 patients) from previous
  reported rate of 83% (10/12 patients) at The American Society of
  Hematology (ASH) on December 2018.
• Digging Through Data. In addition to the improved DCR,  the overall response
  rate also increased; one patient with complete response (CR), one
  incomplete blood recovery (iCR), one morphologic leukemia-freestate (MLFS) and
  one partial response (PR) compar… 

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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Can any other treatment beat anti-VEGF in macular edema?

(Note: companies that could be impacted by the content of this article are listed at the base of the story (desktop version). This article uses third-party references to provide a bullish, bearish and balanced point of view; sources listed in the “Balanced” section)

Macular edema (ME) is an eye disease condition that causes the sudden or chronic decrease in visual acuity. The condition arises from fluid accumulation within the macula, an area in the center of the retina, leading to vascular instability and the breakdown of the blood-retinal barrier (BRB). Characterization of the diseases is made by the swelling and thickening of the macula distorting a person’s central vision, causing a decline in visual acuity and eventually could lead to blindness.

Major causes of macular edema include diabetes, branch and central retinal vein occlusion, choroidal neovascularization, posterior uveitis, postoperative inflammation and central serous chorioretinopathy.

Fluid accumulation results from an imbalance between processes governing fluid entry and exit, when inner or outer blood-retinal barriers are disrupted. ME can arise from various conditions:

1. 7 million subjects due to diabetes, called diabetic macular edema (DME)
2. 3 million subjects due to vein occlusion
3. 40% of visual impairment in patients with uveitis
4. 5% of individuals older than 60 years of age due to neovascular age-related macular degeneration (AMD) in industrialized countries

ME treatment is a rapidly growing market with an increasing elderly population, and people living with diabetes. The anti-vascular endothelial growth factor (VEGF) therapy has revolutionized the treatment landscape for ME providing benefit to patients, however 30-50% of patients don’t respond or develop resistance to anti-VEGF treatment and the opportunity still remains for the development of novel compounds.

Monday, April 1, 2019

TherapeuticsMD (TXMD)

.

TherapeuticsMD Inc is a major drug manufacturing with a focus on creating and commercializing products targeted exclusively for women. The company intends to commercialize advanced hormone therapy pharmaceutical products. TherapeuticsMD’s drug candidates that have completed clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis, and discomfort. 

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to full report for price target, fundamental analysis and rating. 

…

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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Thursday, March 28, 2019

Dyadic International (DYAI)

Could 2019 be transformational?

Dyadic International Inc. is a biotechnology company developing a proprietary expression platform to manufacture of biologic products. The company is employing C1 technology, part of a fungi expression system, to produce variety of modalities of biologic products, including vaccines, oncolytic viruses, monoclonal and bispecific antibodies, as well as biosimilars. 

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to full report for price target, fundamental analysis and rating.  

• R&D
  Advancement. The company continues to make progression in
  establishing C1 expression production and the purification process in multiple
  projects. The Schmallenberg virus (SBV) as part of the ZAPI project exceeded
  the intended expression levels (17x), and is potentially the first to enter in
  human trials. We believe glycan engineering intended in 2019 could be
  transformational for the company.
• Corporate
  Updates. The proof of concept collaborations totaled nine projects,
  including two newly added agreements with large pharmaceuticals in Q1 2019.
  Dyadic continues to validate C1’s potential in biologic manufacturing, guiding
  an $8-$10 million burn rate this year. However, business development efforts
  are ongo… 

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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Thursday, March 21, 2019

ProMIS Neurosciences (PMN:CA)

A door opens in the treatment for Alzheimer’s.

ProMIS Neurosciences,
Inc., a development stage biotech company, discovers and develops precision
medicine therapeutics for the treatment of neurodegenerative diseases,
primarily Alzheimer’s disease (AD) and amyotrophic lateral sclerosis (ALS). Its
proprietary target discovery engine is based on the use of two complementary
techniques. 

Cosme Ordoñez, M.D., Ph. D.

, Life Sciences Analyst, Noble Capital Markets, Inc.

Refer to full report for price target, fundamental analysis and rating. 

• Competitor discontinues development. Biogen (BIIB: Not Rated), a competing company in the Alzheimer’s area,
  this morning announced the decision to discontinue clinical development of aducanumab.  Biogen is
  discontinuing two Phase III clinical trials evaluating the efficacy and safety
  of aducanumab for the treatment of Alzheimer’s patients. 
• Skepticism to heighten. We believe the negative news will fuel skepticism among
  investors looking to deploy capital in Alzheimer’s area. The failure of Biogen
  adds to a string of disappointing results in hum…
  

  
  
  
  
  

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NOTE: investment decisions should not be based upon the content of
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making any investment decision. 

CRISPR-Cas9: The
Gene Editing Tool That Could Fix Disease and Eradicate Cancer

(Note: companies that could be impacted by the content of this article are listed at the base of the story (desktop version). This article uses third-party references to provide a bullish, bearish and balanced point of view; sources listed in the “Balanced” section) 

The discovery of a gene editing tool called CRISPR-Cas9 is perhaps the most exciting finding in molecular biology since the discovery of DNA. Scientists first unearthed the structure of DNA in the 1950s, and by 2003 scientists had sequenced the entire human genome encoding for 20,000 distinct proteins. Following its discovery in bacterial immune systems, CRISPR-Cas9 was first used to replace a piece of DNA in human cells in 2013. But it was only just last year that the CRISPR-Cas9 technology advanced into human trials to treat patients with various inherited diseases and cancers. With this newfound power to edit our own genes, we could be on the verge of a medical revolution.

Many human diseases are genetically driven often caused by the mutation, deletion, or overexpression of genes. Therefore, introducing desired changes into genes has been a long sought-after goal in molecular biology. Gene editing (also known as genome editing) involves the insertion, deletion, or replacement of those chemical base pairs in DNA. DNA (deoxyribonucleic acid), the building block of genes, is used to synthesize proteins via RNA (ribonucleic acid). Genomes of eukaryotic organisms are composed of billions of DNA bases. Cas9 is an enzyme acting as a molecular “scissors” that can cut the two strands of DNA at a specific location in the genome so that bits of DNA can then be added or removed. The guide RNA (gRNA) about 20 bases long is designed to only bind to the target sequence in the DNA. The Cas9 follows the guide RNA to the same location in the DNA sequence. In order to cut a piece of DNA at the right spot, the molecular “zipper” needs to accurately match up with the piece of the DNA to form a tight bond that positions the scissors in just the right place. In CRISPR, the “zipper” is made of specially designed RNA, and the “scissor” effect comes from harnessing the natural cutting action of a protein, or enzyme, called Cas9. In this way, CRISPR-Cas9 can insert, delete, or replace the genes that have plagued humanity with disease since the dawn of time.

Friday, March 8, 2019

Trovagene Inc. (TROV)

Focus on upcoming catalyst, 2018 earnings review and early 2019 developments.

TrovaGene Inc is a US-based life science company which focuses on the development and commercialization of a proprietary molecular genetic detection technology for use in pharmaceutical development, clinical research and medical testing across a variety of clinical disciplines, including oncology and virology. 

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to full report for price target, fundamental analysis and rating.  

• Progressing clinical programs. The company continues to focus on
  advancement of its clinical programs. We have seen two clinical trials readouts
  up to date 1) from Phase 1b/2 acute myeloid leukemia (AML) study-
  demonstrating favorable clinical benefit (80% disease control rate) among 12
  acute myeloid leukemia (AML) patients and 2) from Phase 1/2 metastatic
  castration resistant prostate cancer (mCRPC) program- leading to dosing
  adjustments to extend drug exposure and clinical benefit in mCRPC patients.
• Upcoming catalysts.  We are expecting to see a few key value generating
  events 1) further data readouts from Phase 1b/2 acute myeloid leukemia
  (AML) program at American Association for Cancer Research (AACR) annual
  meeting, 2) data readout f…
  

  
  
  
  
  

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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision.