Connect with us

Biotechnology

Multi-Billion Dollar Markets Are Ready For A Shake-Up; 1 Biotech Stock Could Hold The Key

StockPrice

Published

on

Tiziana Life Sciences (TLSA) Could Hold Humira’s Kryptonite

There’s no denying that biotechnology is one of the hottest markets in the world. Right now a multi-billion-dollar segment is ready for a shakeup and one biotech stock could hold the secret to doing just that!

[NEWS 9/16/19] Tiziana Life Sciences (TLSA) Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy Volunteers

More times than not, biotechnology and healthcare stocks are the “hot markets” and we’ll explain exactly why. We’ll also take a deep dive into a niche that you must be paying attention to in 2019 if you’re looking to take advantage of the next big trend in health science.

Why biotech over other sectors? With this sector we’re literally talking about companies creating life-changing and life-saving treatments. And in the process, some of the greatest wealth has been created. Merck is acquiring cancer drug developer Peloton Therapeutics for $1.05 billion. Pharmaceutical giant Bristol-Myers, a pioneer in immunotherapy, is acquiring rival Celgene for $74 billion.

The announcement came as Peloton was preparing for its IPO.  Earlier this year, Eli Lilly bought Loxo Oncology for $8 billion. And these are just a few of the many BIG stories that biotech investors are witnessing first hand!

Biotech stocks have delivered sizzling returns over the last few years. New drugs have improved the lives of patients and made big profits for investors in the process. Creating or licensing a one-of-a-kind drug creates an opportunity that even the greenest investor can understand. This is part of why the biotechnology industry is full of optimism, from both management and investors. And clinical-stage biotech stocks could present immense potential.

Where To Focus In 2019?

A majority of the biotech industry’s smaller members are in the clinical stage. In other words, they don’t have a product to sell yet, but they’re testing potential drugs in humans. Because of this, new milestones, announcements, progress, etc. can act as massive catalysts in a near term and possibly long term time frames. Even the slightest positive progress update can trigger momentum. Why do we mention this?

One of the hottest subsectors that has gotten more attention in 2019 has been digestive diseases especially things like liver disease, diabetes and myriad digestive system cancers. The obesity epidemic in the U.S. is leading to a new problem for doctors.  In fact, by 2020, a liver disease known as nonalcoholic steatohepatitis, or NASH [1], will be the leading cause of liver failure. That will lead to more liver transplants in the U.S., experts say.

“NASH is silent until it gets very advanced,” JMP analyst Bayko said. “Then it’s too late.”

The National Institutes of Health estimates 30%-40% of adults in the U.S. have a fatty liver. Of those, about 20% have NASH liver disease. But liver disease treatment is complicated, especially in the case of NASH.  According to other reports, the global market for NASH could reach $35 billion [2].

Tiziana Life Sciences (TLSA) Has Created A Biotech Pipeline To Address Multi-Billion Dollar Market Opportunities

There are many companies out there working to treat liver disease and other forms of digestive tract diseases, but one company could stand to disrupt this $35 billion market. Tiziana Life Sciences (TLSA) is focusing on to develop novel treatment for liver diseases such as NASH and hepatocellular carcinoma (HCC). With multiple treatments in advanced Phase Trials, it could make sense to have this biotechnology company in focus for 2019.

Tiziana (TLSA) is supported by extensive IP and a strong pipeline of in-licensed clinical assets and has clinical development programs for Foralumab and Milciclib. Strong IP for oral and nasal administration is for the platform technology, which is applicable to all antibodies drugs for treatment of human diseases.

TLSA pipeline

As you can see, there are multiple indications that Tiziana (TLSA) pipeline treatments are looking to meet. Right now, bigger companies are taking aim at buying up assets in this space. Bristol-Myers Squibb has confirmed it is looking for additional assets to enhance its internally-developed NASH drugs.

Furthermore, other companies like Pfizer have expressed the same, “We are actively looking on the outside for opportunities… to complement our internal program,” Morris Birnbaum told Reuters in an interview. He is the chief scientific officer for internal medicine for Pfizer.

Driven by the obesity and diabetes epidemics, the disease guarantees an enormous pool of patients for decades, making it a prime target for deals for promising therapies for NASH and its consequences – advanced fibrosis and liver-destroying cirrhosis. 

“We anticipate that there will be more transactions, more licensing deals from big pharma involving emerging biotechnology companies.”

Dr. Scott Friedman, dean for therapeutic discovery at Mt. Sinai Hospital in New York

How Is Tiziana Life Sciences (TLSA) Set To Shake Up The Industry?

First off, there could be huge upside potential for its current portfolio of drug candidates. And it isn’t just for the treatment of NASH but other autoimmune diseases as well. Its Milciclib has already shown to produce clinical benefits and the drug is well tolerated. No drug related deaths were reported in a Phase 2a clinical trial in patients with inoperable or metastatic Hepatocellular Carcinoma – a type of liver cancer. In fact, 28 out of 31 of the patients treated could be evaluated with 14 patients having completed a 6-month study. Nine of these patients continued treatment under compassionate use and 5 are still under treatment.

“We are very pleased with the clinical activity and tolerability of Milciclib in these advanced cases of HCC. It is an important milestone to move forward with further clinical development of Milciclib either as a single agent or in combination with other HCC drugs,” said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana. 

Exclusivity Makes This An Attractive Therapy To Stand Up To Industry Heavyweights

Tiziana (TLSA) holds an exclusive license from Nerviano Medical sciences for both method of use and composition that is protected through 2030. Pending patent applications extend the IP protection at least up to 2038.  Milciclib has shown to have reduced toxicity and adverse events compared to current Standard of Care drugs like some of the leading therapies in the market today including:

  • Sorafenib co-developed and co-marketed by Bayer and Onyx Pharmaceuticals as Nexavar
  • Lenvatinib, developed by Eisai Co, and;
  • Regorafenib, developed by Bayer

Last year, Tiziana Lifesciences presented a poster at the AASLD, a premier scientific conference for liver diseases, demonstrating that milciclib produces significant synergistic activity in combination with tyrosine kinase inhibitors (TKIs) such as sorafenib, regorafenib and lenvatinib in preclinical studies. In addition, oral treatment with milciclib is also able to overcome drug resistance towards commonly used chemotherapeutic drugs such as gemcitabine.

Tiziana Life Sciences (TLSA) Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity with Milciclib Monotherapy

This was conducted for patients in Advanced Sorafenib-refractory or -intolerant Patients with Unresectable or Metastatic Hepatocellular Carcinoma.

MAJOR HIGHLIGHTS OF THE CLINICAL DATA

As per the study protocol, data collection was limited to 6-months. Thus, clinical data were not collected from patients under compassionate use treatment. The clinical activity assessment in evaluable patients was based on the investigators’ review using the modified Response Evaluation Criteria in Solid Tumors (mRECIST).

  • 14 out of 28 (50%) evaluable patients completed 6-month duration of the trial.
  • 9 out of 14 patients (64.2%) were approved by their respective ethical committees to continue the treatment.
  • 5 of the 9 patients on compassionate use had received Milciclib for a total of 9, 9, 11, 13 and 16 months.
  • As of 1 September 2019, the remaining 4 patients continuing the treatment are in their 10th, 11th, 11th and 12th months.
  • Both median TTP and PFS were 5.9 months (95% Confidence Interval (“CI”) 1.5-6.7 months) out of the 6-months duration of the trial.
  • 17 of 28 (60.7%) evaluable patients showed ‘Stable Disease’ (SD; met at least once in an 8-week interval).
  • One patient (3.6%) showed ‘Partial Response’ (PR).
  • 18 of 28 (64.3%) evaluable patients showed ‘Clinical Benefit Rate’ defined as CBR=CR+PR+SD (with CR representing Complete Remission).

Pivotal Trials Have Lead To Big Breakthroughs For Biotech In The Past

Sorafenib® (Bayer) was approved, based on the clinical data from the pivotal Phase 3 (SHARP) clinical trial1, as the first line therapy for naive HCC patients. The clinical data from that study showed median TTP of 5.5 months (95% CI 4.1-6.9 months), CBR of 43% and 71% SD by RECIST criteria1. Conversely, the clinical data from a phase 2 trial with Sorafenib in patients with advanced HCC, showed SD (33.6%), TTP of 4.2 months and median OS of 9.2 months2.

Regorafenib was approved, based on the clinical data from the pivotal Phase 3 (RESORCE) clinical trial3, as the second line therapy for sorafenib-resistant HCC patients. In this study, Regorafenib showed median PFS of 3.1 months (95% CI 2.8-4.2 months), median TTP of 3.2 months (95% CI 2.9-4.2 months) and disease control rate (DCR, similar to CBR) of 65% by mRECIST. On the other hand, the clinical data from a Phase 2 study in patients with intermediate and advanced HCC, Regorafenib showed median TTP of 4.3 months (95% CI 2.9-13.1 months), SD (69%) and PR was 3%4.

“The positive clinical activity and tolerability data of Milciclib in Sorafenib-resistant and advanced HCC patients are very encouraging and provides affirmation for continued development of Milciclib, either as monotherapy or combination therapy.”

Dr. Kunwar Shailubhai, CEO & CSO of Tiziana. 

Because it can also be combined with TKIs as well as standard chemotherapy agents, Tiziana’s treatment could be in position to directly compete with the therapies of some of the biotech sectors biggest companies. What may be more important is that patients often become resistant or unresponsive to certain treatments. According to Tiziana, Milciclib works through a unique mechanism with broad-spectrum action to address the complex heterogeneity in HCC patients. The drug could have the potential for long-term efficacy.

Just think about this for a moment: The global market for liver cancer drugs is estimated to reach $1.47 billion by 2022. The current standard of care drugs is not entirely satisfactory due to low response rates and severe toxicities where Tiziana (TLSA) could be positioned to capitalize.

Just The Tip Of The Iceberg

But keep in mind; Tiziana (TLSA) isn’t just focusing on liver cancer. As we discussed, the company has a pipeline of treatments aimed at liver and other diseases. The company’s Foralumab could also present new opportunities to address Crohn’s disease and indications for NASH – that “small” addressable market we were talking about before.

Tiziana’s Foralumab is the first fully human anti-CD3 mAb, which has not shown anti-drug antibody (immune reaction) in humans. Tiziana’s proprietary platform technology for oral and nasal administration of mAb’s could provide clinical benefits by mimicking the body’s natural immune modulation processes and thereby increasing patient compliance.

More importantly…

Foralumab has recently completed a Phase 1 trial at the Harvard Medical School in healthy volunteers to study safety, tolerability and biomarkers of neurodegenerative disease through nasal delivery. The clinical data from this trial will be publicly reported shortly.  Why timing could be so important right now for those looking at Tiziana (TLSA).

The company will also be starting an additional Phase 1 trial to evaluate oral Foralumab’s safety, tolerability and biomarkers of anti-inflammation in healthy volunteers. While the oral administration of Foralumab is for treatments of Crohn’s disease and NASH, the nasal administration is for treatment of neurodegenerative diseases such as progressive multiple sclerosis (pro-MS).

Furthermore, a Phase 2 trial in Crohn’s and NASH is expected to commence next year. So, those taking a closer look at Tiziana (TLSA) right now could not only see it in the midst of big progress with its Milciclib but also during a time when Foralumab’s progress is just getting started.

“Tiziana’s proprietary technology for the oral and nasal delivery of mAb’s in general, and Foralumab specifically, have strong potential indications in autoimmune diseases including Type 1 diabetes, Crohn’s disease and NASH.”

Kunwar Shailubhai, CEO & CSO of Tiziana

If this weren’t quite enough to make a point, third party researchers in the peer reviewed journal Crohn’s & Colitis 360* point out the immense potential for Tiziana’s (TLSA) Foralumab. Titled, “Immunologic alterations associated with oral delivery of anti-CD3 (OKT3) monoclonal antibodies in patients with moderate-to-severe ulcerative colitis,” [3] the published study was conducted at some of the leading medical research institutions in the world.

This included Harvard Medical School, Massachusetts General Hospital, and the Ann Romney Center for Neurologic Diseases at Brigham & Women’s Hospital. According to the company, these independent findings suggest potential clinical activity and support the safety of monoclonal antibodies (mAb’s) when administered orally.

Tiziana Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated

The trial data also showed that Foralumab a Produced Positive Trend in Biomarkers of Immunomodulation and Anti-inflammation in Healthy Volunteers.

MAJOR HIGHLIGHTS OF THE CLINICAL DATA

  • Treatment was well-tolerated and no drug-related safety issues were reported at any of the doses.
  • No drug-related changes were observed in vital signs among subjects at predose, during treatment and at discharge. The mean blood pressure (BP) during the 5 days of treatment were; Cohort A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and Cohort C (250 µg/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among the 3 cohorts compared to the placebo.
  • Nasally administered Foralumab at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin secreting CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS).
  • Treatment at 50 μg stimulated production of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ.
  • Taken together, these results suggest stimulation of Tregs that are needed to provide clinical benefits

“The demonstration of the positive immunomodulatory effects provides the scientific rationale to move forward with further studies in the pro-MS population.”

Dr. Tanuja Chitnis, the study PI at the Brigham and Women’s Hospital

The Company is pioneering oral delivery of mAb’s for the treatment of autoimmune and inflammatory diseases that is applicable to the $100 billion market of mAb’s that are currently only available through IV delivery!

[NEWS 9/10/19] Tiziana Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated and Produced Positive Trend in Biomarkers of Immunomodulation and Anti-inflammation in Healthy Volunteers

An End To Humira? Tiziana May Hold The Key To Disrupt A $21 Billion Market

Tiziana (TLSA) could have the first true platform to directly take on a drug that is doing over $20 billion in sales. Abbvie’s Humira is incredibly diverse and has become one of the biggest autoimmune blockbusters in recent biotechnology history. But one huge flaw has left the door wide open for Tiziana’s (TLSA) lead therapies to capitalize.

In an autoimmune disease, the body’s immune system falsely detects and attacks a threat within the body that does not really exist. This can lead to a number of problems and conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and psoriasis.

Just like Tiziana’s Foralumab, Humira is a monoclonal antibody that targets symptoms related to autoimmune disorders. But here’s where the opportunity is: The only way to use Humira is intravenously via an injectable syringe or pen. Foralumab can be administered nasally or orally and this simple change in delivery method could set a stage for a strong argument supporting the potential of Tiziana’s (TLSA) platform.

But Timing Is Very Important In This Case

The company already has an upcoming Phase 1 trial to evaluate oral Foralumab’s safety, tolerability and biomarkers in Crohn’s disease and NASH.  While the trial is primarily a safety study, it will also evaluate biomarkers for T regulatory cells (Tregs) and anti-inflammation.

Considering the early successes that the drug has already had, there will be a very particular focus on what’s next.  It will see if there are positive immune-modulatory effects on these biomarkers to ultimately show the true potential of oral treatment with Foralumab. Most importantly, if there is any indication of improvement from a nasally-taken treatment it could be a significant breakthrough for the company!

Up until today, there has never been a fully human anti-CD3 antibody. If they can demonstrate success with their data, Tiziana (TLSA) could become the pioneers of this type of treatment.  The big advantage is that the delivery of CD3 antibody through IV is directly associated with toxicity. For Tiziana (TLSA), the possibility of delivery, orally or nasally, it could circumvent the risks associated with the toxicity risk of intravenous delivery methods currently in place.

If Tiziana (TLSA) can demonstrate it can deliver the same fully humanized antibodies in a non-injectable method, it could be a huge breakthrough in science and disease. The potential goes beyond “just a delivery method.”

The company also holds patents that include the fully humanized aspect of the technology (versus mouse derived) as well as covering the delivery methods (nasal & oral) which includes existing and approved monoclonal antibodies like Humira and Remicade – TWO BLOCKBUSTER DRUGS!

If Abbvie or Johnson & Johnson wanted to deliver these treatments orally or nasally, they would need to utilize Tiziana’s (TLSA) patents. Gabriele Cerrone, the company’s Chairman sums it up perfectly, “A lot of people are sitting on the side lines really curious to see if you can deliver an anti-CD3 any other way than injecting. But as soon as we have the data to show it is effective the days of being a [small cap] company are finished.”

This comes from a man who is no stranger to successfully founding biotechnology companies. Mr Cerrone co-founded Trovagene, Inc. (NASDAQ: TROV), a molecular diagnostic company and served as its Co-Chairman.  He was a Director of and led the restructuring of Siga Technologies, Inc. (NASDAQ: SIGA).  Mr Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman of the Board until its merger in September 2007 with Inhibitex, Inc. Mr Cerrone served as a director of Inhibitex, Inc. until its US$2.5bn sale to Bristol Myers Squibb.​

Mr Cerrone is the Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics company focused on oncology using microRNA technology; Chairman and Founder of Tiziana Life Sciences plc (NASDAQ:TLSA) an oncology focused therapeutics company; Chairman and Co-Founder of Rasna Therapeutics Limited, a company focused on the development of therapeutics for leukaemias; Co-Founder of ContraVir Pharmaceuticals, Inc. (fmr: CTRV now HEPA); and founder of BioVitas Capital Ltd.

So when a man of this stature explains the sheer potential and timing of all of this, it may be prudent to start listening and watching closely.

Elite Team Of Management

Mr. Cerrone is just one very valuable piece of a much large, elite management team behind Tiziana Life Sciences (TLSA).


Dr. Napoleone Ferrara


Dr Ferrara’s research led to the development of the anti-VEGF monoclonal antibody bevacizumab (Avastin®) which was initially approved for the treatment of colorectal cancers, now one of the top ten selling global pharmaceutical products and won the 2010 Lasker Award for his work on VEGF. Dr Ferrara is Senior Deputy Director for Basic Sciences at University of California’s Moores Cancer Center in San Diego; and Distinguished Professor of Pathology at the University of California’s School of Medicine, also in San Diego.


Dr. Howard Weiner


Dr. Howard Weiner is the Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women’s Hospital in Boston. The Partners MS Center is the first integrated MS Center that combines clinical care, MRI imaging and immune monitoring to the MS patient as part of the 2000 patient CLIMB cohort study. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer’s disease, amyotrophic lateral sclerosis, stroke and brain tumours. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T cells for the treatment of these diseases.


Kunwar Shailubhai


Kunwar Shailubhai, Ph.D., M.B.A. serves as Chief Executive Officer and Chief Scientific Officer of Tiziana Life Sciences, and is also an Executive Director of the Company. Dr. Shailubhai invented Plecabatide, which was approved by the FDA for GI diseases in 2016. Further, his experience has lead him to top tier biotech companies holding various roles at Rasna Therapeutics, Monsanto Company, and was co-founder, EVP & CSO of Synergy Pharmaceuticals, Inc.

Clinical Stage Biotech Stocks Could Present First-In-Line Opportunity

Anyone can call a blue chip biotech stock a success but were they there when that company was in its clinical stages? If that question were asked to most about Pfizer or Bayer today, the answer would likely be “no.”

But there are countless examples of clinical stage companies hitting it big after reporting meaningful trial results. And it’s usually the early onlookers who may have the upper hand at capitalizing:


Deciphera Pharmaceuticals, Inc. more than doubled after reporting positive top line results from a phase 3 clinical study from $19.95 to as high as $42.99… 115%


CorMedix, Inc. Exploded From $6.30 to $13.60 Following Positive Interim Study Results … 116%


CEL-SCI Corporation Jumps From $3.00 March 2019 To Nearly $9 Following Series Of Phase Trial Updates… 199%


Corindus Vascular Robotics, Inc. Rallies from $0.99 At the Start of 2019 to highs of $4.27 Following Agreement to Be Acquired By Siemens Healthineers Just 8 Months Later…  331%


Zynex Rallies From Just $2.60 in January to highs of $11.75… 351%


And these are just a few examples of biotech stock catalysts that sent these companies soaring in 2019! While many of the drugs in development are two-to-five years from reaching the market if they get that far, betting on the feverish deal activity could give investors a chance to profit near term.

It doesn’t take a rocket scientist to see that biotech catalyst can trigger massive runs, especially in smaller companies. Many small companies developing drugs with a wide variety of approaches across the disease spectrum do not have partners, Tiziana (TLSA) included.

So with the major progress being observed on a number of pipeline therapies, Tiziana (TLSA) may be approaching critical mass as it were. The market for its drugs has become ripe with opportunities and the latest trend in the biotech sector could lead the way for a new groundswell to begin before the end of the year.

With the recent progress that the company has seen from its early trials, the fervent demand for new therapies, and the stampede of investments flooding into the market from major biotech leaders, it may be time to start looking at small-cap biotech stocks before the Main Street rush opens the floodgates.

Top 5 Reasons To Have Tiziana Life Sciences (TLSA) On You Biotech Stock List

1. Major acquisition trends from large-cap biotechs could open near term opportunity for promising drug therapies from smaller cap companies

2. Favorable trial results demonstrate considerable potential from Tiziana Life Sciences (TLSA) treatment pipeline. More near term potential could present itself leading up to Foralumab safety trials & pit it head-to-head with Humira.

3. Additional benefits of Tiziana’s (TLSA) therapies extend to other hotbed markets like Diabetes, Arthritis, and liver cancers to name a few

4. The market opportunity for NASH therapy alone concerns a $35 billion market

5. Early stage catalyst for clinical biotech stocks have presented first mover advantages & Tiziana Life Sciences (TLSA) has a number of major milestones that could point toward further clinical developments to come.

biotech stock to watch 2019
Disclaimer: Pursuant to an agreement between Midam Ventures LLC and Tiziana Life Sciences plc (TLSA), Midam has been paid $150,000 by Tiziana Life Sciences plc (TLSA) for a period from August 22, 2019 to September 22, 2019. We may buy or sell additional shares of Tiziana Life Sciences plc (TLSA) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about Tiziana Life Sciences plc (TLSA). Full Disclaimer Click Here

End Notes:

[1] https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts

[2] https://www.cnbc.com/2018/12/21/the-35-billion-race-for-a-cure-for-a-liver-disease-that-affects-millions.html

[3] Boden, E. K., Canavan, J. B., Moran, C. J., McCann, K., Dunn, W. A., Farraye, F. A., Ananthakrishnan, A. N., Yajnik, V., Gandhi, R., Nguyen, D. D., Bhan, A. K., Weiner, H. L., Korzenik, J. R., Snapper, S. B. Immunologic alterations associated with oral delivery of anti-CD3 (OKT3) monoclonal antibodies in patients with moderate-to-severe ulcerative colitis. Crohn’s & Colitis 360 (2019). 183: 240-246.

Continue Reading
Click to comment

Biotechnology

3 Small-Cap Biotech Stocks To Watch In Coming Weeks

Joe Samuel

Published

on

stock market today

Biotech has been one of the hottest sectors for investors for as long as it has existed and the reasons are self-evident. It is a sector that uses cutting edge technology and comes up with treatments for a wide range of diseases.

Moreover, the fact that biotech companies often improve on existing treatments, makes them a far more attractive target for a range of investors. Here is a look at three biotech stocks to watch during the last few weeks of the quarter.

PharmaCyte Biotech (PMCB)

There has been no lack of attention on biotech penny stocks this year.  At the beginning of August, one small biotech stock broke to highs of over $10 from a starting price below $2 a share after releasing news. PharmaCyte Biotech (PMCB) focuses on ways to effectively deliver treatments to patients with diseases ranging from cancer to diabetes. 

The company’s proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®is the platform that the company uses to develop its therapy delivery methods.  For most of the quarter, shares of PMCB stock have traded between $0.033 and $0.04 with volume recently surging.

On September 19, PharmaCyte saw more than 6 million shares trade; well above its daily average. Most of the attention surrounding the company has been on two things. First, its progress with Cell-In-A-Box and the application for Pancreatic cancer has continued to progress. The company brought on Dr. Manuel Hidalgo, has confirmed that he will be Principal Investigator (PI) for PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) now that he is at Weill Cornell Medical Center.

What To Watch For

This week PharmaCyte (PMCB) will host a call designed to update all shareholders and the investment community simultaneously of material developments. The call will cover PharmaCyte’s preparations for submission of its Investigational New Drug application (IND) to the U.S. FDA to treat locally advanced, inoperable pancreatic cancer. It will also cover developments related to PharmaCyte’s product pipeline. PharmaCyte has been working on these and will discuss things not yet reported in a press release.

Catalyst Pharmaceuticals (CPRX)

The first one to watch is Catalyst Pharmaceuticals Inc (NASDAQ:CPRX). It is a small-cap stock engaged in developing medicines for rare diseases. Catalyst managed to get an approval for one of its products from the FDA earlier this year.

Since the approval of the Lambert-Eaton myasthenic syndrome (LEMS treating medicine Firdapse, Catalyst stock went on a massive rally from January to April. The approval of a rival drug halted the rally. Only after a civil suit from Catalyst did the stock stabilize somewhat.

Last week, Catalyst stock received a fresh boost after the company announced that it was going to make a secondary offering. However, the company decided to pull the offering the very next day and that affected the stock price once again.

What To Watch For

Analysts believe that pulling the secondary offering was the right long term decisions and this stock could be heading for another rally soon.

Eyepoint Pharmaceuticals (EYPT)

The biotech stock that could prove to be a major winner in the biotech sector this month is that of Eyepoint Pharmaceuticals Inc (NASDAQ:EYPT). There are two factors at play. The company revenues are going to rise significantly in the coming years due to the commercial launch of two medicines.

The first one is Yutiq, which is meant for the treatment of chronic non-infectious uveitis and the other one is Dexycu, which is meant for postoperative ocular inflammation.

What To Watch For

The company is currently trading at only double that of its future revenue and that is a very attractive multiple. EYPT stock has caught the attention of analysts on Wall Street. Guggenheim has set a 12-month target price of $4, which reflects 116% gains during the period.

stock market news today
Disclaimer: Pursuant to an agreement between MIDAM VENTURES, LLC and Complete Investment And Management LLC, a Non-affiliate Third Party, Midam was hired for a period from 07/09/2019 – 8/09/2019 to publicly disseminate information about PharmaCyte Biotech including on the Website and other media including Facebook and Twitter. We were paid $150,000 (CASH) for & were paid “0” shares of restricted common shares. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 8/12/2019 – 9/12/2019. We may buy or sell additional shares of PharmaCyte Biotech in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information. Click Here For Full Disclaimer

Continue Reading

Biotechnology

Acadia (ACAD) Stock Price is up 60% This Month; Bullish Signal For Biotechs?

Joe Samuel

Published

on

One sector that has always been a favorite of investors of all varieties is the pharmaceutical sector and all investors like a turnaround story. Over the years, ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) had been one of the better-known strugglers in the industry. That was reflected in the stock price as well. But recent developments have breathed new life in the stock, which could be an indicator for the biotech industry at large.

Biotech Stocks To Watch: PharmaCyte Biotech (PMCB)

There has been no lack of attention on biotech penny stocks this year.  At the beginning of August, one small biotech stock broke to highs of over $10 from a starting price below $2 a share after releasing news. PharmaCyte Biotech (PMCB) focuses on ways to effectively deliver treatments to patients with diseases ranging from cancer to diabetes. 

The company’s proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®is the platform that the company uses to develop its therapy delivery methods.  For most of the quarter, shares of PMCB stock have traded between $0.033 and $0.04 with volume recently surging.

On September 12, PharmaCyte saw more than 4 million shares trade; well above its daily average. Most of the attention surrounding the company has been on two things. First, its progress with Cell-In-A-Box and the application for Pancreatic cancer has continued to progress. The company brought on Dr. Manuel Hidalgo, has confirmed that he will be Principal Investigator (PI) for PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) now that he is at Weill Cornell Medical Center.

Second, the company has been ramping up for a much-anticipated shareholder update call on September 20. The call will cover PharmaCyte’s preparations for submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to treat locally advanced, inoperable pancreatic cancer and developments related to PharmaCyte’s product pipeline on which PharmaCyte has been working and that have not yet been reported in a press release.

Acadia (ACAD) Stock Price: Important Developments

People who had held on to the stock through the barren years got a nice boost recently. This came after Acadia’s well-known medicine Nuplazid recorded better than expected sales. In addition to that, there were encouraging results from a dementia-driven psychosis study. Hence, it is important to figure out whether it is perhaps time to buy the stock.

While the signs are no doubt encouraging, it is important to note that data reveals that around 60,000 people in the United States are diagnosed with Parkinson’s every year. Out of those, a large proportion (50% to 80%) suffers from dementia. Hence it can be argued that the market is simply not too big for Acadia’s Nuplazid.

Moreover, different types of dementia are brought on by Alzheimer’s disease, which is why all of it might not actually fall into Acadia’s lap. That being said, it is also well known that antipsychotic drugs have only been approved for the treatment of Parkinson’s and hence the Alzheimer’s market is already out of the question.

Market Potential

Projections suggest that the sale of Nuplazid could grow to more than $1 billion in 2023 from $224 million in 2018. While that is encouraging, it is also important to note that the growth has been priced into the Acadia stock price.

However, if Acadia’s plans for growth somehow run into any trouble, then there is every chance of the stock price plummeting once again. The company is recovering and there is some time before the patient population for Nuplazid can be expanded sufficiently. In the meantime, investors need to be a bit more patient.

Shares of ACAD are up over 60% over the past week and made a new multi-year high of $43.98.

biotech stock price
Pursuant to an agreement between MIDAM VENTURES, LLC and Complete Investment And Management LLC, a Non-affiliate Third Party, Midam was hired for a period from 07/09/2019 – 8/09/2019 to publicly disseminate information about PharmaCyte Biotech including on the Website and other media including Facebook and Twitter. We were paid $150,000 (CASH) for & were paid “0” shares of restricted common shares. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 8/12/2019 – 9/12/2019. We may buy or sell additional shares of PharmaCyte Biotech in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information. Click Here For Full Disclaimer.

Continue Reading

Biotechnology

Top Biotech Stocks To Watch This Week

Joe Samuel

Published

on

best biotech stocks to watch

Biotech stocks rarely perform well during the summer months, and 2019 has proven to be no exception in regards to this historical pattern. The iShares Nasdaq Biotechnology ETF, for example, has fallen by nearly 2% since the official start of summer.

The values of biotech equities, however, do generally start to pick up as the year winds down. The underlying reason is that the latter part of the year is chock-full of key data readouts, regulatory decisions, and thousands of scientific conferences across the globe. 

Biotech Stocks To Watch

GT Biopharma (GTBP)

Earlier this quarter GT Biopharma, Inc. (GTBP) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager announced that Jeffrey Miller, M.D. has been hired by the Company as its Consulting Chief Medical Officer.

Further to this, the company confirmed that it had notified FDA that it was commencing enrollment in its first-in-human GTB-3550 Phase I/II clinical trial. The clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis, Minnesota under the direction of Dr. Erica Warlick.

GTB-3550 (OXS-3550) is the Company’s first Tri-specific NK cell Engager (TriKE™) product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15.

Since making the announcement, shares of GTBP are up by 13.2%.

NewLink Genetics Corp (NASDAQ:NLNK)

NewLink Genetics Corp (NASDAQ:NLNK) said the FDA has accepted partner Merck & Co., Inc. (NYSE:MRK)’s BLA for its investigational Ebola vaccine, according to the application priority review status. The PDUFA goal date has been set for March 14, 2020.

Potential approval of the vaccine will trigger issuance of a priority review voucher, owned by Merck and in which NewLink has a substantial economic interest. NewLink can then monetize its share of interest in the voucher. The vaccine candidate, originally developed by the Public Health Agency of Canada, was licensed to NewLink.

vTv Therapeutics Inc (NASDAQ:VTVT)

vTv Therapeutics Inc (NASDAQ:VTVT) is scheduled to present at the European Association for the Study of Diabetes 55th annual meeting being held in Barcelona, Spain with a new Phase 1/2 Simplici-T1 study of liver-selective glucokinase activator TTP399 as an adjunctive treatment for Type 1 diabetes.

Biotech IPO To Watch

IGM Biosciences priced its IPO of 10.938 million shares at $16, the midpoint of the estimated price range of $15-$17 per share. The shared of the preclinical and clinical-stage immuno-oncology biotech will be listed on the Nasdaq under the ticker symbol “IGMS.”

best biotech stocks to watch
Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP), Midam has been paid $15,000 per month for 6 months by GT Biopharma (GTBP) for a period from September 4, 2019 to March 4, 2020. We may buy or sell additional shares of GT Biopharma (GTBP) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma (GTBP). Click Here For Full Disclaimer.

Continue Reading

Join Our Newsletter

Get stock alerts, news & trending stock alerts straight to your inbox!


Privacy Policy

We keep all user information pricate & promise to never spam.*

Stock Price Free Text List

Search Stock Price (StockPrice.com)




Trending

Subscribe Now & Begin Receiving Free Stocks News, Articles, Trade Alerts & MORE, all 100% FREE!

We are your #1 source for all things Stock Market & Finance, Subscribe Below!

Privacy Policy: We will NEVER share, sell, barter, etc. any of our subscribers information for any reason ever! By subscribing you agree we can send you via email our free e-newsletter on stock market & finance related, articles, news and trade alerts. Further questions please contact privacy@stockprice.com