Sure, the S&P is reaching new highs, tech is red hot, and oil is surging…but guess what: One industry that the market essentially wrote off in the second quarter just made NEW 3rd Quarter Highs and that could mean big things for biotech stocks.
There’s no denying that the vast majority of multi-billion dollar mergers and acquisitions have been in the biotech sector. Mainly it has been companies that offer novel immune therapies that have caught the attention. This is a big reason why the sector could become an even bigger focus for the second half of 2019.
Our Focus On GT Biopharma
GT Biopharma Inc. (GTBP) has been a key focus on StockPrice.com for a few weeks now and for the most part, it has moved in tandem with the broader biotech sector. A Key Driver has been BIG M&A. Large and Mega Cap companies are scooping up smaller biotech firms that focus on cancer-fighting treatments and have immunotherapy pipelines. And guess what category GT Biopharma Inc. (GTBP) falls into…
GT Biopharma Inc. (GTBP) is a small-cap biotech company that creates immune-oncology products. They utilize a technology platform that combines antibody-drug linkers to single-chain, bi-, tri-, and tetra-specific scFv constructs to produce treatments. One example is for carcinoma, called OXS-1615, which is a tetraspecific treatment.
Since we initiated coverage on the company, we’ve watched GTBP climb as much as 30% and as of June 20, it’s still up by roughly 15.5% in just over a week. We have seen a bit of consolidation to start this week but as we said earlier this month, that could open the door to more excitement in June. The big focus for those looking at GTBP has been on its immunotherapy portfolio.
The Next Step For Immunotherapies
GT Biopharma Pipeline Commands Attention
To date, GT Biopharma has completed one dose escalation Phase I-II expansion clinical trial, and one fixed dose Phase I-II expansion clinical trial, which collectively enrolled a combined 43 patients. On the surface, the Phase I-II expansion clinical trial demonstrated greater than 50% of Evaluable patients receiving 60 mg/kg dose had a positive clinical response.
Two patients exhibited a Complete Remission with one patient currently disease-free at 50 months post-treatment. Additionally, five patients exhibited Stable Disease, cancers that are neither increasing nor decreasing in severity, with the longest response lasting 12 months post-treatment.
The global market for cancer drugs is estimated to be about $123 billion and big players are investing heavily to gain an edge in this increasingly competitive market.
“GTB-1550 has shown positive results in its two Phase I-II clinical trials in advanced cancer patients who have failed all other therapies, and we are now planning to proceed with a Phase II clinical trial.”Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma
In addition to this, the company’s therapy has also shown that it could target HIV infected cells in the University of Minnesota’s preclinical testing. Not only that but in specific tests, data showed that HIV-infected targets that express the HIV envelope on their surface could be eliminated.
What’s Next For GT Biopharma (GTBP)?
In our opinion, market timing for biotech has been a major focus for many. Cancer research remains one of the most critical areas of focus for most investors. This is simply due to the fact that if a company can come up with a truly path-breaking product, then the potential for growth could be significant.
The recent deal between Merck and Tilos Therapeutics has sparked increased enthusiasm within the industry. This just adds yet another big deal to the rapidly growing list of big biotech buyouts in the immunotherapy and cancer research arena. The health sciences market is experiencing unprecedented innovation, and now the race is to get behind the next breakthrough. GT Biopharma’s numerous phase trials, novel treatments, and top tier leadership could be key factors to pay close attention to, considering the current climate for biopharma stocks.
Brad Loncar -https:// finance. yahoo. com /news/why-cancer-fighting-stocks-etfs-184606099. html
Acadia (ACAD) Stock Price is up 60% This Month; Bullish Signal For Biotechs?
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.
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.
Top Biotech Stocks To Watch This Week
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.”
3 Biotech Stocks Jumped Big Last Month
The biotech sector has thrown up a high number of gems over the years and helped generate hefty returns for investors. Due to the advancements made in biotechnology over the years and those which are still being made, it is a sector that will continue to be a favorite of many investors.
Plenty of companies are doing revolutionary work in this space and have the potential of turning into excellent investments eventually. Here is a look at 3 biotech stocks that jumped significantly over the past few weeks and deserve to be on the watch lists of investors.
Tiziana Life Sciences (TLSA)
This biotech stock has been riding under the radar for the better part of the last 6 months. But in September, shares of Tiziana Life Sciences (TLSA) have enjoyed a much more active market. This has been due, in part to recent Phase Trial news related to the company’s pipeline therapies:
[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
[9/4/19] Tiziana Life Sciences (TLSA) Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity with Milciclib Monotherapy in Advanced Sorafenib-refractory or -intolerant Patients with Unresectable or Metastatic Hepatocellular Carcinoma
Tiziana Life Sciences (TLSA) is focusing on to develop novel treatment for liver diseases such as NASH and hepatocellular carcinoma (HCC). Tiziana (TLSA) holds extensive IP and a strong pipeline of in-licensed clinical assets. Tiziana 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. Click To Read More About Tiziana Life Sciences (TLSA)
The next company to watch: Mesoblast Limited (MESO Stock Report). Its shares skyrocketed last week after it emerged that it had entered into a lucrative partnership with Grunethal. Grunethal is a privately held German company. According to the terms of the deal, the companies are focusing on the development as well as sales of the product MPC-06-ID.
According to the terms of the deal, Grunethal is going to pay $15 million to Memoblast straightaway for the right to sell the medicine in South America and Europe. However, the company stands to earn as much as $135 million more if certain targets are met. The Phase 3 trials for patients in the United States are already happening and the data could be available by mid-2020.
Kodiak Science (KOD)
The other stock which made a major move last week was Kodiak Science (KOD Stock Report). The company is involved in AMD or age-related macular degeneration and similar other conditions that hamper the vision in people of advanced age.
Vision loss is one of the most important categories of treatments in the sector and there is a lot of conflict in the sector with regards to the effectiveness of anti-VEGF medicines. Kodiak is developing its own antibody known as KSI-301and recently human proof of concept data points with regards to the anti-VEGF medicine showed that the company might have actually found something that could work. That resulted in the remarkable rise in the stock price last week.
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