Amicus Therapeutics (FOLD) is purchasing a portfolio of ten gene therapies for $100 million and the promise to pay up to $352 million if the treatments are approved and hit undisclosed sales milestones. The deal arrives just a month after the approval of
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, Amicus’ first drug.
“This is really the next step in putting us in a place where I always hoped Amicus could be,” says John Crowley, Amicus’ chairman and chief executive. But there’s more to this story than most business deals. Both Crowley and one of the executives at the company Amicus is purchasing have children with an extremely rare disease.
Amicus has continued to be a company surrounded by excitement. Crowley’s quest, at a previous company, to create a treatment for his two children, Megan and Patrick, was documented in a number of Wall Street Journal stories, a book, and a movie starring Harrison Ford.
At that time, Amicus’ drug, Galafold, for another extremely rare disease called Fabry disease, was facing questions from the FDA even as it was approved in Europe, Canada, Australia, and Japan to treat patients as long as their illness was stemming from specific mutations. The treatment isn’t cheap however as Galafold costs $315,000 per patient per year in the U.S., which is actually a normal price for a drug for an ultrarare disease.
The Galafold approval allowed Crowley to go forward to identify new assets. He identified them in Celenex, the company Amicus is buying. Its story closely mimics Crowley’s own. Celenex was created by a Hollywood producer, Gordon Gray, whose two children had an awful and rare disease called Batten’s disease, which results in profound and lethal neurological decline.
“John, I’m very aware of your family’s journey,” Gray said the first time they talked. “Twelve years ago I was one of the producers considering bidding on your life rights.”
Crowley says Gray, who had produced films including Secretariat and Invincible, exhibited “superhuman effort” to create a drug company. “He put all of that aside to find the science that could save his daughters.” He found the technology he was looking for in gene therapies created at Nationwide Children’s Hospital Center for Gene Therapy that use a virus, called adeno-associated virus, to insert genetic code into cells. The result was a ten-patient study that tested a gene therapy against the CLN6 version of Batten that Gray’s girls have. The girls were among those 10 patients.
Gray and Crowley first connected over the summer. After a long conversation, Crowley brought a team to Ohio State. After a full day, Crowley asked Gordon and his partner if they could return with him to New Jersey. They flew there and went to Crowley’s house, where Meghan was getting ready to go back to Notre Dame. They spent the next day together at Amicus’ headquarters in Cranbury, New Jersey. Across the negotiating table, Crowley says he made a promise.
Biotech Stocks To Watch In June: Cara Therapeutics (CARA) & Intellia Therapeutics (NTLA)
Among biotech companies, the competition between Cara Therapeutics Inc (CARA) and Intellia Therapeutics Inc (NTLA) has been an intriguing one. The two companies had been on the same level as far as the market cap goes during most of the year so far.
But Cara has now pulled ahead by as much as $150 million following positive data from its lead product candidate. That being said, it is also important to keep in mind that if an investor is looking at a long term investment, then the disparity in market cap between the two companies is a minor. Here’s a look at the pros and cons of Cara and Intellia.
Cara Therapeutics (CARA)
Cara Therapeutics is currently on the rise. Its lead product candidate Korsuva injection delivered highly encouraging results in its Phase 3 trial. It’s now believed that it would not be long before Cara has its first product on the market.
It is meant for the treatment of moderate-to-severe chronic kidney disease-associated pruritus. According to reports, the results were great. Another late-stage test is going to be conducted soon. The results could be announced by the end of this year. If Korsuve is approved, then it will be marketed by Fresenius Medical Care and Vifor Pharma Group.
Cara has entered joint ventures with those companies to market the product in the United States, Japan, and South Korea. An oral version of Korsuva is also in the pipeline and could prove to be another important development.
Intellia Therapeutics (NTLA)
Intellia Therapeutics (INTA) is involved in creating CRISPR gene editing therapies. It is a segment that has a lot of promise in the future. Even though the company is some years away from having anything on the market, the promise of gene editing therapy is exciting. So much so that Intellia has already found partners in big-ticket firms like Regeneron and Novartis.
Intellia is expected to file for FDA approval for the clinical study into its lead product NLTA-2001 in 2020. It is meant for the treatment of transthyretin amyloidosis, an uncommon genetic disease. Studies into the products have proven to be promising so far. The company is also working on a product to treat myeloid leukemia.
Now when it comes to choosing between Cara and Intellia, experts believe that the former could a better company. It’s already on the verge of having an approved product on the market. Intellia, on the other hand, is likely to be some years away from winning approval.
Is Palatin Technologies (PTN) A Penny Stock To Buy Or Sell?
Will Shares Of Palatin Technologies (PTN) Head Higher As Biotech Stocks Rally This Month?
Biotech stocks are rallying this month. Despite the “pop and drop” this sector saw earlier in the year, June has been a big month for biotechnology companies and people investing in this sector.
In fact, the iShares Trust Biotechnology ETF (IBB) has climbed by more than 8% since the start of June. This sector has been famous for producing volatile returns for investors. Furthermore, biotech penny stocks have increased that potential.
Palatin Technologies (PTN) Is A Biotech Penny Stock To Watch
One of the best performing penny stocks in the biotechnology sector this month has been Palatin Technologies Inc. (PTN). On January 2, this penny stock opened the year at $0.71 and has seen a 2019 high of $1.74. What’s more is that even though PTN stock has consolidated, it has continued to trade above $1.20.
So what’s all the excitement about? Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential.
The company’s main strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential.
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The recent excitement seems to have started in April after the company reported positive top-line results of its oral clinical study of PL-8177. The treatment is designed to address ulcerative colitis and other inflammatory bowel diseases.
“The main objective of the study was to demonstrate release of polymer-bound PL-8177 in the lower gastrointestinal tract after oral administration. Top line data showed favorable pharmacokinetics, and demonstrated PL-8177 was released in the lower gastrointestinal tract, supporting oral administration of PL-8177 using the delayed release polymer formulation.”
New Milestones From Palatine Technologies (PTN) Triggers New Highs
After hitting new highs on May 17th after posting quarterly earnings, shares of PTN stock have consolidated. Regardless, the company continues to progress. Earlier this month the company obtained orphan drug designation for PL-8177. Yes, this is the same one that I talked about above when the company received positive topline results earlier in the year.
Why is orphan drug designation important? This is a good question especially if you’re newer to biotech penny stocks or biopharmaceutical stocks, in general. In the exact words of the FDA:
“The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphanstatus”).”
Essentially it gives companies incentives above and beyond competitors. These incentives include a partial tax credit for clinical trial expenditures, waived user fees, and eligibility for 7 years of marketing exclusivity. The obvious response would be favorable, which has been seen in the market over the past few trading sessions.
Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies, said in a press release, “Unlike corticosteroids, immunosuppressive agents, and biological therapies targeting specific cytokines or receptors, melanocortin receptor 1 peptides work to resolve chronic inflammations and restore normal immune function. We look forward to initiating clinical trials with PL-8177 for non-infectious uveitis, a high medical need disease with limited treatment options.”
But Here’s Why Palatin Might Be Set For More Excitement
It’s all about sex drive. You read that right. And something that hasn’t really been fully publicized is this “big FDA date.” You see on June 23rd, the application for Vyleesi (bremelanotide), a drug developed by Palatin and licensed to AMAG Pharmaceuticals (AMAG) will be up for review by the FDA as a New Drug.
Vyleesi is a novel melanocortin 4 receptor agonist under evaluation for restoring a natural sexual desire in premenopausal women with HSDD. Think of this like female Viagra. Will this become the sexiest biotech penny stock this month or will stock traders get blue balled?
Like This Article? Check Out: Small Cap Biotech Stocks See Boost From Large Cap M&A
Healthcare Penny Stocks To Watch: Driven Deliveries Inc. (DRVD), Biocept Inc. (BIOC), Cesca Therapeutics Inc. (KOOL), PhaseBio Pharmaceuticals Inc. (PHAS)
Healthcare penny stocks tend to be the largest movers among other penny stocks. This is mainly due to the amount of news they release. For example, any development in treatment becomes a news catalyst, which happens more often than other news.
Driven Deliveries Inc. (DRVD)
Driven Deliveries Inc. (DRVD) is primarily a technology company so why include it with other healthcare penny stocks? It is included because of what Driven’s technology is capable of, delivering medical and recreational marijuana. Medical marijuana legality is sweeping across the US which is only expanding the future demand for the services Driven provides.
More studies are beginning to show the positive effects of marijuana in relation to stress and pain relief. These studies make Driven’s recent announcement way more important. Driven revealed a partnership with Pure Ratios, a company selling 96-hour pain relief CBD and THC patches. This product is the only of its kind as it bypasses the digestive process and is absorbed directly into the bloodstream.
Christian Schenk, CEO of Driven, stated, “We believe that our best-in-class delivery platform coupled with Pure Ratio’s proven popular brands will provide a strong synergistic relationship between the companies. We look forward to expanding our customer base while increasing revenue and enhancing our overall brand recognition. Management has already identified several similar popular brands that it intends to add to our platform in the near future.”
Biocept Inc (BIOC)
Biocept Inc (BIOC) is a healthcare company that uses liquid biopsy technology to assess several forms of cancer for physicians. Biocept has their own liquid biopsy platform known as Target SelectorTM which can analyze tumor markers.
Recently, Biocept announced a new Target SelectorTM platform for breast cancer. It is Biocept’s second tumor-specific panel and will help target the second leading cause of death for women. In addition, Biocept’s platform allows medical personnel to evaluate patients with metastatic breast cancer which is usually very difficult. This news has brought strong volume and a 11% pre-market move.
Cesca Therapeutics Inc. (KOOL)
Cesca Therapeutics Inc. (KOOL) is a medical device healthcare company for cell-based therapeutics. Cesca is an affiliate of the BoyaLife Group which is based out of China. Cesca is using its AutoXpress platform to meet the needs regarding cardio, vascular, and immune diseases.
One of Cesca’s subsidiaries, ThermoGenesis, recently received approval for its Next-Gen AXP II System for cord blood processing. The AXP II System allows for the processing and storage of hematopoietic stem call concentrates. Also, multiple cord blood units can be processed in one centrifuge. Thanks to this approval, Cesca’s stock increased by more than 40%.
PhaseBio Pharmaceuticals Inc. (PHAS)
PhaseBio Pharmaceuticals Inc. (PHAS) is a biopharmaceutical company whose primary goal is creating and selling treatments to orphan diseases. Their primary drug is called PB2452 which reverses antiplatelet activity. PB2452 recently received positive preliminary results from Phase 2a clinical trial. These results pushed the stock from $12.19 to $14.08 on June 18th.
“If approved, PB2452 could help address these critical unmet medical needs by enhancing the safety profile of ticagrelor, which has the potential to become the only antiplatelet therapy on the market with a specific reversal agent. We look forward to reporting full results from the Phase 2a trial at an upcoming medical congress.”John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio
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