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Update: Catalyst Pharmaceutical's Positive Phase III Trial
- The trial results should help to increase investor confidence in FDA approval.
- Investors should expect significant revenues from orphan drug designation.
- I reiterate my buy rating, as this was predicted by my article.
Worlds Inc.: An Interesting Run-Up Before A Crucial Markman Hearing
- Worlds has a Markman hearing coming up against Activision Blizzard.
- Markman hearings represent significant catalyst events for investors.
- Through trading before the October 3rd hearing, investors could be set up for substantial gains with limited downside.
Orexigen: Poised To Grab A Large Part Of The Weight Loss Market
- Contrave will be launched with a larger sales force than both Belviq and Qsymia.
- More robust safety data should lead to a larger amount of doctors prescribing Contrave over other options.
- Middle of the road efficacy should be attractive to doctors.
- Contrave could be the first weight loss drug approved in Europe.
Clinical Trial Results To Watch
- Clinical trial results have the potential to move their respective stocks.
- Each of the companies mentioned have important upcoming clinical trial results that will impact the long term potential of their respective company.
- The phase III data from all of these drugs will be crucial in the path towards future FDA filings and approvals.
2nd Half Of 2014 Biotechnology Catalysts - Part 4
- PDUFA decisions have the potential to move share prices.
- Through knowing when PDUFA decisions are going to be made, investors can benefit from the increased momentum and share price heading into the decision.
- There are many upcoming decisions in the second half of September for investors to watch.
- Each of the stocks mentioned in this article have the potential to move up ahead of their respective FDA decision dates.
Vringo: Next Steps After A Disappointing Decision Versus Google
- Vringo has limited options left to address today's ruling.
- The best option would be an en banc hearing, which might be granted based on the dispute over the finding of the majority.
- The verdict today was a huge blow to Vringo, and a clear win in favor of Google, as Google will no longer have to pay damages.
ZS Pharma: An Undervalued Small Cap Play
- As ZS-9 continues to advance through the development pipeline the shareprice will increase.
- ZS-9 has the potential to be a best in class treatment for Hyperkalamia.
- With sales projections of over $1 billion, the company is substantially undervalued compared to its current marketcap.
Dendreon: Is The End Near?
- Dendreon will not have enough cash to pay for its 2016 convertible notes.
- Note holders are unlikely to convert.
- Dendreon is not likely to be bought out.
- European launch of Provenge will not be enough to save Dendreon.
Time To Panic Over Lipitor Litigation?
- Plaintiffs will have to overcome substantial hurdles in linking Lipitor to Type II diabetes.
- A settlement does not appear to be imminent.
- Pfizer may test the waters before making a settlement decision.
Update: Tekmira Clinical Hold Lifted
- Lifting of FDA clinical hold will allow for Tekmira to continue testing Ebola therapeutic.
- This event helps to confirm my opinion on the long-term potential for Tekmira.
- This event was not anticipated by my article.
2nd Half Of 2014 Biotechnology Catalysts - Part 3
- NDA and advisory committee decisions have the potential to move stocks.
- Through knowing when the FDA is going to make a decision, momentum investors are able to make gains with the buildup ahead of the decision.
- Each of the companies mentioned in this article will be impacted by the FDA decision.
Intelgenx Leadership Change And CRL Response: Why I'm Still Bullish
- CRL response for Migraine product will take longer than expected, however, the company has identified a new API supplier if needed.
- Recent CEO change left shareholders blinded, however, the company appears to have a very able interim CEO.
- Manufacturing division will help to improve margins and quality control.
3 Biotech Catalyst Stocks To Own
- Each of the stocks mentioned in this article have upcoming clinical trial results that should move shares.
- For Xoma and Intercept, it is one step closer towards generating revenue.
- Gilead's clinical trial results will be crucial in its quest to lock down the HIV market.
Update: LPath Clinical Trial Results
- ASONEP data helps to reaffirm investor confidence in the ASONEP program.
- I reiterate previous article and still consider LPath to be a compelling buy.
- ASONEP trial expansion will give investors a clearer picture as the company moves forward.
Update: Synergy Pharmaceuticals Patient Enrollment
- Helps to confirm timeline in my original article.
- Clinical trial results in the last quarter of 2014 will help to provide a catalyst for shares.
- The trial will help to prepare for Phase III testing and should increase valuation of the company.
Did Pfizer Make A Horrible Business Deal?
- Puma Biotechnology licensed neratinib from Pfizer inc. in consideration for a royalty.
- Pursuant to the recent amendment, Pfizer will be due a lower royalty rate in exchange for not funding the upcoming trials.
- With the recently announced results, Puma investors may be in for an unexpected gain on the amended deal.
IntelGenx: A Compelling Investment Opportunity
- IntelGenx is trading at a price that does not remotely reflect its potential - it should be higher based on Rizatriptan film alone.
- The market is substantially undervaluing the pipeline products at IntelGenx.
- Low cash burn rate helps to lower the risk of dilution.
- Partnership agreement for unknown drugs could yield an unexpected source of growth for investors.
- The increasing sales of Forfivo XL along with increased revenue should help to lengthen the company's cash runway, further decreasing the risk of dilution.
Titan: A Compelling Investment Trading Below Fair Value And A Potential Buyout By Its Partner
- Partnership agreement with Braeburn Pharmaceuticals has the potential to be very lucrative for Titan.
- With Braeburn already owning 11% of Titan's stock, it is possible that Braeburn will take another step and buy out Titan.
- Partnership agreements outside of the US have the potential to be unexpected upside for Titan shareholders.
- Titan is trading well below the fair value estimate for the company.
- Conservatively, Titan should be able to get Probuphine on the market by the end of 2016 providing substantial revenues for the company and its shareholders.
Syndax Pharmaceuticals: An Interesting IPO Investment
- Entinostat breakthrough therapy designation helps to make investors confident in the Phase III trial.
- The upcoming IPO should provide the funds needed to advance the clinical trials.
- Syndax is poised to increase in share price as Entinostat continues to progress through clinical trials.
2nd Half Of 2014 Biotechnology Catalysts - Part 2
- NDA decisions can represent significant catalysts for investors.
- By knowing when the FDA is going to make a decision, astute investors are able to benefit from the price increase heading into the decision.
- Each of the companies in this article have the potential to be meaningfully impacted by their respective FDA decisions.
Synergy Pharmaceuticals: An Interesting Investment Ahead Of Multiple Catalysts
- Synergy is substantially undervalued over the long term.
- Plecanatide has the potential to generate significant revenue for Synergy.
- Continued Plecanatide development will provide many catalysts for shareholders.
- SP-333 will also help to provide the potential for growth over the long term.
Ardelyx: A Promising IPO
- Tenapanor should provide many upcoming catalysts for shareholders.
- Promising agreements with both Sanofi and AstraZeneca have the potential to provide significant revenue.
- Tenapanor is being developed to treat a wide array of diseases, and will be a drug to watch as it is important to the growth of Ardelyx.
- Additional partnership agreements could serve as unforeseen catalysts.
What Does A Positive Adcom Mean For Progenics And Salix?
- The positive committee vote should help to save Progenics and Salix time and money.
- The vote, if adopted, will help to bolster the chances of Relistor's sNDA being approved.
- Positive advisory committee vote will help to remove the FDA's concerns for a cardiovascular outcomes trial.
- If the FDA adopts Progenics' viewpoints, it could translate into more sales for Relistor.
Liberty Bancorp: An Enticing Investment Opportunity
- Liberty's loan portfolio is growing in quality, while also growing in total loans issued.
- Recent acquisitions should provide stepping stone for long-term success.
- As economic conditions in Liberty's territories improve, so should the bank's prospects.
- Liberty is well positioned to continue to grow its net income and to provide substantial returns to shareholders.
BioDelivery Sciences: After FDA Approval, Still Room To Run
- BEMA Buprenorphine's early July 2014 data read-out provides a substantial catalyst for shareholders.
- Clonidine Topical Gel development helps to provide another catalyst that has the potential to meaningfully impact shareholders.
- Shareholders will have catalytic events to wait for as BioDelivery prepares for the third-quarter launch of Bunavail.
Versartis: A Long-Term Buy
- VRS-317 offers a potentially best-in-class dosage schedule, which will translate into a competitive edge.
- Versartis has the potential to grab a significant market share of the HGH market.
- Versartis is facing a pending catalyst with the release of its clinical data in June from its VERTICAL trial.
2nd Half Of 2014 Biotechnology Catalysts - Part 1
- FDA catalysts can provide significant returns for investors.
- The two primary FDA catalysts that we are looking for are FDA decision dates (PDUFA dates) and advisory panel dates.
- PDUFA decisions include: Trimel Pharmaceuticals (TRLPF), Progenics (PGNX), AcelRX (ACRX), Anacor (ANAC), Omeros (OMER), Mannkind (MNKD), Eagle (EGRX), Biodelivery Sciences (BDSI), Navidea (NAVB), and Orexigen (OREX).
Northway Financial: A Promising Bank Trading At A Discount
- Growing income from core assets helps to position for growth.
- The market is not adequately valuing the growth potential of Northway.
- Northway's loan portfolio growth has the potential to provide significant long term returns to investors.
- IntelGenx Technologies: A Small Cap Company With The Potential For Significant Gains
- LPath Inc. A Small Biotechnology Company With Big Potential
- 2014 Biotechnology Catalysts
- Pioneer Bankshares: Ready To Put Cash In Your Pocket