BCRX stock ran to $6 after re-initiated coverage last month, which you can read here. Since then, BCRX has dropped back down to just under $4 a share. While there hasn’t been any big news on Galidesivir since our last article, news just hit the tape after-hours the CFO bought $220,000 worth of BCRX stock at $4.08 a share. Now while some might not think this is a lot of money in today’s world, it caught our attention because his yearly salary is only $480,000, which you can confirm in this SEC filing. Mr. Anthony Doyle just put half his salary into BCRX stock. If this isn’t a vote of confidence from an insider, we don’t know what more we can say. Obviously, he knows something or wouldn’t be putting such a large percentage of his salary into the company. Furthermore, this was not an option purchase, but rather cash. As we take a closer look, big things could be about to happen with BCRX stock.
First up, here’s a little background info for those not familiar with BCRX stock.
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist, and an enzyme plays a vital role in the biological pathway of the disease.
BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential therapy for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressive.
RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea, and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.
Fast Track Designation
At the beginning of this month, the FDA granted Fast Track designation for BioCryst Pharmaceuticals’ oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application. Dr. William Sheridan, chief medical officer of BioCryst, said:
“PNH patients have a tremendous need for therapy improvements and it is exciting for patients that the FDA has reviewed our proof of concept PNH data and granted Fast Track status. This designation can significantly accelerate the development timeline for BCX9930. We look forward to working closely with the FDA to fully utilize the opportunities presented by our Fast Track designation to advance this important medicine to patients as quickly as possible in PNH. In addition, we look forward to regulatory discussions later this year on clinical trials for BCX9930 in nephrology indications.”
BCRX Stock and Galidesivir
The news everyone is waiting for from BCRX stock relates to Galidesivir. Galidesivir, a broad-spectrum antiviral drug, is an adenosine nucleoside analog that acts to block viral RNA polymerase. It is in advanced development for the treatment of COVID-19, Marburg virus disease, and Yellow Fever.
Phase 1 clinical safety and pharmacokinetics trials of galidesivir by both intravenous and intramuscular routes of administration in healthy subjects have been completed. In animal studies, galidesivir has demonstrated activity against a variety of dangerous pathogens, including Ebola, Marburg, Yellow Fever, and Zika viruses.
Galidesivir has also demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including coronaviruses, filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, and flaviviruses. BioCryst is developing galidesivir in collaboration with U.S. government agencies and other institutions.
Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well-tolerated in previously reported Phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS. A Phase 1 trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19 is currently enrolling patients across multiple sites in Brazil.
The Latest On Galidesivir
The latest on Galidesivir and BCRX stock comes from the latest earnings call. The company expects data from Part 1 of its COVID-19 trial with galidesivir in Brazil by the end of this quarter, or September 30th at the latest.
ORLADEYO is coming soon as we are just over a quarter away from the December 3th PDUFA date. As the company approaches US launch later this year, and in Europe early next year, we are even more confident that ORLADEYO will exceed $500 million in peak global sales.
BCRX Stock Bull Thesis
Here are just a handful of reasons to be bullish on BCRX stock and why we think the CFO put half his salary into shares.
- BCRX is set to start generating revenues with ORLADEYO before the end of the year.
- BCRX has almost $200 million in cash, enough to last one year without an equity raise.
- Data for 9930 in both naïve and poor responders is coming.
- Information from Part 1 of the COVID trial with galidesivir before September 30th.
- The rationale for the use of galidesivir is based on its broad-spectrum antiviral activity and also on the positive results of Gilead’s Remdesivir, which shares the mechanism of action.
- In animal studies, galidesivir has demonstrated survival benefits against dangerous pathogens, including Ebola, Marburg, Yellow Fever, and Zika viruses. Galidesivir also showed activity in vitro against more than 20 ribonucleic acid (“RNA”) viruses, including coronaviruses.
- A market cap of just $692 million.
- 23% of the float is short compared to 15% in July.
- RSI of 38 starting to turn higher signaling a move higher is coming.
- BCRX stock has remained above the 200-day moving average since April, encouraging dip-buying.
With almost $200 million in the bank and no shortage of patients in Brazil needing treatment, we are just a pr away from BCRX stock making a huge move, especially with 23% of the float short. The combination of news hitting the tape on galidesivir and the shorts scrambling to cover will send BCRX stock to new highs. The latest move from the CFO just gave a clear buy signal.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in NASDAQ:BCRX or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.