BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) is adding to the gains the stock experienced yesterday after issuing a press release announcing that early access to a treatment for hereditary angioedema (HAE) has been granted in France. Here’s what’s going on:
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- BioCryst Pharmaceuticals Announces Early Access Approval
- What Analysts Think About BCRX Stock
- Final Thoughts
BioCryst Pharmaceuticals Announces Early Access Approval
In the press release, BioCryst Pharmaceuticals said that the French National Agency for Medicines and Health Products Safety, also known as the ANSM, has granted Autorisation Temporaire d’Utilisation de cohorte (cohort ATU), equating to temporary authorized use, for the use of berotralstat to prevent HAE attacks in patients 12 years of age or older.
As a result of this approval, HAE patients in France will have access to treatment with berotralstat before the drug is granted marketing authorization by the European Commission, or EC.
In the release, BCRX went on to say that a cohort ATU is dedicated to high unmet medical needs in serious diseases. The status covers medical products that have shown strong safety and efficacy and intended for a group or sub-group of patients treated and monitored in accordance with criteria defined in a protocol for therapeutic use and collection of information.
Importantly, approval across the European Union may be on the horizon. In fact, in late-February, the company said that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending the approval of ORLADEYO, the brand name for berotralstat, for routine prevention of recurrent HAE attacks. The final decision is expected to be released in the second quarter.
In a statement, Dr. Laurence Bouillet, Head of Internal Medicine at the University Hospital Grenoble Coordinating Reference Center for HAE in France, had the following to offer about the news.
HAE is a debilitating and potentially deadly disease so the early access to a new treatment option for patients is exciting news.
The above statement was followed up by Jon Stonehouse, CEO at BCRX. Here’s what he had to say:
The cohort ATU represents BioCryst’s second early access program approved in Europe and provides patients in France with faster access to treatment.
What Analysts Think About BCRX Stock
Analysts have an overwhelmingly positive opinion of BioCryst Pharmaceuticals. In fact, according to TipRanks, there are 10 analysts covering the stock, eight of which rate it a Buy and two of which rate it a Hold.
Price targets range from $9 to $16, with a median of $13.33. However, it’s important to keep in mind that these price targets are largely outdated and simply don’t take recent, overwhelmingly positive news into account. As such, upon review, I’m expecting that the Holds will turn to Buys and price targets will be increased.
All in all, BioCryst is an exciting stock at the moment. The company now achieved early access approval for its ORLADEYO product in France and will likely receive approval to market its drug across Europe.
This will give the company the opportunity to tap into a massive market, setting the stage for significant revenues and tremendous growth in the value of BCRX stock.