Latest news with #Orladeyo
Business Insider
01-07-2025
- Business
- Business Insider
BioCryst price target raised to $15 from $13 at BofA
BofA analyst Tazeen Ahmad raised the firm's price target on BioCryst (BCRX) to $15 from $13 and keeps a Buy rating on the shares after the company announced an agreement to sell the European Orladeyo business to Neopharmed Gentili for up to $264M. The firm is 'encouraged' by the deal given the majority of Orladeyo revenues are realized in the U.S. and it provides clear line of sight for settling outstanding debt, the analyst tells investors. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Yahoo
15-05-2025
- Health
- Yahoo
FDA awards BioCryst's Orladeyo NDA for paediatric HAE
The US Food and Drug Administration (FDA) has accepted BioCryst Pharmaceuticals' new drug application (NDA) for Orladeyo (berotralstat), granting it priority review for use in children aged two to 11 with hereditary angioedema (HAE). A Prescription Drug User Fee Act target action date was set by the agency for 12 September 2025. The application was supported by the APeX-P trial's positive interim data. This trial assessed a prophylactic HAE therapy in these subjects. The results indicated that the therapy was well tolerated and maintained a consistent safety profile in this young age group. It also led to sustained and early minimisations of monthly attack rates. If approved, this plasma kallikrein inhibitor will be the inaugural oral targeted prophylactic therapy for HAE patients under 12. Beyond the US, the company has also submitted a line extension application to the European Medicines Agency for the use of the therapy oral granules in this patient population. The company plans additional regulatory filings in other worldwide territories, including Canada and Japan. BioCryst Pharmaceuticals chief research and development officer Dr Helen Thackray stated: 'As detailed in the results from APeX-P, we observed that participants experienced serious HAE attacks at a very early age, with a median age of symptom onset of two years, which suggests there is a larger burden of disease at an earlier age than has been appreciated thus far. 'If approved, we believe this oral granule formulation of Orladeyo could help children with HAE and their families better manage their condition and avoid the traumatic experience of acute attacks with emergency care or hospital stays.' In December 2020, the therapy was approved by the US regulator initially for HAE attack prevention in the adult population and in children aged 12 and above. It is currently available commercially in 30 countries. in 2024, the company secured a contract worth up to $69m from the US Department of Health and Human Services for the procurement of Rapivab to treat influenza. "FDA awards BioCryst's Orladeyo NDA for paediatric HAE" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-05-2025
- Business
- Yahoo
Why BioCryst Pharmaceuticals, Inc. (BCRX) Soared on Monday
We recently published a list of Why These 10 Firms Soared on Monday. In this article, we are going to take a look at where BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) stands against other Monday's best performers. The stock market kicked off the trading week on a negative note as investors sold off on a new round of uncertainties from President Donald Trump's tariff policies. The Nasdaq fell by 0.74 percent, while the S&P 500 dropped 0.64 percent and the Dow Jones was down by 0.24 percent. Over the weekend, Trump told reporters that the US was negotiating with many countries, 'but at the end of this, I'll set my own deals — because I set the deal, they don't set the deal.' He added that he had no intentions to talk with Chinese President Xi Jinping, dampening hopes of a potential negotiation between the two of the world's largest economies. Beyond the major indices, 10 companies stood out with strong gains amid a flurry of fresh developments. In this article, we name Monday's 10 best performers and detail the reasons behind their gains. To come up with the list, we considered only the stocks with a $2-billion market capitalization and $5-million trading volume. Why BioCryst Pharmaceuticals, Inc. (BCRX) Soared on Monday A scientist in a lab coat observing a line of medicine pills in a container. BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) BioCryst Pharmaceuticals jumped by 23.52 percent on Monday, a second straight day, ending the day at $11.03 apiece following its impressive earnings performance in the first quarter, coupled with a highly optimistic outlook for the rest of the year. In a statement, BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) said it swung to a net income of $32,000 from a net loss of $35.38 million in the same period a year earlier as revenues jumped by 57 percent to $145.5 million from $92.76 million year-on-year, thanks to the strong performance of its hereditary angioedema treatment, Orladeyo. Looking ahead, BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) said it now expects to be fully profitable for the rest of the year ahead of its original target. Revenues from Orladeyo alone were expected to settle between $580 million and $600 million, higher than the $535 million to $550 million targeted previously. Full-year operating expenses were also targeted to settle only between $440 million and $450 million, from the previous $425 million to $435 million. Overall, BCRX ranks 2nd on our list of Monday's best performers. While we acknowledge the potential of BCRX as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than BCRX but that trades at less than 5 times its earnings, check out our report about this cheapest AI stock.
