Biocryst Pharmaceuticals Inc Stock Price, News & Analysis

BioCryst Pharmaceuticals announced executive appointments on September 14, 2022. Dr. Bill Sheridan will take on the role of Chief Development Officer, focusing on the company's pipeline, while Dr. Ryan Arnold has been named the new Chief Medical Officer. Dr. Sheridan brings 15 years of experience from Amgen, with a strong background in medical affairs and product development. Dr. Arnold, who joined BioCryst in March 2022, has over 20 years in the industry, specializing in medical affairs across rare disease indications. This leadership change aims to enhance the company’s development efforts in treating unmet medical needs.

On September 6, 2022, BioCryst Pharmaceuticals (BCRX) announced the granting of stock options and restricted stock units to 17 new employees, totaling 161,500 options and 64,250 RSUs. The options have an exercise price of $13.90, matching the stock's closing price on the grant date. These compensation incentives are part of Nasdaq's compliance and will vest over four years. BioCryst focuses on developing oral medicines for rare diseases, including approved products like ORLADEYO and ongoing projects such as BCX9930.

BioCryst Pharmaceuticals (BCRX) announced its participation in two upcoming healthcare conferences. The company will present at the 2022 Wells Fargo Healthcare Conference on September 7, 2022, at 11:35 a.m. ET, and will also take part in the H.C. Wainwright 24th Annual Global Investment Conference. A pre-recorded fireside chat for this latter event will be available on September 12, 2022, at 7:00 a.m. ET. Links to live webcasts and replays will be accessible on BioCryst's website.

BioCryst Pharmaceuticals (BCRX) has received FDA orphan drug designation for BCX9250, aimed at treating fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder. This designation offers benefits like tax credits, user fee exemptions, and potential market exclusivity. BioCryst is also preparing for trials in FOP patients next year following earlier Fast Track and EMA PRIME designations for BCX9250. The drug demonstrated safety and tolerability in Phase 1 trials, supporting once-daily dosing. The upcoming American Society for Bone and Mineral Research meeting will feature data from BCX9250 studies.

BioCryst Pharmaceuticals announced promising results for its oral Factor D inhibitor, BCX9930, in patients with C3 glomerulopathy (C3G). The study demonstrated over 99% suppression of the alternative pathway (AP) of the complement system, maintained for 24 hours after dosing. The drug achieved rapid suppression of C3a levels and was generally safe and well-tolerated. These findings support further development of BCX9930 for treating C3G and other complement-mediated diseases. The data will be presented at the 18th European Meeting on Complement in Human Disease in Bern, Switzerland.

On August 25, 2022, BioCryst Pharmaceuticals (BCRX) announced a contract extension with the U.S. Department of Health and Human Services (HHS) to supply an additional 10,000 doses of its antiviral drug, RAPIVAB (peramivir injection), valued at approximately $7 million. This order fulfills the final requirement under a $34.7 million contract for 50,000 doses over five years, aimed at enhancing pandemic preparedness. RAPIVAB is approved for treating acute influenza in patients over six months old, with administration via intravenous infusion.

BioCryst Pharmaceuticals (BCRX) announced that the Saudi Food and Drug Authority has approved ORLADEYO® (berotralstat) for the prevention of hereditary angioedema attacks in patients aged 12 and older. This approval highlights the demand for new HAE treatment options in Saudi Arabia. ORLADEYO is the first oral therapy specifically designed for HAE prophylaxis. BioCryst also has distribution agreements with NewBridge Pharmaceuticals for the GCC region. The drug demonstrated safety and tolerability in clinical trials, with some common adverse reactions noted.

BioCryst Pharmaceuticals (BCRX) reported Q2 2022 net revenue of $65.2 million, a 129% increase year-over-year. The company anticipates FY 2022 ORLADEYO net revenue of $255 million to $265 million and projects peak global sales of ORLADEYO nearing $1 billion. Growth continues in patient prescriptions, with a significant portion from key HAE treaters. However, R&D expenses rose to $62.0 million, and net losses increased to $58.9 million. The company has lifted the clinical hold on BCX9930 and expects increased focus on its development.

BioCryst Pharmaceuticals announced the FDA has lifted the partial clinical hold on its BCX9930 program. Enrollment in pivotal trials for paroxysmal nocturnal hemoglobinuria (PNH) and other kidney diseases will resume with a reduced dose of 400 mg twice daily. Previous doses of 500 mg showed elevated serum creatinine levels in some patients. The change aims to prevent crystal formation in kidneys. If successful, BioCryst plans to invest more in BCX9930; if not, they will shift focus to other pipeline candidates.