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BioCryst Pharmaceuticals Inc. (Nasdaq: BCRX) is a global biotechnology company dedicated to improving the lives of individuals living with rare and serious diseases. Founded in 1986, BioCryst specializes in designing, optimizing, and developing novel small-molecule drugs that block key enzymes involved in infectious and rare diseases. Headquartered in Research Triangle Park, North Carolina, with a discovery center in Birmingham, Alabama, the company harnesses its expertise in drug discovery, clinical development, regulatory affairs, and product commercialization.
BioCryst is known for its flagship product, ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor specifically designed to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 12 years and older. The efficacy of ORLADEYO has been demonstrated through multiple clinical studies and real-world data, showing significant reductions in HAE attack rates across various patient profiles.
The company's robust pipeline includes several innovative programs such as BCX17725 for Netherton syndrome and avoralstat for diabetic macular edema (DME). BioCryst's research spans multiple scientific disciplines, including biology, computer modeling, and medicinal chemistry, targeting therapeutic areas like acute uncomplicated influenza, hereditary angioedema, filoviruses (Ebola and Marburg), and oncology.
In recent announcements, BioCryst reported strong financial performance with ORLADEYO net revenue experiencing substantial growth. The company also continues to expand globally, with recent approvals of ORLADEYO in major markets, including Brazil and Mexico. Partnerships with organizations such as Pint Pharma help BioCryst extend its reach and bring life-changing treatments to patients worldwide.
BioCryst remains committed to advancing its clinical programs, generating new compounds, and upholding a culture of engagement and accountability. The company's ongoing dedication to developing innovative therapeutics aims to address unmet medical needs and provide better health outcomes for patients suffering from rare and serious conditions.
For more information, please visit www.biocryst.com or follow them on LinkedIn.
BioCryst Pharmaceuticals (BCRX) announced promising initial data from its phase 1 trials for BCX10013, a potential best-in-class oral Factor D inhibitor targeting complement-mediated diseases. The trials demonstrated a sustained suppression of the alternative pathway by over 97% following a single dosage, indicating its safety and effectiveness. Plans are set to advance to patient studies for conditions like paroxysmal nocturnal hemoglobinuria (PNH) and immunoglobulin A nephropathy (IgAN). Additionally, the company is expanding its research on oral therapies for other complement pathways.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced its participation in the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 6:00 p.m. ET in San Francisco. The event will feature a presentation from the company, and a live audio webcast will be accessible on their website. BioCryst specializes in developing oral medicines for rare diseases, including its approved product ORLADEYO (berotralstat) and RAPIVAB (peramivir injection). The company is also advancing multiple therapeutic projects, including BCX10013.
BioCryst Pharmaceuticals (BCRX) has announced the discontinuation of its development program for BCX9930 due to recent competitive data presented at the ASH annual meeting, indicating it would not be commercially viable. The focus will now shift entirely to BCX10013, an oral Factor D inhibitor showing promise in clinical trials. This strategic pivot is expected to have a positive financial impact, lowering 2022 operating expenses by about $100 million. Preliminary data on BCX10013 is anticipated in Q1 2023, as BioCryst aims to expand its complement therapeutic program.
BioCryst Pharmaceuticals (BCRX) announced the granting of stock options and restricted stock units (RSUs) to 21 newly-hired employees as an inducement for employment. This grant, effective November 30, 2022, includes options to purchase 134,600 shares at an exercise price of $13.36, equal to the stock's closing price on the grant date. The options and RSUs will vest over four years, contingent upon continued employment. BioCryst focuses on developing small-molecule medicines for rare diseases, including the approved oral treatment ORLADEYO®.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will present virtually at the JMP Securities Hematology & Oncology Summit on December 7, 2022, at 11:40 a.m. ET. The presentation will be accessible via a live audio webcast on their website. The company specializes in developing oral, small-molecule medications for rare diseases, with its product ORLADEYO® (berotralstat) already approved in the U.S. BioCryst also has ongoing clinical programs for oral factor D inhibitors BCX9930 and BCX10013.
BioCryst Pharmaceuticals (BCRX) announced the Israeli Ministry of Health has granted marketing authorization for ORLADEYO® (berotralstat), a once-daily oral therapy for preventing hereditary angioedema (HAE) attacks in patients aged 12 and older. The company plans to partner with Neopharm for its launch in Israel. Clinical trials indicate ORLADEYO was safe and well tolerated, though gastrointestinal reactions were reported, typically resolving over time. This authorization marks a significant stride for HAE patients in Israel, providing a less burdensome treatment option.
BioCryst Pharmaceuticals (BCRX) unveiled new real-world data indicating that patients aged 12 and older using ORLADEYO (berotralstat) for hereditary angioedema (HAE) experience rapid and sustained reductions in attack rates. Presented at the 2022 ACAAI Annual Meeting, the data highlight significant efficacy improvements post-switch from other therapies, with an average attack rate reduction of 80% within the first 90 days. The results suggest ORLADEYO is effective regardless of prior treatment history, with lower adverse event rates compared to clinical trials.
BioCryst Pharmaceuticals (BCRX) announced its participation in several investor conferences. The company will present at the Jefferies London Healthcare Conference on November 16, 2022, at 12:00 p.m. ET. Additionally, BioCryst will take part in the virtual 5th Annual Evercore ISI HealthCONx Conference on November 29, 2022, at 8:25 a.m. ET, followed by the Piper Sandler 34th Annual Healthcare Conference in New York on November 30, 2022, at 8:30 a.m. ET. Live audio webcasts will be available on BioCryst's website, ensuring stakeholders can follow the updates easily.
BioCryst Pharmaceuticals (BCRX) announced that its compensation committee granted stock options and restricted stock units (RSUs) to 14 new employees as of October 31, 2022. The stock options total 125,700 shares with an exercise price of $13.35, equal to the grant date's closing stock price. The RSUs cover 46,350 shares and both vest over four years, contingent on continued employment. This action complies with Nasdaq Listing Rule 5635(c)(4) and aims to attract talent to support the company's growth in developing oral medicines for rare diseases.
BioCryst Pharmaceuticals reported Q3 2022 revenues of $75.8 million, a 85% year-over-year increase, driven mainly by $66.0 million from ORLADEYO. The patient base for ORLADEYO grew by 9% in Q3. The company is advancing its pipeline with new Factor D inhibitors, BCX10013 entering clinical trials, while screening for BCX9930 continues, with data expected mid-2023. The company anticipates full-year ORLADEYO revenue of $255 million and operating expenses between $365 million and $370 million.