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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 FDA has granted Fast Track designation for BCX9250 aimed at preventing heterotopic ossification in fibrodysplasia ossificans progressiva (FOP) patients. This designation expedites drug development and review for serious conditions with unmet medical needs. BCX9250 targets the ALK-2 enzyme, crucial for FOP, with positive Phase 1 trial results indicating good safety and tolerability. This follows recent PRIME eligibility from EMA, reflecting significant progress in the drug’s development, addressing a critical need in an ultra-rare disease community.
BioCryst Pharmaceuticals (BCRX) announced that Swissmedic has authorized the marketing of ORLADEYO (berotralstat) for preventing recurrent hereditary angioedema (HAE) attacks in patients aged 12 and older in Switzerland. The drug is the first oral, non-steroidal therapy for HAE, enhancing treatment options. Following its European approval last year, BioCryst anticipates launching ORLADEYO in Switzerland after finalizing reimbursement plans. Clinical trials reported gastrointestinal issues which were generally mild and self-resolving.
BioCryst Pharmaceuticals (BCRX) announced the approval of ORLADEYO (berotralstat) by Health Canada for the prevention of recurrent hereditary angioedema (HAE) attacks in patients aged 12 and older. This marks a significant advancement for the Canadian HAE community, offering a much-needed oral prophylactic therapy. ORLADEYO is already approved in multiple global markets, and the company is committed to ensuring timely access for Canadian patients. Clinical trials reported that ORLADEYO was generally well tolerated, with gastrointestinal reactions being the most common adverse effects.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will present at two upcoming healthcare conferences: the Jefferies Healthcare Conference on June 8, 2022, at 9:00 a.m. ET, and the JMP Securities Life Sciences Conference on June 15, 2022, at 12:00 p.m. ET. Investors can access live audio webcasts and replays of these events via the Investors & Media section of BioCryst's website. The company specializes in developing oral small-molecule medicines for rare diseases, with drugs like ORLADEYO® approved in multiple regions, and several ongoing development programs including BCX9930 and galidesivir.
BioCryst Pharmaceuticals (BCRX) announced its participation in several key investor conferences. The company will present at the Bank of America Securities 2022 Healthcare Conference on May 10 at 11:00 a.m. ET in Las Vegas, and at the RBC Capital Markets Global Healthcare Conference on May 18 at 1:35 p.m. ET in New York. Additionally, a pre-recorded fireside chat at the H.C. Wainwright Global Investment Conference will be accessible starting May 24 at 7:00 a.m. ET. Live webcasts will be available on BioCryst's investor relations website.
BioCryst Pharmaceuticals (BCRX) reported Q1 2022 net revenue of $49.7 million from ORLADEYO, contributing to a projected $250 million in revenue for the year. The company notes strong demand and expansion in prescriber bases, with patient satisfaction rising. However, it has paused BCX9930 trials due to safety concerns linked to dosing. The total revenues for Q1 2022 reached $49.9 million, up 161.3% YoY, while the net loss was $74.2 million, or $0.40 per share. Cash reserves totaled $446.8 million as of March 31, 2022.
BioCryst Pharmaceuticals (BCRX) announced on May 4, 2022, that its board's compensation committee granted stock options and restricted stock units (RSUs) to 23 newly-hired employees. The total granted includes options for 138,100 shares and RSUs for 69,050 shares, with an exercise price of $9.29 per share, equivalent to the stock's closing price on the grant date. These options and RSUs will vest over four years, contingent on continued employment, and are compliant with Nasdaq Listing Rule 5635(c)(4).
BioCryst Pharmaceuticals has announced that the European Medicines Agency (EMA) has granted BCX9250 access to its Priority Medicines (PRIME) scheme, making it the first investigational drug for fibrodysplasia ossificans progressiva (FOP) eligible for this program. The PRIME initiative aims to expedite the development of medicines addressing unmet medical needs through enhanced interaction with developers. BCX9250, an oral ALK-2 inhibitor, has shown promising safety and tolerability in Phase 1 trials, indicating potential for once-daily dosing.
BioCryst Pharmaceuticals (BCRX) will announce its Q1 2022 financial results on May 5, 2022. A conference call will be held at 8:30 a.m. ET to discuss these results and provide corporate updates. Interested parties can join the call via telephone or access it through a live webcast from the company's investor relations page. BioCryst focuses on developing oral treatments for rare diseases, with products like ORLADEYO approved in multiple countries and ongoing programs for other novel therapies. For more details, visit www.biocryst.com.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced participation in the 21st Annual Needham Virtual Healthcare Conference on April 14, 2022, at 11:45 a.m. ET. A live audio webcast and replay will be accessible in the Investors & Media section of BioCryst’s website. The company focuses on discovering novel oral medicines for rare diseases, with products like ORLADEYO® approved in multiple regions. BioCryst also has ongoing programs for complement-mediated diseases and viral infections.
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