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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 (Nasdaq: BCRX) has initiated enrollment in a Phase 1 trial for BCX17725, a potent and selective kallikrein 5 (KLK5) inhibitor designed to treat Netherton syndrome. This protein therapeutic aims to address the underlying cause of the disease, potentially offering a best-in-class targeted treatment. The trial will evaluate safety, tolerability, pharmacokinetics, and immunogenicity in healthy adults and Netherton syndrome patients.
Key points:
- First participant enrolled in the Phase 1 trial
- Initial data expected by the end of 2025
- BCX17725 is BioCryst's first protein therapeutic to reach clinical stage
- Netherton syndrome is a rare genetic disorder affecting skin, hair, and immune system
- Currently, no approved treatments exist for Netherton syndrome
BioCryst Pharmaceuticals has been awarded a contract worth up to $69 million by the U.S. Department of Health and Human Services for the procurement of up to 95,625 doses of RAPIVAB® (peramivir injection) over a five-year period. The contract is structured with a 12-month base ordering period and four optional 12-month periods. The first ordering period, worth $13.9 million for 19,125 doses, has been executed and will be fulfilled by September 29, 2025.
RAPIVAB will be supplied to the Strategic National Stockpile for use in potential public health emergencies related to influenza. This contract follows a previous $34.7 million contract awarded in 2018 for 50,000 doses, which was completed in 2022. RAPIVAB has been part of the U.S. government's influenza preparedness efforts since the 2009 H1N1 pandemic.
BioCryst Pharmaceuticals (Nasdaq: BCRX) presented six posters at the 7th Bradykinin Symposium, including interim results from the APeX-N trial and data on shared decision making in hereditary angioedema (HAE) management. The APeX-N study, evaluating ORLADEYO® (berotralstat) in Europe, showed non-serious gastrointestinal adverse events in 12.5% of patients, with a 7% discontinuation rate. The shared decision making study in Germany identified the need for improved HCP-patient communication and education about HAE treatment. These findings aim to enhance HAE management strategies and patient outcomes.
BioCryst Pharmaceuticals (Nasdaq: BCRX) has appointed Dr. Donald S. Fong as its new chief medical officer, effective immediately. Dr. Fong, who joined BioCryst in April 2024 as vice president of the ophthalmology therapeutic area, brings over 25 years of clinical experience in leading clinical trials and drug development. His appointment strengthens BioCryst's leadership team as they advance their pipeline of novel therapies, including programs for Netherton syndrome and diabetic macular edema.
Dr. Fong's extensive background includes serving as vice president of ophthalmology clinical development at Annexon Biosciences, founding the clinical trials division at Kaiser Permanente Southern California, and advising numerous FDA committees. His expertise aligns with BioCryst's focus on developing potential life-changing therapies for diseases with significant unmet needs.
BioCryst Pharmaceuticals (Nasdaq: BCRX) has announced the granting of stock options and restricted stock units (RSUs) to nine newly-hired employees. The compensation committee approved options to purchase 28,400 shares and RSUs covering 20,025 shares of BioCryst common stock. These grants, made on August 30, 2024, serve as inducements for employment and comply with Nasdaq Listing Rule 5635(c)(4).
The stock options have an exercise price of $8.69 per share, matching the closing price on the grant date. Both options and RSUs will vest in four equal annual installments, starting from the one-year anniversary of the grant date, contingent on continued employment. The stock options have a 10-year term. These equity incentives are subject to BioCryst's Inducement Equity Incentive Plan and respective agreements.
BioCryst Pharmaceuticals (Nasdaq: BCRX) has announced its participation in three upcoming investor conferences in September 2024. The company will present at the 2024 Wells Fargo Healthcare Conference in Boston on September 5 at 1:30 p.m. ET, the H.C. Wainwright 26th Annual Global Investment Conference in New York on September 9 at 9:00 a.m. ET, and the 2024 Cantor Global Healthcare Conference in New York on September 19 at 12:45 p.m. ET.
Investors and interested parties can access live audio webcasts and replays of the presentations through the Investors & Media section of BioCryst's website at http://www.biocryst.com. This series of presentations provides an opportunity for BioCryst to showcase its progress and engage with the investment community.
BioCryst Pharmaceuticals reported Q2 2024 financial results, highlighting a 34% y-o-y increase in ORLADEYO net revenue to $108.3 million. Full-year 2024 ORLADEYO revenue guidance has been raised to $420-$435 million from $390-$400 million. The company achieved a GAAP operating profit of $8.8 million, compared to a loss in Q2 2023, and a non-GAAP operating profit of $21.9 million. Total revenues rose 32.5% y-o-y to $109.3 million. R&D expenses fell 26.6% y-o-y to $37.6 million, while SG&A expenses increased 20% y-o-y to $61.2 million. Net loss was $12.7 million, down from $75.3 million in Q2 2023. Cash reserves totaled $338.1 million as of June 30, 2024. The pipeline includes advancing BCX17725 for Netherton syndrome and avoralstat for diabetic macular edema. BioCryst plans to achieve full-year operating profit in 2024 and positive EPS by 2026 without additional fundraising.
BioCryst Pharmaceuticals (Nasdaq: BCRX) has announced the granting of stock options and restricted stock units (RSUs) to nine newly-hired employees. The compensation committee approved options to purchase 40,350 shares and RSUs covering 28,200 shares of BioCryst common stock. These were granted on July 31, 2024, as inducements for employment.
The stock options have an exercise price of $7.28 per share, equal to the closing price on the grant date. Both options and RSUs will vest in four equal annual installments, starting from the one-year anniversary of the grant date. The stock options have a 10-year term. These grants are subject to BioCryst's Inducement Equity Incentive Plan and respective agreements.
BioCryst Pharmaceuticals (Nasdaq: BCRX) has announced that it will release its second quarter 2024 financial results on Monday, August 5, 2024. The company's management team will host a conference call and webcast at 8:30 a.m. ET on the same day to discuss the financial results and provide a corporate update. Interested parties can access the live call by dialing 1-844-481-2942 (domestic) or 1-412-317-1866 (international). Additionally, a live webcast and replay of the call will be available in the investors section of the company's website at www.biocryst.com.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced the approval of its drug, ORLADEYO® (berotralstat), by the General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru. This oral, once-daily medication is designed for the prevention of hereditary angioedema (HAE) attacks in individuals aged 12 and older. The approval allows BioCryst, in collaboration with Pint Pharma, to provide new treatment options for HAE patients in Peru. This marks another milestone for ORLADEYO, which has already secured approvals in other Latin American countries like Chile, Argentina, Brazil, and Mexico.
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