FDA Grants Approval for Orladeyo Oral Pellets for Pediatric Patients with Hereditary Angioedema
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 12 2025
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Source: NASDAQ.COM
FDA Approval: BioCryst Pharmaceuticals received FDA approval for an oral pellet formulation of Orladeyo for pediatric patients aged 2 to under 12 years with hereditary angioedema (HAE).
First Targeted Therapy: Orladeyo is now the first and only targeted oral prophylactic therapy available for HAE patients aged 2 and older, complementing the existing capsule form approved for those aged 12 and older.
Market Reaction: Following the announcement, BioCryst's shares increased by over 8% in pre-market trading after a previous close of $7.58.
Global Availability: The capsule form of Orladeyo is already available in more than 45 countries, including the United States.
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Analyst Views on BCRX
Wall Street analysts forecast BCRX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BCRX is 19.45 USD with a low forecast of 8.00 USD and a high forecast of 32.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
11 Analyst Rating
9 Buy
2 Hold
0 Sell
Strong Buy
Current: 6.660
Low
8.00
Averages
19.45
High
32.00
Current: 6.660
Low
8.00
Averages
19.45
High
32.00
About BCRX
BioCryst Pharmaceuticals, Inc. is a biotechnology company focused on developing and commercializing medicines for hereditary angioedema (HAE) and other rare diseases. Its marketed products include oral, once-daily ORLADEYO for the prevention of hereditary angioedema (HAE) attacks and RAPIVAB (peramivir injection) for the treatment of acute uncomplicated influenza in the United States. Its other products and product candidates include BCX10013, RAPIACTA (peramivir injection), PERAMIFLU (peramivir injection), and early-stage discovery programs. BCX10013, is a potent and specific Factor D inhibitor. RAPIACTA focuses on uncomplicated seasonal influenza. The RAPIVAB (peramivir injection) is approved in the United States for the treatment of acute uncomplicated influenza for patients six months and older. Its portfolio also includes navenibart, which is a late-stage, long-acting plasma kallikrein inhibitor. It has also obtained an early-stage program for atopic dermatitis, STAR0310.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Astria Therapeutics to be Sold to BioCryst for $8.55 per Share
- Transaction Investigation: Former Louisiana Attorney General Charles C. Foti and his law firm are investigating the proposed sale of Astria Therapeutics to BioCryst Pharmaceuticals, which involves a compensation of $8.55 in cash and 0.59 shares of BioCryst stock per Astria share, aiming to assess whether this deal undervalues the company.
- Shareholder Rights Concern: KSF is seeking to confirm the adequacy of the transaction process and compensation, emphasizing the importance of protecting shareholder rights by inviting those who believe the deal undervalues the company to discuss their legal options.
- Legal Consultation Services: KSF offers no-obligation legal consultations, encouraging shareholders to contact Managing Partner Lewis S. Kahn, which highlights the firm's commitment to shareholder interests and the pursuit of transaction transparency.
- Market Reaction Potential: The investigation into this transaction could impact shareholder confidence and market performance for Astria, as any findings of unfairness may lead to legal actions that could subsequently affect the company's stock price trajectory.
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BioCryst Grants 18,300 RSUs to New Employee as Inducement
- Employee Incentive Program: BioCryst granted 18,300 restricted stock units (RSUs) to a newly hired employee on January 2, 2026, as an inducement to attract and retain key talent essential for the company's growth.
- Vesting Terms: The RSUs will vest in four equal annual installments starting on the one-year anniversary of the grant date, ensuring the new employee's continued service, which enhances long-term commitment and stability within the workforce.
- Compliance Assurance: This grant complies with Nasdaq Listing Rule 5635(c)(4), ensuring transparency and adherence to regulations in the company's incentive measures, thereby boosting investor confidence.
- Company Background: BioCryst focuses on developing medicines for hereditary angioedema and other rare diseases, having successfully commercialized ORLADEYO®, the first oral, once-daily plasma kallikrein inhibitor, while advancing its innovative drug pipeline to meet market needs.
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