BioCryst Receives FDA Approval for Orladeyo Oral Pellets
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 12 2025
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Should l Buy BCRX?
Source: SeekingAlpha
FDA Approval: BioCryst Pharma's Orladeyo has received FDA approval for an oral pellet formulation as a once-daily preventive treatment for children aged 2 to 12 with hereditary angioedema (HAE).
First of Its Kind: This approval makes Orladeyo the first targeted oral prophylactic therapy available for HAE patients under 12, providing a more convenient administration method compared to previous intravenous or subcutaneous options.
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Analyst Views on BCRX
Wall Street analysts forecast BCRX stock price to rise
11 Analyst Rating
9 Buy
2 Hold
0 Sell
Strong Buy
Current: 6.800
Low
8.00
Averages
19.45
High
32.00
Current: 6.800
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.
BioCryst Pharmaceuticals Faces Dismal Outlook
- Poor Market Performance: BioCryst Pharmaceuticals (NASDAQ:BCRX) has been labeled a consistently underperforming stock by Jim Cramer, suggesting that market expectations for its future performance are low, which could lead to diminished investor confidence.
- New Drug Acquisition: The company finalized a $700 million acquisition of Astria Therapeutics on January 23, adding navenibart, a long-acting therapy for hereditary angioedema, to its portfolio; however, market reactions remain tepid despite this strategic move.
- Therapeutic Expansion: BioCryst focuses on treatments for rare diseases, including an oral medication for hereditary angioedema and injectable flu therapies, yet insufficient market confidence in its drug development may hinder future sales growth.
- Investment Risk Advisory: While BCRX presents investment potential, analysts indicate that certain AI stocks offer greater upside potential and lower downside risk, which may lead investors to consider more attractive investment alternatives.
See More
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.
See More
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.
See More
BioCryst to Present at J.P. Morgan Healthcare Conference on January 12, 2026
- Conference Presentation: BioCryst Pharmaceuticals will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 1:30 p.m. ET in San Francisco, showcasing its latest advancements in rare diseases, which is expected to attract significant investor and industry attention.
- Product Launch: The company has successfully commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, marking a significant breakthrough in the treatment of hereditary angioedema (HAE) and further solidifying its position in the biopharmaceutical industry.
- R&D Pipeline: BioCryst is advancing a pipeline of potential first-in-class or best-in-class oral small-molecule and injectable protein therapeutics aimed at addressing unmet medical needs in rare diseases, demonstrating the company's ongoing commitment to innovative drug development.
- Investor Relations: The company will provide a link to the live audio webcast and replay of the presentation in the Investors & Media section of its website, aiming to enhance communication with investors, increase transparency, and attract more investor interest.
See More
BioCryst Receives FDA Approval for Oral Medication to Treat Rare Swelling Disorder in Children
FDA Approval: The FDA has approved BioCryst Pharmaceuticals' oral pellet formulation of Orladeyo (berotralstat) for pediatric patients aged 2 to <12 years with hereditary angioedema (HAE), making it the first targeted oral prophylactic therapy for this age group.
Clinical Trial Support: The approval was based on positive interim data from the APeX-P clinical trial, which demonstrated that Orladeyo was well tolerated and effective in reducing monthly attack rates in young patients with HAE.
Administration Method: The new Orladeyo pellet can be easily administered by pouring it directly into the mouth or sprinkling it over soft, non-acidic food, enhancing its usability for young children.
Global Regulatory Efforts: BioCryst is pursuing additional regulatory approvals for the Orladeyo oral pellets in Europe, Japan, and other global markets, while the company's stock experienced a slight decline following the announcement.
See More
BioCryst Receives FDA Approval for ORLADEYO Oral Therapy for Pediatric HAE Patients
- New Treatment Option for Children: BioCryst's ORLADEYO oral medication has received FDA approval as the first targeted prophylactic therapy for HAE in patients aged 2 and older, addressing the urgent need for more convenient treatment options for pediatric patients and their families.
- Clinical Trial Support: The APeX-P clinical trial demonstrated that ORLADEYO effectively reduces monthly attack rates in pediatric patients while maintaining a favorable safety profile, further solidifying its critical role in HAE treatment for children.
- Significant Market Potential: With over 3,500 patients in the U.S. currently prescribed ORLADEYO, the new oral pellet formulation is expected to attract more families, enhancing BioCryst's competitive position in the HAE treatment market.
- Global Expansion Plans: BioCryst has filed applications with the European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency, indicating its commitment to expanding ORLADEYO's availability in international markets.
See More
BioCryst Pharmaceuticals Faces Dismal Outlook
- Poor Market Performance: BioCryst Pharmaceuticals (NASDAQ:BCRX) has been labeled a consistently underperforming stock by Jim Cramer, suggesting that market expectations for its future performance are low, which could lead to diminished investor confidence.
- New Drug Acquisition: The company finalized a $700 million acquisition of Astria Therapeutics on January 23, adding navenibart, a long-acting therapy for hereditary angioedema, to its portfolio; however, market reactions remain tepid despite this strategic move.
- Therapeutic Expansion: BioCryst focuses on treatments for rare diseases, including an oral medication for hereditary angioedema and injectable flu therapies, yet insufficient market confidence in its drug development may hinder future sales growth.
- Investment Risk Advisory: While BCRX presents investment potential, analysts indicate that certain AI stocks offer greater upside potential and lower downside risk, which may lead investors to consider more attractive investment alternatives.
See More
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.
See More
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.
See More
BioCryst to Present at J.P. Morgan Healthcare Conference on January 12, 2026
- Conference Presentation: BioCryst Pharmaceuticals will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 1:30 p.m. ET in San Francisco, showcasing its latest advancements in rare diseases, which is expected to attract significant investor and industry attention.
- Product Launch: The company has successfully commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, marking a significant breakthrough in the treatment of hereditary angioedema (HAE) and further solidifying its position in the biopharmaceutical industry.
- R&D Pipeline: BioCryst is advancing a pipeline of potential first-in-class or best-in-class oral small-molecule and injectable protein therapeutics aimed at addressing unmet medical needs in rare diseases, demonstrating the company's ongoing commitment to innovative drug development.
- Investor Relations: The company will provide a link to the live audio webcast and replay of the presentation in the Investors & Media section of its website, aiming to enhance communication with investors, increase transparency, and attract more investor interest.
See More
BioCryst Receives FDA Approval for Oral Medication to Treat Rare Swelling Disorder in Children
FDA Approval: The FDA has approved BioCryst Pharmaceuticals' oral pellet formulation of Orladeyo (berotralstat) for pediatric patients aged 2 to <12 years with hereditary angioedema (HAE), making it the first targeted oral prophylactic therapy for this age group.
Clinical Trial Support: The approval was based on positive interim data from the APeX-P clinical trial, which demonstrated that Orladeyo was well tolerated and effective in reducing monthly attack rates in young patients with HAE.
Administration Method: The new Orladeyo pellet can be easily administered by pouring it directly into the mouth or sprinkling it over soft, non-acidic food, enhancing its usability for young children.
Global Regulatory Efforts: BioCryst is pursuing additional regulatory approvals for the Orladeyo oral pellets in Europe, Japan, and other global markets, while the company's stock experienced a slight decline following the announcement.
See More
BioCryst Receives FDA Approval for ORLADEYO Oral Therapy for Pediatric HAE Patients
- New Treatment Option for Children: BioCryst's ORLADEYO oral medication has received FDA approval as the first targeted prophylactic therapy for HAE in patients aged 2 and older, addressing the urgent need for more convenient treatment options for pediatric patients and their families.
- Clinical Trial Support: The APeX-P clinical trial demonstrated that ORLADEYO effectively reduces monthly attack rates in pediatric patients while maintaining a favorable safety profile, further solidifying its critical role in HAE treatment for children.
- Significant Market Potential: With over 3,500 patients in the U.S. currently prescribed ORLADEYO, the new oral pellet formulation is expected to attract more families, enhancing BioCryst's competitive position in the HAE treatment market.
- Global Expansion Plans: BioCryst has filed applications with the European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency, indicating its commitment to expanding ORLADEYO's availability in international markets.
See More
