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BIOCRYST PHARMACEUTICALS (BCRX)

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Earnings summaries and quarterly performance for BIOCRYST PHARMACEUTICALS.

Recent press releases and 8-K filings for BCRX.

BioCryst Announces Preliminary Full Year 2025 ORLADEYO Net Revenue and 2026 Guidance
BCRX
Earnings
Guidance Update
M&A
  • BioCryst Pharmaceuticals reported preliminary, unaudited ORLADEYO net revenue of $601 million for full year 2025, exceeding its prior guidance range.
  • Preliminary, unaudited ORLADEYO net revenue for the fourth quarter of 2025 was $151 million.
  • For full year 2026, the company expects global net ORLADEYO revenue to be between $625 million and $645 million, and total revenue between $635 million and $660 million.
  • BioCryst anticipates continued non-GAAP profitability in 2026 and reported preliminary cash, cash equivalents, restricted cash & investments of $338 million as of December 31, 2025.
  • Full year 2026 non-GAAP operating expenses are projected to be between $380 million and $390 million, or between $450 million and $470 million including the expected Astria acquisition.
6 days ago
BioCryst Reports Strong 2025 Results, Provides 2026 Guidance, and Advances Strategic Pipeline
BCRX
M&A
Guidance Update
New Projects/Investments
  • BioCryst reported preliminary 2025 ORLADEYO revenue of $601 million, exceeding its latest guidance, and achieved profitability for the first time in company history, ending the year with nearly $340 million in cash.
  • The company provided 2026 guidance, anticipating ORLADEYO revenue of $625-$645 million and total revenue of $635-$660 million, with non-GAAP base operating expenses projected at $380-$390 million.
  • BioCryst sold its European business for $250 million in cash and expects to close the acquisition of Astria Therapeutics, adding the late-stage HAE asset Novanavart, which is projected to contribute to double-digit revenue growth into the 2030s alongside ORLADEYO.
  • ORLADEYO received pediatric approval for ages two and up and is on track to reach $1 billion in peak sales by 2029. The company is also advancing BCX 17725 for Netherton Syndrome, with proof of concept data expected by the end of 2026.
6 days ago
BioCryst Pharmaceuticals Reports Strong 2025 Results, Provides 2026 Guidance, and Details Strategic Acquisitions
BCRX
M&A
Guidance Update
New Projects/Investments
  • BioCryst Pharmaceuticals reported $601 million in ORLADEYO revenue for 2025, exceeding its latest guidance, and anticipates $625 million-$645 million in ORLADEYO revenue and $635 million-$660 million in total revenue for 2026. The company achieved profitability for the first time in 2025 and expects to remain profitable going forward.
  • The company sold its European business for $250 million in cash upfront and is in the process of acquiring Astria Therapeutics for $700 million in total enterprise value, with the deal expected to close in the next couple of weeks.
  • ORLADEYO saw its most new patient prescriptions in the U.S. in 2025 since its launch year and received approval for pediatric use down to age two. The company projects ORLADEYO to reach $1 billion in peak sales by 2029.
  • The acquisition of Astria Therapeutics adds navenibart, a late-stage rare disease HAE asset, to the pipeline, which is expected to contribute to double-digit revenue growth into the 2030s. BioCryst is also advancing BCX17725 for Netherton Syndrome, with proof-of-concept data expected by the end of 2026.
6 days ago
BioCryst Reports Strong 2025 Performance, Issues 2026 Guidance, and Announces Astria Acquisition
BCRX
Earnings
Guidance Update
M&A
  • BioCryst achieved its first full year of profitability in 2025 and received FDA approval for ORLADEYO's pediatric pellet formulation for patients 2 to <12 with HAE.
  • The company reported preliminary ORLADEYO revenue of $601 million for FY 2025 and provided 2026 guidance for total revenue between $635 million and $660 million.
  • BioCryst announced the acquisition of Astria for approximately $700 million TEV, which adds navenibart, a Phase III asset for HAE with pivotal topline results expected in early 2027.
  • The combined HAE portfolio is projected to generate over $1 billion in revenue by 2029 and over $1.8 billion by 2033, with a projected cash balance exceeding $1 billion by 2029.
6 days ago
BioCryst Pharmaceuticals Reports Strong 2025 Results, Provides 2026 Guidance, and Details Strategic Initiatives
BCRX
Guidance Update
M&A
New Projects/Investments
  • BioCryst Pharmaceuticals reported preliminary 2025 ORLADEYO revenue of $601 million, exceeding its latest guidance, and achieved profitability for the first time in the company's history.
  • The company issued 2026 guidance, anticipating ORLADEYO revenue of $625-$645 million and total revenue of $635-$660 million.
  • BioCryst expects to close the acquisition of Astria Therapeutics for $700 million in total enterprise value, which will add the late-stage rare disease HAE asset Novanavart.
  • ORLADEYO is projected to reach $1 billion at peak by 2029, with a 15% year-over-year CAGR in revenue growth, and has composition of matter protection out to May 2040.
  • The BCX 17725 program for Netherton Syndrome is advancing to an initial proof of concept trial, with part four data (up to a dozen patients through three months with follow-up) anticipated by the end of 2026.
6 days ago
BioCryst Announces Preliminary Full Year 2025 ORLADEYO Revenue and 2026 Guidance
BCRX
Earnings
Guidance Update
M&A
  • BioCryst Pharmaceuticals reported preliminary, unaudited ORLADEYO net revenue of $601 million for full year 2025, exceeding its prior guidance range of $590 million to $600 million.
  • For full year 2026, the company anticipates global net ORLADEYO revenue to be between $625 million and $645 million, with total revenue projected between $635 million and $660 million.
  • The company expects full year 2026 non-GAAP operating expenses to be between $380 million and $390 million, or between $450 million and $470 million including the expected Astria acquisition.
  • BioCryst reported preliminary, unaudited cash, cash equivalents, restricted cash & investments of $338 million as of December 31, 2025, and expects continued non-GAAP profitability in 2026.
6 days ago
BioCryst Announces FDA Approval for ORLADEYO Oral Pellets for Pediatric HAE Patients
BCRX
Product Launch
New Projects/Investments
  • BioCryst Pharmaceuticals, Inc. announced on December 12, 2025, that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for an oral pellet formulation of ORLADEYO® (berotralstat).
  • This approval is for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years, making ORLADEYO the first and only targeted oral prophylactic therapy for HAE patients aged 2 and above.
  • The new oral pellet formulation offers a child-friendly method of administration.
  • ORLADEYO was previously approved in December 2020 for patients 12 years and older and has been prescribed to more than 3,500 patients in the U.S. to date.
  • The approval was supported by positive interim data from the APeX-P clinical trial, which showed ORLADEYO was well tolerated and resulted in early and sustained reductions in monthly attack rates in the pediatric age group.
Dec 12, 2025, 12:51 PM
BioCryst Announces FDA Approval for ORLADEYO Oral Pellets
BCRX
Product Launch
New Projects/Investments
  • BioCryst Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for an oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years.
  • This approval establishes ORLADEYO as the first and only targeted oral prophylactic therapy for HAE patients aged 2 and older, offering a child-friendly administration method.
  • The approval was supported by positive interim data from the APeX-P clinical trial, which demonstrated the treatment was well tolerated and led to early and sustained reductions in monthly attack rates.
  • BioCryst has also filed applications for ORLADEYO oral pellets with the European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency, with additional regulatory filings planned in other global territories, including Canada.
Dec 12, 2025, 12:00 PM
BioCryst Pharmaceuticals Updates on ORLADEYO Performance, Astria Acquisition, and Financial Outlook
BCRX
Guidance Update
M&A
Product Launch
  • BioCryst Pharmaceuticals expects ORLADEYO revenue to be between $590-$600 million for the year, with a projected peak sales guidance of $1 billion by 2029.
  • The company achieved its first year of profitability ahead of schedule and anticipates continued profitability even after the proposed acquisition of Astria.
  • The proposed acquisition of Astria, which includes the late-stage HAE asset Nevenabart, is on track for a Q1 2026 closing. Nevenabart is anticipated to launch in late 2028.
  • BioCryst completed the divestiture of its EU business for $250 million, which supported the Astria acquisition and improved the balance sheet.
  • The company lowered its expense guidance from $440-$450 million to $430-$440 million.
Nov 19, 2025, 5:00 PM
BioCryst Pharmaceuticals Updates on ORLADEYO Sales, Astria Acquisition, and Financial Outlook
BCRX
Guidance Update
M&A
New Projects/Investments
  • BioCryst Pharmaceuticals anticipates ORLADEYO sales of $590-$600 million for the current year and maintains its $1 billion peak sales guidance by 2029, supported by strong US growth and the expected pediatric indication approval. The company achieved profitability this year, a year ahead of schedule, and expects to sustain it.
  • The company divested its EU business for $250 million, which was previously loss-making or break-even, to strengthen its balance sheet and facilitate the proposed acquisition of Astria Pharmaceuticals. This acquisition, on track for Q1 2026 closing, adds the late-stage HAE asset Nevenabart, projected to launch in the latter part of 2028.
  • BioCryst has lowered its expense guidance from $440-$450 million to $430-$440 million for the current year, with expectations for significantly reduced expenses and higher operating profitability in 2027 and beyond.
  • Upcoming pipeline catalysts include a PDUFA date on December 12 for ORLADEYO's pediatric indication and initial data for its Netherton Syndrome program (17725) by the end of Q1 next year.
Nov 19, 2025, 5:00 PM