Latest news with #BioCrystPharmaceuticals
The Australian
7 days ago
- Business
- The Australian
ILA completes Galidesivir anti-viral drug acquisition
ILA completes antiviral drug acquisition ahead of schedule Drug has a broad spectrum across viruses FDA submissions and a meeting request anticipated this quarter Special Report: Island Pharmaceuticals has finalised its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals after completing due diligence ahead of schedule. Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in more than 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika and Yellow fever. Notably, these are all viruses with significant unmet medical needs that may contribute to national security threats. Island Pharmaceuticals (ASX:ILA) is confident in the drug's potential, thanks to its robust development history and more than US$70m R&D spend from the US government to date. The company is now focused on fast tracking regulatory initiatives, including potentially leveraging the FDA's Animal Rule, which allows for drug approvals in indications based on animal efficacy data, when human trials are unethical or not feasible, provided safety is shown in humans and the disease is well modelled in animals. Drug dossier planned to FDA this quarter Island intends to submit documentation on the Galidesivir program to the FDA in the short term and seek a meeting with the regulator, possibly during the December quarter. Pending positive feedback, this may allow for the commencement of an animal study before the end of the year. 'We are very pleased to have completed this transaction with BioCryst ahead of schedule,' CEO and managing director Dr David Foster said. 'Following the asset purchase agreement and a final review of the program, we have gained considerable confidence in Galidesivir and the potential to fast track a New Drug Application and the opportunity for a Priority Review Voucher. 'Work will now focus on collating a relevant data package to submit to the FDA, alongside a meeting request to discuss Galidesivir's eligibility under the Animal Rule. 'We expect to submit this dossier this quarter, allowing for a potential meeting next quarter, prior to initiating an animal study in Marburg shortly thereafter.' This article was developed in collaboration with Island Pharmaceuticals, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Globe and Mail
31-07-2025
- Business
- Globe and Mail
BioCryst Announces Charlie Gayer to Succeed Jon Stonehouse as Chief Executive Officer Upon his Retirement in December
RESEARCH TRIANGLE PARK, N.C., July 31, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its president and chief executive officer, Jon Stonehouse, has informed the board of directors of his intention to retire on December 31, 2025. The board has appointed Charlie Gayer, currently the company's chief commercial officer (CCO), as the company's next president, effective August 1, 2025, and next chief executive officer, effective January 1, 2026. Mr. Stonehouse will continue to serve on the board of directors and Mr. Gayer will join the company's board, effective January 1, 2026. Mr. Gayer has built and led the commercial organization responsible for the successful launch of ORLADEYO ® (berotralstat), bringing the first oral prophylactic therapy to people with hereditary angioedema and driving exceptional revenue growth, with expected peak sales of $1 billion. He also has played a pivotal role in shaping the company's recent business development strategy, including the planned sale of its European operations. 'We want to thank Jon for building BioCryst into the commercial, profitable company it is today, with such a bright future,' said Nancy Hutson, chair of the board. 'As part of our succession planning process, we have evaluated outstanding internal and external potential successors and Charlie stood out in that process, with an ability to build on the success he has achieved with ORLADEYO to further deliver on our mission to bring life-changing therapies to patients and create long-term value for our stakeholders.' 'I am delighted to hand the leadership responsibility of the company to Charlie. He has a proven track record of delivering results and is largely responsible for one of the best commercial launches of a rare disease drug in recent history. Charlie is a purpose-driven leader who understands our company's mission to serve patients living with rare diseases in extraordinary ways,' said Stonehouse. 'I am thrilled the board chose Charlie, as he understands we have worked hard to build a special culture at BioCryst that we believe has a direct impact on the company's performance in creating value. He is the perfect leader to take the company even further.' 'I am grateful for Jon's leadership and the patients-first culture he has fostered over my 10 years at BioCryst. Under his guidance, BioCryst has matured to the point where it is generating significantly increasing cash resources through ORLADEYO revenue while also advancing a promising pipeline. This is an exciting time for the company and I am deeply honored that the board has entrusted me to lead BioCryst into its next chapter," said Gayer. Mr. Gayer was promoted to CCO in January 2020, after joining the company in 2015 as vice president of global strategic marketing. Prior to BioCryst, he held U.S. and global commercial leadership roles in competitive rare disease categories at Talecris Biotherapeutics, Inc. and led U.S. alpha-1 antitrypsin deficiency marketing, and later European sales and marketing. After Grifols, S.A. acquired Talecris in 2011, he led the U.S. marketing team for the combined immune globulin portfolio of the two companies. Prior to joining Talecris, Mr. Gayer spent six years at GlaxoSmithKline in a range of professional marketing, consumer marketing and sales roles. He began his career as a strategic consultant for biopharmaceutical companies and spent three years as a business analyst at Genzyme Corporation. Mr. Gayer received his B.A. in politics from Princeton University and his M.B.A from the Fuqua School of Business of Duke University. About BioCryst Pharmaceuticals BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema and other rare diseases. BioCryst leverages its expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat diseases. BioCryst has commercialized ORLADEYO ® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies. For more information, please visit or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding future results, performance, achievements, plans and expectations regarding BioCryst's growth, pipeline, and value creation, BioCryst's expectations with respect to the transition of the CEO role, and statements related to the anticipated sale of BioCryst's European ORLADEYO business. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: BioCryst's ability to successfully implement or maintain its commercialization plans for ORLADEYO; BioCryst's ability to successfully progress its pipeline development plans; the commercial viability of ORLADEYO, including its ability to achieve sustained market acceptance and demand; ongoing and future preclinical and clinical development of product candidates may take longer than expected and may not have positive results; the FDA or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may not review regulatory filings on our expected timeline, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay or withdraw market approval for products and product candidates; product candidates, if approved, may not achieve market acceptance; BioCryst's ability to successfully commercialize its products and product candidates; BioCryst's ability to successfully manage its growth and compete effectively; timing for achieving and sustainability of profitability and positive cash flow may not meet management's expectations; statements regarding financial goals and the attainment of such goals may differ from actual results based on market factors and BioCryst's ability to execute its operational, capital deployment and budget plans; actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management's expected ranges; and BioCryst's completion of the planned sale of its European operations on anticipated terms and timing, including obtaining required regulatory approvals. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst's projections and forward-looking statements.
Yahoo
31-07-2025
- Business
- Yahoo
BioCryst Announces Charlie Gayer to Succeed Jon Stonehouse as Chief Executive Officer Upon his Retirement in December
RESEARCH TRIANGLE PARK, N.C., July 31, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its president and chief executive officer, Jon Stonehouse, has informed the board of directors of his intention to retire on December 31, 2025. The board has appointed Charlie Gayer, currently the company's chief commercial officer (CCO), as the company's next president, effective August 1, 2025, and next chief executive officer, effective January 1, 2026. Mr. Stonehouse will continue to serve on the board of directors and Mr. Gayer will join the company's board, effective January 1, 2026. Mr. Gayer has built and led the commercial organization responsible for the successful launch of ORLADEYO® (berotralstat), bringing the first oral prophylactic therapy to people with hereditary angioedema and driving exceptional revenue growth, with expected peak sales of $1 billion. He also has played a pivotal role in shaping the company's recent business development strategy, including the planned sale of its European operations. 'We want to thank Jon for building BioCryst into the commercial, profitable company it is today, with such a bright future,' said Nancy Hutson, chair of the board. 'As part of our succession planning process, we have evaluated outstanding internal and external potential successors and Charlie stood out in that process, with an ability to build on the success he has achieved with ORLADEYO to further deliver on our mission to bring life-changing therapies to patients and create long-term value for our stakeholders.' 'I am delighted to hand the leadership responsibility of the company to Charlie. He has a proven track record of delivering results and is largely responsible for one of the best commercial launches of a rare disease drug in recent history. Charlie is a purpose-driven leader who understands our company's mission to serve patients living with rare diseases in extraordinary ways,' said Stonehouse. 'I am thrilled the board chose Charlie, as he understands we have worked hard to build a special culture at BioCryst that we believe has a direct impact on the company's performance in creating value. He is the perfect leader to take the company even further.' 'I am grateful for Jon's leadership and the patients-first culture he has fostered over my 10 years at BioCryst. Under his guidance, BioCryst has matured to the point where it is generating significantly increasing cash resources through ORLADEYO revenue while also advancing a promising pipeline. This is an exciting time for the company and I am deeply honored that the board has entrusted me to lead BioCryst into its next chapter," said Gayer. Mr. Gayer was promoted to CCO in January 2020, after joining the company in 2015 as vice president of global strategic marketing. Prior to BioCryst, he held U.S. and global commercial leadership roles in competitive rare disease categories at Talecris Biotherapeutics, Inc. and led U.S. alpha-1 antitrypsin deficiency marketing, and later European sales and marketing. After Grifols, S.A. acquired Talecris in 2011, he led the U.S. marketing team for the combined immune globulin portfolio of the two companies. Prior to joining Talecris, Mr. Gayer spent six years at GlaxoSmithKline in a range of professional marketing, consumer marketing and sales roles. He began his career as a strategic consultant for biopharmaceutical companies and spent three years as a business analyst at Genzyme Corporation. Mr. Gayer received his B.A. in politics from Princeton University and his M.B.A from the Fuqua School of Business of Duke University. About BioCryst Pharmaceuticals BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema and other rare diseases. BioCryst leverages its expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat diseases. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies. For more information, please visit or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding future results, performance, achievements, plans and expectations regarding BioCryst's growth, pipeline, and value creation, BioCryst's expectations with respect to the transition of the CEO role, and statements related to the anticipated sale of BioCryst's European ORLADEYO business. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: BioCryst's ability to successfully implement or maintain its commercialization plans for ORLADEYO; BioCryst's ability to successfully progress its pipeline development plans; the commercial viability of ORLADEYO, including its ability to achieve sustained market acceptance and demand; ongoing and future preclinical and clinical development of product candidates may take longer than expected and may not have positive results; the FDA or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may not review regulatory filings on our expected timeline, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay or withdraw market approval for products and product candidates; product candidates, if approved, may not achieve market acceptance; BioCryst's ability to successfully commercialize its products and product candidates; BioCryst's ability to successfully manage its growth and compete effectively; timing for achieving and sustainability of profitability and positive cash flow may not meet management's expectations; statements regarding financial goals and the attainment of such goals may differ from actual results based on market factors and BioCryst's ability to execute its operational, capital deployment and budget plans; actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management's expected ranges; and BioCryst's completion of the planned sale of its European operations on anticipated terms and timing, including obtaining required regulatory approvals. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst's projections and forward-looking statements. BCRXW Contact:Investors:investorrelations@ Media:media@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
28-07-2025
- Business
- Yahoo
BioCryst Pharmaceuticals (BCRX) Reports Next Week: Wall Street Expects Earnings Growth
BioCryst Pharmaceuticals (BCRX) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report, which is expected to be released on August 4, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. Zacks Consensus Estimate This drugmaker is expected to post quarterly earnings of $0.03 per share in its upcoming report, which represents a year-over-year change of +150%. Revenues are expected to be $148.85 million, up 36.2% from the year-ago quarter. Estimate Revisions Trend The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Earnings Whisper Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). How Have the Numbers Shaped Up for BioCryst? For BioCryst, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -66.67%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that BioCryst will beat the consensus EPS estimate. Does Earnings Surprise History Hold Any Clue? While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that BioCryst would post a loss of$0.07 per share when it actually produced break-even earnings, delivering a surprise of +100.00%. Over the last four quarters, the company has beaten consensus EPS estimates two times. Bottom Line An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. BioCryst doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Expected Results of an Industry Player Among the stocks in the Zacks Medical - Drugs industry, Indivior PLC (INDV), is soon expected to post earnings of $0.26 per share for the quarter ended June 2025. This estimate indicates a year-over-year change of -40.9%. This quarter's revenue is expected to be $244.27 million, down 18.3% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Indivior has been revised 2% up to the current level. Nevertheless, the company now has an Earnings ESP of +11.54%, reflecting a higher Most Accurate Estimate. This Earnings ESP, combined with its Zacks Rank #3 (Hold), suggests that Indivior will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BioCryst Pharmaceuticals, Inc. (BCRX) : Free Stock Analysis Report Indivior PLC (INDV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
07-07-2025
- Business
- Globe and Mail
BioCryst Appoints Babar Ghias Chief Financial Officer and Head of Corporate Development
RESEARCH TRIANGLE PARK, N.C., July 07, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the appointment of Babar Ghias as chief financial officer (CFO) and head of corporate development. Mr. Ghias joins BioCryst from AvenCell Therapeutics, a clinical-stage CAR-T company focused on hematologic malignancies, where he served as CFO since 2022. 'Babar brings extensive deal making and operational experience in addition to his previous roles as a CFO at rare disease companies. The addition of these skills and expertise to the leadership team are exactly what we need at this time as we look to deploy capital and accelerate our path to sustainable growth and increasing value that continues well into the next decade,' said Jon Stonehouse, chief executive officer of BioCryst. Previously, Mr. Ghias was executive vice president of investments and portfolio management at Paragon Biosciences, a global biotech development firm. He also served as chief financial and operating officer for several Paragon portfolio companies. At Paragon, he launched four biotechnology companies focused on rare diseases from early clinical to successful commercial launch. From 2014 to 2017, he served as CFO and head of corporate development at Marathon Pharmaceuticals, a specialty rare disease company, where he prepared the company for a commercial launch and led the successful sale of the firm. Mr. Ghias has raised over $1 billion in capital for the companies he has been involved with. Earlier in his career, for over a decade, he was an investment banker who served as a senior member of the mergers and acquisitions team at Credit Suisse, providing strategic advice to clients and boards of directors in the healthcare and life sciences industries and successfully closing over $80 billion in transactions. 'I am thrilled to join BioCryst at such a pivotal time in its growth journey. The strong commercial momentum from ORLADEYO alongside the advancing pipeline and the opportunity to deploy capital behind new growth initiatives present an enormous opportunity for building long term value. I look forward to partnering with the leadership team to drive operational excellence and financial discipline, and support our ambitious growth plans,' Ghias said. Mr. Ghias earned his M.B.A. with honors from Washington University in St. Louis and holds a B.S. in economics from Lahore University of Management Sciences in Pakistan. About BioCryst Pharmaceuticals BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema and other rare diseases. BioCryst leverages its expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat diseases. BioCryst has commercialized ORLADEYO ® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies. For more information, please visit or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding future results, performance, achievements, plans and expectations regarding BioCryst's growth, capital deployment, and pipeline. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: BioCryst's ability to successfully implement or maintain its commercialization plans for ORLADEYO; BioCryst's ability to successfully progress its pipeline development plans; the commercial viability of ORLADEYO, including its ability to achieve sustained market acceptance and demand; ongoing and future preclinical and clinical development of product candidates may take longer than expected and may not have positive results; the FDA or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may not review regulatory filings on our expected timeline, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay or withdraw market approval for products and product candidates; product candidates, if approved, may not achieve market acceptance; BioCryst's ability to successfully commercialize its products and product candidates; BioCryst's ability to successfully manage its growth and compete effectively; timing for achieving and sustainability of profitability and positive cash flow may not meet management's expectations; statements regarding financial goals and the attainment of such goals may differ from actual results based on market factors and BioCryst's ability to execute its operational, capital deployment and budget plans; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management's expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst's projections and forward-looking statements. BCRXW
