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BioCryst Pharma

BioCryst Pharmaceuticals Inc is a biotechnology company involved mainly in the research and development of novel small-molecule drugs, to block key enzymes involved in infectious and inflammatory diseases. Biocryst's research is based on multiple scientific disciplines like biology, computer modeling, and medicinal chemistry. Its products and candidates target the following therapeutic areas: acute uncomplicated influenza; uncomplicated seasonal influenza; hereditary angioedema; filoviruses, including the Ebola and Marburg viruses; and oncology.

BioCryst Pharmaceuticals, Inc. - Common Stock

BioCryst Pharmaceuticals Inc

BioCryst Pharmaceuticals, Inc.&nbsp;(Nasdaq:&nbsp;BCRX) today announced that the Health Services Executive (HSE) in Ireland has recommended ORLADEYO&#xAE;&nbsp;(berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older. With this recommendation, HAE patients in Ireland will have access to the first oral, once-daily therapy for the reduction of recurrent HAE attacks.
"The positive HSE recommendation of ORLADEYO&nbsp;broadens access to modern prophylaxis, providing greater choice for prescribing physicians and potentially a better quality of life for HAE patients in Ireland," said Charlie Gayer, chief commercial officer of BioCryst.
The HSE decision in Ireland follows the European Commission marketing authorization of ORLADEYO in April 2021. To date, ORLADEYO is licensed in 44 countries.

Government

News

Regulations

BCRX

BioCryst's ORLADEYO Gets Ireland's Approval: Expanding Access to Once-Daily HAE Therapy

RBC Capital analyst Brian Abrahams reiterates BioCryst Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCRX#NASDAQ">BCRX</a>) with a Outperform and maintains $10 price target.

Price Target

Reiteration

Analyst Ratings

RBC Capital Reiterates Outperform on BioCryst Pharma, Maintains $10 Price Target

Needham analyst Serge Belanger reiterates BioCryst Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCRX#NASDAQ">BCRX</a>) with a Buy and maintains $14 price target.

Needham Reiterates Buy on BioCryst Pharma, Maintains $14 Price Target

Barclays analyst Gena Wang maintains BioCryst Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCRX#NASDAQ">BCRX</a>) with a Equal-Weight and raises the price target from $7 to $8.

Barclays Maintains Equal-Weight on BioCryst Pharma, Raises Price Target to $8

<h3>Gainers</h3>
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<li>Nuwellis (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NUWE#NASDAQ">NUWE</a>) shares rose 127.9% to $3.1 during Monday's regular session. The company's market cap stands at $5.7 million. </li>
<li>Singular Genomics Sys (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMIC#NASDAQ">OMIC</a>) stock moved upwards by 58.24% to $21.3. The company's market cap stands at $53.1 million. </li>
<li>Neurogene (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NGNE#NASDAQ">NGNE</a>) shares increased by 44.04% to $66.36. The market value of their outstanding shares is at $862.2 million. </li>
<li>Integra Lifesciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IART#NASDAQ">IART</a>) stock rose 24.27% to $23.96. The company's market cap stands at $1.8 billion. As per the press release, Q3 earnings came out today. </li>
<li>BioSig Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BSGM#NASDAQ">BSGM</a>) stock rose 23.42% to $1.37. The market value of their outstanding shares is at $22.3 million. </li>
<li>Disc Medicine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IRON#NASDAQ">IRON</a>) shares moved upwards by 22.19% to $57.59. The market value of their outstanding shares is at $1.7 billion. </li>
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<h3>Losers</h3>
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<li>XTL Biopharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XTLB#NASDAQ">XTLB</a>) shares decreased by 15.8% to $1.98 during Monday's regular session. The company's market cap stands at $10.7 million. </li>
<li>BioCryst Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCRX#NASDAQ">BCRX</a>) stock declined by 15.6% to $7.12. The company's market cap stands at $1.4 billion. The company's, Q3 earnings came out today. </li>
<li>Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) shares declined by 15.57% to $12.1. The market value of their outstanding shares is at $497.2 million. </li>
<li>Cadrenal Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVKD#NASDAQ">CVKD</a>) shares decreased by 15.52% to $14.87. The market value of their outstanding shares is at $22.2 million. </li>
<li>Tevogen Bio Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TVGN#NASDAQ">TVGN</a>) stock declined by 13.5% to $2.05. The company's market cap stands at $349.8 million. </li>
<li>Journey Medical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DERM#NASDAQ">DERM</a>) stock decreased by 13.3% to $5.35. The market value of their outstanding shares is at $110.8 million. 
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This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Monday's Intraday Session

WIIM

BioCryst Pharma shares are trading lower following mixed Q3 financial results.

Financial Outlook for 2024
Based on the strength of patient demand for ORLADEYO seen in the third quarter, and expected continued strength in the fourth quarter, the company is adjusting its outlook for full year 2024 global net ORLADEYO revenue to be between $430 million and $435 million (top end of prior range) and introducing full-year 2024 total revenue guidance of between $443 and $448 million based on additional 2024 RAPIVAB revenue.

Guidance

BioCryst Adjusts ORLADEYO Revenue Guidance To $430M-$435M, Sees Total Product Revenue Of $443M-$448M

BioCryst Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCRX#NASDAQ">BCRX</a>) reported quarterly losses of $(0.07) per share which missed the analyst consensus estimate of $(0.06) by 16.67 percent. This is a 63.16 percent increase over losses of $(0.19) per share from the same period last year. The company reported quarterly sales of $117.085 million which beat the analyst consensus estimate of $112.503 million by 4.07 percent. This is a 34.98 percent increase over sales of $86.742 million the same period last year.

Earnings

Earnings Beats

Earnings Misses

BioCryst Pharma Q3 2024 GAAP EPS $(0.07) Misses $(0.06) Estimate, Sales $117.085M Beat $112.503M Estimate

Biotech

General

BioCryst Highlights Real-World Data Showing High Adherence And Sustained Efficacy Of ORLADEYO For Hereditary Angioedema; Significant Reduction In HAE Attack Rates And Strong Patient Preference For Oral Therapy Reported

<a href="https://www.globenewswire.com/Tracker?data=thMGJcWW8AjTyfCdJD1xEBtP9-UfOazyoISk64JnA5BjVTgverx4tk3EokPzyivmSOugN4h9qO92NeHgMVH1owl-X3tJ-hIrPYB6qZ4UkYU=">BioCryst Pharmaceuticals, Inc.</a> (Nasdaq:&nbsp;BCRX) today announced new real-world evidence on the use of oral, once-daily ORLADEYO&#xAE; (berotralstat) demonstrating that patients with hereditary angioedema (HAE) in the United States experience significant reductions in healthcare resource utilization (HRU), including significant reductions in hospitalizations, emergency room visits and use of on-demand therapies, after beginning treatment with ORLADEYO. &nbsp;
The study will be presented in a poster at the Academy of Managed Care Pharmacy (AMCP) Nexus 2024 national meeting, which is being held in Las Vegas from October 14-17, 2024.
"Our interrogation of claims data builds upon previously reported findings demonstrating that ORLADEYO not only has a favorable impact on the lives of patients with HAE – but the broader healthcare system, as well. Here, our analysis reveals that significant reductions in healthcare resource utilization are achieved across multiple outcomes – such as reductions in hospitalizations and medical visits, including those related to HAE attacks. Decreases in on-demand treatment were also observed. Taken together, our investigation provides promising real-world evidence which supports ORLADEYO's clinical and financial value as a prophylactic therapy for HAE," said Sandra Christiansen, MD, professor of medicine and director of translational research at the US HAEA Angioedema Center at the University of California, San Diego.
The poster Healthcare Resource Utilization among Patients Initiating Berotralstat for the Long Term Prophylaxis of Hereditary Angioedema in the United States (#D20) detailed findings from a retrospective pre-post study that featured analysis of administrative U.S. claims data of patients with HAE in the United States. The analysis focused on eligible patients enrolled in commercial and public health plans who initiated ORLADEYO between December 2020 and December 2022 who had a baseline of at least six months of continuous health plan enrollment prior to starting ORLADEYO&nbsp;(n=260).
<ul>
<li>Significant reductions in HRU were observed in the overall study population following initiation of ORLADEYO (p&lt;0.05), including in: 
<ul>
<li>All-cause hospitalizations (34 percent reduction) and outpatient or emergency room visits (14 percent reduction).</li>
<li>Angioedema-related hospitalizations (52 percent reduction) and outpatient or emergency room visits (44 percent reduction). &nbsp;</li>
</ul>
</li>
<li>Significant reductions in HAE attack-related HRU were also observed (p&lt;0.05), including in: 
<ul>
<li>HAE attack-related visits (51 percent reduction), driven by significant decreases in hospitalization (60 percent) and outpatient or emergency room visits (50 percent).</li>
<li>Reduction in HAE attack-related visits were observed when stratified by body location of the attack, including in the head and upper airways (48 percent reduction), gastrointestinal system (58 percent reduction) and unspecified locations (52 percent reduction).</li>
<li>Additionally, a decrease in use of on-demand therapies administered by a healthcare professional was observed (39 percent reduction) among patients who previously received on-demand treatment.</li>
</ul>
</li>
</ul>

BioCryst's ORLADEYO Reduces Hospital Visits and Emergency Care for Hereditary Angioedema Patients, Study Shows

Health Care

BioCryst Pharmaceuticals Has Enrolled The First Participant In A Phase 1 Trial Evaluating BCX17725 For Netherton Syndrome, A Genetic Disorder Affecting The Skin, Hair, And Immune System; Initial Data Expected By End Of 2025

Contracts

The Us Department Of Health And Human Services Has Awarded BioCryst Pharmaceuticals Up To A $69M Contract For The Procurement Of Up To 95,625 Doses Over A Five-year Period Of Rapivab (Peramivir Injection) For Influenza

BioCryst Pharmaceuticals Has Completed Negotiations With The Pan-Canadian Pharmaceutical Alliance For Orladeyo (Berotralstat), Which Is Approved In Canada For The Routine Prevention Of Attacks Of Hereditary Angioedema For Patients 12 Years Of Age And Older

<a href="https://www.globenewswire.com/Tracker?data=7XUiJbtvdrsn6XxPZLvhx4I22y-w7FTXimBG_O8iw4lOkc10Ojls36Kl3lM2i5K9PWZiuCOFzYW-AR3rKYGVxlDj1CLihCxmk4CrjN3knVye720WpsxZTuGQ6vqru2fbimAvQoqw7Y4tRAi9o9KXJf1ugb6PXVnzfdI7hdFOb0nvo51qlaEHL_jFJ7s20yy8YFW7moeB5w--sUIjrglDrS9axU1AIYk5ywudjhGpunM4knWngdq-Si9LmJVz7U0BYNGjfshIiOZEI1Zp84IZhQ==">BioCryst Pharmaceuticals, Inc.</a>&nbsp;(Nasdaq:&nbsp;BCRX) today announced the presentation of six posters, including the first interim real-word evidence from the APeX-N trial, and new data highlighting the value of shared decision making (SDM) between healthcare providers (HCPs) and their hereditary angioedema (HAE) patients to provide optimal patient outcomes.
The company is presenting the posters at the 7th Bradykinin Symposium in Berlin from September 5-6, 2024.
<ul>
<li>APeX-N interim results: Oral berotralstat for HAE prophylaxis in Europe</li>
<li>HCP and patient perspectives: HAE long-term prophylaxis and shared decision-making</li>
<li>Adverse health outcomes and perspectives of androgen use in HAE</li>
<li>Evaluation of adherence to berotralstat in patients with hereditary angioedema</li>
<li>Tolerability and effectiveness of berotralstat for long-term prophylaxis in HAE</li>
<li>Effectiveness and safety of berotralstat in HAE with normal C1-inhibitor</li>
</ul>
APeX-N interim results
APeX-N is a European multi-center observational study assessing the safety (primary objective), effectiveness and quality of life (secondary objectives) of berotralstat 150 mg in routine clinical use. This interim analysis included 56 patients from the United Kingdom, France, Germany and Sweden.
Non-serious gastrointestinal adverse events were reported in 12.5 percent of patients. Seven percent (n=4) of patients discontinued treatment (three due to unsatisfactory response, one to participate in a clinical trial). One patient had a severe HAE attack but continued treatment.
"These initial data from APeX-N in Europe reinforce and closely replicate the clinical trial and real-world evidence of berotralstat as the first oral prophylaxis for HAE," said Dr. Sorena Kiani, consultant immunologist at Royal Free London NHS Foundation.
HCP and patient perspectives: HAE long-term prophylaxis and shared decision-making
This study, conducted in Germany, explored the dynamics between HCPs and patients in HAE management, identifying barriers to SDM and strategies to improve it. Ten HCPs participated in 60 minute interviews and simulated patient consultations. Eight HAE patients participated in 30 minute interviews. Participants then convened in structured focus groups to discuss their findings.
The participants identified a need for enhanced HCP awareness of patient perspectives, more comprehensive HCP-patient conversations and improved education about HAE treatment management.
"The findings from this study support the need for further insights to develop future guidance and HAE management strategies to facilitate successful shared decision making and improved patient quality of life," said Dr. Emel Aygören-Pürsün, department for children and adolescents, University Hospital Frankfurt, Germany.

BioCryst Presents Results on HAE Treatment and Patient Care at Global Symposium

JMP Securities analyst Jonathan Wolleben maintains BioCryst Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCRX#NASDAQ">BCRX</a>) with a Market Outperform and raises the price target from $15 to $16.

JMP Securities Maintains Market Outperform on BioCryst Pharma, Raises Price Target to $16

Barclays analyst Gena Wang maintains BioCryst Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCRX#NASDAQ">BCRX</a>) with a Equal-Weight and raises the price target from $6 to $7.

Barclays Maintains Equal-Weight on BioCryst Pharma, Raises Price Target to $7

HC Wainwright &amp; Co. analyst Andrew Fein reiterates BioCryst Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCRX#NASDAQ">BCRX</a>) with a Buy and maintains $30 price target.

HC Wainwright & Co. Reiterates Buy on BioCryst Pharma, Maintains $30 Price Target

BioCryst Pharmaceuticals shares are trading higher after the company reported better-than-expected Q2 financial results. Additionally, the company raised its FY24 Orladeyo revenue guidance above estimates.

BioCryst Pharmaceuticals Says It Expects To Achieve Full-year Operating Profit In 2024, Approach Quarterly Positive EPS And Positive Cash Flow In 2H Of 2025, And Be Profitable On An EPS Basis, With Positive Cash Flow, For Full Year 2026

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BioCryst's Orladeyo Drives Strong Performance and Growth Potential, Earning a Buy Rating

BioCryst Pharmaceuticals ( ($BCRX) ) has released its Q3 earnings. Here is a breakdown of the information BioCryst Pharmaceuticals presented to its...

BioCryst Pharmaceuticals Reports Strong Q3 2024 Results

Barclays analyst Gena Wang maintained a Hold rating on BioCryst (BCRX – Research Report) today and set a price target of $8.00. The company's share...

Barclays Keeps Their Hold Rating on BioCryst (BCRX)

Barclays raised the firm's price target on BioCryst (BCRX) to $8 from $7 and keeps an Equal Weight rating on the shares post the Q3 report. Orladey...

BioCryst price target raised to $8 from $7 at Barclays

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RBC Capital Reaffirms Their Buy Rating on BioCryst (BCRX)

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Evercore ISI Reaffirms Their Buy Rating on BioCryst (BCRX)

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BioCryst launches Orladeyo in ireland

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Press Releases

BioCryst Begins Enrollment in Phase 1 Trial Evaluating BCX17725, a KLK5 Inhibitor, for the Treatment of Netherton Syndrome

BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BioCryst to Present New Real-World Evidence on Long-Term Prophylaxis in HAE, including ORLADEYO® (berotralstat), at the American College of Allergy, Asthma & Immunology 2024 Annual Scientific Meeting

BioCryst to Present New Real-World Evidence Showing Significant Reductions in Medical Visits and Hospitalizations After Starting ORLADEYO® (berotralstat)

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