Navenibart

Top-line phase 3 data on navenibart are due in early 2027. Having already established a commercial infrastructure for its oral hereditary angioedema (HAE) drug Orladeyo and eager to pinpoint the source of its future growth, BioCryst Pharmaceuticals has struck a $700 million deal to buy Astria Therapeutics. The deal will give the rare disease specialist control of a phase 3 challenger to Takeda’s HAE therapy Takhzyro.North Carolina-based BioCryst already sells the daily oral capsule Orladeyo, which won approval in 2020 to prevent HAE attacks in patients 12 and older. Forecasting that Orladeyo sales will peak at $1 billion around the end of the decade, the company has been investing in drug discovery and scouting around for deals to drive its next phase of growth.The search has resulted in an agreement to buy Astria for $13 a share, a 53% premium over the acquired biotech’s closing share price Monday.BioCryst is buying Astria for navenibart, an injectable, long-acting inhibitor of plasma kallikrein. Takeda already sells an injectable plasma kallikrein inhibitor, Takhzyro, which is administered every two or four weeks.On a call with investors to discuss the deal, Charlie Gayer, chief commercial officer at BioCryst, said roughly 5,000 HAE patients in the U.S. use existing injectable prophylaxis therapies despite needing to receive frequent, sometimes painful injections.   “What if they could control their attacks with similar efficacy with an injection that doesn’t hurt and do it two to four times per year instead of 24 or even 12 times per year?” Gayer said. “Low dosing frequency is the main remaining unmet need identified by HAE patients and their physicians. They see every-three-month dosing as the tipping point that would motivate a switch. That is the potential of navenibart.”Evidence that navenibart has the profile targeted by BioCryst comes in part from an open-label trial that delivered data in June. Astria linked three-month dosing to a 95% mean monthly attack-rate reduction. The reduction in the six-month cohort was 86%. Gayer said achieving three-month dosing is the most important goal, while showing six-month dosing is effective would be “icing on the cake." Astria is studying both regimens in a phase 3 trial that started enrolling patients this year. Top-line data are due in early 2027. The timeline informed Gayer’s belief that navenibart is likely to be the first HAE drug to launch with the three-month dosing that BioCryst has identified as key to persuading patients to switch from Takhzyro. If navenibart wins approval, BioCryst expects to largely rely on the operation it built to support Orladeyo to launch the drug. The low level of investment needed for commercialization and timing of the launch, which is scheduled for around when Orladeyo sales are forecast to plateau, led BioCryst Chief Financial Officer Babar Ghias to predict navenibart can “supercharge” earnings growth well into the next decade. Astria’s pipeline also includes an OX40 antagonist, STAR-0310, that is in development for the treatment of eczema. BioCryst plans to seek strategic alternatives for the asset. Jon Stonehouse, CEO of BioCryst, told investors STAR-0310 is “a really interesting product” but is outside the biotech’s focus on rare disease. That led the CEO to conclude the asset is “better in the hands of somebody that's in that area.”

10月14日，北卡罗来纳州和波士顿，BioCryst Pharmaceuticals（Nasdaq:BCRX）和Astria Therapeutics（Nasdaq:ATXS）宣布两家公司已签订最终协议，根据该协议，BioCryst同意收购Astria，一家专注于开发过敏性和免疫性疾病的生命改变疗法的生物制药公司，现金和股票混合，Astria的每股隐含价值为13美元，隐含总股权价值约为9.2亿美元，隐含企业价值约为7亿美元。该交易获得了BioCryst和Astria董事会的一致批准。根据惯例成交条件，该交易预计将于2026年第一季度完成，Astria Therapeutics首席执行官Jill C.Milne博士将加入BioCryst董事会。  Astria的主要候选产品navenibart（STAR-0215）是一款可注射长效血浆激肽释放酶抑制剂单抗，用于预防遗传性血管性水肿（HAE）。Navenibart的潜在最佳临床特征和每3个月和6个月的高度差异化给药计划可以显著改善现有的注射选择，并解决HAE患者社区中未满足的关键需求。 BioCryst已建立的商业化基础设施和在HAE方面的深厚专业知识有望最大限度地扩大navenibart的覆盖范围，扩大患者的可及性。随着navenibart的加入，BioCryst的产品组合将包括领先的口服和可能是同类最佳的HAE注射疗法，为医生和患者提供个性化护理的最佳选择。 交易完成后，BioCryst还将获得Astria的早期特应性皮炎项目STAR-0310（长效OX40抗体）。BioCryst计划为该资产寻找战略替代方案。（3.2亿美元！Astria引进一款长效OX40抑制剂） BioCryst首席执行官Jon Stonehouse表示：“我们相信，这笔交易为BioCryst提供了一个完美的第二个候选产品，与我们的HAE核心竞争力无缝契合，使我们能够建立一个全面的产品组合，无论管理偏好如何，都能提供最有利于患者的选择。Navenibart可以成为寻求不频繁、无痛给药、强有力的攻击控制以及他们知道和理解的作用机制的患者的首选注射剂。凭借我们的领先产品Orladeyo和Navenibard潜在的一流产品，我们将能够很好地推动可持续增长和盈利，同时为HAE患者群体提供最佳服务。” Astria Therapeutics首席执行官Jill C.Milne博士表示：“我们很高兴navenibart成为BioCryst HAE产品组合中不可或缺的一部分，推进我们共同的使命，即让患者超越疾病的局限性。我们对BioCryst经过验证的专业知识和能力充满信心，能够成功地将navenibart带给需要更好选择来管理HAE和提高生活质量的患者。重要的是，这笔交易对Astria股东来说是一个令人信服的结果，在交割时为他们的股票提供现金，并继续拥有BioCryst。我为我们才华横溢的Astria团队感到无比自豪，他们的奉献精神和辛勤工作使我们达到了这一重要的里程碑。” 引人注目的战略优势： 与晚期罕见病候选产品一起扩大投资组合。 ​Navenibart正处于3期临床开发阶段，预计2027年初将进行关键的ALPHA-ORBIT试验，并有望成为领先的注射性HAE治疗药物。在早期的临床试验中，navenibart显示出很强的疗效和良好的安全性和耐受性。 HAE的重大创新机会​预防。BioCryst预计navenibart将在5000多个目标市场进行商业发布​接受注射预防治疗的患者，其中许多人更喜欢长效、低治疗负担的选择。Navenibart高度差异化的临床特征使其能够改变当前的注射治疗格局。 商业化基础设施使发射曲线陡峭。BioCryst在经验丰富的销售和营销团队、强大的患者服务平台、最先进的数据分析和强大的利益相关者关系的推动下，在商业执行方面取得了成功，这是一个可重复的剧本，可以加速navenibart的增长轨迹，并从推出之日起为患者提供服务。 令人信服的财务效益： 改变长期收入增长轨迹。navenibart的加入有可能延长BioCryst在未来十年实现两位数收入增长的跑道。 保持强劲的近期财务状况。BioCryst预计持续盈利（非公认会计准则）和交易后的正现金流。 与上市后立即上涨的显著运营协同效应。BioCryst预计，在navenibart预计推出后的第一个全年收入中，该交易将增加营业利润（非公认会计准则）。BioCryst将利用其现有的行业领先的商业化基础设施，加速navenibart的推出，并随着时间的推移提供实质性的运营协同效应。 根据协议条款，BioCryst将以每股8.55美元的现金和0.59股BioCryst普通股的对价收购Astria的所有已发行股份，根据BioCryst截至2025年10月8日的20天VWAP 7.54美元，这反映了Astria每股13.00美元的隐含价值和约7亿美元的企业价值。每股合并对价的隐含价值为13.00美元，比Astria在2025年10月13日的收盘价溢价约53%，比Astria截至2025年10月13日的20天VWAP溢价71%。 BioCryst在完成其欧洲业务的出售后，于2025年10月8日偿还了Pharmakon的所有剩余债务。作为此次交易的一部分，BioCryst还与黑石集团管理的资金签订了一份战略融资协议的债务承诺书，总容量高达5.5亿美元。BioCryst预计，总对价的现金部分将由手头现金和黑石贷款的一部分提供资金。 Astria股东将根据已发行的基本股份持有合并后公司约15%的形式股权。该交易已获得两家公司董事会的一致批准，预计将于2026年第一季度完成，等待惯例监管批准和Astria股东的批准。Astria的某些股东包括每位董事和每位执行官，以及Astria最大股东Perceptive Advisors，LLC的附属公司已签订投票和支持协议以支持该交易。 关注下方公众号，带你看世界!