Astria Therapeutics, Inc.

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!

BioCryst Pharmaceuticals plans to buy Astria Therapeutics for around $700 million in cash and stock. The deal, announced Tuesday, means BioCryst will get a drug intended to prevent hereditary angioedema (HAE), an area in which it already specializes. The Durham, NC-based company will pay $8.55 in cash and 0.59 shares of its common stock per share of Astria stock, implying a value of $13.00 per share or around $700 million in enterprise value for Astria. That is a premium of about 53% over Astria’s closing share price $ATXS on Monday. BioCryst has also arranged a financing facility worth up to $550 million with funds managed by Blackstone. It expects the cash portion of the deal to be funded with cash on hand and part of the Blackstone facility. BioCryst’s shares $BCRX fell as much as 14% premarket and were later down about 9%. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard. You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Astria’s lead candidate is an injected kallikrein inhibitor named navenibart, which is intended to prevent the episodes of severe swelling in the limbs, face, intestinal tract and airway that characterize HAE. The company expects to have topline data from an ongoing Phase 3 study of the drug called ALPHA-ORBIT in early 2027. Navenibart still has to prove itself effective, but BioCryst believes that the drug’s real advantage is its dosing schedule. The drug can potentially be injected every six or even nine months. The leading product sold to prevent HAE is Takeda’s Takhzyro, which was approved in 2023. It’s an effective medication but must be injected every two weeks. “The market isn’t looking for more efficacy. What it’s looking for is less burdensome dosing, and that’s what navenibart has the potential to provide,” BioCryst President and Chief Commercial Officer Charlie Gayer said Tuesday on a conference call. BioCryst also sells an HAE preventive called Orladeyo. The oral plasma kallikrein inhibitor was approved in 2020 . BioCryst CEO Jon Stonehouse said on the call that Orladeyo was “on its way to $1 billion at peak around the end of the decade.” It had sales of $157 million in the second quarter of 2025. BioCryst believes that having two products to prevent the same disease makes sense. “Brand-new patients to [prophylaxis] really prefer oral. Patients who are already doing well on an injectable would prefer to have an injectable that even better meets their needs, specifically with dosing,” Gayer said on the call. BioCryst said its sales infrastructure and expertise in HAE could maximize the reach of navenibart, which it believes could be the best drug in its class alongside having a dosing advantage. If the late-stage trials pan out, it could end up claiming a substantial slice of the roughly 5,000 patients who already take an injected preventive therapy for HAE. Gayer, who is set to take over as BioCryst’s CEO in January, said the company believes that navenibart and Orladeyo could have combined sales of “at least $1.8 billion by 2033.” BioCryst sold its European Orladeyo business in June to pay off debt. Under the deal, BioCryst will also gain Astria’s program for atopic dermatitis, STAR-0310. But it doesn’t plan to keep the asset. BioCryst said it would seek strategic alternatives for STAR-0310, which is in a Phase 1 trial in healthy volunteers. Even after absorbing the R&D costs of navenibart, BioCryst will “remain highly profitable on a non-GAAP basis and cash flow positive,” CFO Babar Ghias said on the call. The company declined to say if there were other bidders for Astria. When the deal closes, which is expected in the first quarter of next year, Astria CEO Jill Milne will join BioCryst’s board. Milne said the deal was “a compelling outcome for Astria stockholders.” Astria stockholders will own roughly 15% of equity in the combined company.

BioCryst Pharmaceuticals is broadening its reach in hereditary angioedema (HAE) with a deal to buy Astria Therapeutics, gaining a late-stage injectable therapy to complement its existing oral drug Orladeyo (berotralstat). The tie-up could bolster BioCryst's position in a market now edging toward gene-editing approaches that promise lifelong control of angioedema attacks.Under the terms announced Tuesday, BioCryst will pay $8.55 in cash and 0.59 shares of its common stock for each Astria share, representing an implied value of $13 per share, which represents a 53% premium to Astria's closing price on October 13. The deal, valuing the combined enterprise at about $700 million, is expected to close in the first quarter of 2026.Quarterly, twice-yearly dosingThe acquisition centres on navenibart (STAR-0215), a monoclonal antibody that inhibits plasma kallikrein. In the long-term, open-label ALPHA-SOLAR study reported in June, navenibart cut monthly attack rates by an average of 92% — with up to 95% reduction in patients receiving injections every three months and 86% in those dosed every six months.The therapy's extended dosing interval addresses a key patient need in a market where treatment dissatisfaction runs high. Ionis Pharmaceuticals' RNA-targeting preventive shot Dawnzera (donidalorsen), which scored an FDA approval in August, has demonstrated an 81% reduction in HAE attacks with monthly dosing, compared to placebo. In a recent interview with FirstWord, CEO Brett Monia cited an independent survey finding that 90% of HAE patients would switch treatments if they found better efficacy, tolerability or convenience (see – ViewPoints: How Ionis' Dawnzera stands out from the HAE prophylaxis pack).Meanwhile, gene-editing approaches could eliminate the need for ongoing prophylaxis. Intellia Therapeutics last month completed enrollment for its Phase III HAELO trial of lonvoguran ziclumeran (NTLA-2002), an in vivo CRISPR-based therapy that inactivates the gene encoding kallikrein precursor protein. Last year, it reported that the one-time treatment reduced HAE attacks by over 80% in Phase II testing. Intellia expects to report top-line data from HAELO in the first half of 2026 and plans a US launch in early 2027.'Perfect second product'Jon Stonehouse, BioCryst's chief executive, described navenibart as "a perfect second product candidate" that fits with his company's HAE focus. The therapy "can emerge as the injectable of choice for patients seeking infrequent, pain-free dosing, strong attack control, and a mechanism of action they know and understand," he said.Top-line data from navenibart's pivotal Phase III ALPHA-ORBIT trial are expected in early 2027, with a potential commercial launch targeting more than 5000 patients currently using injectable prophylaxis.If navenibart ultimately succeeds, it could allow BioCryst to offer both oral and injectable options in a space where current therapies face tolerability challenges. Takeda's Takhzyro (lanadelumab-flyo), the standard-of-care injectable, can be painful to administer and causes injection-site reactions, while Orladeyo — which was approved by the FDA in 2020 — produces gastrointestinal effects that can be confused with HAE attacks.BioCryst recently completed the sale of its European Orladeyo business to Neopharmed Gentili for $250 million, with a view to concentrating on its core US business.