Core Points - The FDA has accepted Milestone Pharmaceuticals' response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) nasal spray, with a new PDUFA target action date set for December 13, 2025 [1][5] - Milestone has extended its $75 million Royalty Purchase Agreement with RTW Investments until December 31, 2025, to support the planned launch of CARDAMYST following FDA approval [2][4] FDA Review and Response - The FDA's acceptance of the response to the CRL is a significant milestone for CARDAMYST, and the company is optimistic about a potential approval decision later this year [3] - Milestone's response to the CRL included results from additional in-vitro studies and a plan to transfer manufacturing duties to vendors with recent FDA inspection history [5][6] Royalty Purchase Agreement - The Royalty Purchase Agreement allows RTW to purchase tiered royalty payments on etripamil's annual net product sales in exchange for a $75 million purchase price, contingent on FDA approval by December 31, 2025 [4] - The amendment to the agreement reflects RTW's ongoing commitment to Milestone and provides a future funding source for the company [2][3] Product Overview - Etripamil is a novel calcium channel blocker nasal spray designed for self-administration to treat paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular response (AFib-RVR) [7][9] - If approved, CARDAMYST™ aims to offer a new treatment option for patients, allowing for on-demand care and self-management [7][9] Clinical Development - Etripamil has completed a Phase 3 clinical program for PSVT and a Phase 2 trial for AFib-RVR, indicating a robust clinical development pathway [8]

Biogen's Strategic Direction - Biogen is broadening its portfolio across Neuro, Immunology & Rare Disease, aiming for long-term sustainable growth[4,17] - Approximately 50% of Biogen's total company revenue is projected to come from outside of MS, including Biosimilars[17] Felzartamab's Potential in Nephrology - Felzartamab targets CD38-expressing cells, offering a differentiated approach for antibody-mediated diseases[27,29] - Phase 3 programs for Felzartamab are underway, targeting Antibody Mediated Rejection (AMR), IgA Nephropathy (IgAN), and Primary Membranous Nephropathy (PMN)[106] Antibody Mediated Rejection (AMR) - Late AMR affects approximately 11,000 patients in the U S, with >75% transplant loss and a median graft survival of ~2 years after diagnosis[36,37,40] - In a Phase 2 study, Felzartamab treatment resulted in >80% biopsy late AMR resolution at week 24, compared to 20% in the placebo group[53] - A Phase 3 study for Felzartamab in late AMR is underway, with data expected in 2027[56] IgA Nephropathy (IgAN) - IgAN affects approximately 130,000 patients in the U S, with up to 40% of patients reaching end-stage kidney disease within 20 years of diagnosis[61] - Phase 2 data showed that with 5 months of Felzartamab treatment, patients had sustained clinical benefit out to 2 years, with ~50% UPCR reduction at 24 months in the 9-dose group[69,71] - A Phase 3 study for Felzartamab in IgAN is designed to demonstrate improvement in kidney function, with data expected in 2029[74] Primary Membranous Nephropathy (PMN) - PMN affects approximately 36,000 patients in the U S, with up to 40% progressing to end-stage kidney disease within 15 years[80,81,103] - Phase 2 data showed robust and sustained reductions in anti-PLA2R and improvements in both newly diagnosed/relapsed (NDR) and refractory PMN patients[103] - A Phase 3 study for Felzartamab in PMN is designed to demonstrate complete remission of proteinuria, with data expected in 2029[100]

July 9, 2025 07:54 AM GMT 中国医疗健康行业 | Asia Pacific M Foundation 进入全球化新时代的领先制药 企业；首次覆盖恒瑞医药H股/ 重新覆盖A股，超配评级 作为研发巨头，恒瑞有望受益于国内政策环境的改善，和全 球化步伐的加快，而后者仍未充分被市场反映。我们看到了 恒瑞发展成为全球领先生物制药公司的巨大潜力。首次覆盖H 股，重新覆盖A股，均给予超配(OW)评级； H股为首选股。 要点 行业领先的端到端能力支撑其开发深入而广泛的管线：我们认为，恒瑞是中国生 物制药公司中拥有最广泛和最均衡产品组合和管线的公司之一，涵盖肿瘤、代谢 和心血管疾病、免疫和呼吸系统疾病和其他治疗领域。公司预计2025/26/27年分 别将有5/5/11款新药批准，2025-27年总共有47项NDA（新药申请）/BLA（生物制 品许可申请）批准。特别是，其最近获批的HER2 ADC和一系列后期GLP-1在研药 物展现了具有竞争力的临床表现，同时其开发进度处于市场领先位置。 通过多种模式加速全球化，产生可持续的对外许可收入：截至2023年，全球医药 市场价值1.47万亿美元，是中国国内市场规 ...

Group 1 - Maze Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for patients with renal, metabolic, and cardiovascular diseases [2] - The company will participate in two upcoming investor conferences in July, with live webcasts available on their website [1] - Maze Therapeutics utilizes its Compass platform to link genetic variants with biological pathways in disease, advancing a pipeline that includes two wholly owned programs, MZE829 and MZE782 [2] Group 2 - The H.C. Wainwright 4th Annual Kidney Virtual Conference is scheduled for July 14, 2025, at 2:30 p.m. ET [3] - The BTIG Virtual Biotech Conference will take place on July 30, 2025, at 9:20 a.m. ET [3]

Core Insights - Vor Bio has appointed Sandy Mahatme as Chief Financial Officer and Chief Business Officer, effective July 9, 2025, to support the company's transformation and growth in autoimmune disease treatment [1][3] Company Overview - Vor Bio is a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, particularly through the development of telitacicept, a novel dual-target fusion protein [5] - The company is advancing telitacicept through Phase 3 clinical development and aims to commercialize it for serious autoantibody-driven conditions worldwide [5] Leadership Experience - Sandy Mahatme brings over 30 years of executive leadership experience in the biopharmaceutical industry, with a strong track record in capital markets, business development, and global operations [2][3] - Prior to joining Vor Bio, Mahatme raised over $2.5 billion in equity and non-dilutive capital at National Resilience, Inc., and led capital formation efforts exceeding $3.5 billion at Sarepta Therapeutics [2][3] Strategic Importance - The appointment of Mahatme is seen as pivotal for Vor Bio as it advances telitacicept through global Phase 3 development and aims to improve the lives of patients with autoimmune diseases [3][5] - Mahatme's experience in navigating strategic growth in both private and public biotech settings is expected to be instrumental for the company's future [3] Inducement Plan - On July 9, 2025, Vor Bio granted Mahatme 13,882,750 restricted stock units (RSUs) as a material inducement to employment, with a vesting schedule over four years [7]

The money. What will you use it for. Oh, we have big plans.The series series is great because it allows us to open up our biologics lab down the street, and the entire purpose of that is to prepare biologics formulations so medicines for flight in outer space. And the entire purpose of this is microgravity allows us to create new drug formulations that otherwise would be impossible to create on Earth. That's the whole purpose of BARDA.And so with this series funding, we're able to build out a large lab spac ...

Company Overview - Tevogen Bio Holdings Inc. has officially opened its newly expanded corporate headquarters in Warren, New Jersey, which was fully funded by the CEO, Ryan Saadi, resulting in no costs to the company or its shareholders [2][6]. Facility Expansion - The new facility has been completed ahead of schedule and more than doubles the previous footprint of Tevogen, allowing for the centralization of research, regulatory affairs, and the expanding Tevogen.AI teams under one roof [3][6]. Future Plans - A formal ribbon-cutting ceremony is planned to celebrate the new headquarters, which will include local officials, employees, and community partners [3].

Core Viewpoint - Soleno Therapeutics, Inc. has announced a public offering of 2,352,941 shares of common stock priced at $85.00 per share, aiming to raise approximately $200 million before expenses [1][3]. Group 1: Offering Details - The public offering consists of 2,352,941 shares, with an additional 30-day option for underwriters to purchase up to 352,941 more shares at the same price [1]. - The offering is expected to close on or about July 11, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds will primarily fund the commercialization of VYKAT XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, which received FDA approval on March 26, 2025 [3]. - Additional proceeds will support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3]. Group 3: Underwriters - Goldman Sachs & Co. LLC, Guggenheim Securities, TD Cowen, Cantor, and Oppenheimer & Co. are serving as joint book-running managers for the offering [2]. Group 4: Company Overview - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product aimed at treating hyperphagia in individuals aged 4 and older with Prader-Willi syndrome [6].

Core Viewpoint - A lawsuit has been filed against Iovance Biotherapeutics, Inc. and certain senior executives for potential violations of federal securities laws, with claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 [1][2]. Company Overview - Iovance Biotherapeutics is a commercial-stage biopharmaceutical company focused on developing treatments for melanoma and other solid tumor cancers [3]. - The company launched its key melanoma treatment, Amtagvi, in February 2024, administered at authorized treatment centers (ATCs) [3]. Allegations and Issues - The lawsuit alleges that Iovance misrepresented the effectiveness of its ATCs in driving demand for Amtagvi, while in reality, these centers faced long timelines for patient treatment and high patient drop-off rates due to ineffective patient identification and selection [4]. - Following disappointing financial results for Q1 2025, Iovance revised its full-year 2025 revenue guidance, attributing the poor performance to slow treatment timelines and high patient drop-off rates [5]. Stock Performance - On May 8, 2025, Iovance's stock price fell over 44%, dropping from $3.17 per share to $1.75 per share the following day, in response to the negative news regarding its financial performance and operational challenges [6].

Core Viewpoint - A lawsuit has been filed against Organon & Co. and its senior executives for potential violations of federal securities laws, particularly related to misleading statements about the company's dividend policy following a significant acquisition [1][2]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the District of New Jersey, titled Hauser v. Organon & Co., et al., No. 25-cv-05322, and investors have until July 22, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Organon securities [2]. Group 2: Company Background and Acquisition - Organon is a global healthcare company focused on women's health, known for rewarding shareholders with dividends [3]. - In October 2024, Organon completed a $1.2 billion acquisition of Dermavant, a biopharmaceutical company, which increased its debt [3]. Group 3: Dividend Policy and Stock Performance - Following the acquisition, Organon assured investors it would maintain its dividend, claiming it was the "1 capital allocation priority," but later shifted focus to debt reduction, leading to a significant dividend cut [3]. - On May 1, 2025, Organon announced a reduction in its dividend payout from $0.28 per share to $0.02 per share, resulting in a stock price decline of approximately 27%, from $12.93 to $9.45 per share [4].