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]

Core Viewpoint - The article highlights the potential investment opportunities in healthcare companies Merck and Bristol Myers Squibb, which are currently undervalued due to company-specific challenges but have strong long-term prospects. Group 1: Merck - Merck is nearing the loss of patent exclusivity for its key drug Keytruda, which is expected to face biosimilars by the end of the decade [4] - Despite the challenges, Merck's subcutaneous version of Keytruda has shown positive phase 3 results, potentially extending its patent exclusivity into the next decade [5] - The subcutaneous formulation is easier and faster to administer, reducing patient and physician time in the administration process by 49.7% and 45.7% respectively [6] - Merck has a strong pipeline with new approvals, including Winrevair and Enflonsia, and offers a reliable dividend program [7][8] - The stock's forward price-to-earnings ratio is 9.1, significantly lower than the healthcare industry average of 16.3, indicating potential upside for long-term investors [8] Group 2: Bristol Myers Squibb - Bristol Myers Squibb is facing patent expiration for its cancer drug Opdivo and has already lost exclusivity for Revlimid and Sprycel [9] - The company reported a 6% year-over-year revenue decline to $11.2 billion in the first quarter, but its growth portfolio saw a 16% increase in sales to $5.6 billion [11] - BMS has received recent approvals, including a subcutaneous version of Opdivo, which will help mitigate losses from biosimilar competition [10] - The company has a robust pipeline and is expected to secure additional approvals, positioning it to navigate current challenges [12] - Bristol Myers Squibb's stock is undervalued with a forward P/E ratio of 7, suggesting strong long-term return potential despite a 17% decline this year [13]

Company Overview and Financial Status - Crinetics has a strong financial position with $1.3 billion in cash, cash equivalents, and investments[31] - The company anticipates its first commercial launch this year and holds IP rights into the 2040s[31] Pipeline Programs and Focus - Crinetics is developing paltusotine, with a PDUFA date in September 2025, for acromegaly[27] - The company is developing CRN12755, a TSHR antagonist, for Graves' Hyperthyroidism and Graves' Orbitopathy (TED), with plans for an IND submission[123] - Crinetics is advancing CRN10329, an SST3 agonist, for Autosomal Dominant Polycystic Kidney Disease (ADPKD), with IND-enabling studies ongoing[150] - The company is developing CRN09682, a nonpeptide drug conjugate (NDC), targeting SST2-expressing tumors, currently in Phase 1/2 study[254] Market and Patient Reach - Graves' Hyperthyroidism affects over 3 million individuals in the US, with a significant portion developing TED[75] - ADPKD affects approximately 145,000 diagnosed patients in the US, with 50% developing end-stage kidney disease[130, 131] - The addressable patient population for Graves' Orbitopathy (TED) is up to approximately 170,000 incident cases[120]

Company Strategy & Market Opportunity - Lilly aims to provide freedom from diabetes, eliminate serious health issues caused by obesity, and reduce cardiovascular deaths[10] - The company estimates a significant addressable market of over 170 million patients by 2030 for obesity and related conditions[13] - Outside of the US, the addressable market is expected to be approximately 1 billion patients[15] Orforglipron Development Program - Orforglipron, a GLP-1 small molecule, has a broad development plan including studies for Type 2 Diabetes, obesity, hypertension, and obstructive sleep apnea[20] - In the ACHIEVE-1 trial, all three doses of orforglipron achieved superiority versus placebo in reducing HbA1c levels in patients with Type 2 Diabetes[27] - ACHIEVE-1 trial data showed significant reductions in HbA1c observed as early as 4 weeks, with approximately 3/4 of patients achieving an ADA HbA1c target of less than 7%, and 2/3 reaching HbA1c ≤6.5%[27] - ACHIEVE-1 trial also demonstrated dose-dependent reduction in body weight, with approximately 2/3 of patients achieving ≥5% weight reduction and approximately 1/3 achieving ≥10% weight reduction[30] - Topline results for ATTAIN-1, an orforglipron trial in obesity, are expected in Q3 2025[39] Retatrutide Development Program - Retatrutide is undergoing global development with the TRIUMPH program for obesity and related complications, and the TRANSCEND program for Type 2 Diabetes[41] - Topline results for TRIUMPH-4, a retatrutide trial in knee osteoarthritis pain and overweight or obesity, are expected in Q4 2025[48] Tirzepatide & Early Phase Pipeline - The SURPASS-CVOT trial is designed to evaluate tirzepatide against dulaglutide in patients with established cardiovascular disease[51] - Eloralintide, a selective amylin receptor agonist, showed weight loss up to 11.3% in Phase 1 trials and is well-tolerated with less than 10% incidence of GI side effects[60]

SGR-1505 Development & Rationale - Schrödinger's computational platform aims to improve drug discovery success rates by accurately calculating molecular properties [8, 10] - MALT1 is identified as a key regulator of NF-κB signaling in B-cells and T-cells, making it a potential target for B-cell malignancies where BTK inhibitor resistance develops [18] - The company rapidly designed SGR-1505, a best-in-class MALT1 inhibitor, by modeling 8.2 billion compounds and synthesizing 78 in the SGR-1505 series within 10 months [21] Phase 1 Clinical Trial Results - The Phase 1 study of SGR-1505 showed a favorable safety profile and was well-tolerated in patients with relapsed/refractory B-cell neoplasms [36, 42] - Approximately 43% of patients experienced treatment-related adverse events (TRAEs), and there were no dose-limiting toxicities or deaths due to treatment-emergent adverse events (TEAEs) [44] - SGR-1505 demonstrated strong target engagement, with ~90% inhibition of IL-2 in the majority of PD-evaluable patients treated at ≥150 mg QD and all Q12H doses at steady state [47] - Encouraging preliminary efficacy was observed across a range of B-cell malignancies, including monotherapy signals in CLL and Waldenström macroglobulinemia (WM) [36, 49] Market Opportunity & Future Steps - There is a potential MALT1 opportunity in higher-risk CLL patients, as well as in relapsed/refractory lymphoma where resistance to BTK agents has emerged [29, 60, 67] - The company plans to discuss the recommended Phase 2 dose with the FDA later this year [57] - Preclinical data suggests that combining SGR-1505 with BTK and/or BCL-2 inhibitors may lead to deeper anti-tumor activity [66] - Ibrutinib, a BTK inhibitor, has achieved $10.9 billion in sales, indicating a significant market for B-cell malignancy treatments [68]

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]

Core Viewpoint - The healthcare industry, with annual expenditures of $4.9 trillion in the U.S., presents significant opportunities for dividend investing through quality companies that exhibit consistent growth and strong financial health [1][4]. Group 1: Medtronic - Medtronic is a leading healthcare technology company with a focus on cardiovascular, diabetes, medical-surgical, and neuroscience products, conducting over 190 active clinical trials and holding 43,000 active patents [4][6]. - The company has a history of 47 consecutive annual dividend increases and is on track to become a Dividend King upon its 50th increase, currently yielding 3.2% [5][6]. - Analysts project Medtronic's earnings to grow by 6% to 7% annually over the next three to five years, supported by strategic moves such as spinning off its diabetes business [6][5]. Group 2: AbbVie - AbbVie is a pharmaceutical giant known for its successful drug Humira and has effectively transitioned post-patent expiration, with new drugs Rinvoq and Skyrizi showing promise [8][10]. - The company has achieved 53 consecutive dividend increases since its 2013 spin-off from Abbott Laboratories, currently yielding 3.5% and averaging a 7.7% increase in dividends over the past five years [9][10]. - Analysts expect AbbVie to generate nearly $60 billion in revenue this year, with long-term earnings growth projected at 13% annually, highlighting its strong product development capabilities [10][9]. Group 3: Johnson & Johnson - Johnson & Johnson is a highly recognized healthcare company that spun off its consumer segment in 2023 to focus on pharmaceuticals and medical devices [11][12]. - The company boasts an AAA credit rating and has maintained 62 consecutive years of dividend payments and increases [12][13]. - Analysts forecast earnings growth of just over 6% annually for the next three to five years, with a dividend payout ratio of only 50% of estimated earnings for 2025, starting with a yield of 3.3% [13][12].

Earnings Report - Johnson & Johnson is set to release its second-quarter earnings results on July 16, with analysts expecting earnings of $2.68 per share, a decrease from $2.82 per share in the same period last year [1] - The company is projected to report quarterly revenue of $22.86 billion, an increase from $22.45 billion a year earlier [1] Drug Application - On July 8, Johnson & Johnson submitted a supplemental new drug application to the US FDA for CAPLYTA, aimed at preventing relapse in schizophrenia based on long-term safety and efficacy data [2] - Following the announcement, Johnson & Johnson shares rose by 0.9%, closing at $157.69 [2] Analyst Ratings - Morgan Stanley analyst Terence Flynn maintained an Equal-Weight rating and raised the price target from $169 to $171 [5] - Leerink Partners analyst David Risinger downgraded the stock from Outperform to Market Perform, reducing the price target from $169 to $153 [5] - Barclays analyst Matt Miksic maintained an Equal-Weight rating and cut the price target from $166 to $165 [5] - Raymond James analyst Jayson Bedford maintained an Outperform rating and increased the price target from $162 to $164 [5] - B of A Securities analyst Tim Anderson maintained a Neutral rating and reduced the price target from $171 to $159 [5]

Weed Rx: “Pharmaceutical cannabis is the biggest future for cannabis,” says Joel Stanley (left, with his brother Jared), founder of Ajna BioSciences, which has a botanical drug in the FDA pipeline. https://t.co/Q2rTHfUQwO https://t.co/Q2rTHfUQwO ...

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 ...