Core Viewpoint - A securities fraud class action lawsuit has been filed against Soleno Therapeutics, Inc. for alleged material misstatements and omissions regarding its Phase 3 clinical trial program for diazoxide choline extended-release tablets (DCCR) [1] Company Overview - Soleno Therapeutics, Inc. is a pharmaceutical company based in Redwood City, California, focused on developing therapies for rare diseases [1] - The company's only commercial product is DCCR, aimed at treating hyperphagia in individuals with Prader-Willi syndrome (PWS) [1] Lawsuit Details - The class action lawsuit covers investors who purchased Soleno common stock between March 26, 2025, and November 4, 2025 [1] - Allegations include that the company downplayed and concealed significant safety concerns related to DCCR, including issues of excess fluid retention in clinical trial participants [1] - The lawsuit claims that these misrepresentations led to materially lower commercial viability for DCCR and undisclosed risks associated with its launch [1] Stock Performance - Following the release of financial results on November 4, 2025, Soleno's stock price dropped over 26% due to concerns raised by a report from Scorpion Capital regarding the Phase 3 clinical trial program [1] Investor Actions - Investors are encouraged to contact Kessler Topaz Meltzer & Check, LLP for recovery options and to file for lead plaintiff status by May 5, 2026 [1] - The firm operates on a contingency fee basis, meaning there is no cost to the investors for legal representation [1]

Core Insights - Collegium Pharmaceutical reported a record-breaking performance in 2025, driven by the growth of its ADHD product JORNAY PM and a stable pain portfolio [5][4][21] JORNAY PM Performance - JORNAY PM achieved a remarkable growth of 48.9% year-over-year in 2025, with management highlighting its unique once-nightly dosing and efficacy upon awakening as key differentiators in the ADHD market [3][1] - The growth in 2025 was attributed to substantial volume growth of around 20% year-over-year, supported by expanded commercial initiatives and programs aligned with the back-to-school season [2][4] - For 2026, JORNAY PM is expected to generate revenue between $190 million and $200 million, reflecting approximately 31% growth at the midpoint, primarily driven by prescription demand [7][9] Pain Portfolio Insights - The pain franchise, which includes products like Nucynta, Xtampza, and Belbuca, grew by 6% year-over-year in 2025, with low- to mid-single-digit growth expected in 2026 [3][10] - The pain portfolio faces challenges from upcoming generic competition, particularly for Nucynta, which is expected to impact overall performance [11][12] Financial Performance - Collegium generated over $325 million in free cash flow in 2025 and lowered its cost of capital through refinancing, indicating strong financial health [6][19] - The company provided 2026 total revenue guidance of $805 million to $825 million, representing a 4% year-over-year increase, largely driven by JORNAY PM growth [16][7] Strategic Priorities - The company is focused on diversifying its portfolio through business development, opportunistic share repurchases, and debt reduction, with a balance sheet capacity for transactions up to approximately $1 billion [17][18] - Collegium aims to maintain a disciplined capital deployment strategy while prioritizing assets that align with its existing focus on pain management and ADHD [17][21]

The Phase II  COVALENT-111 study results highlighted that icovamenib maintained a favorable safety profile throughout the 52-week observation period, with no serious treatment-related adverse events. Additionally, the study showed statistically significant reductions in HbA1c levels among certain patient subgroups, suggesting icovamenib’s potential to transform diabetes treatment.“We are encouraged by the durability of icovamenib’s effect observed nine months post-dosing at Week 52,” said Mick Hitchcock, Ph ...

Core Insights - Medicus Pharma has reported promising data from its Phase 2 clinical trial for SkinJect, a non-invasive treatment for basal cell carcinoma, indicating a potential reduction in the need for surgical interventions [1][3][5] Company Updates - The CEO of Medicus Pharma, Raza Bokhari, expressed excitement over the Phase 2 dataset, which shows that approximately 75% of treated patients may not require Mohs surgery, addressing a significant unmet medical need [3][5] - The clinical trial demonstrated a 73% clinical or visual clearance rate at day 57 for the 200 microgram cohort following excisional biopsy, which is considered very promising by clinicians [4][9] Industry Context - There are nearly 5 million new cases of basal cell carcinoma diagnosed annually in the U.S., with a backlog of over a million procedures due to a shortage of trained Mohs surgeons, highlighting the urgent need for effective treatments [4] - The microneedle technology used in SkinJect is patent protected and shows biological activity, especially when loaded with doxorubicin, enhancing clinical outcomes [6][8] Regulatory and Future Plans - Medicus Pharma is preparing for an end-of-Phase 2 meeting with the FDA to discuss the design of a pivotal study, with expectations to submit a request by mid-2023 [5][10] - The company aims to secure a strategic partner for co-development of the therapy, which could potentially lead to a blockbuster product [9][10]

整理 | GLP1减重宝典内容团队 3月13日晚，恒瑞医药发布公告称，公司舒地胰岛素诺利糖肽注射液的上市许可申请已获国家药监局受理。 本次申报的适应症为：用于血糖控制不佳的成人2型糖尿病患者，在饮食和运动基础上联合其他口服降糖药物，改善血糖控制。 根据公告，舒地胰岛素诺利糖肽注射液是恒瑞医药自主研发的固定比例复方制剂，由长效基础胰岛素类似物和胰高糖素样肽-1受体激动剂组 成。 此次申报上市，基于两项在成人2型糖尿病患者中开展的关键Ⅲ期临床研究，研究编号分别为HR17031-301和HR17031-302。两项研究均为多 中心、随机、开放、阳性药平行对照研究，分别针对口服降糖药治疗后血糖控制不佳，以及基础胰岛素治疗后血糖控制不佳的2型糖尿病患者， 评价舒地胰岛素诺利糖肽注射液与对照药物的有效性和安全性。 其中，HR17031-301研究共启动54家中心，随机入组401例受试者；HR17031-302研究共启动65家中心，随机入组393例受试者。 恒瑞医药表示，两项研究结果均显示，舒地胰岛素诺利糖肽注射液在主要终点上显著优于试验对照组，且在2型糖尿病患者中长期安全性和耐受 性良好。 公告还提到，目前全球范围内已有 ...

整理 | GLP1减重宝典内容团队 如果只看过去两年，中国减重药市场几乎是被硬生生挤出来的。先是诺和诺德的Wegovy在2024年6月获批，并于同年11月在中国正式上 市；随后礼来的替尔泊肽以Mounjaro名义进入中国市场；到2025年7月，信达生物的玛仕度肽上市；到了2026年3月，先维盈，也就是埃 诺格鲁肽，也拿到中国长期体重管理适应症批文。换句话说，中国减重药市场已经不再是外资双雄单挑，而是快速变成外资、本土创新 药和后续跟进者同时挤进场的多方混战。 以前大家总说中国GLP-1管线多，但很多还停留在PPT、临床一期或二期阶段；现在不一样了，已经有多款产品真正拿到批文、真正开 始卖、真正开始拼价格、拼渠道、拼支付、拼患者教育。市场从讲故事阶段，进入了近身肉搏阶段。 ▍已上市的药越来越多，但位置其实并不一样 表面看，今天中国已上市的减重药都归在GLP-1大类里，但它们并不是同一代产品。 第一梯队当然还是诺和诺德和礼来。Wegovy代表的是经典GLP-1路径，替尔泊肽则是GLP-1/GIP双靶点路线，两者都已经在全球市场证 明了放量能力，也都率先在中国教育了减重药市场。Wegovy中国上市时，诺和诺德就明确 ...

Core Viewpoint - Rosen Law Firm has announced a class action lawsuit on behalf of purchasers of securities of Aquestive Therapeutics, Inc. for the period between June 16, 2025, and January 8, 2026, due to alleged misleading statements regarding the company's New Drug Application for Anaphylm [1][5]. Group 1: Lawsuit Details - The class action lawsuit claims that Aquestive made false and/or misleading statements and failed to disclose the true state of its New Drug Application for Anaphylm, particularly regarding the human factors involved in the use of its sublingual film [5]. - Investors who purchased Aquestive securities during the class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. Group 2: Participation Information - Interested parties can join the class action by visiting the provided link or contacting Phillip Kim, Esq. for more information [3][6]. - A lead plaintiff must move the Court by May 4, 2026, to represent other class members in directing the litigation [1][3]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved significant settlements, including the largest securities class action settlement against a Chinese company [4]. - The firm has been consistently ranked among the top firms for securities class action settlements and has recovered hundreds of millions of dollars for investors [4].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. due to allegations of violations of federal securities laws related to misleading statements about the company's New Drug Application for Anaphylm [4][6]. Company Overview - Aquestive Therapeutics, Inc. is under scrutiny for allegedly providing false and misleading information regarding the approval timeline for its New Drug Application (NDA) for Anaphylm (Dibutepinephrine) sublingual film [6]. - The company claimed confidence in the NDA submission and optimistic expectations for approval by the FDA's Prescription Drug User Fee Act (PDUFA) date of January 31, 2026 [6]. Legal Proceedings - A federal securities class action has been filed against Aquestive, with a deadline of May 4, 2026, for investors to seek the role of lead plaintiff [4][8]. - The complaint alleges that the company concealed material adverse facts about the NDA, particularly regarding human factors in the use of its sublingual film [6]. Stock Performance - Following the announcement of deficiencies identified by the FDA in the NDA on January 9, 2026, Aquestive's stock price fell by more than 37% on the same day [7].

Group 1 - GSK and Amgen will add their medicines to TrumpRX, a prescription drug website initiated by the Trump administration [1] - The collaboration aims to enhance the availability of medications through the platform [1]

Core Viewpoint - The White House is set to announce an expansion of drugmakers offering discounts on TrumpRx.gov, with Amgen and GSK being added to the list, totaling 54 medications from six companies under most-favored-nation pricing [1][6]. Group 1: Drug Pricing and Discounts - Amgen will offer discounts of up to 80% on its medication Amjevita, reducing the price from $1,484 to $299, which treats rheumatoid arthritis, psoriasis, and ulcerative colitis [2]. - GSK plans to offer discounts of 62% on Aimovig and Repatha, and 55% on Incruse, which will be priced at $159 for COPD treatment. Other GSK drugs will have discounts ranging from 10% to 51% [5]. Group 2: Government Policy and Industry Response - The initiative is part of President Trump's push for affordable healthcare, with expectations of greater discounts and transparency in drug pricing as Congress considers the Great Healthcare Plan [7]. - The Pharmaceutical Research and Manufacturers of America has expressed concerns that government-imposed pricing policies could undermine U.S. competitiveness and negatively impact research and development funding [9][10]. Group 3: Historical Context of Drug Pricing - Under the Biden administration, prescription drug costs have increased by 10.4% from January 2021 to January 2025, while under the Trump administration, prices rose only 0.2% from January 2025 to February 2026 [13].