Core Insights - Biogen has initiated dosing in a global, late-stage study of felzartamab for treating adult patients with primary membranous nephropathy (PMN), with top-line data expected in 2029 [1][4] - Felzartamab is an anti-CD38 antibody with a unique mechanism of action, and currently, there are no approved therapies for PMN, which typically relies on immunosuppressants or chemotherapy [1][6] - The PROMINENT study will evaluate the efficacy and safety of felzartamab compared to tacrolimus in moderate-to-high-risk PMN patients [3][5] Company Developments - Felzartamab was added to Biogen's pipeline through the acquisition of Human Immunology Biosciences last year, originally developed by MorphoSys AG [2] - The PROMINENT study will enroll approximately 180 PMN patients, with the primary endpoint being the percentage of patients achieving complete remissions at week 104 [5] - Biogen has also initiated dosing patients with felzartamab in two other phase III studies for late antibody-mediated rejection in kidney transplant recipients and IgA nephropathy [7] Clinical Study Details - The PROMINENT study will compare felzartamab to tacrolimus in 180 moderate-to-high-risk PMN patients, including newly diagnosed and relapsed cases [4][5] - Secondary endpoints will evaluate the effect of felzartamab on serum aPLA2R antibodies and patient-reported outcomes [5] - Previous phase II studies showed that felzartamab led to significant reductions in aPLA2R antibody levels and improvements in kidney markers [10] Market Context - PMN affects about 36,000 people in the United States and represents a serious unmet medical need, as current treatment options fail in about one-third of patients [6] - Year to date, Biogen's shares have declined by 17.9%, compared to the industry's decline of 3.6% [3]

Core Viewpoint - AbbVie has entered into a definitive agreement to acquire Capstan Therapeutics for up to $2.1 billion in cash, aiming to enhance its immunology pipeline with innovative therapies [1][7]. Acquisition Details - The acquisition will incorporate Capstan's lead asset, CPTX2309, which is a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy currently in phase I development for treating B-cell-mediated autoimmune diseases [2][3]. - Capstan's proprietary tLNP platform technology, CellSeeker, will also be added, facilitating RNA delivery to engineer specific cell types within the body [2][7]. - The acquisition is subject to customary closing conditions, including regulatory approvals [3]. AbbVie's Acquisition Strategy - AbbVie has been actively pursuing acquisitions to strengthen its pipeline, particularly in the immunology sector, while also exploring early-stage deals in oncology and neuroscience [4]. - Since the beginning of 2024, AbbVie has signed over 20 early-stage deals, focusing on promising technologies that can enhance care standards in immunology, oncology, and neuroscience [4]. Recent Acquisitions - Earlier in 2024, AbbVie acquired rights to develop GUB014295 (ABBV-295), a long-acting amylin analog for obesity treatment, marking its entry into the obesity market [5]. - In January 2025, AbbVie completed the acquisition of Nimble Therapeutics, adding an investigational oral peptide IL23R inhibitor for psoriasis treatment and a proprietary peptide synthesis platform for autoimmune diseases [8].

Summary of Atai Life Sciences (ATAI) Update / Briefing July 01, 2025 Company Overview - **Company**: Atai Life Sciences - **Focus**: Development of psychedelic therapies for mental health, specifically targeting treatment-resistant depression with the drug BPL-three Key Industry Insights - **Market Context**: Treatment-resistant depression is a significant public health issue, affecting millions globally and is the second leading cause of disability worldwide [12][12] - **Competitor Analysis**: SPRAVATO, a leading treatment in this space, achieved blockbuster status with approximately $930 million in sales in the U.S. in the previous year [47][47] Core Findings from Phase 2B Trial of BPL-three - **Trial Success**: The Phase 2b trial of BPL-three exceeded expectations, meeting both primary and secondary endpoints, demonstrating rapid and durable antidepressant effects [6][6][10][10] - **Efficacy**: - Significant reductions in MADRS scores were observed with both 8 mg and 12 mg doses compared to the active comparator (0.3 mg) [7][7] - The drug showed a robust effect lasting at least two months post-administration [42][42] - Approximately one-third of subjects were responders by day eight, maintaining this response through day 57 [27][27] - **Safety Profile**: - The drug was well tolerated, with 99% of adverse events being mild or moderate, and no serious drug-related adverse events reported [8][8][32][32] - No suicide-related safety signals were detected, which is critical given the population studied [36][36] Dosing and Administration Insights - **Dosing Strategy**: The 8 mg dose was identified as potentially optimal, showing comparable efficacy to the 12 mg dose with fewer side effects [25][25][30][30] - **Administration Time**: The treatment requires a short in-clinic time of approximately two hours, allowing for rapid discharge post-treatment, which aligns with the interventional psychiatry model [10][10][34][34] Future Development Plans - **Phase 3 Readiness**: The company is preparing to advance BPL-three into Phase 3 trials, with an end-of-phase 2 meeting with the FDA anticipated in Q3 2025 [45][45] - **Redosing Strategy**: Future studies will explore a potential redosing paradigm, likely within a two to three-month window, which would significantly improve treatment convenience compared to SPRAVATO [68][68] Competitive Advantages - **Unique Positioning**: Atai Life Sciences is positioned uniquely with BPL-three and VLS-one, both designed for a two-hour treatment paradigm, contrasting with competitors requiring multiple doses over extended periods [51][51][52][52] - **Commercial Scalability**: The single administration model with a two-hour follow-up is expected to enhance commercial scalability and patient convenience [51][51] Upcoming Milestones - **Data Releases**: Additional data from ongoing studies, including an open-label extension study, are expected in the near future, which will further inform the efficacy and safety profile of BPL-three [44][44] - **Regulatory Engagement**: The company plans to engage with regulatory bodies regarding potential breakthrough designations and the national review voucher program for expedited approval processes [117][117] Conclusion - **Overall Assessment**: The Phase 2b trial results for BPL-three indicate a promising new treatment option for patients with treatment-resistant depression, with a favorable safety profile and significant efficacy, setting the stage for further development and potential market entry [62][62]

Core Insights - Vivos Therapeutics has received approval from the Centers for Medicare & Medicaid Services (CMS) for its VidaSleep™ oral appliance, which is designed to treat mild to moderate obstructive sleep apnea (OSA) and snoring in adults [1][4][5] - The approval allows Vivos to significantly expand its market presence, as it now has two Medicare-covered oral appliances, enhancing its competitive position in the sleep therapy market [5][6] Company Overview - Vivos Therapeutics, Inc. is a medical technology company focused on innovative treatments for OSA and snoring, with its products cleared by the FDA for various severity levels of OSA [10][12] - The company aims to address the structural root causes of OSA through its proprietary oral appliances, which are non-invasive and non-pharmaceutical [13] Market Opportunity - With over 80% of OSA cases in the U.S. undiagnosed and an estimated 80 million Americans affected, Vivos is positioned to capture a significant share of the underpenetrated sleep therapy market [4][11] - The dual-PDAC approval of VidaSleep™ and mmRNA® appliances allows Vivos to serve a broader range of patients, from Medicare beneficiaries to those covered by commercial payers, tapping into the estimated $36 billion sleep therapy market [6][8] Clinical and Commercial Advantages - The VidaSleep™ device is designed to be a standalone therapy or an adjunct to CPAP, providing flexibility for both providers and patients [7][8] - The streamlined design and efficient manufacturing process of VidaSleep™ enable Vivos to offer high-impact therapy at a cost-effective price, increasing adoption across Medicare and commercial insurance networks [8] Health Implications - OSA is linked to severe comorbidities such as heart disease, stroke, and dementia, yet remains largely underdiagnosed [9][11] - Vivos' oral appliances have shown significant improvements in airway patency and symptom resolution, as evidenced by peer-reviewed studies [9]

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [9] - The company has launched LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) in Europe, specifically in Germany and the UK, for the treatment of wet age-related macular degeneration (AMD) [9] Leadership Appointment - Bob Jahr has been appointed as the Chief Executive Officer (CEO) of Outlook Therapeutics and will also join the Board of Directors [1][2] - Lawrence A. Kenyon will continue in his role as Chief Financial Officer (CFO) and remain a member of the Board of Directors [1] Executive Experience - Mr. Jahr brings over 20 years of experience in the biopharmaceutical industry, having led commercial teams across various therapeutic areas including rare disease, oncology, and hematology [3] - He has a proven track record of managing multiple billion-dollar assets and franchises [3] Strategic Importance - The appointment of Mr. Jahr is seen as timely due to the ongoing commercial launch in Europe and the potential for U.S. FDA approval in the coming months [2] - Mr. Jahr expressed excitement about joining the company at a pivotal time, emphasizing the potential of LYTENAVA™ to transform the global retina market [4] Inducement Grant - The Board of Directors approved an option for Mr. Jahr to purchase 800,000 shares of common stock as an inducement for his employment [6] - The option will be issued on July 1, 2025, with an exercise price equivalent to the closing price of the stock on that date, vesting over four years [7]

Core Insights - Soleno Therapeutics, Inc. announced the selection of two abstracts for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025) regarding VYKAT™ XR (diazoxide choline) extended-release tablets, aimed at treating hyperphagia in individuals with Prader-Willi syndrome [1][2] Company Overview - Soleno Therapeutics is focused on developing and commercializing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product [10] - VYKAT XR was approved by the U.S. FDA on March 26, 2025, and is now available for patients in the U.S. [3] Product Information - VYKAT XR is indicated for treating hyperphagia in adults and pediatric patients aged 4 years and older with Prader-Willi syndrome [3] - The product's safety information includes contraindications for patients with known hypersensitivity to diazoxide or thiazides [4] Presentation Details - The first presentation at ENDO 2025 will focus on the glycemic outcomes of VYKAT XR in treating hyperphagia over four years [2] - The second presentation will characterize peripheral edema in individuals with Prader-Willi syndrome during long-term administration of VYKAT XR over 4.5 years [6] Health Implications - Prader-Willi syndrome is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [2] - The treatment with VYKAT XR aims to address the life-threatening aspects of hyperphagia and improve the quality of life for affected individuals [2]

PURCHASE, N.Y., July 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study surpasses 50% enrollment. The START Study is being conducted with partners at the Alzheimer’s Clinical Trials Consortium (ACTC), with $81 million in grant support from the National Institute of Aging (NIA) at the National Institutes of Health. Christopher van Dyck, ...

Core Viewpoint - Apellis Pharmaceuticals has entered into a capped royalty purchase agreement with Sobi, allowing Apellis to receive up to $300 million in exchange for 90% of its future ex-U.S. royalties for Aspaveli, which is a treatment for rare diseases [1][2][3] Transaction Details - Apellis will receive $275 million upfront and may earn up to $25 million in milestone payments upon EMA approval for Aspaveli in treating C3G and IC-MPGN [3][7] - The agreement includes defined caps tied to Aspaveli's performance, after which 100% of ex-U.S. royalties will revert to Apellis [4] Product Information - Aspaveli (systemic pegcetacoplan) is approved in the EU and the U.S. for treating paroxysmal nocturnal hemoglobinuria (PNH) and is under review for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) [2][5] - Approximately 50% of patients with C3G and IC-MPGN may experience kidney failure within five to ten years of diagnosis, highlighting the urgency for effective treatments [6] Strategic Implications - The transaction is seen as a non-dilutive funding method that strengthens Apellis' balance sheet and provides operational flexibility as the company approaches sustainable profitability [2][7] - Sobi's expertise in rare diseases and its commercial footprint are expected to enhance the reach of Aspaveli globally following regulatory approvals [3]

Financing Overview - atai Life Sciences has entered into subscription agreements for the purchase of 18,264,840 ordinary shares and pre-funded warrants to purchase an additional 4,566,210 shares, expected to generate gross proceeds of approximately $50 million [1][2] - The financing is co-led by Ferring Ventures S.A. and Apeiron Investment Ltd., with participation from healthcare-focused institutional investors such as Ally Bridge Group and ADAR1 [2][4] Use of Proceeds - The net proceeds from the financing will be utilized for general corporate purposes, including working capital and advancing the clinical development of atai's product candidates and programs [1][3] Clinical Development and Future Plans - atai aims to accelerate its efforts in delivering new therapeutic options for mental health challenges, with a clear Phase 3 plan anticipated by early 2026 [3] - The company is advancing its pipeline of psychedelic-based therapies, including VLS-01 for treatment-resistant depression and EMP-01 for social anxiety disorder, both in Phase 2 clinical development [7] Investment Rationale - Ferring Ventures S.A. emphasizes the transformative potential of psychedelics for mental health conditions and supports atai's innovation in this space [4] - The financing is seen as a strategic move to position atai for future commercialization as it transitions from a clinical-stage biotech to a fully integrated commercial company [3][4]

Core Viewpoint - Achieve Life Sciences, Inc. has successfully closed a public offering of 15 million shares of common stock, raising gross proceeds of $45 million to advance the development of cytisinicline for nicotine dependence treatment [1][2]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment for nicotine dependence, with a New Drug Application submitted to the FDA in June 2025 [5]. - The company has completed two Phase 3 studies and an open-label safety study for cytisinicline, and has also conducted a Phase 2 study for vaping cessation [5]. Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, aimed at reducing nicotine cravings and the satisfaction derived from nicotine products [7]. - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death globally, with over 8 million deaths annually [6]. - There are currently no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need that cytisinicline aims to address [6]. Financial Details - The public offering included 15 million shares at a price of $3.00 per share, along with warrants to purchase up to 16,766,666 additional shares [1]. - Proceeds from the offering will be used for advancing cytisinicline towards FDA marketing approval and for general corporate purposes [2].