Financial Performance & Growth - Catalyst Pharmaceuticals experienced a 43.6% increase in total net product revenue in 1Q25 compared to 1Q24[55] - The company's 1Q25 net product revenues reached $141.4 million, up from $98.4 million in 1Q24[61] - Net income (GAAP) for 1Q25 was $56.7 million, significantly higher than the $23.3 million reported in 1Q24[61] - Catalyst forecasts total revenues between $545 million and $565 million for the full year 2025[60] Product Portfolio - FIRDAPSE revenue for 1Q25 was $83.7 million, compared to $66.8 million in 1Q24[56] - AGAMREE revenue for 1Q25 was $30.4 million[56] - FYCOMPA revenue for 1Q25 was $35.6 million, compared to $22.0 million in 1Q24[56] - FIRDAPSE is projected to generate between $355 million and $360 million in revenue for 2025[60] - AGAMREE is projected to generate between $100 million and $110 million in revenue for 2025[60] - FYCOMPA is projected to generate between $90 million and $95 million in revenue for 2025[60] Market & Strategic Focus - The total addressable market for the LEMS population is estimated to be over $1 billion[29] - The total addressable market for the DMD population is estimated to be over $1 billion[39]

Asia Pacific Equity Research July 2025 Asia Deep Dive: Akeso & Innovent China Healthcare Research Yang HuangAC, PhD (852) 2800 3812 yang.huang@jpmorgan.com J.P. Morgan Securities (Asia Pacific) Limited/ J.P. Morgan Broking (Hong Kong) Limited Eric Zhao, CFA (86-21) 6106 6256 eric.zhao@jpmorgan.com SAC Registration Number: S1730524050001 J.P. Morgan Securities (China) Company Limited Derek Choi, CPA (852) 2800-8744 derek.c.choi@jpmorgan.com J.P. Morgan Securities (Asia Pacific) Limited/ J.P. Morgan Broking ( ...

NEW YORK, July 06, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Organon & Co. (NYSE: OGN) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Organon you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/organon-co-class-action. Investors have until July 22, 2025, to ask the Court to be appointed to lea ...

NEW YORK, July 06, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Iovance you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/iovance-biotherapeutics-inc-class-action-lawsuit. Investors have until July 14, 2 ...

Core Viewpoint - The article discusses a class action lawsuit against Sarepta Therapeutics, alleging violations of the Securities Exchange Act of 1934 related to the company's gene therapy product, ELEVIDYS, which has been linked to severe safety risks and adverse events [1][3]. Group 1: Lawsuit Details - The class action lawsuit is titled Dolgicer v. Sarepta Therapeutics, Inc., and it involves purchasers of Sarepta securities from June 22, 2023, to June 24, 2025 [1]. - The lawsuit claims that Sarepta and its executives made false statements regarding the safety and efficacy of ELEVIDYS, which is intended to treat Duchenne muscular dystrophy [2][3]. Group 2: Allegations and Impact - Allegations include that ELEVIDYS posed significant safety risks, trial protocols failed to detect severe side effects, and adverse events would lead to regulatory scrutiny and halt of clinical trials [3]. - On March 18, 2025, Sarepta reported a patient death due to acute liver failure linked to ELEVIDYS, causing a stock price drop of over 27% [4]. - Following further disclosures about patient deaths and regulatory actions, Sarepta's stock experienced additional declines of more than 7% and 42% on subsequent dates [5][6]. - On June 24, 2025, the FDA announced an investigation into the risks associated with ELEVIDYS, resulting in an 8% drop in stock price [7]. Group 3: Legal Process - Investors who purchased Sarepta securities during the class period can seek appointment as lead plaintiff, representing the interests of the class [8]. - The lead plaintiff can choose a law firm to litigate the case, and participation as lead plaintiff does not affect the ability to share in any potential recovery [8]. Group 4: About Robbins Geller - Robbins Geller Rudman & Dowd LLP is a leading law firm specializing in securities fraud and shareholder litigation, having secured over $2.5 billion for investors in 2024 alone [9][10]. - The firm has a strong track record in obtaining significant recoveries in securities class action cases, including the largest recovery in history at $7.2 billion [10].

Seralutinib Partnership with Chiesi - Chiesi will provide a $160 million immediate development reimbursement to Gossamer[13] - Gossamer and Chiesi will split US profits 50/50, with mid-to-high teens royalties to Gossamer ex-US[13] - Regulatory milestones could reach up to $146 million, and sales milestones up to $180 million[13] - R&D costs will be split 50/50 worldwide, with Gossamer leading global development and US commercialization of PAH & PH-ILD[13] - Gossamer has a pro forma cash position of approximately $396 million[20, 38] Seralutinib in PAH - Seralutinib is in an ongoing registrational Phase 3 trial for PAH, with topline results expected in Q4 2025[13, 24, 26] - The PROSERA Phase 3 study is a double-blind, placebo-controlled trial with 175 patients per arm[26] - The US has approximately 30,000 to 50,000 PAH patients, with a 5-year survival rate of 57%[13, 22, 23, 35] Seralutinib in PH-ILD - The US has approximately 60,000 to 100,000 PH-ILD patients[13, 29, 35] - The median 5-year survival for PH-ILD patients is 23%[13, 35] - A Phase 3 study in PH-ILD is expected to begin in mid-2025[13, 20] - Only one therapy is approved for PH-ILD in the US[29, 30, 35]

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][3]. 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].

Transaction Overview - Recursion and Exscientia are combining to bring better medicines to patients more rapidly and cost efficiently[11] - Exscientia shareholders will receive 0.7729 shares of Recursion Class A common stock for each Exscientia ordinary share[27] - Recursion shareholders will own approximately 74% of the combined company, while Exscientia shareholders will own approximately 26%[27] - The transaction is expected to close by early 2025, subject to shareholder approvals and closing conditions[27] Financial Synergies and Cash Position - The combined company will have approximately $850 million in cash as of the end of Q2 2024[11, 27] - Estimated annual synergies of $100 million or more are expected[11, 27] - The pro forma combined financial plans are expected to extend the cash runway into 2027[27] Pipeline and Partnerships - The combined company anticipates approximately 10 clinical readouts over the next 18 months[11, 12, 14] - Current partnerships have the potential for over $200 million in milestone payments over the next 2 years[11, 18] - The combined company has the potential for over $20 billion in total revenue before royalties from partners[18] - CDK4/6 inhibitors generated $11 billion in sales in 2023[31]

William Blair 45th Annual Growth Stock Conference Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases June 2025 Nasdaq: DVAX Forward-Looking Statements Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about Dynavax's expected financial results and market share as of and for the quarter ended M ...

Core Insights - Nxera Pharma will receive US$4.8 million in milestone payments from Centessa Pharmaceuticals due to the initiation of clinical development of ORX142, a novel orexin receptor 2 (OX2R) agonist [1][2] - The milestone payments include US$1.8 million recognized as revenue in Q2 2025 and US$3.0 million in Q3 2025 [2] Company Overview - Nxera Pharma is a technology-driven biopharma company focused on developing specialty medicines for unmet medical needs in Japan and globally [3] - The company has established a commercial business in Japan to develop and market innovative medicines, addressing a growing market in the APAC region [3] Pipeline and Development - Nxera Pharma has an extensive pipeline of over 30 active programs, utilizing its NxWave™ discovery platform, targeting major unmet needs in neurology, metabolic diseases, and immunology [4] - The pipeline includes potentially first- and best-in-class candidates, advancing from discovery to late clinical stages in collaboration with leading pharmaceutical and biotech companies [4] Workforce and Locations - Nxera employs approximately 400 people across key locations including Tokyo, Osaka, London, Cambridge, Basel, and Seoul [5]