Biopharmaceuticals

Search documents
CYCLACEL PHARMACEUTICALS ANNOUNCES AMENDMENT TO EXCHANGE AGREEMENT
Globenewswire· 2025-07-07 10:00
Core Viewpoint - Cyclacel Pharmaceuticals has amended its Exchange Agreement with FITTERS Diversified Berhad to facilitate the acquisition of Fitters Sdn. Bhd., a subsidiary of FITTERS, through the exchange of shares and a cash payment [1][2][3]. Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle, epigenetics, and mitosis biology [6]. - The company is evaluating plogosertib, a PLK1 inhibitor, in patients with solid tumors and hematological malignancies, aiming to build a diversified biopharmaceutical business [6]. Transaction Details - Under the amended Exchange Agreement, Cyclacel will exchange all ordinary shares of Fitters Sdn. Bhd. for common stock, representing 19.99% of Cyclacel's issued and outstanding shares at closing [2]. - Cyclacel will also pay USD 1,000,000 or a mutually agreed amount to FITTERS as part of the transaction [2]. - The final date for the transaction has been extended to September 30, 2025 [2]. Approval and Governance - The transaction is subject to approval from the stockholders of both Cyclacel and FITTERS, and has been unanimously approved by the Boards of Directors of Cyclacel, FITTERS, and Fitters Sub [3]. Fitters Sdn. Bhd. Overview - Fitters Sdn. Bhd. specializes in distributing, trading, and installing fire safety materials and equipment, with a strong reputation for reliability and compliance with regulatory standards [4][8]. - The company offers a wide range of fire safety products, including fire extinguishers, fire-resistant doors, and personal protective equipment [8].
CYCLACEL PHARMACEUTICALS HIGHLIGHTS PUBLICATION OF PRECLINICAL DATA SHOWING THAT PLOGOSERTIB IS ACTIVE IN A HARD-TO-TREAT SUBTYPE OF LIVER CANCER
GlobeNewswire News Room· 2025-07-07 10:00
- Fibrolamellar hepatocellular carcinoma (FLC) has no approved treatment and occurs mostly in adolescents and young adults - KUALA LUMPUR, Malaysia, July 07, 2025 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; “Cyclacel” or the “Company”), a biopharmaceutical company developing innovative cancer medicines, highlighted a publication from independent investigators titled, “DNAJ-PKAc fusion heightens PLK1 inhibitor sensitivity in fibrolamellar carcinoma,” pub ...
Catalyst Pharmaceuticals (CPRX) Earnings Call Presentation
2025-07-07 06:47
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 Deep Dive_ Akeso & Innovent
2025-07-07 00:51
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 ( ...
OGN SHAREHOLDER ALERT: Suffer Losses on Organon & Co.? Contact BFA Law by July 22 Securities Fraud Class Action Deadline (NYSE:OGN)
GlobeNewswire News Room· 2025-07-06 11:46
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 ...
IOVA SHAREHOLDER ALERT: Suffer Losses on Iovance Biotherapeutics? Contact BFA Law by July 14 Securities Fraud Class Action Deadline (NASDAQ:IOVA)
GlobeNewswire News Room· 2025-07-06 11:46
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 ...
INVESTOR DEADLINE: Robbins Geller Rudman & Dowd LLP Announces that Sarepta Therapeutics, Inc. (SRPT) Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit
GlobeNewswire News Room· 2025-07-05 15:40
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].
Gossamer Bio (GOSS) Earnings Call Presentation
2025-07-04 14:12
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]
OGN SHAREHOLDERS: The Organon & Co. July 22 Class Action Deadline is Approaching -- Contact BFA Law if You Suffered Losses (NYSE:OGN)
GlobeNewswire News Room· 2025-07-04 12:08
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].
Exscientia (EXAI) Earnings Call Presentation
2025-07-04 11:32
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]