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Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer
Prnewswire· 2025-07-24 01:14
Core Viewpoint - Akeso, Inc. has initiated a pivotal Phase III clinical trial for ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, aimed at treating metastatic pancreatic cancer in combination with chemotherapy and potentially ligufalimab [1][3] Industry Overview - Pancreatic cancer is a highly aggressive malignancy with a rising global incidence, leading to approximately 511,000 new cases and 467,000 deaths in 2022. The overall survival rate remains alarmingly low, with current first-line treatments primarily consisting of chemotherapy showing limited success, resulting in a median overall survival of less than one year [4] - The unique immune evasion mechanisms and immunosuppressive tumor microenvironment of pancreatic cancer have made it resistant to existing therapies, with no immunotherapy approved for first-line treatment to date [2][4] Company Overview - Akeso is a leading biopharmaceutical company focused on developing innovative biological medicines, with a robust pipeline of over 50 assets in various therapeutic areas, including cancer. The company employs an integrated R&D innovation system and has developed a comprehensive drug development platform [10] - The ongoing Phase III trial for ivonescimab is part of Akeso's strategy to address significant unmet clinical needs in oncology, particularly for metastatic pancreatic cancer [3][10]
Palisade Bio Announces Exercise of Previously Issued Warrants for $3.9 Million
GlobeNewswire News Room· 2025-07-24 00:00
Core Viewpoint - Palisade Bio, Inc. has entered into an agreement with accredited investors to exercise existing warrants for the purchase of up to 4,318,905 shares of common stock at a reduced exercise price, generating approximately $3.9 million in gross proceeds for the company [1][2]. Group 1: Existing Warrants and Financial Details - The existing warrants were issued at adjusted exercise prices of $1.40 and will be exercised at a reduced price of $0.9047 per share [1]. - The gross proceeds from the exercise of the existing warrants are expected to be approximately $3.9 million before deducting fees and expenses [2]. - The company intends to use the net proceeds from the offering for working capital and general corporate purposes [4]. Group 2: Replacement Warrants - In exchange for the immediate exercise of existing warrants, holders will receive new unregistered replacement warrants to purchase up to 8,637,810 shares of common stock at an exercise price of $0.9047 per share, with a term of five years from shareholder approval [3]. - The replacement warrants are offered in a private placement and have not been registered under the Securities Act [5]. Group 3: Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases [7].
Vanda Pharmaceuticals to Announce Second Quarter 2025 Financial Results on July 31, 2025
Prnewswire· 2025-07-23 20:45
Company Announcement - Vanda Pharmaceuticals Inc. will release its second quarter 2025 results on July 31, 2025, before the market opens [1] - A conference call will be held at 8:00 AM ET on the same day to discuss the financial results and corporate activities [2] - The conference call will be available for live broadcast and archived on Vanda's website [3] Replay Information - A replay of the conference call will be accessible starting at 11:00 AM ET on July 31, 2025, until August 7, 2025, at 11:59 PM ET [4] - Specific call-in numbers for domestic and international callers are provided for the replay [4] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to meet high unmet medical needs [5]
Viking Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Prnewswire· 2025-07-23 20:05
Core Insights - Viking Therapeutics reported significant clinical and financial developments in Q2 2025, including the initiation of the Phase 3 VANQUISH program for VK2735, aimed at treating obesity and type 2 diabetes [2][4] - The company ended the quarter with a strong cash position of $808 million, supporting ongoing clinical trials and development programs [5][16] Clinical Pipeline Updates - The VANQUISH Phase 3 program for VK2735 includes two studies targeting approximately 4,500 adults with obesity and 1,100 adults with type 2 diabetes, assessing the efficacy and safety of VK2735 administered weekly for 78 weeks [4][5] - The Phase 2 VENTURE-Oral Dosing study of VK2735's oral formulation completed enrollment with approximately 280 patients, with top-line results expected in the second half of 2025 [6][8] - VK2735 demonstrated statistically significant weight loss of up to 14.7% in previous trials, with a favorable safety profile [3][4] Financial Performance - Research and development expenses for Q2 2025 were $60.2 million, up from $23.8 million in Q2 2024, primarily due to increased clinical study costs [10][11] - General and administrative expenses rose to $14.4 million in Q2 2025 from $10.3 million in Q2 2024, driven by higher stock-based compensation [11] - The net loss for Q2 2025 was $65.6 million, compared to a net loss of $22.3 million in Q2 2024, reflecting increased operational costs [12] Balance Sheet Overview - As of June 30, 2025, Viking held cash, cash equivalents, and short-term investments totaling $808 million, a decrease from $903 million at the end of 2024 [16] - The total liabilities stood at $32.4 million, with stockholders' equity at $795.5 million [25]
Galapagos Bolster Leadership Team with Seasoned Life Sciences Executives to Accelerate Business Transformation
Globenewswire· 2025-07-23 20:03
Appoints Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer Both executives possess proven track records in strategic execution and deal-making and will help drive long-term value creation at Galapagos Mechelen, Belgium; July 23, 2025, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced the appointments of Ms. Sooin Kwon as Chief Business Officer (CBO) and Mr. Dan Grossman as Chief Strategy Officer (CStO), effective August 4, 2025, further strengthening the Company ...
Galapagos Welcomes Seasoned Pharmaceutical Executives Dawn Svoronos and Jane Griffiths to Its Board of Directors
GlobeNewswire News Room· 2025-07-23 20:02
New Directors bring deep commercial, operational, and transaction experience to the Board Mechelen, Belgium; July 23, 2025, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced the appointments by way of co-optation of Dawn Svoronos and Jane Griffiths as Non-Executive Independent Directors to its Board of Directors, effective July 28, 2025. Dawn Svoronos and Jane Griffiths will replace Peter Guenter and Simon Sturge, who will step down from the Board on July 28, 2025. Jérôme Contamine, Chair o ...
Arcutis to Report Second Quarter 2025 Financial Results and Host Conference Call on August 6, 2025
GlobeNewswire News Room· 2025-07-23 20:00
WESTLAKE VILLAGE, Calif., July 23, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will report second quarter 2025 financial results and provide a business update on Wednesday, August 6, 2025 after the U.S. financial markets close. The Company will also host a conference call and webcast the same day at 4:30 p.m. ET. A live webcast of the call and th ...
Will Reblozyl Enable BMY to Offset the Impact of Generic Competition?
ZACKS· 2025-07-23 15:55
Core Insights - Bristol Myers is focused on expanding the label for its key drugs, with Reblozyl being a significant contributor, generating $478 million in Q1, reflecting a 35% year-over-year increase [1][9] Drug Indications and Performance - Reblozyl is approved in the U.S. for treating anemia in adult patients with beta thalassemia requiring regular RBC transfusions and for ESA-naïve patients with very low- to intermediate-risk myelodysplastic syndromes [2] - It is also indicated for patients with anemia failing an erythropoiesis stimulating agent and requiring multiple RBC units over 8 weeks [3] Clinical Study Results - The phase III study INDEPENDENCE for Reblozyl did not meet its primary endpoint of RBC transfusion independence in myelofibrosis-associated anemia patients [4] - Despite this, patients showed a numerical improvement in RBC transfusion independence, and several secondary measures indicated a clinically meaningful benefit [5] Competitive Landscape - Keros Therapeutics is developing a competing treatment for transfusion-dependent anemia, having recently initiated a phase III study [6] - Reblozyl also competes with established erythropoiesis-stimulating agents like Procrit, which operates through different mechanisms [7] Financial Performance and Valuation - Bristol Myers' shares have decreased by 9.6% year-to-date, contrasting with the industry growth of 0.7% [8] - The company is trading at a price/earnings ratio of 7.78x forward earnings, lower than its historical mean and the large-cap pharma industry's average of 14.91x [11] Earnings Estimates - The bottom-line estimate for 2025 has been revised down to $6.37 from $6.89 over the past 60 days, with a similar decline for 2026 [12] - Recent consensus estimate trends show a downward revision across multiple time frames [13]
Rising Cash Flows Make These 4 Stocks Worth Choosing Now
ZACKS· 2025-07-23 15:36
Key Takeaways CPRX, STKL, GAMB and ORN show rising cash flow trends versus their 5-year per-share averages. Each stock meets criteria, including price above $5, top broker ratings and a VGM Score of B or better. EPS estimates for 2025 have been revised upward recently, reflecting positive sentiment and momentum.We are already into the second-quarter reporting cycle, and stocks with top-line growth and increasing profit numbers might be popular choices. Moreover, choosing stocks based on a company’s effici ...
European Commission Approved DARZALEX Faspro® for Adult Patients with Smouldering Multiple Myeloma
Prnewswire· 2025-07-23 15:36
DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technologyApproval represents critical advancement in early intervention for multiple myelomaSAN DIEGO, July 23, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval of a new indication for DARZALEX Faspro® (daratumumab) co-formulated with ENHANZE®, as monotherapy for the treatment of adult ...