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Crescent Biopharma Appoints Jan Pinkas, Ph.D., as Chief Scientific Officer
Globenewswire· 2025-07-08 11:30
Seasoned Leader Brings Deep Experience in Oncology Drug Development as Company Advances Portfolio of Next Generation Therapeutics for Solid Tumors WALTHAM, Mass., July 08, 2025 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced the appointment of Jan Pinkas, Ph.D., as chief scientific officer. Dr. Pinkas brings more than two decades of experience in o ...
FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug
ZACKS· 2025-07-03 14:20
Key Takeaways REGN gained FDA approval for Lynozyfic to treat relapsed or refractory multiple myeloma. Lynozyfic showed a 70% response rate and 45% complete response rate in the LINKER-MM1 trial. The approval makes Lynozyfic the first FDA-cleared BCMAxCD3 bispecific with biweekly or monthly dosing.Regeneron Pharmaceuticals, Inc. (REGN) obtained FDA approval for linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM).The regulatory body granted accelerated approval to lin ...
EXEL Stock Rises on Positive Data From Colorectal Cancer Study
ZACKS· 2025-06-24 14:41
Key Takeaways More on EXEL's STELLAR-303 Study on Zanzalintinib Zanzalintinib is a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. The STELLAR-303 study met one of its two dual primary endpoints, demonstrating a statistically significant improvement in overall survival (OS) for the intent-to-treat (ITT) population when treated with zanzalintinib in combination with Tece ...
Gilead Sciences (GILD) 2025 Conference Transcript
2025-06-04 16:07
Gilead Sciences (GILD) 2025 Conference June 04, 2025 11:05 AM ET Speaker0 Good morning everyone. Welcome to our next panel discussion with Gilead Sciences. We have a couple of important members of the executive team from Gilead here up with us. To my left, Dietmar Berger, who's the new CMO, and I like to say running the hot seat of R and D in front of Wall Street to talk about obviously everything going on in the pipeline. As well as Cindy Paretti. She's Executive Vice President of Kite and runs everything ...
Regeneron Initial Data on Multiple Myeloma Drug Encouraging
ZACKS· 2025-05-23 21:11
Core Insights - Regeneron Pharmaceuticals, Inc. announced promising initial results from the early-stage study of oncology drug linvoseltamab, particularly in patients with relapsed/refractory multiple myeloma [1][2] Group 1: Study Results - The LINKER-MM2 trial showed linvoseltamab combined with carfilzomib or bortezomib yielded high response rates in earlier treatment lines for relapsed/refractory multiple myeloma [2] - Efficacy results indicated a 90% objective response rate (ORR) and a 76% complete response (CR) at a median follow-up of 15 months [6] - Among patients treated with linvoseltamab and bortezomib, an 85% ORR was observed with 50% achieving CR [7] Group 2: Patient Demographics - The study included patients who had progressed after at least two lines of therapy, with many being double-class refractory or triple-class exposed [4] - 48% of enrolled patients had baseline soft tissue plasmacytomas, and 39% were over 75 years old, indicating a high-risk patient population [5] Group 3: Regulatory Developments - The European Commission granted conditional marketing approval for linvoseltamab under the brand name Lynozyfic for adults with relapsed/refractory multiple myeloma [8] - The FDA has accepted the resubmission of the Biologics License Application (BLA) for linvoseltamab, with a target action date of July 10, 2025 [9] Group 4: Oncology Portfolio Expansion - Regeneron is focused on strengthening its oncology portfolio, which includes Libtayo for various cancers [10] - The approval of odronextamab for treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma has also contributed to the oncology franchise [11] Group 5: Market Competition - The decline in sales of Regeneron's lead drug Eylea is a concern, attributed to competition from Roche's Vabysmo, which has significantly impacted Eylea's market share [12][13]
Kazia Therapeutics Highlights Recent Progress and Provides Business Update
Prnewswire· 2025-05-15 12:00
Awarded research grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to fund research between The Hebrew University of Jerusalem (Hebrew University) and Kazia to explore the therapeutic potential of paxalisib as a treatment for Parkinson's disease (PD) Launched clinical trial evaluating the combination of paxalisib and immunotherapy in patients with advanced breast cancer Reached alignment with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study of pa ...
Merus: Riding The Bispecific Wave In Oncology
Seeking Alpha· 2025-04-07 08:34
The oncology drug development landscape is competitive and requires innovation and clinical validation. In this space, companies leveraging novel platform technologies to create differentiated therapies stand out. With its focus on Biclonics and Multiclonics bispecific and multispecific antibodies, Merus (I have a strong inclination towards high-growth companies, often treading in sectors poised for exponential expansion. My expertise lies in understanding and investing in disruptive technologies and forwar ...
BioLineRx(BLRX) - 2024 Q4 - Earnings Call Transcript
2025-03-31 14:52
BioLineRx Ltd. (NASDAQ:BLRX) Q4 2024 Earnings Conference Call March 31, 2025 8:30 AM ET Company Participants Irina Koffler - IR, LifeSci Advisors Phil Serlin - CEO Mali Zeevi - CFO Ella Sorani - Chief Development Officer Conference Call Participants Joe Pantginis - HC Wainwright John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Fourth Quarter and Full Year 2024 Financial Results Conference Call. All participants are present in listen-only mode. Foll ...
Immuneering Names Dr. Igor Matushansky as Chief Medical Officer
Globenewswire· 2025-03-20 11:00
Industry veteran brings extensive oncology drug development expertise and experience in clinical treatment of cancer patients Dr. Matushansky joins as Immuneering plans to present updated data from Phase 2a trial of IMM-1-104 in pancreatic cancer in Q2 2025 CAMBRIDGE, Mass., March 20, 2025 (GLOBE NEWSWIRE) -- Immuneering (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today announced that Igor Matushans ...