Prelude Therapeutics (PRLD) FY Conference June 11, 2025 09:20 AM ET Speaker0 Are necessary for a successful SMARK A2 directed agent? Obviously, sounds like the greater over inhibitor is one of the But what are some of Speaker1 the key properties you think are necessary for this kind of agent to be successful? Yes. So we know from our preclinical models that if you hit both four and two that you have quite a bit of toxicity. And so the degradation of II allows and selectivity and potency for II actually allo ...

-- PCRX-201 demonstrated sustained clinical efficacy with improvements in pain, stiffness, and function for up to three years – BRISBANE, Calif., June 11, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced new long-term follow-up data from its Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), a novel gene therapy candidate for osteoarthritis of ...

SYDNEY, June 11, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a clinical-stage biotechnology company pioneering next-generation oncology therapeutics, today announced the publication of transformative preclinical research in the journal Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research that underscores the powerful potential of its lead asset, paxalisib, in reshaping the treatment landscape for triple-negative breast cancer (TNBC), one of the most ag ...

~ Proven biotech executive to lead commercialization of AMT-130 in Huntington’s disease ~ LEXINGTON, Mass. and AMSTERDAM, June 11, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the appointment of Kylie O’Keefe as Chief Customer and Strategy Officer, effective June 6, 2025. In this role, Ms. O’Keefe will lead the development and execution of uniQure’s global commercialization stra ...

WILMETTE, Ill. and HOUSTON, Texas, June 11, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. ("Monopar," the "Company," "us" and "our") (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, in collaboration with Excel Diagnostics and Nuclear Oncology Center ("EDNOC"), a premier diagnostic medical imaging and therapeutic nuclear medicine center, today announced that the physician-sponsored Expanded Access Program ("EAP" ...

-Aetna authorizes claim for PoNS Device at out-of-network negotiated price of $18,350, becoming the third payer to join Anthem and United in providing PoNS reimbursement- -Out of Network reimbursement is only the first step towards expanding third-party paid access to PoNS- NEWTOWN, Pa., June 11, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq: HSDT) ("Helius" or the "Company"), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait def ...

SAN DIEGO and CALGARY, AB, June 11, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the appointment of Jared Kelly as Chief Executive Officer and a member of its Board of Directors.Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson ...

-Ends- Enquiries: OXB: Sophia Bolhassan, Head of Investor Relations – T: +44 (0) 1865 509 737 / E: ir@oxb.com Oxford, UK – 11 June 2025: OXB (LSE: OXB) ("the Company"), a global quality and innovation-led cell and gene therapy CDMO, provides an update to coincide with its Annual General Meeting being held at 3pm BST today at Windrush Court, Oxford, UK. OXB has demonstrated strong commercial momentum and made good operational and commercial progress in the year 2025 to date, as it continues to provide viral ...

Lantheus (LNTH) FY Conference June 10, 2025 02:40 PM ET Speaker0 Following session is not open to the press. Okay. Speaker1 Good afternoon, everyone. I'm Paul Choi, and I cover the biotechnology sector here at the firm at Goldman Sachs. It's my pleasure to welcome Lampius. Joining me on stage to my immediate left is Brian Markinson, CEO, and Bob Marshall to my far left. What I'll do is turn it over to Brian maybe for some introductory or overview comments and then we'll get into Q and A after that. Speaker0 ...

Financial Data and Key Metrics Changes - The company has approximately $688 million in cash as of Q1, which is expected to last through the first half of 2028, covering existing programs and initial launch activities [77][79]. Business Line Data and Key Metrics Changes - The company is preparing to file a Biologics License Application (BLA) this year, targeting the BCG unresponsive high-risk population, which consists of about 15,000 patients annually [3][37]. - In a trial called BON-three, the company reported a 75.5% complete response rate at any time, with a durable response rate of 65% at one year and 58% at two years [7][8]. Market Data and Key Metrics Changes - In the U.S., there are 85,000 new bladder cancer patients diagnosed each year, with 75% being non-muscle invasive, and 70% of those being in the intermediate and high-risk categories [37]. - The company is addressing a growing number of patients in the BCG exposed category, estimated to be well over 30,000 to 50,000 patients [37]. Company Strategy and Development Direction - The company aims to revolutionize the treatment landscape for non-muscle invasive bladder cancer, focusing on both intermediate and high-risk populations [5]. - The strategy includes simplifying the administration process from a five-step to a two-step process, which is expected to save time and improve patient throughput [23][24]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming BLA filing, emphasizing the importance of demonstrating a minimum duration of response of at least twelve months [22]. - The company is optimistic about its unique position in the market due to the ongoing BCG shortage, which allows for faster enrollment in clinical trials [41]. Other Important Information - The company has generated data showing consistent response rates in patients who have had prior chemotherapy, which will be leveraged in discussions with providers [53]. - The company is focused on building relationships with key accounts, particularly in high-volume centers, to prepare for the commercial launch [73][75]. Q&A Session Summary Question: What is the current cash position and runway guidance? - The company has about $688 million in cash, which is expected to last through the first half of 2028, covering all existing programs and commercial preparations [77][79]. Question: What are the key endpoints for the papillary population study? - The benchmark for the papillary population is a recurrence-free survival rate of about 40% at twelve months, with the company aiming to exceed this in their studies [66]. Question: How does the company plan to prepare for a potential approval? - The commercial leadership team is already in place, focusing on building relationships with key accounts and preparing for the launch [73].