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The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune reactions to the investigational treatment recorded in preclinical mouse studies. The regulator has requested that Denali adjust its trial protocol “to include a lower starting dose, revised inclusion criteria, certain safety monitoring commitments and stopping rules,” the Bay Area biotech said in a Dec. 4 filing with the Securities and Exchange Commission (SEC). The FDA identified the concerns during its 30-day review of Denali's Investigational New Drug (IND) application for an enzyme replacement therapy dubbed DNL952. The agency is not asking the biotech to conduct any additional preclinical research. “We have submitted our response to the FDA and plan to start the phase 1 study in the first half of 2026, pending the agency’s feedback,” a Denali spokesperson told Fierce Biotech. Denali doesn't expect the hold to significantly delay its phase 12025-12-06 • investors.biogen.com
Biogen and Stoke Therapeutics Present Data that Further Support the Disease-Modifying Potential of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 2025 American Epilepsy Society (AES) Annual Meeting2025-12-06 • manilatimes.net
Transcenta Therapeutics Presents Updated Efficacy Data from the Phase I/II Transtar102 Trial of Osemitamab plus Nivolumab and CAPOX in First-Line G/GEJ Cancer at ESMO Asia2025-12-06 • streetinsider.com
Intensity Therapeutics Granted 180-Day Extension to Regain Compliance with Nasdaq's Minimum Bid Price Requirement2025-12-06 • in.investing.com
Trevi Therapeutics Appoints David Hastings As Chief Financial Officer 93ch 51403262025-12-06 • defenseworld.net
Geode Capital Management LLC Purchases 453,085 Shares of Heron Therapeutics, Inc. $HRTX2025-12-06 • globenewswire.com
Galimedix Therapeutics presents compelling Phase 1 study results showing excellent safety and pharmacokinetics with oral small molecule GAL-101 at CTAD 20252025-12-06 • globenewswire.com
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Pliant Therapeutics reports interim PLN-101095 Phase I trial data2025-12-06 • PR Newswire
Nektar Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)2025-12-05 • pmlive.com
TRIMTECH Therapeutics appoints Alison Lawton as Chair of the Board2025-12-05 • PR Newswire
K36 Therapeutics announces presentation of First-in-Human Clinical Data for Gintemetostat (KTX-1001) Demonstrating Target Engagement and Clinical Activity in Multiple Myeloma at ASH 2025 and the Appointment of Dr. Shinta Cheng, M.D., Ph.D., as Chief Medical Officer2025-12-05 • PR Newswire
Jubilant Therapeutics Inc. appoints Daniel J. O'Connor as President and Chief Executive Officer2025-12-05 • globenewswire.com
Crescent Biopharma Announces Transformational Partnership with Kelun-Biotech and $185 Million Private Placement, Accelerating and Expanding Global Pipeline of Next Generation Therapeutics for Solid Tumors2025-12-05 • PR Newswire
Intensity Therapeutics Granted 180-Day Extension to Regain Compliance with Nasdaq's Minimum Bid Price Requirement2025-12-05 • thepharmaletter.com
Crescent and Kelun-Biotech get creative with two-way licensing deal2025-12-05 • manilatimes.net
MapLight Therapeutics Reports Third Quarter Financial Results and Highlights Corporate Progress2025-12-05 • biospace.com
Rondo Therapeutics Doses First Patient in Phase 1 Trial of RNDO-564, a First-in-Class Co-Stimulatory Bispecific Antibody Targeting Nectin-4 in Advanced Solid Tumors2025-12-05 • newscase.com
Viking Therapeutics Gains Momentum with Accelerated Clinical Trial2025-12-05 • pf-media.co.uk
MSD to acquire Cidara Therapeutics after positive trial results2025-12-05 • globenewswire.com
Merakris Therapeutics Announces Completion of Type C Meeting with FDA – Alignment on MTX-001 Biologic Drug Development Pathway2025-12-05 • globenewswire.com
Plus Therapeutics Highlights Three REYOBIQ™ Clinical Data Presentations at 2025 WFNOS/SNO Annual Meeting2025-12-05 • glance.eyesoneyecare.com
FDA clears Zhongmou Therapeutics' IND for RP optogenetic gene therapy2025-12-05 • clinicaltrialsarena.com
Rondo Therapeutics begins dosing in Phase I/Ib trial for solid tumours2025-12-04 • investorwire.com
Oncotelic Therapeutics, Inc. (OTCQB: OTLC) identifies Biomarker Signature Predicting Sensitivity to IV Sapu0032025-12-05 • EIN Presswire
Rare Disease Therapeutics Market to hit US$ 495.27 billion by 2033, (CAGR 13.8%)2025-12-06 • prnewswire.co.uk
Lundbeck announces positive Phase 2 long-term data for bexicaserin in rare childhood-onset epilepsies, at American Epilepsy Society (AES) Annual Meeting2025-12-06 • bizjournals.com
Varanese completes $250K renovation2025-12-06 • economictimes.indiatimes.com
NDA govt doubled MSP, quadrupled crop procurement: Shivraj Singh Chouhan in Rajya Sabha2025-12-06 • born2invest.com
Angelini Ventures Signs €150 Million EIB Deal to Accelerate Biotech Innovation in Europe2025-12-06 • fuelcellsworks.com
VZDI Inaugurates First Methane Pyrolysis Plant at V-ZUG2025-12-06 • bizjournals.com
Steel manufacturer doubles Memphis production2025-12-06 • jamestown.org
Russia Approves Expanding Rare Earths Mining And Refining Program2025-12-06 • economictimes.indiatimes.com
DBT milestone, railways’ 80% on-time record, electronics imports surge & more2025-12-06 • cantechletter.com
Shawn Johal Acquires Unicor Industries, Strengthening Leadership in Precision Injection Molding and Sustainable Manufacturing in Canada2025-12-06 • aa.com.tr
UK charity seeks $583K to repair Shakespeare's home2025-12-06 • northernnews.ca
Blanche River Health secures millions in funding for sewage and storm water pipes replacement2025-12-06 • hindustantimes.com
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Rusty’s Seafood & Oyster Bar Named 2025 Best of Florida Regional Award Winner2025-12-06 • jamestown.org
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Russia plans 27 per cent oil export rise in December to clear backlog2025-12-06 • ftnnews.com
River Rock announces first Russian hotel: River Rock Gelendzhik Bay opening in 20262025-12-06 • fuelcellsworks.com
Major Port Finalizes Technical Studies for Clean Hydrogen Hub2025-12-06 • thestatesman.com
Delhi Health Minister opens MAMC centre to boost future-ready healthcare2025-12-06 • economictimes.indiatimes.com
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