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- Feed Preview Clinical Trials - MedCity News
Beam’s Base-Editing Sickle Cell Therapy Shows Early Promise, But a Fatality Overshadows Results
The death wasn’t due to Beam Therapeutics’ sickle cell disease therapy, BEAM-101, but was instead attributed to the preconditioning treatment needed before the genetic medicine is infused...
https://medcitynews.com/2024/11/gene-therapy-base-editing-beam-therapeutics-sickle-cell-disease-scd/
Novo Nordisk Commits $285M to Ascendis to Kick Off Alliance on Longer-Acting GLP-1 Drugs
The Novo Nordisk/Ascendis partnership’s lead program is once-monthly injectable semaglutide for type 2 diabetes and obesity. This product candidate will be developed with Ascendis Pharma te...
Viking Therapeutics’ Early Clinical Data Continue to Build Case for Its Oral Obesity Drug
Higher doses of a Viking Therapeutics pill that targets two receptors led to greater weight loss without worsening safety or tolerability, according to Phase 1 results presented during the Ob...
https://medcitynews.com/2024/11/viking-therapeutics-oral-obesity-drug-vk2735-glp1-gip-vktx/
Novo Nordisk GLP-1 Drug Meets Goals of MASH Trial, Setting Stage for FDA & EMA Filings
Novo Nordisk’s Wegovy achieved statistically significant improvement in a Phase 3 study in the fatty liver disease MASH. Based on these preliminary results, the company plans to seek U.S. a...
https://medcitynews.com/2024/11/novo-nordisk-glp-1-wegovy-mash-fatty-liver-disease-nvo/
Precision Oncology Startup Kivu Unveils $92M for More Stable & Durable ADC Cancer Drugs
Novo Holdings led the Series A investment in Kivu Bioscience, developer of next-generation antibody drug conjugates for solid tumors. The startup’s ADCs and technology were licensed from Sy...
Biogen, Sage Therapeutics Drop Plans to Develop Partnered Drug in Major Depressive Disorder
The FDA had asked Biogen and Sage Therapeutics to provide more clinical data supporting Zurzuvae in major depressive disorder. Citing the time and expense of additional clinical trials, the p...
Going In Reverse Is Faster Way Forward for Crescent Bio’s Cancer Immunotherapy
Crescent Biopharma is going public via a reverse merger with GlycoMimetics that will capitalize the combined company with $200 million. Crescent’s lead program is a bispecific antibody for ...
AbbVie Adds Another Alzheimer’s Prospect With $1.4B Aliada Therapeutics Acquisition
Aliada brings AbbVie an early clinical Alzheimer’s disease drug candidate as well as the platform technology that produced it. Aliada licensed its brain delivery technology from Johnson & J...
Novartis to Pay $150M for Monte Rosa Glue Drug in the Clinic for Immunology Indications
Novartis is getting global rights to a Monte Rosa Therapeutic molecular glue degrader drug in early clinical testing as a potential treatment for autoimmune disorders. The deal comes months a...
Seaport Therapeutics Secures $225M for New Kind of Depression Drug
Seaport Therapeutics’ Series B financing was one of the largest rounds of funding in our recap of biotech financing news, which spans startups developing drugs for neurological diseases, ca...
https://medcitynews.com/2024/10/seaport-therapeutics-secures-225m-for-new-kind-of-depression-drug/
Septerna’s Upsized IPO Brings In $288M to Support a Pipeline of GPCR Drugs
Septerna’s lead program is in Phase 1 testing for hypoparathyroidism. The therapies available and in development for this rare disease are injectable, and Septerna aims to stand apart with ...
https://medcitynews.com/2024/10/septerna-ipo-gpcr-drug-hypoparathyroidism-pth-sepn/
Alto Neuroscience’s Depression Trial Failure Sends Shares Into Downward Spiral
An Alto drug candidate for major depressive disorder failed to meet primary and secondary goals of a placebo-controlled Phase 2b test. The disappointing result could stymie plans for further ...
Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer
The FDA approved Astellas’s Vyloy as a treatment for advanced cases of gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for a protein called claudin 18.2. It’s the first...
How Generative AI Will Find a Place in the Pharma Industry Now and in the Years to Come
Pharmaceutical and biotech companies are using generative AI to predict drug-target interactions, optimize lead compounds, and generate novel molecular structures. During the recent MedCity N...
Gilead Sciences Voluntarily Pulls Drug for Bladder Cancer After Trial Failure
Gilead Sciences’ Trodelvy did not meet the main overall survival goal of its confirmatory Phase 3 test. The antibody drug conjugate was awarded accelerated approval for advanced urothelial ...
Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer
The FDA approved Novocure medical device Optune Luna as a treatment for advanced cases of non-small cell lung cancer. The wearable technology delivers electrical fields that kill cancer cells...
On Heels of Positive Parkinson’s Gene Therapy Data, MeiraGTx Looks Ahead to Pivotal Test
In addition to meeting the main safety and tolerability goal, MieraGTx Holdings’ gene therapy for Parkinson’s disease also showed signs of efficacy. The one-time treatment is intended to ...
https://medcitynews.com/2024/10/meiragtx-parkinsons-gene-therapy-mgtx/
Aiming to Outdo Rivals in Severe Asthma, Upstream Bio Upsizes IPO to $225M
Upstream Bio will use its IPO haul to continue clinical testing of verekitug, which it contends could be a better treatment option for severe asthma compared to a commercialized Amgen and Ast...
https://medcitynews.com/2024/10/severe-asthma-upstream-bio-ipo-tslp-verekitug-upb-camp-cbll/
Scholar Rock Scores $300M for Regulatory Filings & Launch Plans for Neuromuscular Disease Drug
On the heels of Phase 3 data showing muscle improvement in the rare neuromuscular disease spinal muscular atrophy, Scholar Rock raised $300 million in a stock offering. U.S. and European regu...
Another Astellas Gene Therapy Deal, This Time $50M for Option on AviadoBio Dementia Program
Astellas secured an exclusive option to license global rights to an AviadoBio gene therapy in development as a one-time treatment for a certain type of frontotemporal dementia. A Phase 1/2 te...
Metabolic Meds Biotech Kailera Launches With $400M for Next-Generation Weight-Loss Drugs
Kailera Therapeutics licensed its portfolio of metabolic disorder drugs from Hengrui. The most advanced program has results from a Phase 2 test in China suggesting it could be competitive wit...
Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD
Dupixent, a Sanofi and Regeneron Pharmaceuticals drug, is now approved for chronic obstructive pulmonary disease (COPD), a progressive lung disease prevalent in smokers. It’s the sixth FDA-...
https://medcitynews.com/2024/09/sanofi-regeneron-copd-dupixent-fda-approval-biologic-drug/
FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades
Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety. Th...
Exercise Benefit in a Pill: BioAge Labs Goes Public, Raising More Than $200M for Clinical Trials
BioAge Labs’ lead drug candidate, azelaprag, is in Phase 2 testing in combination with Eli Lilly’s weight management medication Zepbound. The biotech’s oral drug activates a receptor it...
https://medcitynews.com/2024/09/bioage-labs-ipo-obesity-weight-loss-azelaprag-apelin-receptor-bioa/
Two Venture Investors Offer Their Takes on the State of Biotech Investing Today
The way venture capital firms invest in biotech startups has changed. Veteran VCs Chris Garabedian and Arjun Goyal offered their perspectives during a panel discussion at the World Medical In...
Real-World Data Salvage Biohaven Drug, Paving Way for FDA Filing in Neuro Disease With No Approved Meds
Biohaven’s troriluzole, which initially failed a pivotal study in spinocerebellar ataxia, is now being readied for an FDA submission in this rare neurodegenerative disease. The turnabout is...
AI-Designed Insilico Drug Flashes Signs of Efficacy in Lung Disease, But Rivals Are Still Ahead
Insilico Medicine’s idiopathic pulmonary fibrosis drug led to dose-dependent improvement in lung function in a mid-stage study. Meanwhile, Pliant Therapeutics and PureTech Health are also m...
FDA Approval Makes a Zevra Drug the First Therapy for Rare and Fatal Metabolic Disease
Zevra Therapeutics drug Miplyffa is now FDA approved for Niemann-Pick disease type C, a lysosomal storage disorder. The affirmative regulatory decision took into account additional clinical d...
Neuro Startup Nura Bio Adds $68M to Spare Axons With Its Brain-Penetrating Drug
Nura Bio aims to treat neurodegeneration with a small molecule designed to block SARM1, a novel target involved in axon degeneration. Following positive Phase 1 results in healthy volunteers,...
https://medcitynews.com/2024/09/neurodegeneration-startup-nura-bio-axon-neuroprotection-sarm1/
New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds
Eli Lilly drug Ebglyss is now FDA-approved for atopic dermatitis, an inflammatory skin disorder also known as eczema. The biologic drug came from Lilly’s $1.1 billion acquisition of Dermira...
https://medcitynews.com/2024/09/eli-lilly-eczema-atopic-dermatitis-ebglyss-lebrikizumab-lly/