Market News & Trends
Aptinyx Exploratory Clinical Studies Provide First Evidence that NYX-2925 Elicits Rapid, Persistent, NMDAr-Mediated Pharmacodynamic Activity in Humans
Aptinyx Inc. recently announced that exploratory clinical studies of its novel NMDA receptor (NMDAr) modulator, NYX-2925, provide the first evidence that oral dosing of the…
Commercial Prospects for Immuno-Oncology Development Across Oncology Indications in Untapped Cancer Types or in Combinations
Immuno-Oncology (IO) development is booming across the 8MM (US, France, Germany, Italy, Spain, UK, Japan, and China) with IO agents being investigated in most cancer…
Catalent to Open Second Clinical Supply Facility; Enables Broader Integrated Solutions for Global & Local Customers
Catalent Pharma Solutions recently announced its plans to invest $2.5 million in a new, second clinical supply facility in Shanghai, China, due to open in early 2019. When completed, the facility is expected to employ 100 people and will double Catalent’s total clinical storage capacity in China.
PCI Clinical Services Announces Site Expansion to Support Growth & Flexibility
PCI Pharma Services, a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, recently announced the expansion of its Clinical site at Rockford, IL.
Enable Injections Enters Strategic Partnerships With UCB & Apellis
Enable Injections, Inc., a patient-centric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of high-volume therapeutics, recently announced it has entered into development agreements with Apellis Pharmaceuticals, and most recently, UCB.
Organovo Partners With IIAM on Multi-Year Clinical Biomaterial Sourcing Agreement
Organovo Holdings, Inc. recently announced it has entered into a cell and tissue clinical sourcing agreement with the International Institute for the Advancement of Medicine (IIAM).
Nkarta Therapeutics Reports Potent Natural Killer Cell Anti-Cancer Activity in Preclinical Tumor Model
Nkarta Therapeutics recently announced preclinical data highlighting the anti-cancer activity of engineered NK cells in a presentation at the Society of Immunotherapy for Cancer meeting…
Alligator Bioscience & Aptevo Therapeutics Present New Preclinical Data
Alligator Bioscience and Aptevo Therapeutics Inc. recently announced new preclinical data for ALG.APV-527 at the Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting being…
Moleculin Announces New Independent Study Expands Potential Use of Its Pancreatic Drug Candidate
Moleculin Biotech, Inc. recently announced that a new mechanism of action may have been uncovered expanding the potential use of its inhibitor of glycolysis, WP1122.…
Entera Bio Reports Positive Results from Part 1 of a Phase 2 PK/PD Study
Entera Bio Ltd. recently announced it has received positive results from the first part of its pharmacokinetic (PK) and pharmacodynamic (PD) study in patients with…
Intensity Therapeutics Highlights Data in Advanced Solid Tumors
Intensity Therapeutics, Inc. recently announced additional data from a Phase 1/2 clinical study of INT230-6, the company’s novel lead product candidate designed for direct intratumoral injection,…
Codexis Announces Results of Phase 1a Clinical Trial
Codexis, Inc. recently announced top-line results from its Phase 1a single ascending-dose study in healthy volunteers with CDX-6114, its orally administered enzyme candidate for the…
Enable Injections’ First Closing of Series B Round to Include New Investor
Enable Injections, Inc. recently announced it has completed a first closing of a Series B round that will raise up to $50 million, led by…
Esperion Announces Completion of Phase 3 LDL-C Lowering Development Program
Esperion recently announced completion of the Phase 3 LDL-C Lowering Development Program of bempedoic acid and positive cumulative results. The program consisted of four, pivotal,…
ProQR In-licenses Worldwide Rights to Ophthalmology Drug Candidate From Ionis Pharmaceuticals
ProQR Therapeutics N.V. recently announced the signing of an agreement with Ionis Pharmaceuticals to license QR-1123 (formerly IONIS-RHO-2.5Rx), an RNA medicine for autosomal dominant retinitis…
Athenex Announces FDA Allowance of Investigational New Drug Application
Athenex, Inc. recently announced the FDA has allowed the Investigational New Drug (IND) application for Athenex's oral version of Eribulin currently named Eribulin ORA. This…
TESARO Announces $18-Million Milestone Payments
TESARO, Inc. recently announced the achievement of development milestones that trigger an $18-million payment from Janssen Biotech Inc. The milestones are related to Janssen’s ongoing…
Acer Therapeutics Submits NDA for EDSIVO; Requests Priority Review
Acer Therapeutics Inc. recently announced it has submitted a New Drug Application (NDA) to the US FDA for EDSIVO for the treatment of vascular Ehlers-Danlos…
Verona Pharma Completes Enrollment in Phase 2 Clinical Trial
Verona Pharma plc recently announced it has enrolled the last patient in its Phase 2 clinical trial evaluating the effect of nebulized RPL554 as an add-on to dual therapy using long-acting anti-muscarinic/long-acting beta2-agonists (LAMA/LABA) and triple therapy (LAMA/LABA with an inhaled corticosteroid) in the maintenance treatment of patients with moderate to severe COPD.
Sanofi & Denali Therapeutics to Develop Multiple Molecules; $125 Million Upfront
Sanofi plans to collaborate with Denali Therapeutics Inc. on the development of multiple molecules with the potential to treat a range of neurological and systemic inflammatory diseases.
