RHO

Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU400—Modifier Gene Therapy for Broad Retinitis Pigmentosa Indication

Retrieved on: 
수요일, 4월 10, 2024
FDA, RP, Retinitis pigmentosa, Safety, Marketing, MAA, CHMP, Vaccine, U.S. FDA, Arm, IND, Patient, EMA, Committee, RHO, BLA, Clinical trial, Leber congenital amaurosis, European Medicines Agency

EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study.

Key Points: 
  • EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study.
  • In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 1010 vg/eye of OCU400) and untreated control group, respectively.
  • The positive scientific advice from EMA is in alignment with U.S. FDA clearance of the IND amendment to initiate the Phase 3 liMeliGhT clinical trial of OCU400.
  • OCU400 is the first gene therapy to enter Phase 3 with a broad RP indication.

Actor Glen Powell Kicks Off Next Chapter of the Ram Truck Brand With the Launch of All-new 2025 Ram 1500 RHO as Part of the Full Lineup of Off-road Trucks

Retrieved on: 
목요일, 4월 25, 2024
Dodge Power Wagon, J.D. Power, Perseverance, The Calling, Rebel, Ram pickup, Human, Top Gun: Maverick, STLA, RHO, Ram Trucks, Convoy, Doner, Video game

"Ram only does trucks and that focus, passion and dedication is the foundation of every product that we bring to market," said Tim Kuniskis, Ram brand CEO – Stellantis.

Key Points: 
  • "Ram only does trucks and that focus, passion and dedication is the foundation of every product that we bring to market," said Tim Kuniskis, Ram brand CEO – Stellantis.
  • Powell arrived as the new talent of the Ram Truck brand in early April, lending his voice in the cross-channel campaign for the new 2025 Ram 1500, " The Calling ."
  • We put our everything into every truck, so that when you find your calling, nothing can stop you from answering."
  • In 2009, the Ram Truck brand launched as a stand-alone division, focused on meeting the demands of truck buyers and delivering benchmark-quality vehicles.

Ram Announces New Off-road Truck Lineup With Benchmark Light- and Heavy-duty Offerings

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목요일, 4월 25, 2024
Diamond, MeadWestvaco, HEMI, Calibration, Lane departure warning system, Code, Sand, Control, Negotiation, SRT-10, Torque, HDMI, Traction, Snow, Ram pickup, Attention, LED, SST, Equipment, Navigation, V-8, Safety, J.D. Power, Travel, V-6, HUD, Engineering, STLA, VCT, Capability, Sale, WARN, Dodge Power Wagon, World War II, Dodge, Red Express, Ram Rebel TRX, Chrysler Pentastar engine, RHO, TorqueFlite, Ram Trucks, TRX, Heavy equipment

The most off-road models Ram has offered spans both the light- and heavy-duty lineup, including the all-new 2025 Ram 1500 RHO, 2025 Ram 1500 Rebel, 2025 Ram 1500 Warlock, 2024 Ram 2500 Power Wagon and 2024 Ram 2500 Heavy Duty Rebel.

Key Points: 
  • The most off-road models Ram has offered spans both the light- and heavy-duty lineup, including the all-new 2025 Ram 1500 RHO, 2025 Ram 1500 Rebel, 2025 Ram 1500 Warlock, 2024 Ram 2500 Power Wagon and 2024 Ram 2500 Heavy Duty Rebel.
  • Leading off for the new off-road truck lineup, the new 2025 Ram 1500 Rebel and 2025 Ram 1500 Warlock, as well as the 2024 Ram 2500 Power Wagon and 2024 Ram 2500 Heavy Duty Rebel, are available now.
  • The entire Ram lineup offers customers benchmark vehicles that get the hard work done and families where they need to go.
  • Ram is committed to innovation and powertrain leadership with a lineup that consists of anything and everything truck buyers want and need.

All-new 2025 Ram 1500 RHO Offers Best Value, Fortifies Industry's Leading Light-duty Lineup

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목요일, 4월 25, 2024
Bilstein, Water, Corrosion, HVAC, Snow, Composite, SRT-10, Massage, Torque, HDMI, Traction, Ram pickup, Steel, LED, Aluminium, SST, Flare, V-8, J.D. Power, Travel, HUD, Tropical cyclone, Graphite, STLA, Music, Harman Kardon, Agility, Weather, Red Express, Level 2, BorgWarner, RHO, Dana 60, Ram Trucks

As part of Ram's Core/Electric/Sport approach, Ram 1500 RHO expands the Sport light-duty lineup that already consists of Warlock and Rebel.

Key Points: 
  • As part of Ram's Core/Electric/Sport approach, Ram 1500 RHO expands the Sport light-duty lineup that already consists of Warlock and Rebel.
  • RHO features a new exhaust system that is different than the rest of the Ram 1500 lineup.
  • The Ram 1500 RHO offers more than 40% additional rear wheel travel when compared to the rest of the Ram 1500 lineup.
  • Ram 1500 RHO features box outers made of steel and are wider than that of a traditional Ram 1500.

Ocugen, Inc. Announces U.S. FDA Clearance of IND Amendment to Initiate OCU400 Phase 3 Clinical Trial — First Gene Therapy to Enter Phase 3 with a Broad Retinitis Pigmentosa Indication

Retrieved on: 
월요일, 4월 8, 2024
Arm, Retinitis pigmentosa, Disease, Patient, Lux, RP, IND, Clutch (eggs), Vaccine, Food, RHO, FDA, BLA, Pharmaceutical industry

“OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.

Key Points: 
  • “OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.
  • Until now, there has been only one marketed product to treat one of the 100 gene mutations associated with RP.
  • In the Phase 1/2 OCU400 clinical trial, a Multi-Luminance Mobility Testing (MLMT) scale was the primary functional endpoint.
  • With the initiation of the Phase 3 clinical trial, OCU400 remains on track for the 2026 BLA approval target.

Ocugen Provides Business Update with Certain Financials for the Year Ending 2023

Retrieved on: 
화요일, 4월 2, 2024
Stargardt disease, Disease, Safety, Webcast, Inflammation, Patient, CGMP, Data, Inhalation, Cohort, RP, Life, Bank statement, Investment, Clinical trial, NIAID, Injection, AMD, Vaccine, Nextgen, Geographic atrophy, RHO, FDA, Lipid metabolism, Government, Oxidative stress, Pharmaceutical industry

Completed Cohort 1 dosing for OCU410 and OCU410ST gene therapy clinical studies for geographic atrophy (GA) and Stargardt disease, respectively

Key Points: 
  • Completed Cohort 1 dosing for OCU410 and OCU410ST gene therapy clinical studies for geographic atrophy (GA) and Stargardt disease, respectively
    MALVERN, Pa., April 02, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today provided a general business update with certain financials for the year ending 2023.
  • During the fourth quarter of 2023, the Company announced its mucosal vaccine candidate, OCU500, was chosen for the multi-billion-dollar NIAID Project NextGen initiative.
  • The first patient was dosed in the Phase 1/2 trials to assess the safety and efficacy of OCU410ST for Stargardt disease in November 2023.
  • Ocugen’s cash, cash equivalents, and investments totaled $39.5 million as of December 31, 2023, compared to $90.9 million as of December 31, 2022.

Avicanna Announces the Canadian Launch of 10% CBD (THC Free) Proprietary Formulation

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수요일, 3월 27, 2024
Cannabinoid, Absorption, Dravet syndrome, Seizure, Lennox–Gastaut syndrome, Patient, Research, CBD, Health Canada, TSX, THC, Plasma protein binding, RHO

TORONTO, March 27, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the launch of RHO Phyto Micro Drop 100, a 10% CBD (THC free), proprietary oral formulation in Canada. RHO Phyto Micro Drop 100, is designed to deliver enhanced absorption of cannabinoids through an inverted emulsion technology. RHO Phyto Micro Drop 100 will be available to Canadian patients with medical authorization exclusively at the MyMedi.ca medical cannabis care platform.

Key Points: 
  • TORONTO, March 27, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the launch of RHO Phyto Micro Drop 100, a 10% CBD (THC free), proprietary oral formulation in Canada.
  • RHO Phyto Micro Drop 100, is designed to deliver enhanced absorption of cannabinoids through an inverted emulsion technology.
  • RHO Phyto Micro Drop 100 will be available to Canadian patients with medical authorization exclusively at the MyMedi.ca medical cannabis care platform.
  • RHO Phyto Micro Drop 100 contains the same proprietary oral formulation as the product Trunerox™.

argenx Advances Clinical Development of Efgartigimod in Primary Sjogren’s Disease

Retrieved on: 
수요일, 3월 27, 2024
Disease, Patient, Biomarker, STAR, Euronext, Woman, EULAR, Safety, Composite, Immunoglobulin G, RHO, Serology

“We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.

Key Points: 
  • “We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.
  • “Consistent with our indication selection strategy, we confirmed our IgG biology hypothesis with these data, and now have a demonstrated clinical effect across multiple efficacy scales to support proof-of-concept.
  • Sjogren’s disease can be debilitating, predominantly affects women, and given its heterogeneous nature, is often misdiagnosed with its symptoms poorly understood.
  • Efficacy assessments showed a treatment effect across multiple clinical endpoints, which were also consistent with biomarker data.

Prime Medicine Reports Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
금요일, 3월 1, 2024
Sequence, Composition, Liver, RHO, Immunotherapy, Investment, FDA, Research and development, HSC, Food, CGD, Patent, SCIP, Lung, Ataxia, Cystic Fibrosis Foundation, Hematology, Administration, Patient, Target, IND, AAV, CTA, Pharmaceutical industry

CAMBRIDGE, Mass., March 01, 2024 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the full year ended December 31, 2023 and provided a business update.

Key Points: 
  • “In 2024, we anticipate undergoing a significant transformation, maturing into a clinical-stage company and bringing the first-ever Prime Editing-based therapeutic candidate to patients.
  • This funding will allow Prime Medicine to progress two distinct strategies for applying Prime Editing to treat CF: hotspot editing and PASSIGE™ (Prime Assisted Site Specific Integrase Gene Editing).
  • Gross proceeds to Prime Medicine from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $161.0 million.
  • In January 2024, Prime Medicine announced the appointment of Allan Reine, M.D., as the Company’s Chief Financial Officer.

Ocugen Clinical Showcase Webcast Now Available

Retrieved on: 
수요일, 2월 28, 2024
Retinitis pigmentosa, RHO, Vaccine, University, Faculty, Event, Associate, Harvard Medical School, Mutation, Communication

MALVERN, Pa., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Clinical Showcase webcast from the February 21, 2024 live event is now available in the Events & Presentations section of the Ocugen website.

Key Points: 
  • MALVERN, Pa., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Clinical Showcase webcast from the February 21, 2024 live event is now available in the Events & Presentations section of the Ocugen website.
  • The showcase replay includes more detail on the Phase 3 study design for OCU400, as well as market potential for this first-in-class product candidate.
  • The panel discussion offers first-hand experience from an OCU400 Phase 1/2 clinical trial patient with the RHO mutation who has completed 12 months of therapy and lead investigator, Dr. Byron Lam, Professor of Ophthalmology, Mark J.
  • Please direct any questions related to the webcast to Tiffany Hamilton, Head of Communications, at [email protected] .