OCUP

Ocuphire Announces the U.S. Commercial Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution 0.75%) by its Partner Viatris

Retrieved on: 
Monday, April 1, 2024
Viatris, Patient, OCUP

FARMINGTON HILLS, Mich., April 01, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) by its partner Viatris Inc. (NASDAQ: VTRS).

Key Points: 
  • FARMINGTON HILLS, Mich., April 01, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) by its partner Viatris Inc. (NASDAQ: VTRS).
  • Ocuphire has a global license agreement with Viatris to co-develop and commercialize Phentolamine Ophthalmic Solution 0.75%.
  • Under the terms of this agreement, Ocuphire is eligible to receive regulatory and commercial milestones as well as royalties.

Ocuphire Pharma Announces Financial Results for Fourth Quarter and Full Year 2023 and Provides Corporate Update

Retrieved on: 
Friday, March 8, 2024
OCUP, Research, Mydriasis, FDA, Protocol, PS, Presbyopia, Calendar, Diabetic retinopathy, Interim, Safety, DR, Diabetes, Patient, SPA, Security (finance), Ash, LPC, Pharmaceutical industry

In October 2023, Ocuphire held an End-of-Phase 2 meeting with the FDA and aligned on the registrational primary endpoint of 3-step or more worsening on binocular DRSS Person scale.

Key Points: 
  • In October 2023, Ocuphire held an End-of-Phase 2 meeting with the FDA and aligned on the registrational primary endpoint of 3-step or more worsening on binocular DRSS Person scale.
  • In February 2024, Ocuphire submitted a Special Protocol Assessment (“SPA”) to seek agreement on the clinical trial protocol and statistical analysis plan for Phase 3.
  • In September 2023, Ocuphire and Viatris, Inc. (“Viatris”) announced FDA approval of PS under the brand name RYZUMVI™ for the treatment of pharmacologically-induced mydriasis.
  • Financial Highlights for the Fourth Quarter and Full Year Ended December 31, 2023
    As of December 31, 2023, Ocuphire had cash and cash equivalents of approximately $50.5 million.

Ocuphire Pharma to Present in the BIO CEO & Investor Conference

Retrieved on: 
Friday, February 23, 2024
OCUP, BIO, Conference

FARMINGTON HILLS, Mich., Feb. 23, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) (“Ocuphire”), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that George Magrath, M.D.

Key Points: 
  • FARMINGTON HILLS, Mich., Feb. 23, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) (“Ocuphire”), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that George Magrath, M.D.
  • CEO of Ocuphire, will be presenting a company overview at the BIO CEO & Investor Conference being held February 26-27 2024 in New York City.
  • Company management will also be participating in one-on-one meetings throughout the conference.
  • BIO CEO & Investor Conference – February 26-27, 2024

Ocuphire Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Thursday, February 15, 2024
OCUP, Employment, Acceleration, Lease

The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.

Key Points: 
  • The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.
  • In connection with entering into employment with Ocuphire, Dr. Jayagopal, who was not a previous employee or director of Ocuphire, received an option to purchase 225,000 shares of the Company’s common stock and 75,000 restricted stock units (“RSUs”).
  • The option award has an exercise price of $2.66 per share, the closing price of Ocuphire’s common stock on February 12, 2024.
  • The option award has an exercise price of $2.66 per share, the closing price of Ocuphire’s common stock on February 12, 2024.

Ocuphire Pharma Strengthens Leadership Team with Key Appointments

Retrieved on: 
Wednesday, February 14, 2024
Opus, Drug development, University, IPO, Biomedicine, Vanderbilt University Medical Center, Biomedical engineering, Pharmacology, Genetics, American Diabetes Association, ARVO, Principal, NIH, Bank, Business development, Diabetic retinopathy, Therapy, Biomarker, Journal, Retina, Vanderbilt University, Biology, Discovery Medicine, Indiana University, OCUP, Roche, Visual impairment, Business, Diabetes, Paratriathlon, Economics, IND, Bank of America, Intelligence, FDA, Fortress Biotech, Doctor of Philosophy, Genentech, Insilico Medicine, Patient, Science, Editorial board, Citigroup, Pharmaceutical industry

FARMINGTON HILLS, Mich., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) (“Ocuphire”), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced the appointments of Ash Jayagopal, Ph.D., M.B.A. as Chief Scientific and Development Officer, and Nirav Jhaveri, C.F.A., M.B.A. as Chief Financial Officer, effective today.

Key Points: 
  • The team is now set and focused on executing our phase 3 program to turn our science into a reality for patients suffering from diabetic retinopathy, the leading cause of blindness in America.
  • I'm excited to work alongside such a talented team and together to take on significant unmet medical needs with compelling science.”
    Dr. Jayagopal added, “I am excited to join the talented Ocuphire team that has a successful track record in drug development and execution.
  • Prior to joining Ocuphire, he served as the Chief Scientific Officer of Opus Genetics.
  • In this role he had scientific and clinical leadership responsibility for Opus’ retinal gene therapy portfolio, including management of discovery, manufacturing, nonclinical development, and clinical development functions.

Ocuphire Pharma Announces Presentation on APX3330 at the Annual Angiogenesis, Exudation, and Degeneration 2024 Conference

Retrieved on: 
Monday, February 5, 2024
PDR, Conference, DRSS, Diabetes, Patient, FDA, Retina, Physician, Week, Diabetic retinopathy, Binocular, Angiogenesis, University, OCUP, Champaign–Urbana metropolitan area, Pharmaceutical industry

Dr. Sheth reviewed the current treatment paradigm for diabetic retinopathy.

Key Points: 
  • Dr. Sheth reviewed the current treatment paradigm for diabetic retinopathy.
  • The majority of patients who are diagnosed have non-proliferative diabetic retinopathy (NPDR), but there is a high likelihood of progression to proliferative diabetic retinopathy (PDR) over time.
  • APX3330 showed favorable safety and tolerability in diabetic patients that continued dosing their medications through the study durations to manage their diabetic comorbidities.
  • We look forward to advancing our oral APX3330 program.”

Ocuphire Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Wednesday, January 24, 2024
OCUP, Employment, Acceleration

FARMINGTON HILLS, Mich., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the independent members of its Board of Directors approved equity awards under Ocuphire’s 2021 Inducement Plan, as a material inducement to two new employees in connection with their employment with the Company effective on January 18, 2024.

Key Points: 
  • FARMINGTON HILLS, Mich., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the independent members of its Board of Directors approved equity awards under Ocuphire’s 2021 Inducement Plan, as a material inducement to two new employees in connection with their employment with the Company effective on January 18, 2024.
  • The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.
  • In connection with entering into employment with Ocuphire, the two individuals, who were not previous employees or directors of Ocuphire, received options to purchase an aggregate of 65,000 shares of the Company’s common stock.
  • The option awards have an exercise price of $2.77 per share, the closing price of Ocuphire’s common stock on January 18, 2024.

Ocuphire Pharma Receives FDA Agreement Under Special Protocol Assessment for LYNX-2 Phase 3 Trial of Phentolamine Ophthalmic Solution for the Treatment of Decreased Visual Acuity under Dim (mesopic) Light Conditions

Retrieved on: 
Thursday, January 4, 2024
Presbyopia, SPA, Pupil, Ciliary muscle, Food, FDA, GLARE, Night vision, Protocol, OCUP, Phentolamine, Patient, Safety, Viatris, Pharmaceutical industry

“The SPA agreement with the FDA provides a clear regulatory path for phentolamine ophthalmic solution in patients with poor night vision after keratorefractive surgery,” said George Magrath, M.D., M.B.A, M.S, CEO of Ocuphire.

Key Points: 
  • “The SPA agreement with the FDA provides a clear regulatory path for phentolamine ophthalmic solution in patients with poor night vision after keratorefractive surgery,” said George Magrath, M.D., M.B.A, M.S, CEO of Ocuphire.
  • LYNX-2 will be a multi-center, randomized, double-masked, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of phentolamine ophthalmic solution in up to 200 patients in the U.S.
  • Under the terms of the November 2022 license agreement, Viatris will fund the development of phentolamine ophthalmic solution for the treatment of decreased visual acuity under dim (mesopic) light conditions and presbyopia.
  • Ocuphire is eligible to receive a milestone payment upon FDA approvals in these indications.

Ocuphire Pharma Announces Presentation at Ophthalmology Innovation Summit (OIS) XIII

Retrieved on: 
Thursday, November 30, 2023
Diabetic retinopathy, OIS, OCUP

FARMINGTON HILLS, Mich., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the Company’s CEO, George Magrath M.D., M.B.A., M.S., will deliver a presentation at the Ophthalmology Innovation Summit (OIS XIII) , to take place in San Diego, CA on December 1-2, 2023.

Key Points: 
  • FARMINGTON HILLS, Mich., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the Company’s CEO, George Magrath M.D., M.B.A., M.S., will deliver a presentation at the Ophthalmology Innovation Summit (OIS XIII) , to take place in San Diego, CA on December 1-2, 2023.
  • Dr. Magrath will also host a conference call for the investment community on Tuesday, December 5, 2023.
  • During this call he will provide a strategic update, including the company's plans to advance APX3330 into registrational trials in diabetic retinopathy in 2024.

Ocuphire Pharma Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Monday, November 27, 2023
Employment, Acceleration, OCUP

FARMINGTON HILLS, Mich., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the independent members of its Board of Directors approved an equity award under Ocuphire’s 2021 Inducement Plan, as a material inducement to Joseph K. Schachle, the Company’s newly appointed Chief Operating Officer, in connection with his employment with the Company effective on November 27, 2023.

Key Points: 
  • FARMINGTON HILLS, Mich., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the independent members of its Board of Directors approved an equity award under Ocuphire’s 2021 Inducement Plan, as a material inducement to Joseph K. Schachle, the Company’s newly appointed Chief Operating Officer, in connection with his employment with the Company effective on November 27, 2023.
  • The equity award was approved in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.
  • In connection with his entering into employment with Ocuphire, Mr. Schachle, who was not previously an employee or director of Ocuphire, received an option to purchase 300,000 shares of the Company’s common stock.
  • The option award has an exercise price of $2.79 per share, the closing price of Ocuphire’s common stock on November 27, 2023.