Phase 3

CEO Spotlight: Acurx Pharmaceuticals in Focus with CEO David Luci Talking Potentially Transformative Phase 2b Trial, Pipeline, and Potential Near-Term Catalysts

Monday, September 13, 2021 - 2:48pm

Acurx Pharmaceutical's CEO tells Soulstring Media why he thinks 2021-22 can be a breakout year for his company

Key Points: 
  • Rather than speculate on each drug's market potential, HPM reached out to Mr. David Luci, CEO of Acurx, allowing him to respond to investor questions.
  • Acurx is outside that mold because we have a new class of antibiotics treating life-threatening infections with two in the class.
  • Our scientific team has indicated publicly that these data portend future success in Phase 2b and Phase 3.
  • Q: The Phase 2b trial can be transformative to Acurx, especially if data proves superior to standard of care Vancomycin in the imminent head-to-head match-up.

CEO Spotlight: Acurx Pharmaceuticals in Focus with CEO David Luci Talking Potentially Transformative Phase 2b Trial, Pipeline, and Potential Near-Term Catalysts

Monday, September 13, 2021 - 1:03pm

Acurx Pharmaceutical's CEO tells Soulstring Media why he thinks 2021-22 can be a breakout year for his company

Key Points: 
  • Rather than speculate on each drug's market potential, HPM reached out to Mr. David Luci, CEO of Acurx, allowing him to respond to investor questions.
  • Acurx is outside that mold because we have a new class of antibiotics treating life-threatening infections with two in the class.
  • Our scientific team has indicated publicly that these data portend future success in Phase 2b and Phase 3.
  • Q: The Phase 2b trial can be transformative to Acurx, especially if data proves superior to standard of care Vancomycin in the imminent head-to-head match-up.

Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2021 Financial Results

Monday, August 9, 2021 - 1:00pm

ET

Key Points: 
  • ET
    DUBLIN, Ireland, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, today provided a corporate update and announced its financial results for the second quarter ended June 30, 2021.
  • R&D expenses were $6.8 million in the quarter ended June 30, 2021, compared to $4.1 million for the same period in 2020.
  • SG&A expenses were $15.2 million in the quarter ended June 30, 2021, compared to $7.1 million for the same period in 2020.
  • These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events.

Opthea Expands Global Phase 3 ShORe and COAST Wet AMD Trials of OPT-302 into Canada

Monday, August 9, 2021 - 12:00pm

Following formal authorization from the regulatory agency Health Canada, patient enrollment in the two concurrent Phase 3 registrational clinical trials, ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study) can now begin in Canada.

Key Points: 
  • Following formal authorization from the regulatory agency Health Canada, patient enrollment in the two concurrent Phase 3 registrational clinical trials, ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study) can now begin in Canada.
  • The goal of the two studies is to evaluate the benefits of the Companys VEGF-C/D trap inhibitor, OPT-302, for wet AMD in treatment-nave patients.
  • We believe that OPT-302, if successful in Phase 3 and approved, has the potential to improve the trajectory of wet AMD disease progression.
  • Therefore, we are working with regulatory authorities worldwide to initiate the Phase 3 registrational clinical trials as quickly as possible in other countries.

Global Clinical Trials Market Analysis Report 2021-2028 by Phase (Phase I, Phase II, Phase III, Phase IV), Study Design (Interventional, Observational, Expanded Access), Indication - ResearchAndMarkets.com

Thursday, June 3, 2021 - 3:50pm

The "Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Study Design (Interventional, Observational, Expanded Access), by Indication, by Region, and Segment Forecasts, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Study Design (Interventional, Observational, Expanded Access), by Indication, by Region, and Segment Forecasts, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.
  • The global clinical trials market size is expected to reach USD 69.5 billion by 2028.
  • Also, clinical studies have become increasingly costly ventures, adding to the overall cost of developing a drug.
  • Out of this, nearly 7.0% of therapeutics are in Phase IV, 21.0% in Phase III, 43.0% & 13.0% in Phase II & Phase I respectively.

RegeneRx Joint Venture Reports Positive Results from ARISE-3 Clinical Trial Using RGN-259 to Treat Dry Eye Syndrome

Friday, May 14, 2021 - 1:30pm

Thus far, ReGenTree has sponsored three Phase 3 studies in the U.S. for dry eye, which are ARISE-1 (Phase 2b/3), ARISE-2 (Phase 3), and the recently completed ARISE-3 (Phase 3) for dry eye.

Key Points: 
  • Thus far, ReGenTree has sponsored three Phase 3 studies in the U.S. for dry eye, which are ARISE-1 (Phase 2b/3), ARISE-2 (Phase 3), and the recently completed ARISE-3 (Phase 3) for dry eye.
  • In addition to dry eye, the Company completed a Phase 3 study (SEER-1) for neurotrophic keratopathy (NK), an orphan indication in ophthalmology.
  • Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.
  • Moreover, there is no guarantee any clinical trial will be successful or confirm previous clinical results.

Madrigal Pharmaceuticals Announces Completion of Enrollment in Phase 3 MAESTRO NAFLD-1 Trial and Reports 2020 Third Quarter Financial Results and Highlights

Thursday, November 5, 2020 - 11:50am

The Company also announced its third quarter 2020 financial results and highlights.

Key Points: 
  • The Company also announced its third quarter 2020 financial results and highlights.
  • We believe this trial will also provide an even more robust safety data base for our Phase 3 NASH program.
  • The increases are primarily attributable to additional activities related to the Phase 3 clinical trials initiated in 2019, and an increase in head count.
  • Undue reliance should not be placed on forward- looking statements, which speak only as of the date they are made.

First Patient Randomized in the Phase 3 DISSOLVE Clinical Program of SEL-212 for Chronic Refractory Gout

Wednesday, September 23, 2020 - 12:00pm

We are pleased to have commenced the phase 3 DISSOLVE program evaluating SEL-212 in two phase 3 double-blind, placebo-controlled studies, said Carsten Brunn, Ph.D., President and CEO of Selecta.

Key Points: 
  • We are pleased to have commenced the phase 3 DISSOLVE program evaluating SEL-212 in two phase 3 double-blind, placebo-controlled studies, said Carsten Brunn, Ph.D., President and CEO of Selecta.
  • The phase 3 program for SEL-212 is being run by Selecta and funded by Sobi.
  • Topline data from the Phase 3 clinical program is expected in the second half of 2022.
  • Selecta recently licensed its Phase 3 clinical program in chronic refractory gout to Sobi.

Clinical Trials Market Size, Share & Trends Analysis Report by Phase, by Study Design, by Indication and Segment Forecasts 2020-2027 - ResearchAndMarkets.com

Tuesday, July 28, 2020 - 1:14pm

The "Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Study Design (Interventional, Observational, Expanded Access), by Indication and Segment Forecasts, 2020 - 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Study Design (Interventional, Observational, Expanded Access), by Indication and Segment Forecasts, 2020 - 2027" report has been added to ResearchAndMarkets.com's offering.
  • The global clinical trials market size is expected to reach USD 69.9 billion by 2027.
  • Also, clinical trials have become increasingly costly ventures, adding to the overall cost of developing a drug.
  • Phase III clinical trials dominated the market with a revenue share of 53.0% in 2019.