BID

Aclaris Therapeutics Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis

Retrieved on: 
Wednesday, January 10, 2024

WAYNE, Pa., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced top-line results from its Phase 2b study of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis (AD) (ATI-1777-AD-202; NCT05432596). ATI-1777 was generated from Aclaris’ proprietary KINect® drug discovery platform.

Key Points: 
  • For this trial, ATI-1777 was developed as an emollient-containing spray formulation.
  • The trial randomized 250 patients with mild, moderate or severe AD, including adults and children as young as 12 years old, across 30 clinical trial sites in the United States.
  • “The trial demonstrated efficacy results, a pharmacokinetic profile and safety results that were consistent with what was seen in the Phase 2a trial of ATI-1777,” stated Dr. Neal Walker, Aclaris’ Chairman of the Board of Directors.
  • These results are particularly encouraging given the higher than anticipated vehicle response and the mid-study inclusion of a milder patient population.

Harrow Announces Availability of VEVYE® (Cyclosporine Ophthalmic Solution) 0.1%, the First and Only Cyclosporine-Based Product Indicated for Treating Both Signs and Symptoms of Dry Eye Disease

Retrieved on: 
Thursday, January 11, 2024

VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED).

Key Points: 
  • VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED).
  • In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We are thrilled to announce the availability of VEVYE for our customers and their patients.
  • VEVYE is powered by the unique combination of the reliable and trusted active ingredient, cyclosporine, and a water-free semifluorinated alkane delivery vehicle, perfluorobutylpentane.
  • In addition, 92% of this patient population remains un- or under-treated due to limited efficacy and poor tolerability of existing prescription and non-prescription choices.4

GOLDEN HAIKU POETRY COMPETITION MARKS 11th YEAR OF BRINGING POEMS & CREATIVITY DOWNTOWN

Retrieved on: 
Tuesday, January 9, 2024

WASHINGTON, Jan. 9, 2024 /PRNewswire/ -- The Golden Triangle Business Improvement District (BID) today announced the opening of its highly anticipated Golden Haiku poetry competition. Poets of all ages from DC and around the world may submit original haiku until Feb. 4 at 11:59 p.m. ET.

Key Points: 
  • WASHINGTON, Jan. 9, 2024 /PRNewswire/ -- The Golden Triangle Business Improvement District (BID) today announced the opening of its highly anticipated Golden Haiku poetry competition .
  • "Golden Haiku is one of the ways we welcome spring to DC," said Leona Agouridis, President of the Golden Triangle BID.
  • Golden Haiku follows the Haiku Society of America's guidelines for modern haiku, which does not require the traditional 5-7-5 structure.
  • Submissions for the 2024 Golden Haiku poetry competition will be accepted through Feb. 4, 2024.

Atea Pharmaceuticals Announces Positive Initial Data from Phase 2 Study for Hepatitis C Virus (HCV) and Significant Enrollment Milestone for Phase 3 SUNRISE-3 Trial for COVID-19

Retrieved on: 
Monday, January 8, 2024

BOSTON, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the achievement of two significant clinical milestones from its Hepatitis C Virus (HCV) and COVID-19 programs. The Company reported positive initial data from the first 52 patients in the lead-in cohort of its Phase 2 combination 8-week study of bemnifosbuvir and ruzasvir (RZR) for the treatment of HCV. Additionally, Atea has enrolled more than 650 patients in the monotherapy arm of its Phase 3 SUNRISE-3 trial for the treatment of COVID-19, and enrollment continues with the current wave. This enrollment milestone allows for the first interim analysis of the study by the DSMB, which is expected this March.

Key Points: 
  • This enrollment milestone allows for the first interim analysis of the study by the DSMB, which is expected this March.
  • “We are excited to share that the initial data from the Phase 2 combination 8-week study showed a 98% SVR4, which exceeds our efficacy criterion of >90% for continuing the study.
  • Preliminary data are being presented as available, with SVR4 data currently available from 52 of the 60 lead-in patients.
  • The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the monotherapy arm in 2,200 patients.

Incyte Highlights Growth Opportunities and Provides Business Updates at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024

Incyte (Nasdaq:INCY) will highlight growth opportunities and provide key updates across its investigational pipeline and commercial portfolio during a presentation today at 7:30 a.m. PT at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco.

Key Points: 
  • Incyte (Nasdaq:INCY) will highlight growth opportunities and provide key updates across its investigational pipeline and commercial portfolio during a presentation today at 7:30 a.m. PT at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco.
  • The overall safety profile of ruxolitinib cream is consistent with previous data, and no new safety signals were observed.
  • The Company intends to provide additional financial guidance and updates on key clinical programs during its 2023 fourth quarter and year-end earnings conference call.
  • The J.P. Morgan Healthcare Conference presentation and Q&A session can be accessed at investor.incyte.com .

OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Both Sign and Symptom Endpoints in its First-in-Human Phase 2 Trial of OK-101 in Patients with Dry Eye Disease

Retrieved on: 
Monday, January 8, 2024

This first-in-human trial of OK-101 established a clear and informed path for further development in Phase 3 registration trials.

Key Points: 
  • This first-in-human trial of OK-101 established a clear and informed path for further development in Phase 3 registration trials.
  • The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with DED dosed twice-daily (BID).
  • OK-101 First-In-Human trial establishes a clear clinical path for further clinical development in a Phase 3 study design using FDA recognized endpoints per the Dry Eye: Developing Drugs for Treatment Guidance for Industry.
  • A statistically significant improvement in blurred vision was also achieved at Day 29 (p = 0.01).

CN Energy Group. Inc. Announces Nasdaq Delisting Notification and Intends to Appeal

Retrieved on: 
Friday, January 5, 2024

Inc. (NASDAQ: CNEY) (the "Company"), a high-tech enterprise specializing in cogeneration of high-quality wood-activated carbon and clean energy, today announced that it received a letter from the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") on December 29, 2023.

Key Points: 
  • Inc. (NASDAQ: CNEY) (the "Company"), a high-tech enterprise specializing in cogeneration of high-quality wood-activated carbon and clean energy, today announced that it received a letter from the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") on December 29, 2023.
  • As previously disclosed, the Company received a deficiency letter from the Staff on January 13, 2023, indicating non-compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) (the "Bid Price Rule") for continued listing on Nasdaq.
  • On July 13, 2023, Nasdaq granted the Company an additional 180-day period, ending on January 8, 2024, to regain compliance with the Bid Price Rule.
  • There can be no assurance as to the success or outcome of the appeal.

Applied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy

Retrieved on: 
Thursday, January 4, 2024

NEW YORK, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the topline results of the ARISE-HF Phase 3 trial of AT-001 (caficrestat) in patients with Diabetic Cardiomyopathy (DbCM) at high risk of progression to overt heart failure.  

Key Points: 
  • While a trend favored active treatment, the difference between active and placebo treated groups (0.30 ml/kg/min) was not statistically significant (p=0.210).
  • The ARISE-HF study evaluated the treatment effect of AT-001 as an add-on to diabetes standard of care therapies.
  • Approximately 38% of study subjects were on SGLT2 or GLP-1 therapies for treatment of diabetes, while 62% were not.
  • Full study results will be presented at an upcoming medical conference, along with results of the Diabetic Peripheral Neuropathy sub-study, which are still being analyzed.

InflaRx Announces Positive Topline Results from the Multiple Ascending Dose (MAD) Phase I Study with C5aR Inhibitor INF904

Retrieved on: 
Thursday, January 4, 2024

INF904 was well tolerated and there were no adverse safety events of concern after repeated dosing in participants over the entire tested dose range.

Key Points: 
  • INF904 was well tolerated and there were no adverse safety events of concern after repeated dosing in participants over the entire tested dose range.
  • “We are very pleased that the MAD part of the Phase I study exceeded the already compelling results from the SAD part of the study.
  • InflaRx currently plans to initiate a short-term dosing Phase II study towards the end of 2024, followed by a longer-term dosing Phase II study in 2025.
  • A replay will be available on the InflaRx website in the Investors – Events & Presentations section after the live conference call has concluded.

Entera Bio Receives Extension from Nasdaq to Regain Compliance with Minimum Bid Price Rule

Retrieved on: 
Wednesday, January 3, 2024

JERUSALEM, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, announced that, on December 27, 2023, it received an extension of 180 calendar days from the Nasdaq Stock Market LLC (“Nasdaq”) to regain compliance with the Nasdaq’s minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market (the “Bid Price Requirement”).

Key Points: 
  • JERUSALEM, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, announced that, on December 27, 2023, it received an extension of 180 calendar days from the Nasdaq Stock Market LLC (“Nasdaq”) to regain compliance with the Nasdaq’s minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market (the “Bid Price Requirement”).
  • As a result of the extension, the Company has until June 24, 2024 to regain compliance with the Bid Price Requirement.
  • To regain compliance, the closing bid price of the Company’s ordinary shares must be at least $1.00 for at least 10 consecutive business days (with such compliance period extendable at the discretion of Nasdaq) prior to June 24, 2024.
  • If the Company does not regain compliance with the Bid Price Requirement by June 24, 2024, Nasdaq will provide written notification to the Company that its shares will be subject to delisting.