BID

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

Retrieved on: 
Thursday, January 4, 2024
Cardiology, Hospital, Food, Survival, BID, Physician, FDA, EMA, MAA, Diabetes, Disease, Massachusetts General Hospital, NDA, Incidence, MD, Doctor of Philosophy, Therapy, Odds ratio, Diabetic cardiomyopathy, New Drug Application, European Medicines Agency, SGLT2, Patient, Safety, Galactosemia, Heart failure, Pharmaceutical industry

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
Receptor (biochemistry), EST, Conference, C5a, Aes, Biotechnology, BID, Cmax, MD, Conference call, PD, Food, SAD, Patient, Safety, Therapy, Atomic mass, Pharmaceutical industry

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
BID, Calendar, Cryptocurrency

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.

Agios Announces Phase 3 ENERGIZE Study of Mitapivat Met Primary Endpoint and Both Key Secondary Endpoints in Adults with Non-Transfusion-Dependent Alpha- or Beta-Thalassemia

Retrieved on: 
Wednesday, January 3, 2024
Agios Pharmaceuticals, Partnership, Thalassemia, BID, American University of Beirut, Disease, Mortality, Host, Head, Hematology, American University, Patient, AGIO, NTD, Pharmaceutical industry

CAMBRIDGE, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism and pioneering therapies for rare diseases, today announced that the global Phase 3 ENERGIZE study of mitapivat in adults with non-transfusion-dependent (NTD) alpha- or beta-thalassemia achieved its primary endpoint of hemoglobin response. Statistical significance was also achieved for both key secondary endpoints associated with change from baseline in FACIT-Fatigue Score and hemoglobin concentration.

Key Points: 
  • Statistical significance was also achieved for both key secondary endpoints associated with change from baseline in FACIT-Fatigue Score and hemoglobin concentration.
  • “The results of the Phase 3 ENERGIZE study underscore the potential of mitapivat to be a meaningful treatment option for adults with non-transfusion dependent alpha- or beta-thalassemia.
  • All subgroup analyses favored the mitapivat treatment arm compared to placebo,” said Sarah Gheuens, M.D., Ph.D., chief medical officer and head of R&D at Agios.
  • ET to review the ENERGIZE Phase 3 data and next steps for the Phase 3 ENERGIZE-T study.

Harrow Partners with Leading Healthcare Market Access Technology Platforms

Retrieved on: 
Wednesday, January 3, 2024
Biotechnology, Pharmaceutical, Optical, Medical Supplies, Health, Health Technology, Clinical Trials, Other Health, DED, EHR, SFA, BID, Physician, ECP, Telecanthus, Insurance, Patient, Penn Entertainment, PAS, Pharmaceutical industry

Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that it has partnered with three leading healthcare technology platforms to expand U.S. availability of VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed, ophthalmic solution prescription drug based on a “water-free” semifluorinated alkane (SFA) eyedrop technology.

Key Points: 
  • Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that it has partnered with three leading healthcare technology platforms to expand U.S. availability of VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed, ophthalmic solution prescription drug based on a “water-free” semifluorinated alkane (SFA) eyedrop technology.
  • Harrow’s three market access partnerships for VEVYE include:
    PhilRx is an innovative patient access platform that provides end-to-end visibility into the entire prescription life cycle, starting when the eyecare professional (ECP) writes a VEVYE prescription electronically to PhilRx directly from their electronic health record (EHR).
  • Apollo Care is a comprehensive program designed to establish and manage copay program deployment, optimizing patient access and affordability of VEVYE.
  • In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “Harrow was founded on a commitment to patient access.

Brookfield Corporation Update on Initiatives for 2023

Retrieved on: 
Friday, December 22, 2023
Brookfield Renewable Partners, BID, BPY, Acquisition, Entropy, Transition, CCS, LVMH, DBRS, NEWS, Insurance, Warburg Pincus, BCP, Growth, AEL, TSX, Barclays, Carbon, Brookfield (corporation), Champs, Canary Wharf, Financial services

BROOKFIELD, NEWS, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Brookfield Corporation (“Brookfield”) (NYSE: BN, TSX: BN) today released a summary of recent highlights to close out 2023, which is appended and posted on our website.

Key Points: 
  • BROOKFIELD, NEWS, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Brookfield Corporation (“Brookfield”) (NYSE: BN, TSX: BN) today released a summary of recent highlights to close out 2023, which is appended and posted on our website.
  • All told, almost $100 billion of financings were arranged across our businesses and access to capital continues to be very strong.
  • Our Brookfield Corporation (BN) credit rating was upgraded to A by DBRS, and on the back of the upgrade, earlier this month we issued $700 million of 10-year debt at 6.35%.
  • We all wish to take this opportunity to thank you for your interest in Brookfield, and we wish you and your families all the best for 2024.

Cara Therapeutics Announces Outcome from Dose-Finding Part A of KIND 1 Study Evaluating Oral Difelikefalin for Moderate-to-Severe Pruritus in Patients with Atopic Dermatitis

Retrieved on: 
Monday, December 18, 2023
Atopic dermatitis, Notalgia paresthetica, Itch, BID, TCS, MD, Therapy, NRS, Week, KIND, Tablet, Patient, Safety, CKD, Pharmaceutical industry

STAMFORD, Conn., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the outcome from the dose-finding Part A of the KIND 1 study evaluating the efficacy and safety of oral difelikefalin as adjunct therapy to topical corticosteroids (TCS) for moderate-to-severe pruritus in adult patients with atopic dermatitis (AD). Oral difelikefalin as adjunct to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone, resulting in the Company’s decision to discontinue its clinical program in pruritus associated with atopic dermatitis.

Key Points: 
  • Oral difelikefalin as adjunct to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone, resulting in the Company’s decision to discontinue its clinical program in pruritus associated with atopic dermatitis.
  • “We are disappointed with the outcome of this study recognizing that comparing the adjunctive use of oral difelikefalin with TCS to TCS alone represented a high clinical bar based on anticipated real-world commercial use.
  • Oral difelikefalin as adjunct therapy to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone.
  • Oral difelikefalin was generally well tolerated with a safety profile similar to prior trials.

Celestica Announces TSX Acceptance of Normal Course Issuer Bid

Retrieved on: 
Tuesday, December 12, 2023
CLS, BID, TSX, Toronto Stock Exchange, Ontario Securities Commission, Security (finance)

TORONTO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Celestica Inc. (NYSE: CLS) (TSX: CLS), a leader in design, manufacturing, hardware platform and supply chain solutions for the world's most innovative companies, today announced that the Toronto Stock Exchange (the “TSX”) has accepted the Company's notice to launch a Normal Course Issuer Bid (the “Bid”).

Key Points: 
  • TORONTO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Celestica Inc. (NYSE: CLS) (TSX: CLS), a leader in design, manufacturing, hardware platform and supply chain solutions for the world's most innovative companies, today announced that the Toronto Stock Exchange (the “TSX”) has accepted the Company's notice to launch a Normal Course Issuer Bid (the “Bid”).
  • Under the TSX rules, the average daily trading volume of the subordinate voting shares on the TSX during the six months ended November 30, 2023 was approximately 367,542 and, accordingly, daily purchases on the TSX pursuant to the Bid will be limited to 91,885 subordinate voting shares, other than purchases made pursuant to the block purchase exception.
  • The Bid will be funded using existing cash resources and draws on its credit facility, and any subordinate voting shares repurchased by the Company under the Bid will be cancelled.
  • The Company previously implemented a normal course issuer bid for its subordinate voting shares which expires on December 12, 2023.

Cogent Biosciences Announces Positive Data from Ongoing Phase 2 APEX Trial Evaluating Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

Retrieved on: 
Monday, December 11, 2023
University of Alabama, Patient, Associate, Deficit spending, Division, BID, Efficacy, Part Two, Novel, Poster, APEX, American Society of Hematology, Liver injury, PPR, KIT, Society, Stromal cell, TKI, Clinical trial, Mast cell leukemia, ASH, University, VAF, Part, Biomarker, Webcast, Safety, ASM, PEAK, GIST, MCL, Pharmaceutical industry

WALTHAM, Mass. and BOULDER, Colo., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported positive data from Part 1 of the Company’s ongoing Phase 2 APEX clinical trial evaluating bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) at the 65th American Society of Hematology (ASH 2023) Annual Meeting & Exposition taking place December 9-12, 2023 in San Diego, CA.

Key Points: 
  • “Advanced systemic mastocytosis is a serious and life-threatening disease,” said Pankit Vachhani, M.D., Associate Professor of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham.
  • Patients were enrolled with the following sub-types: seven patients with aggressive systemic mastocytosis (ASM), 23 patients with systemic mastocytosis with associated hematologic neoplasm (SM-AHN), and two patients with mast cell leukemia (MCL).
  • In addition, Cogent plans to present data from the completed SUMMIT Part 1 trial (1a and 1b) in the first quarter of 2024.
  • ET (5:00 a.m. PT) to discuss today’s APEX data and the SUMMIT data in NonAdvSM released on December 9.

Tarsus Announces Positive Topline Results from the Ersa Phase 2a Clinical Trial Evaluating TP-03 for the Treatment of Meibomian Gland Disease in Patients with Demodex Mites

Retrieved on: 
Monday, December 11, 2023
Science, Food, BID, TID, Disease, Meibomian gland, TARS, Demodex, MGD, Patient, Pharmaceutical industry

Collarette cure and lid margin erythema cure results were also statistically significant and consistent with the results of previous TP-03 studies.

Key Points: 
  • Collarette cure and lid margin erythema cure results were also statistically significant and consistent with the results of previous TP-03 studies.
  • No statistically significant differences were observed between the BID and TID treatment arms and TP-03 was well tolerated.
  • “We are encouraged by these early results, which underscore the potential of TP-03 to address the underlying cause of disease,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus.
  • “We look forward to further analyzing the data from this trial and continued discussions with the U.S. Food and Drug Administration about the best path forward for TP-03 in MGD.”