BID

BioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501 (sublingual dexmedetomidine) for Potential Treatment of Opioid Use Disorder (OUD)

Retrieved on: 
Monday, November 6, 2023
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NEW HAVEN, Conn., Nov. 06, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced an update on the National Institute on Drug Abuse (NIDA)-funded trial evaluating BXCL501 (sublingual dexmedetomidine) as a potential treatment for opioid use disorder (OUD).

Key Points: 
  • NIDA has requested Columbia University, the trial coordinator, to add a fourth site to target trial completion in 2024.
  • After this time, BioXcel Therapeutics plans to seek FDA feedback on potential registrational paths.
  • “With BXCL501, we are excited about the potential to treat patients who are physically dependent on illicit and prescription opioids.
  • In addition to OUD as an indication, BioXcel Therapeutics has been awarded key opportunities for the development of BXCL501 in post-traumatic stress disorder and alcohol use disorder.

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

Retrieved on: 
Thursday, November 2, 2023
Trae tha Truth, ECOG, Vomiting, CYP3A4, WT, Abstract, NPM1, KMT2A, OBD, PK, DLT, TKD, Cancer, Diabetes, ORR, Clinical study design, Safety, Patient, Cohort, HSCT, SETBP1, CR, DSM-IV codes, NUP214, DOR, Dicarboxylic acid, CRi, ASH, CD135, QT interval, RFS, FLT3, Arm, Cellular, FMS, Transplant, ALL, Toxic leukoencephalopathy, Gene family, Survival, Postcholecystectomy syndrome, DS, Trial of the century, Incidence, CRC, Infrared spectroscopy correlation table, AL, Osteopathic medicine in Canada, MN1, BID, CNS, KRAS, ATD, NUP98, Society, WBC, Pharmacokinetics, CLL, Acute leukemia, Common, ITD, Toxicity, AML, Cardiovascular disease, Pharmaceutical industry, Dentistry, Vaccine, Decitabine, DLBCL

Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.

Brookfield Raises Record $6 Billion For Global Infrastructure Debt Investments

Retrieved on: 
Thursday, November 2, 2023
Partner (business rank), Nature, NEWS, Investment, BID, III, Fund, Bank

BROOKFIELD, NEWS, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Brookfield Asset Management (“Brookfield”) announced today the closing of its global infrastructure debt program, Brookfield Infrastructure Debt Fund III (“BID III” or the “Fund”).

Key Points: 
  • BROOKFIELD, NEWS, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Brookfield Asset Management (“Brookfield”) announced today the closing of its global infrastructure debt program, Brookfield Infrastructure Debt Fund III (“BID III” or the “Fund”).
  • With capital commitments exceeding $6 billion, including over $400 million in discretionary co-investment capital, BID III is the world’s largest private infrastructure debt fund.
  • Brookfield has committed $600 million to the Fund, underscoring the firm’s alignment of interests with other investors.
  • BID III has already deployed over 50% of its commitments, having made investments across its core infrastructure sectors, including the renewable power and data infrastructure sectors.

Gran Tierra Energy Inc. Announces Normal Course Issuer Bid and Automatic Share Purchase Plan

Retrieved on: 
Tuesday, October 31, 2023
Gran Tierra Energy, CDN, NYSE, GTE, Toronto Stock Exchange, LSE, NYSE American, Calendar, TSX, BID, Security (finance), Auction, Share (finance)

CALGARY, Alberta, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Gran Tierra Energy Inc. (“Gran Tierra”) (NYSE American: GTE)(TSX: GTE)(LSE: GTE), today announces that the Toronto Stock Exchange (“TSX”) has approved its notice of intention to make a normal course issuer bid (the “Bid”) for its shares of common stock (the “Shares”).

Key Points: 
  • CALGARY, Alberta, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Gran Tierra Energy Inc. (“Gran Tierra”) (NYSE American: GTE)(TSX: GTE)(LSE: GTE), today announces that the Toronto Stock Exchange (“TSX”) has approved its notice of intention to make a normal course issuer bid (the “Bid”) for its shares of common stock (the “Shares”).
  • Gran Tierra has also entered into an Automatic Share Purchase Plan (the “ASPP”) in connection with the Bid.
  • The brokerage firm conducting the Bid on behalf of Gran Tierra and administering the ASPP is Eight Capital.
  • The ASPP is intended to allow for the purchase of Shares under the Bid when Gran Tierra would ordinarily not be permitted to purchase Shares due to regulatory restrictions and customary self-imposed blackout periods.

Biomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, October 30, 2023
Week, DLBCL, FDA, Research, Research and development, NSCLC, Trial of the century, IND, DSM-IV codes, Food, Diabetes, Health Canada, G&A, BID, CRS, KRAS, Investment, R, NUP98, Glycated hemoglobin, CLL, CD135, Disease, Clinical trial, CRC, Cancer, QT interval, Menin, MM, FLT3, Safety, PDAC, Patient, FMS, Administration, AML, Mutation, Pharmaceutical industry, Medical imaging, Cryptocurrency, Osteopathic medicine in Canada

Both studies are now open for enrollment more than a quarter ahead of schedule.

Key Points: 
  • Both studies are now open for enrollment more than a quarter ahead of schedule.
  • Finally in this quarter, we also initiated the clinical study of our second, Biomea-discovered investigational covalent inhibitor, BMF-500, a novel FLT3 inhibitor.
  • Continued to advance development candidates derived from Biomea’s proprietary FUSION™ System platform to discover novel covalently binding small molecules.
  • G&A expenses were $17.1 million for the nine months ended September 30, 2023 compared to $15.2 million for the same period in 2022.

IDRx Presents Preliminary Clinical Data from Ongoing Phase 1 StrateGIST Study at CTOS 2023 Supporting Best-in-Class Potential of IDRX-42 in Patients with GIST

Retrieved on: 
Thursday, November 2, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, TKI, Patient, KIT, PRS, MTD, MPH, Physician, BID, Exon, Poster, Strategist, UZ Leuven, Annual general meeting, GIST, RECIST, Stromal cell, Therapeutic index, Pharmaceutical industry, MD

“Importantly, these preliminary data will help guide our discussions with physicians regarding development strategies for IDRX-42 in patients with GIST in early lines of therapy to prevent the emergence of genomically-driven resistance mutations.

Key Points: 
  • “Importantly, these preliminary data will help guide our discussions with physicians regarding development strategies for IDRX-42 in patients with GIST in early lines of therapy to prevent the emergence of genomically-driven resistance mutations.
  • Median duration on treatment was 16 weeks and continuing, with 70% (23/33) of patients remaining on treatment at time of data cutoff.
  • 4/28 patients are on study for
  • Title: Phase 1 Study of IDRX-42 in Patients with Advanced Gastrointestinal Stromal Tumors Resistant to Prior Systemic Therapy: Early Results
    Session: CTOS Poster Reception 5:30-6:30 p.m. GMT, Thursday, November 2nd

Karora Resources Renews Normal Course Issuer Bid

Retrieved on: 
Monday, October 30, 2023
Toronto Stock Exchange, Person, KRR, Indian stock exchange, TSX, Calendar, BID, Corporation, Security (finance), Auction

TORONTO, Oct. 30, 2023 /CNW/ - Karora Resources Inc. (TSX: KRR) ("Karora" or the "Corporation") is pleased to announce it has received approval from the Toronto Stock Exchange (the "TSX") to renew its normal course issuer bid (the "Bid") to purchase up to no more than 8,886,939 of its issued and outstanding common shares (the "Common Shares").

Key Points: 
  • TORONTO, Oct. 30, 2023 /CNW/ - Karora Resources Inc. (TSX: KRR) ("Karora" or the "Corporation") is pleased to announce it has received approval from the Toronto Stock Exchange (the "TSX") to renew its normal course issuer bid (the "Bid") to purchase up to no more than 8,886,939 of its issued and outstanding common shares (the "Common Shares").
  • The average daily trading volume of the Common Shares for the most recently completed six calendar months ("ADTV") was 555,662 Common Shares.
  • The 8,886,939 Common Shares that may be repurchased under the Bid represents 5% of the Common Shares issued and outstanding.
  • If during the course of the Bid the Corporation becomes aware that such persons intend to sell their Common Shares then the Corporation will not intentionally acquire such Common Shares pursuant to the Bid.

Enthusiast Gaming Announces Intention to Voluntarily Delist from Nasdaq

Retrieved on: 
Monday, October 23, 2023
Toronto Stock Exchange, EGLX, EDGAR, Form, Bank statement, File, TSX, BID, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., Cryptocurrency, Share (finance)

LOS ANGELES, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Enthusiast Gaming Holdings Inc. (Nasdaq: EGLX; TSX: EGLX) (the “Company”), the leading gaming media and entertainment company in North America, today announced that it has notified the Nasdaq Stock Market LLC (“Nasdaq”) of its intention to voluntarily delist its common shares (“Shares”) from Nasdaq.

Key Points: 
  • LOS ANGELES, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Enthusiast Gaming Holdings Inc. (Nasdaq: EGLX; TSX: EGLX) (the “Company”), the leading gaming media and entertainment company in North America, today announced that it has notified the Nasdaq Stock Market LLC (“Nasdaq”) of its intention to voluntarily delist its common shares (“Shares”) from Nasdaq.
  • Shares will continue to trade on the Toronto Stock Exchange (“TSX”).
  • As previously announced in its press release dated May 4, 2023, the Listing Qualifications department of Nasdaq approved the Company’s request for a 180-day extension (the “Extension”) to regain compliance with Nasdaq’s minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) (the “Bid Price Rule”).
  • Although the Company has until October 30, 2023, to regain compliance with the Bid Price Rule, after careful consideration, the Company has evaluated the benefits and costs of continuing its listing on Nasdaq and has concluded that it is appropriate to voluntarily delist from Nasdaq.

Vivoryon Therapeutics N.V. Reports Positive Outcome from Independent Data Safety Monitoring Board with Unanimous Decision for VIVA-MIND U.S. Study of Varoglutamstat in Alzheimer’s Disease to Proceed at Highest Investigated Dose

Retrieved on: 
Monday, October 23, 2023
Alzheimer's Disease Cooperative Study, Element, Cognition, Plasma, Euronext Amsterdam, AD, Alzheimer's disease, ADCS, BID, Skin, Hepatology, OLE, European, Probability, University, VIVA, Safety, Therapy, Patient, Memory, DSMB, Pharmaceutical industry, Neuroscience

VIVA-MIND (NCT03919162) is an ongoing Phase 2 study for varoglutamstat conducted in the U.S., complementary to Vivoryon’s VIVIAD Phase 2b study being conducted in Europe.

Key Points: 
  • VIVA-MIND (NCT03919162) is an ongoing Phase 2 study for varoglutamstat conducted in the U.S., complementary to Vivoryon’s VIVIAD Phase 2b study being conducted in Europe.
  • The primary endpoint of the study is evaluating Clinical Dementia Rating scale Sum of Boxes (CDR-SB) over a 72-week treatment period.
  • “We are thrilled to report this new important and validating element of our rigorously and meticulously designed program for varoglutamstat.
  • Vivoryon remains on track to report the final data readout from the VIVIAD study in the first quarter of 2024.

Initial Phase 1 Dose Escalation Data of ORIC-114 in Patients with EGFR and HER2 Exon 20 Mutations Demonstrates Potential Best-In-Class Profile

Retrieved on: 
Saturday, October 21, 2023
Patient, First grade, MTD, Q&A, NSCLC, Half-life, ESMO, Trae Elston, Rash, TDD, HER2, Lung cancer, Congress, ORIC, BID, European Society for Medical Oncology, CNS, Great Lakes tornadoes of September 26, 1951, Grade 3, Systemic, Clinical trial, DLT, Webcast, Oncology, ORR, Brain, Toxic leukoencephalopathy, Safety, Diarrhea, Toxicity, SAN, EGFR, Medical imaging, Pharmaceutical industry, Vaccine, MD

“This is the first comprehensive data set for EGFR exon 20 patients with such an exceptionally high rate of CNS disease at baseline and prior exon 20 inhibitor therapy.

Key Points: 
  • “This is the first comprehensive data set for EGFR exon 20 patients with such an exceptionally high rate of CNS disease at baseline and prior exon 20 inhibitor therapy.
  • Patients previously treated with an exon 20 targeted agent are eligible, including patients with CNS metastases that are either treated or untreated but asymptomatic.
  • As of September 26, 2023, 50 patients (21 EGFR exon 20, 24 HER2 exon 20 and 5 HER2+ patients) received ORIC-114 and were heavily pre-treated, with exceptionally high rates of prior exon 20 targeted therapies and brain metastases at baseline.
  • The Phase 1 trial will enroll patients with EGFR exon 20 insertion mutations that are EGFR exon 20 inhibitor-naïve, and additional patients who are post-amivantamab.