BioRestorative Therapies(BRTX)
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BioRestorative Expands Global Protection for ThermoStem®, a Potentially Longer-Lasting and Safer Cell-Based Alternative to GLP-1 Drugs
Globenewswire· 2026-02-24 13:30
GLP-1 drugs have captured global attention, but they come with limitations — tolerability issues, muscle mass loss, and potential cardiovascular risks. BioRestorative believes its cell-based therapeutic candidates may offer the potential for longer-lasting efficacy with improved safety and dosing advantages. MELVILLE, N.Y., Feb. 24, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a late stage clinical regenerative medicine innovator focused ...
BioRestorative Announces Closing of $5.0 Million Public Offering
Globenewswire· 2026-02-14 01:30
Core Viewpoint - BioRestorative Therapies, Inc. has successfully closed a public offering of 14,285,715 shares of common stock and warrants, raising approximately $5.0 million to fund clinical trials and development initiatives [1][3]. Group 1: Offering Details - The public offering price was set at $0.35 per share, with warrants having the same exercise price and an expiration of five years from issuance [1]. - Rodman & Renshaw LLC served as the exclusive placement agent for the offering [2]. - The offering was registered with the SEC, and a final prospectus has been filed [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to clinical trials for BRTX-100, pre-clinical research for the ThermoStem Program, development of a commercial biocosmeceuticals platform, and general corporate purposes [3]. Group 3: Company Overview - BioRestorative focuses on regenerative medicine, particularly stem cell-based therapies, with key programs targeting disc/spine diseases and metabolic disorders [6]. - The lead therapy candidate, BRTX-100, is designed for non-surgical treatment of lumbosacral disc disorders and is currently in Phase 2 clinical trials [6]. - The ThermoStem Program aims to develop therapies for obesity and metabolic disorders using brown adipose-derived stem cells [7]. - The company also operates a BioCosmeceutical platform, offering products aimed at cosmetic improvements [8][9].
BioRestorative Announces Pricing of $5.0 Million Public Offering
Globenewswire· 2026-02-12 03:30
Core Viewpoint - BioRestorative Therapies, Inc. has announced a public offering of 14,285,715 shares of common stock at a price of $0.35 per share, aiming to raise approximately $5.0 million for clinical trials and development projects [1][3]. Group 1: Offering Details - The public offering includes 14,285,715 shares of common stock and warrants to purchase an equal number of shares, priced at $0.35 each [1]. - The warrants will have an exercise price of $0.35 per share, are immediately exercisable, and will expire five years from issuance [1]. - The closing of the offering is expected around February 13, 2026, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to clinical trials for BRTX-100, pre-clinical research for the ThermoStem Program, development of a commercial biocosmeceuticals platform, and general corporate purposes [3]. Group 3: Company Overview - BioRestorative focuses on regenerative medicine, particularly stem cell-based therapies, with two main clinical development programs: the Disc/Spine Program and the Metabolic Program [6][7]. - The Disc/Spine Program features BRTX-100, a cell therapy for treating lumbosacral disc disorders, currently in Phase 2 clinical trials [6]. - The Metabolic Program aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells [7]. - The company also operates a BioCosmeceutical platform, offering products designed to improve cosmetic appearance through cell-based secretome technology [8].
BioRestorative Announces Positive Outcome from Type B Meeting with FDA
Globenewswire· 2026-02-11 12:30
Core Viewpoint - BioRestorative Therapies, Inc. has received positive feedback from the FDA regarding an expedited Biologics License Application (BLA) approval pathway for its BRTX-100 program aimed at treating chronic lumbar disc disease (cLDD) [1][6] Group 1: FDA Interaction and Approval Pathway - The Type B meeting with the FDA provided clarity for an expedited BLA approval pathway for the BRTX-100 program in cLDD [2][6] - The FDA endorsed the proposed Phase 3 study design, including outcome assessments, dosing strategy, and eligibility criteria [6] - The company plans to submit the Phase 3 IND application in the second half of 2026 [2] Group 2: Clinical Trial and Product Details - BRTX-100 is a novel cell-based therapeutic targeting areas with low blood flow, currently evaluated in a Phase 2 clinical trial involving 99 subjects across 15 clinical sites in the U.S. [5][7] - The trial has a randomized 2:1 design for BRTX-100 versus placebo, with ongoing positive safety and efficacy results [5][6] - The standard treatment for cLDD currently lacks therapies that reverse disc degeneration or address intervertebral disc cell homeostasis [4] Group 3: Company Overview and Other Programs - BioRestorative develops therapeutic products using adult stem cells, focusing on disc/spine disease and metabolic disorders [7] - The company is also developing a metabolic program targeting obesity using brown adipose-derived stem cells [8] - BioRestorative operates a BioCosmeceutical platform, offering a cell-based secretome product aimed at cosmetic effectiveness [9]
BioRestorative Therapies(BRTX) - Prospectus(update)
2026-02-10 22:20
As filed with the Securities and Exchange Commission on February 10, 2026. Registration No. 333-293322 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 (Amendment No. 1) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) incorporation or organization) Classification Code Number) Identification Number) Nevada 8099 30-1341024 (State or other jurisdiction of (Primary Standard Industrial (I ...
BioRestorative Completes Patient Enrollment in Landmark Phase 2 Trial of BRTX-100 for Chronic Lumbar Disc Disease
Globenewswire· 2026-02-10 13:00
Core Insights - BioRestorative Therapies, Inc. has completed patient enrollment in its Phase 2 clinical trial for BRTX-100, targeting chronic lumbar disc disease (cLDD) [1][3][8] Company Overview - BioRestorative is focused on stem cell-based therapies and products, with BRTX-100 as its lead clinical candidate, designed for low-oxygen, low-nutrient disc environments [2][11] - The company operates in the regenerative medicine sector, developing therapeutic products primarily using adult stem cells [12] Clinical Trial Details - The Phase 2 trial has enrolled 99 patients across 15 U.S. clinical sites, believed to be the largest Phase 2 cell-therapy trial for cLDD under FDA IND application [3][5] - The trial employs a randomized, double-blind, sham-controlled design, considered the gold standard for clinical studies in spine interventions [4][9] - Primary safety endpoints include the frequency and severity of adverse events, while efficacy endpoints focus on a greater than 30% improvement in function and pain reduction at week 52 [5][10] Enrollment and Milestones - Enrollment completion is seen as a significant operational and clinical milestone, reflecting years of disciplined execution and scientific focus [8][7] - Approximately 40% of total enrollment occurred in the last six months, indicating increased site productivity and investigator engagement [7] Future Prospects - The completion of enrollment positions the program favorably for regulatory dialogue and advancement towards Phase 3 development and potential Biologics License Application (BLA) submission [8][9]
BioRestorative Therapies(BRTX) - Prospectus
2026-02-09 22:31
As filed with the Securities and Exchange Commission on February 9, 2026. Registration No. 333-_________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) Nevada 8099 30-1341024 4 ...
Biotech Stocks Shine After Hours: Novo Nordisk, IDEAYA, Healthcare Triangle Among Gainers
RTTNews· 2025-12-23 04:49
Core Insights - Healthcare and biotechnology stocks experienced significant movements in after-hours trading, with several companies showing strong gains despite limited news flow [1] Company Summaries - Novo Nordisk A/S (NVO) saw a notable increase of 9.48%, closing at $52.66, following FDA approval of its Wegovy pill, the first oral GLP-1 medicine for obesity in the U.S., which is also approved to reduce cardiovascular risks [2] - Neumora Therapeutics, Inc. (NMRA) advanced 16.02% to $2.10, indicating investor interest possibly driven by broader sector momentum or speculative trading, as there were no specific news updates [3] - BioRestorative Therapies, Inc. (BRTX) rose 6.90% to $1.24, with investors reacting to a prior announcement regarding an FDA Type B meeting to discuss a potential accelerated BLA pathway for its BRTX-100 program for chronic lumbar disc disease [4] - RenovoRx, Inc. (RNXT) added 4.44% to close at $0.94, with earlier news of an accepted abstract submission for the ASCO Gastrointestinal Cancers Symposium 2026 contributing to investor interest [5] - IDEAYA Biosciences, Inc. (IDYA) gained 6.49% to $37.81, following the full enrollment of 435 patients in its Phase 2/3 trial for darovasertib, with expected data reporting in Q1 2026 [6] - Healthcare Triangle, Inc. (HCTI) climbed 6.72% to $1.43, with a recent announcement of an Advance Agreement for acquiring AI-powered customer experience firms, enhancing its position in global AI-driven solutions [7] - Alphatec Holdings, Inc. (ATEC) posted a modest gain of 2.80%, rising to $21.28, benefiting from ongoing investor confidence in the spine surgery provider [8]
BioRestorative Therapies(BRTX) - Prospectus
2025-11-18 21:45
As filed with the Securities and Exchange Commission on November 18, 2025 Registration No. 333-_________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) incorporation or organization) Classification Code Number) Identification Number) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Nevada 8099 30-1341024 4 ...
NOTV, APLT Lead After-Hours Biotech Gains; ALMS, TELA, CORT, BRTX Also Advance
RTTNews· 2025-11-18 04:33
Core Insights - Several small-cap biotech and therapeutics companies experienced significant gains in after-hours trading, driven by earnings updates, financial guidance, and regulatory developments [1] Company Summaries - Inotiv, Inc. (NOTV) saw a 36.61% increase in after-hours trading to $0.94, recovering from a 33.20% decline at the close, following preliminary Q4 revenue expectations of $137.5 million to $138.5 million and full-year revenue projections of $512.5 million to $513.5 million [2] - Applied Therapeutics, Inc. (APLT) rose 16.89% to $0.33 after a 30.19% gain at the close, with investors reacting positively to a narrower Q3 net loss of $19.0 million, or $0.13 per share, compared to a $68.6 million loss, or $0.48 per share, in the same quarter last year [3] - Alumis Inc. (ALMS) advanced 7.09% to $5.97, despite reporting a Q3 net loss of $110.8 million, wider than the $93.1 million loss in the prior year, with $2.1 million in collaboration income potentially boosting investor confidence [4] - TELA Bio, Inc. (TELA) increased 7.89% to $1.23 after a 14.08% gain at the close, reporting a reduced Q3 net loss of $8.6 million compared to $10.4 million a year earlier, with revenue growth of 9% to $20.7 million and revised 2025 guidance projecting at least 16% revenue growth over 2024 [5] - Corcept Therapeutics Inc. (CORT) gained 4.90% to $78.80, reflecting continued investor interest despite no specific news released [6] - BioRestorative Therapies, Inc. (BRTX) jumped 8.06% to $1.34, rebounding from a 6.77% decline at the close, following the announcement of a Type B meeting with the FDA to discuss a potential accelerated Biologics License Application pathway for its BRTX-100 program [7]