630 Patients Enrolled To Date; Enrollment Completion Now Expected in Q1 2025 with Top-line Results Anticipated in Q2 2025;
Upon Potential Positive Phase 3 Data the Company Expects to Submit a New Drug Application (“NDA”) for D-PLEX100 under Fast Track and Breakthrough Therapy Designations, Previously Granted to D-PLEX100 by the FDA;
Proceeds from this Financing and Exercise of Data-Triggered Warrant Expected to Extend Cash Runway Beyond Potential NDA... Read more
BOSTON / Dec 23, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Dr. Reshma Kewalramani, Chief Executive Officer and President, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 10:30 a.m. ET/7:30 a.m. PT.
A live webcast of management's remarks will be available through the Vertex website, www.vrtx.com in the "Investors" section under the "News and Events" page. A replay of the... Read more
Marlborough, Massachusetts--(Newsfile Corp. - December 23, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company that develops therapeutics using its INTASYL® siRNA gene silencing technology to make the body's immune cells more effective in killing cancer cells, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 240,000 shares of its common stock at a purchase price of $2.00 per... Read more
AUSTIN, Texas / Dec 23, 2024 / Business Wire / Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid-induced toxicities (the “Company” or “Anebulo”), today announced a positive regulatory update and the close of a capital raise. In a Phase 2 proof-of-concept study, Anebulo enrolled 134 adult subjects challenged with oral delta-9-tetrahydrocannabinoil (“THC”),... Read more
LOS ANGELES / Dec 23, 2024 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cervical Cancer were updated to include an addition involving neratinib (NERLYNX®).
The updated NCCN Practice Guidelines for Cervical Cancer include neratinib monotherapy for use as second-line or subsequent therapy for recurrent... Read more
Binding Term Sheet with a leading global pharmaceutical company includes a substantial upfront payment and funding for the Phase 3 study
Additionally, milestone payments and double-digit royalties on annual net sales
The transaction is subject to finalization of a definitive agreement, anticipated in Q1 2025 CAMBRIDGE, Mass., Dec. 23, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company... Read more
Company committed to building a robust global patent estate across its innovative pipeline of NKT cell modulators LA JOLLA, CA, Dec. 23, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that European Patent Office (EPO) has issued a decision... Read more
WASHINGTON, Dec. 23, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), pharmaceutical company, and Tufts Medical Center (“Tufts MC”), a leading academic medical center, today announced the signing of a Patent License Agreement to jointly advance the development and commercialization of tafenoquine for the treatment and prevention of babesiosis.
Tafenoquine is not currently approved by the U.S. Food... Read more
Inmagene Biopharmaceuticals is a clinical stage company focused on developing IMG-007, a non-depleting anti-OX40 monoclonal antibody with an extended half-life and a silenced ADCC function
The transaction is expected to result in approximately $175 million to support further development of IMG-007, including $75 million from an oversubscribed Private Placement that will close immediately following the merger
The Financing includes both new investors such as Deep Track... Read more
WVE-007 is a novel approach for treating obesity and is designed to silence INHBE to achieve healthy, sustainable weight loss through fat burning, muscle maintenance and the potential for once or twice-annual administration
WVE-007 is Wave’s first siRNA program to enter clinical development and uses best-in-class oligonucleotide chemistry and GalNAc delivery
Wave expects to initiate the first-in-human study of WVE-007 in 1Q 2025 CAMBRIDGE, Mass., Dec. 23, 2024... Read more
New Drug Application (NDA) is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free survival in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)
If approved, taletrectinib represents a potential best-in-class treatment option for patients with advanced ROS1+ NSCLC
U.S. Food and Drug Administration (FDA) has assigned a target action date... Read more
Tonix received FDA’s Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025
TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA
Fibromyalgia affects more than 10 million adults in the U.S., who are mostly women
TNX-102 SL has the potential to be the first member of a new class of analgesic drugs for fibromyalgia and first new drug for its treatment in more than 15 years
NDA... Read more
WOBURN, Mass., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members of the Replimune management team will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 2:15 PM PT.
A simultaneous webcast will be available in the Investors section of Replimune’s website at replimune.com. A replay... Read more
ARO-INHBE targets a known pathway that signals the body to store fat in adipose tissue
In preclinical studies ARO-INHBE reduced body weight and fat mass with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies PASADENA, Calif. / Dec 23, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-INHBE,... Read more
MIAMI, FL / ACCESSWIRE / December 23, 2024 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), or the "Company", an emerging leader in age-reversal science, today announced significant findings from its copper binding studies with Telomir-1. This is a promising development as the company explores Telomir-1 for the treatment of Wilson's disease and other copper related disorders. The announcement marks an important step forward in Telomir's mission to address critical unmet medical... Read more
The Company has received approval to begin enrollment of the Phase 1b clinical trial in Australia
Phase 1b clinical trial will assess safety and tolerability along with biomarkers during three months of dosing with GT-02287 in people diagnosed with Parkinson’s disease
Phase 1b clinical trial follows successful Phase 1 study in which GT-02287 was safe and well tolerated while demonstrating GCase target engagement BETHESDA, Md., Dec. 23, 2024 (GLOBE NEWSWIRE) --... Read more
Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today reported... Read more
SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The MAA will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP).
“With regulatory filings for aficamten... Read more
Promising results support VYN202’s potential as a novel, once-daily oral treatment for a broad range of immune-mediated disorders
Consistent with Phase 1a SAD results, VYN202 demonstrated a favorable safety and tolerability profile with no drug-related adverse events historically associated with earlier generation, less selective BET inhibitors
VYN202 demonstrated robust pharmacodynamic activity including evidence of target engagement and significant inhibition of... Read more
NEW YORK, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that Michael Rossi, President and Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA... Read more
SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing novel therapies for patients with significant unmet needs in inflammatory diseases, today announced that it has entered into a securities purchase agreement with a group of accredited investors for the private placement of (i) 100,000,000 shares of common stock... Read more
Investigational agent in development for treatment or prevention of H5N1 Bird Flu
Phase 1 dosing completed in healthy volunteers
Potent inhibition of drug-resistant and bird flu viruses in vitro
In vivo study in mice, with H5N1 isolated from an infected dairy worker, showed potent protection and suppression of virus replication in lungs
Phase 2 study expected to begin in H1 2025
Traws Pharma is expanding its influenza program to address the potential... Read more
Blarcamesine: Potential novel oral treatment to target upstream Alzheimer’s disease pathology through autophagy enhancement
Submission based on favorable ANAVEX®2-73-AD-004 trial results in patients with early Alzheimer’s disease
Once daily oral administration of blarcamesine meaningfully slowed clinical decline in early Alzheimer's disease patients, demonstrating a favorable safety profile with no associated neuroimaging adverse events NEW YORK, Dec. 23, 2024... Read more
IMC-P115C (PRAME-HLE-A02) targets the same peptide and has the same CD3 effector and TCR specificity as brenetafusp, and is designed with extended half-life
The Phase 1 trial will assess the safety and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with advanced solid tumors that express PRAME (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, 23 December 2024) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore”... Read more
RAPT obtains worldwide rights excluding China
Jemincare receives $35 million upfront payment, up to $672.5 million in milestone payments and high single-digit to low-double digit royalties on future sales
Jemincare is currently conducting Phase 2 trials in asthma and chronic spontaneous urticaria in China
RAPT plans to initiate Phase 2b trial in food allergy next year
RAPT to host a conference call at 8:30 a.m. ET SOUTH SAN FRANCISCO,... Read more
TibuSURE is the first clinical trial designed to investigate anti-BAFF and IL-17 pathways in systemic sclerosis.
TibuSURE launches with the initiation of its first clinical site. HENDERSON, Nev. / Dec 23, 2024 / Business Wire / Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced the launch of TibuSURE, a Phase 2 global study... Read more
HOUSTON, Dec. 23, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics”), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced that it has entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN LTD. (“Yorkville”), an investment fund managed by... Read more
KANSAS CITY, Kan., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, has completed a financing transaction with an accredited investor which provided net proceeds to CING of $5 million. The transaction was structured as a non-convertible, unsecured promissory... Read more
PARIS, France, December 23, 2024, 10:05 PM CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the inflammatory response in patients with chronic inflammatory diseases, today announced that Dr. Philippe Pouletty, representative of Truffle Capital, tendered his resignation as director of the... Read more
First quarter revenues increased by 360% year over year
First quarter net loss for the quarter of $0.002 per share
Grant of 1,535,715 stock options to independent directors QUEBEC CITY / Dec 23, 2024 / Business Wire / Devonian Health Group Inc. (“Devonian” or the “Company”) (TSXV: GSD; OTCQB: DVHGF), today announced financial results for its first quarter ended on October 31, 2024.
Management Comments
“Devonian continued to improve its financial position... Read more
ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies
In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV1 and further decreased sweat chloride compared to TRIKAFTA® BOSTON / Dec 20, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved... Read more
Approximately 300 more people with cystic fibrosis in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time BOSTON / Dec 20, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and... Read more
BOSTON, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to include children as young as 2 years old. IMCIVREE is indicated to reduce excess body weight and maintain weight reduction... Read more
WASHINGTON, Dec. 20, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2000 Americans.1
PV is a chronic myeloproliferative disorder characterized by aberrant... Read more
TORONTO / Dec 20, 2024 / Business Wire / Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (“Satellos” or the “Company”), a public biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, today announced that it has closed an equity offering, issuing a total of 63,285,000 equity securities for gross proceeds of approximately $57 million (USD$40 million) (the “Offering”).
“We are thrilled... Read more
SAN DIEGO, Dec. 20, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company (“BioAtla” or the “Company”) focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that it has entered into definitive agreements with certain institutional investors for the issuance and sale of 9,679,158 shares of its common stock in a registered direct offering.... Read more
Renovaro will Establish the GEDi CUBE Next Generation Nvidia Blackwell Cluster with Nebul's certified AI Healthcare Cloud solutions LOS ANGELES, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Renovaro Inc. (NASDAQ: RENB), a pioneer in cancer diagnostics and therapeutics powered by artificial intelligence, today announced its subsidiary Renovaro Cube (the “Cube”), a leader in specific AI-driven healthcare solutions, has entered into a strategic collaboration with Nebul (www... Read more
FREEHOLD, N.J., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Channel Therapeutics Corporation, (“Channel” or the “Company”), (NYSE American: CHRO), a pioneer in the development of non-opioid pain treatment therapeutics, is providing a statement regarding Vertex Pharmaceutical’s recently announced Phase 2 data of Suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor in people with painful lumbosacral radiculopathy.
“We are encouraged to see... Read more
EDINBURGH, Scotland, Dec. 20, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced 3 patients have now completed the full-dose regimen in the ACHIEVE Phase 2b trial in the UK with no drug-related Adverse Events seen in any of the restart patients.
The ACHIEVE UK clinical... Read more
Funds expected to be used to advance IO Biotech’s immune-modulating therapeutic cancer vaccines, including potential BLA submission for IO102-IO103 in 2025
Commitment is part of the European Investment Bank’s strategy to support biotech companies with cutting-edge expertise in therapeutic areas such as immuno-oncology
Debt facility expected to extend company’s cash runway into the second quarter of 2026 COPENHAGEN, Denmark and NEW YORK, Dec. 20, 2024 (GLOBE... Read more
CRENESSITY, a First-in-Class Treatment for Classic Congenital Adrenal Hyperplasia (CAH), is now commercially available in the U.S.
CAH-trained pharmacists are available 24/7 to support patients with prescriptions exclusively through PANTHERx Rare, a specialty pharmacy
Neurocrine Access Support is available to provide free, comprehensive access and support information to patients, caregivers and healthcare providers SAN DIEGO, Dec. 20, 2024 /PRNewswire/ -- Neurocrine... Read more
In the pre-specified per-protocol population, belapectin showed a statistically significant reduction (p-value < 0.05) in development of esophageal varices in 2mg/kg cohort compared to placebo
While there was a favorable trend for incidence of varices in the primary end point intent-to-treat population, belapectin did not achieve statistical significance
Belapectin was overall well tolerated with no safety signals; incidence of adverse events and serious adverse... Read more
FOSTER CITY, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, announced today the results from its Phase 3 bridging trial of uproleselan in China in patients with relapsed or refractory acute myeloid leukemia. The trial did not demonstrate favorable benefit... Read more
JENA, Germany, Dec. 20, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the first patient has been dosed in its Phase 2a basket study in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), investigating the Company’s oral C5aR inhibitor, INF904.
Camilla Chong, MD, Chief Medical Officer of InflaRx, commented:... Read more
SAN FRANCISCO and SUZHOU, China, Dec. 20, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announced that China's National Medical Products Administration (NMPA) has approved a New Drug Application (NDA) of DOVBLERON ®... Read more
Shoshana Shendelman Steps Down as CEO; Les Funtleyder Appointed Interim Chief Executive Officer
Announces Business Updates NEW YORK, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the following leadership changes, effective immediately: John H. Johnson, a recognized leader in the pharmaceutical and biotechnology industry, has... Read more
Dispensed applicator units in the fourth quarter of 2024 have exceeded the complete prior quarter even with significant cost reductions in sales and operational infrastructure
Observed significant reduction in YCANTH distributor inventory levels
New single applicator configuration for YCANTH® expected to be available in the first quarter of 2025 to help meet growing product demand, reduce acquisition costs for physician practices and expand distribution and patient... Read more
Acquisition bolsters Eton’s commercial pediatric endocrinology portfolio
Product is now available through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions DEER PARK, Ill., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has completed... Read more
THE WOODLANDS, Texas, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
This expected communication from the FDA aligns with the company’s... Read more
PEDMARQSI® (anhydrous sodium thiosulfate) is the first and only treatment available within NHS England and Wales for the prevention of cisplatin-induced ototoxicity (hearing loss) in children and young people (1 month-17 years of age)
Data from two open-label, randomized Phase 3 trials, SIOPEL 6 (pivotal) and the Clinical Oncology Group (COG) Protocol ACCL0431, demonstrated an approximate 50% reduction in the occurrence of cisplatin-induced ototoxicity in patients... Read more
