CAMBRIDGE, Mass., Sept. 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the pricing of an upsized underwritten public offering of 5,000,000 shares of Class A common stock at a price to the public of $100.00 per share. All shares are being... Read more
CAMBRIDGE, Mass., Sept. 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that it has commenced an underwritten public offering of $350.0 million of its shares of Class A common stock. All shares are being offered by Nuvalent. The offering is... Read more
LONDON, Sept. 16, 2024 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses and diagnosis of viral diseases, today announced that it has entered into an extension of its already existing exclusive distribution agreement with Cosmos Health Inc. (Nasdaq: COSM) ("Cosmos") to commercialize Mpox Virus... Read more
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - September 16, 2024) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) has been informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the US Food and Drug Administration has extended the review period for the New Drug Application for treosulfan by three months. The FDA has set a new PDUFA target action date of January 30,... Read more
Confirmed partial responses (PRs) doubled to four since ASCO GI in MSS CRC patients without liver and peritoneal metastases for overall response rate (ORR) of 24% (4/17) with ADG126 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab Median progression-free survival of 8.5 months observed in patients without liver and peritoneal metastases at the ADG126 10 mg/kg Q3W dose At the 10... Read more
ROCKVILLE, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”) a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the THERICEL project has been awarded funding of €2.28 million from the National Knowledge Transfer Program of the Spanish government’s... Read more
GAITHERSBURG, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today it has entered into agreements with two additional site locations to administer the Phase 2 clinical trial of... Read more
The World Health Organization (WHO) released its preferred target product profile (TPP) criteria for mpox vaccines at its Mpox Research and Innovation Scientific Conference held August 29-30 TNX-801, Tonix’s attenuated live-virus vaccine candidate, has characteristics that align closely with WHO’s TPP On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa... Read more
NEW YORK, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Psyence Group Inc ("Psyence Group") (CSE: PSYG), a life science biotechnology company pioneering the use of nature-derived psilocybin in mental health and wellbeing, is pleased to announce that its NASDAQ-listed associate, Psyence Biomedical Ltd (NASDAQ: PBM) ("PBM" or "Psyence Biomed"), has successfully completed the first site initiation visit at the first... Read more
Innovative drug treatment developed in collaboration with SciSparc aims to enhance safety and efficacy in mental health and addiction care Vancouver, Canada, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major... Read more
Achieves $5.3 Million First Quarter Revenue, Reaches Milestone Developing Antibodies End-to-End Using LENSai VICTORIA, British Columbia / Sep 16, 2024 / Business Wire / IMMUNOPRECISE ANTIBODIES LTD. (the “Company” or “IPA”) (NASDAQ: IPA), an artificial intelligence-driven biotherapeutic research and technology company, today reported financial results for the first quarter of its 2025 fiscal year (“FY25”), which... Read more
Updated Phase 1 dose-escalation data from ARROS-1 and ALKOVE-1 clinical trials continue to support potential best-in-class profiles for zidesamtinib and NVL-655 Rapid enrollment in Phase 2 portions of the ARROS-1 and ALKOVE-1 clinical trials; Pivotal data from both ROS1 and ALK programs now anticipated in 2025 Initiation of ALKAZAR Phase 3 randomized, controlled trial of NVL-655 for treatment-naïve patients... Read more
Tumors shrank in 89% of taletrectinib-treated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were TKI-pretreated in the study Taletrectinib demonstrated durable responses and prolonged progression-free survival (PFS) with long-term follow up; median duration of response (DOR) and median PFS in TKI-naïve patients... Read more
Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE... Read more
Publication provides comprehensive assessment of NVL-655's preclinical activity and includes preliminary clinical case studies CAMBRIDGE, Mass., Sept. 13, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the publication of a manuscript in... Read more
On track to announce topline results from ORIGIN 3 trial in Q2 2025 Expect to present 96-week data from ORIGIN Phase 2b clinical trial of atacicept in IgAN in Q4 2024 BRISBANE, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological... Read more
In Phase 2a arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel, complete or partial responses have been observed in the first two patients (2/5) to date, for an initial response rate of 40% and an initial disease control rate of 80%, with all five patients continuing on treatment Initial data are at 240 mg QD (safety lead-in dose) of IMM-1-104; additional patients have now... Read more
Centers for Disease Control and Prevention (CDC) reports death rate due to COVID-19 has continued to increase throughout 2024 Immunocompromised patients at greatest risk for serious infections or even death due to COVID-19 PEMGARDA™ available under Emergency Use Authorization (EUA) for certain immunocompromised adults and adolescents; recommended by Infectious Disease Society of Americas (IDSA)... Read more
Bright Minds Biosciences announces Phase 2 Clinical trial to evaluate BMB-101 in a group of drug-resistant epilepsy disorders with high unmet needs BMB-101 is a novel highly selective 5-HT2C agonist. Its G-protein biased agonism provides an improved mechanism of action for chronic dosing Financial runway extending into 2026 enabling key data readout Conference call & KOL Event – will be held as a... Read more
Q3-24 revenues of $12.6 million, down 11% from Q3-23, excluding XIIDRA, growth trend from continued business remains healthy at +9%, Q3-24 vs Q3-23 Q3-24 adjusted EBITDA loss of $1.5 million compared to $2.5 million for Q3-23, down 40% MONTREAL, Sept. 12, 2024 /CNW/ - Valeo Pharma Inc. (TSX: VPH) (FSE: VP2) ("Valeo" or the "Company"), a... Read more
SAN DIEGO, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Singular Genomics Systems, Inc. (Nasdaq: OMIC), a company leveraging novel next-generation sequencing (NGS) and spatial multiomics technologies to empower researchers and clinicians, announced today that it has received a non-binding proposal from Deerfield Management Company, L.P. and certain affiliated funds (collectively, “Deerfield”), to acquire all of the Company’s... Read more
Innovative compounds designed to address critical unmet needs in PTSD treatment Vancouver, Canada, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced the submission of a... Read more
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 12, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today announced the closing of its previously announced best-efforts offering priced at-the-market under Nasdaq rules for 12,325,000 common... Read more
FOSTER CITY, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced the closing of its previously announced underwritten public offering of 14,064,048 shares of its common stock,... Read more
Three new post-hoc analyses highlight EYLEA HD rapid and sustained fluid control and consistent safety profile over two years in patients with wet age-related macular degeneration (wAMD) New indirect comparison evaluates disease control of EYLEA HD and faricimab across different pivotal Phase 3 trials in wAMD TARRYTOWN, N.Y., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)... Read more
Confirming the results of Study A, this second pivotal trial in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines Data will support regulatory resubmission in the... Read more
Trial met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placebo Dupixent is the first medicine to show significant steroid-sparing effect in this debilitating and life-threatening disease If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S. and... Read more
Expanded cleanroom and improved distribution facilities enhance manufacturing capacity and shipping efficiencies ANN ARBOR, MI / ACCESSWIRE / September 11, 2024 / Zomedica Corp. (NYSE American:ZOM) ("Zomedica" or the "Company"), a veterinary health company offering diagnostic and therapeutic products for equine and companion animals, is pleased to announce the completion of renovations at its... Read more
Median overall survival of 15.6 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint inhibitor OS of 15.6 months compares favorably with 6.7-9.3 months reported for similar patients in the literature Ongoing Phase 3 study investigating Bria-IMT™ in similar metastatic breast cancer population No drug related discontinuations to date PHILADELPHIA and VANCOUVER, British... Read more
BOSTON and LONDON, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that it has commenced an underwritten public offering of $150 million of American Depositary Shares (“ADSs”), each representing one ordinary share. All of the ADSs are being... Read more
Building on successful pre-clinical in vivo CAR-M data in oncology, the companies will develop in vivo CAR-M for autoimmune diseases Moderna nominated two autoimmune disease targets under the collaboration Carisma is eligible to receive milestones and royalty payments PHILADELPHIA, Sept. 10, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical... Read more
Receipt of RMAT Designation is based on preliminary clinical evidence from the CANaspire Phase 1/2 clinical trial, which showed functional improvements in all dosed patients indicating that BBP-812 has potential to address the unmet needs of individuals with Canavan disease BridgeBio will leverage the benefits of RMAT designation, including early and more frequent interactions with the FDA, to establish an... Read more
Increase in endogenous cortisol production achieved in all patients in higher dose cohorts of BBP-631, a result seen for the first time ever in CAH patients The gene therapy was well tolerated with no treatment-related serious adverse events (SAEs) reported Despite novel scientific advancements achieved with this program, the data do not warrant additional capital investment at this time and the gene therapy... Read more
Mosliciguat, a potential first-in-class and best-in-category inhaled soluble Guanylate Cyclase (sGC) activator with targeted delivery to the lungs and once-daily administration, is being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD), which affects ~200,000 patients in the U.S. and Europe; PH-ILD prevalence is meaningfully greater than that of pulmonary arterial... Read more
2.5 mg dose restored normative wakefulness with mean sleep latency of 32 minutes as measured by the Maintenance of Wakefulness Test (MWT) Favorable safety and tolerability profile with no observations of frequently reported on-target adverse events (AEs) associated with other OX2R agonists, visual disturbances or hepatotoxicity as of the data cutoff date 1 PK profile supports once-daily dosing Company plans... Read more
Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin TIR measures approach target set by American Diabetes Association Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc.... Read more
U.S. FDA-registered 503B outsourcing facility, Wells Pharma of Houston, will compound and distribute Niagen (nicotinamide riboside chloride) IV and injections to 14 new clinics LOS ANGELES / Sep 10, 2024 / Business Wire / ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research with a focus on healthy aging, is excited to announce the second wave of intravenous... Read more
Phase 2/3 of the DRAGON II trial will evaluate the efficacy, safety, and tolerability of Tinlarebant in approximately 60 adolescent STGD1 subjects across the U.S., U.K., and Japan Phase 1b of DRAGON II trial to evaluate pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese subjects was recently completed Tinlarebant granted Orphan Drug and Sakigake (Pioneer Drug) Designation in Japan for the... Read more
BOSTON, Sept. 10, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, in collaboration with Michigan State University, published an article in the journal Oncotarget titled, Inhibition of miR-10b treats metastatic breast cancer by targeting stem cell-like properties. The article was... Read more
BriaCell has received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with FDA for Bria-PROS+™ in prostate cancer The meeting provides a clear path towards filing an IND and conducting a Phase 1/2 study of Bria-PROS+™ PHILADELPHIA and VANCOUVER, British Columbia, Sept. 10, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell”... Read more
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