CAMBRIDGE, MA / ACCESS Newswire / January 17, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced ongoing support from the U.S. Department of Health and Human Services (HHS) to accelerate the development of mRNA-based pandemic influenza vaccines. The award was made through the Rapid Response Partnership Vehicle (RRPV) Consortium with funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS...Read more
SHANGHAI & CAMBRIDGE, Mass. / Jan 17, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults. “There are more than 8 million patients living with schizophrenia in China who face significant unmet needs due to the limited efficacy and undesirable side...Read more
The New Drug Application is based on positive results from the Phase 3 PALISADE study People living with familial chylomicronemia syndrome have extremely high triglyceride levels and a substantially higher risk of developing acute pancreatitis and associated long-term complications, including poor quality of life PASADENA, Calif. / Jan 17, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the...Read more
LONDON, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces an oral presentation and three poster presentations accepted to the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held from February 12-15, 2025, in Hawai'i...Read more
AUSTIN, Texas / Jan 17, 2025 / Business Wire / ImmunoPrecise Antibodies Ltd. (NASDAQ: IPA) today announced the launch of its AI-powered pipeline of both optimized and new therapeutics, a system set to transform therapeutic development. By combining advanced artificial intelligence with first-principles thinking, the BioStrand pipeline reimagines drug discovery, offering unmatched speed, precision, and transparency. Traditional drug...Read more
Sales Highlights: Global December 2024 Quarter AUD$2.5 million up 70% on prior quarter, up 249% on pcp December 2024 Half Year AUD$4.0 million up 70% on pcp Australia December 2024 Quarter AUD$1.9 million up 83% on prior quarter, up 314% on pcp December 2024 Half Year AUD$2.9 million up 54% on pcp North America December 2024 Quarter AUD$0.7 million up 43% on prior quarter, up 141% on pcp December...Read more
– Newly Completed Sensitivity Analyses Demonstrate Robustness of Previously Announced Survival Superiority Over External Control in Patients with TA-TMA – Sensitivity analyses support the results of the primary endpoint analysis, with representative sensitivity analyses demonstrating: Narsoplimab-treated patients had an over 2-fold reduction (hazard ratio = 0.42 [95% confidence interval: 0.21, 0.83]) to an over 4-fold reduction...Read more
REDWOOD CITY, Calif., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced the appointment of Christos Richards to the Company’s Board of Directors. “I am delighted to welcome Christos to our Board. His broad and deep knowledge and understanding of the life sciences industry will be invaluable as we continue the...Read more
MALVERN, Pa., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME). “OCU200 has the potential to change the treatment landscape for DME,...Read more
ONS-5010 demonstrated to be non-inferior to Lucentis at 12 weeks BLA resubmission on track for calendar Q1 2025 Entered into agreements for warrant inducement transaction expected to result in up to $20.4 million in gross proceeds ISELIN, N.J., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Outlook Therapeutics, or the Company) (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the...Read more
Atara received FDA Complete Response Letter (CRL) solely related to inspection findings at third-party manufacturer CRL did not identify deficiencies related to clinical efficacy or safety data in the Biologics License Application (BLA), and the FDA did not request any new clinical studies to support approval Atara remains committed to working with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to bring EBVALLO to...Read more
Calgary, Alberta--(Newsfile Corp. - January 16, 2025) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF), and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), today is pleased to announce that the Chinese patent office has issued a notice of allowance for its lead compound MB-204. This is the first allowance worldwide for this family. "We are pleased with this allowance of claims to...Read more
PRINCETON, N.J., Jan. 16, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company will deliver a corporate presentation at the upcoming conferences below. Sequire Investor Summit, held January 21 to 23 at Condado...Read more
Marlborough, Massachusetts--(Newsfile Corp. - January 16, 2025) - 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 610,000 shares of its common stock...Read more
Company on track to report topline data in first half of 2025 Positive preliminary data from all five single ascending dose (SAD) cohorts ranging from 15mg to 450mg support safety and tolerability of PALI-2108 Continued progress toward Phase 1b/2a of PALI-2108 trial for the treatment of UC Carlsbad, CA, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a...Read more
Improved overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR) were observed in the China subpopulation treated with TIVDAK compared to chemotherapy, consistent with those in the global population The safety profile of TIVDAK among the China subpopulation was manageable and consistent with that observed in the global population Zai Lab intends to submit a New Drug Application (NDA) to China’s...Read more
Marketing authorization application for BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in situ (CIS) submitted to European Medicines Agency (EMA) in December 2024 and anticipated acceptance of application in 2025 Marketing authorization application for BCG Unresponsive NMIBC CIS submitted to United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2024 and anticipated acceptance...Read more
BCG unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication: Anticipated supplemental biologics license application (BLA) submission in 2025 Alternative source of BCG in partnership with Serum Institute of India: Anticipated submission for market access as an alternative source in Q1 2025 Second- and third-line non-small cell lung cancer (NSCLC) progressing on checkpoint inhibitors (QUILT-3.055): Anticipated...Read more
U.S. launch expected in early February Niktimvo is the first and only approved treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis Pivotal data from the AGAVE-201 trial supporting FDA approval show treatment with Niktimvo resulted in durable responses across all organs studied and patient subgroups WILMINGTON, Del. and WALTHAM, Mass., Jan. 15, 2025 /PRNewswire/ -- Incyte (Nasdaq:INCY)...Read more
Blarcamesine potential novel oral treatment to target upstream Alzheimer’s disease pathology through autophagy enhancement Impairment of autophagy precedes both amyloid beta and tau tangles, and therefore anticipates the neurodegenerative process in Alzheimer’s disease NEW YORK, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused...Read more
LEXINGTON, Mass., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that it has voluntarily halted all dosing...Read more
ENVISION Reports 79.6% Complete Response Rate at 3 Months, 82.3% Duration of Response at 12 Months, and Consistent Safety Profile PRINCETON, N.J. / Jan 15, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the 3-month complete response (CR) rate and 12-month durability of response...Read more
New executive leadership supports the company’s transition to a fully integrated commercial-stage organization in a year of transformative growth with a potential new product launch in mid-2025. BOSTON / Jan 15, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the appointment of Matthew E. Ros as...Read more
Strategic Partnership Agreements will facilitate collaboration among sites, cultivate long term partnerships, enhance efficiency in trial operations, and improve overall site performance First program member is Segal Trials, a preferred provider for leading pharmaceutical companies globally Phase 2 data confirmed that two 16 mg doses of CYB003 administered three weeks apart provides remission from depression symptoms for 12 months in...Read more
JENA, Germany, Jan. 15, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome...Read more
EMERYVILLE, Calif., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX), a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary gene editing toolbox, today announced that Eric Bjerkholt, MBA, CFO of Mirum Pharmaceuticals, Inc., will join Metagenomi’s Board of Directors, serving on Metagenomi’s Audit and Compensation committees, effective January 27, 2025. “We...Read more
The primary endpoint of 12-month Event Free Survival (EFS) for OST-HER2- treated patients (33.3%) was statistically significant (p= 0.0158) when compared with peer-reviewed comparable historical control (20%) Ongoing follow up demonstrates strong trend in favor of OST-HER2 in 1-year and 2-year interim analyses of the secondary endpoint, 3-year overall survival (OS) when compared with comparable peer-reviewed historical control 100% of...Read more
New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1 SAN DIEGO and CALGARY, AB, Jan. 15, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the...Read more
WILMINGTON, Del., Jan. 15, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, and HOPE Therapeutics, Inc., a development stage medical and technology driven company and wholly owned subsidiary of NRx, today announced the appointment of Mr. Michael Taylor and Ms. Anita Nunes as Member and Observer of its Board of Directors, respectively. ...Read more
BASKING RIDGE, N.J., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that David J. Mazzo, PhD, President and Chief Executive Officer of Lisata, will present a corporate overview at the upcoming Sequire Investor Summit being held January 21-23,...Read more
Trial remains on track for completion and data readout in the second half of 2025 COPENHAGEN, Denmark, January 15, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, has now completed the dosing of all 16 patients in its phase 2 trial with the company’s lead asset EVX-01. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a...Read more
VANCOUVER, British Columbia, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) is excited to announce that its cutting-edge anti-aging compound, TFC-1326, has been highlighted in Stonegate Healthcare Partners’ latest research report. The publication, titled "Sirona Biochem’s TFC-1326 Clinical Data Versus Retinoid Clinical Data," provides an extensive evaluation of TFC-1326’s clinical trial...Read more
Highlights: New Research Collaboration with Monash University One proposal will target Antimicrobial Resistant Pathways to develop broad spectrum therapeutic drug products Second project proposal will focus on the Develop of new therapeutic drug candidates against Vancomycin-resistant enterococci (VRE) MELBOURNE, Australia, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and...Read more
Company to report on progress with clinical trials to be initiated in 2025 and expected milestones ATLANTA / Jan 15, 2025 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company, focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today...Read more
Marlborough, Massachusetts--(Newsfile Corp. - January 15, 2025) - 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 833,335 shares of its common stock...Read more
EDINBURGH, Scotland, Jan. 15, 2025 /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 that it intends to begin Proof of Concept preclinical studies for its lead therapeutic TCB008, for treatment in H5N1, commonly known as "Bird Flu." The Company is...Read more
Vancouver, British Columbia – TheNewswire - 15 January, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), is a clinical stage biopharmaceutical company in psychiatric medicine development using microdoses of psychedelic medicines to treat depressive disorders. The Company is delighted to provide an update on clinical trial progress and technology developments. MindBio is currently...Read more
WARRINGTON, Pa., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the issuance of a patent in Japan for “Inhibitors of atypical protein kinase C (aPKCi) and their use in treating hedgehog pathway-dependent cancers.” The patent number is...Read more
Set to begin larger Phase 2b study in sarcopenia and new trial in GLP-1-induced sarcopenia and frailty Transformative potential for novel TNF-alpha inhibitor drug: Estimated $40 billion TNF inhibitor market and $50 billion GLP-1 agonist market BALTIMORE / Jan 15, 2025 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral...Read more
Preliminary U.S. BRIUMVI fourth quarter and full year 2024 net product revenue of $103.6 million and $310 million, respectively Full Year 2025 target total global revenue of approximately $540 million, including BRIUMVI U.S. net product revenue of approximately $525 million NEW YORK, Jan. 14, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), yesterday announced preliminary U.S. net product revenue for BRIUMVI® for...Read more
Filing marks company’s first Marketing Authorization Application in Europe SAN DIEGO / Jan 14, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. If granted marketing authorization,...Read more
Full-Year 2024 Total Revenue Growth of 20% and Adjusted EBITDA Growth of Approximately 55% MACI Full-Year 2024 Revenue Growth of 20%, with Fourth Quarter Revenue of $68.2 to $68.7 Million Highest Quarterly MACI Implants, Surgeons, and Biopsies Since Launch and Strong Early MACI Arthro Launch Indicators Record Fourth Quarter Gross Margin of Approximately 77% and Adjusted EBITDA Margin of 39% 2025 Total Revenue Guidance of 20% to 23%...Read more
311 subjects enrolled across various stages of loading and randomization in SOL-R, Ocular’s second registrational trial of AXPAXLI™ in wet AMD, as of January 10, 2024 First wet AMD registrational trial, SOL-1, completed randomization in December 2024 with topline data anticipated in Q4 2025 Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR BEDFORD, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) --...Read more
SEATTLE and FORT MYERS, Fla., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq:ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, and NeoGenomics, Inc. (Nasdaq:NEO), a leading oncology testing services company, today announced a multi-year exclusive strategic commercial collaboration that will...Read more
REGENXBIO to receive $110 million upfront, potential milestone payments of up to $700 million and meaningful double-digit royalties on net sales, and lead manufacturing Nippon Shinyaku to lead commercialization of first potential gene therapies for Mucopolysaccharidosis II (MPS II) and Mucopolysaccharidosis I (MPS I) in U.S. and Asia REGENXBIO retains rights to RGX-121 Priority Review Voucher (PRV) with potential accelerated approval...Read more
Cemsidomide Data Presented at American Society of Hematology (ASH) Annual Meeting Support Best-in-Class Profile; Program Advancing to Next Phase of Clinical Development in Multiple Myeloma and Non-Hodgkin’s Lymphoma CFT1946 Phase 1 Trial Continues to Progress in BRAF V600X Solid Tumors With Monotherapy Dose Escalation Expected to Complete in 1H 2025; Data in Melanoma and Colorectal Cancer Expected in Second Half of 2025 CFT8919...Read more
VS-7375 is a potential best-in-class oral and selective KRAS G12D (ON/OFF) inhibitor currently in Phase 1 development in China in advanced KRAS G12D mutant solid tumors; Verastem anticipates filing a U.S. IND application for VS-7375 during Q1 2025 and expects to initiate a Phase 1/2a study mid-2025 License establishes global development and commercialization rights for Verastem for VS-7375 outside of China, Hong Kong, Macau, and...Read more
COVID-19 Phase 2b study poised to initiate 10,000 participant portion of trial pending U.S. Food and Drug Administration (FDA) review of sentinel cohort 30-day safety data Norovirus program to proceed with Phase 1 study following scientific advisory board and FDA feedback; Trial to initiate the first half of 2025 with topline data expected as early as mid-2025 New avian influenza vaccine candidate being tested in preclinical...Read more
STAFFORD, Texas, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the initiation of clinical sites in Germany. The Company has partnered with GBG (German Breast Group), the largest academic breast...Read more
ImmuneOnco announced dosing of first patient in its recently initiated Phase 1b/2 clinical trial of IMM2510/SYN-2510 in combination with chemotherapy in patients with advanced NSCLC in China ImmuneOnco announced initial clinical data from the 1L advanced NSCLC trial in China is expected as early as 2H 2025 Instil is targeting initiation of a potential first-line advanced NSCLC clinical trial of IMM2510/SYN-2510 combined with...Read more
VANCOUVER, British Columbia & DALLAS / Jan 14, 2025 / Business Wire / Alpha Cognition Inc. (Nasdaq: ACOG) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company committed to developing novel therapies for debilitating neurodegenerative disorders, today announced the strategic appointments of Jen Pesa, Vice President of Commercial; Jack Kelly, Head of Market Access; Rommel Fernandez, Vice President of Corporate Strategy and...Read more
HALIFAX, NS / ACCESSWIRE / January 14, 2025 / MedMira Inc. (MedMira) (TSXV:MIR) announced today that it has received today the approval from Health Canada for its Reveal®Rapid G4 HIV-1/2 Test (Reveal® HIV test) for Point-of-Care (POC) use. The Reveal® HIV rapid test has achieved a sensitivity of 99.64% and a specificity of 99.71% and with it is highly suitable for health care professionals who require a fast, reliable, and high-quality...Read more
SAN DIEGO and SUZHOU, China, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced it will host a virtual key opinion leader (KOL) event on Saturday, January 25, 2025 at 1:00 PM ET, featuring Aurélien Marabelle, MD, PhD (Université Paris-Saclay), Daneng Li, MD (City of Hope), and Marwan Fakih, MD (City of Hope), who...Read more
PH284 nasal spray demonstrated improvements to subjective feelings of hunger in cancer patients PH284 is the fifth pherine product candidate in Vistagen’s neuroscience pipeline with a positive efficacy signal SOUTH SAN FRANCISCO, Calif. / Jan 14, 2025 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced positive results from...Read more
CTIM-76 Phase 1 trial focused on CLDN6-positive gynecologic and testicular cancers Trial marks key milestone in driving pipeline progress PHILADELPHIA, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating...Read more
HUNTSVILLE, AL, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug delivery technology, today announced the appointment of Karen J. Wilson to the Board of Directors. "We are excited to welcome Karen to the Board of Directors. Karen’s financial expertise and deep understanding of the biotech landscape will play a...Read more
LA JOLLA, Calif., Jan. 14, 2025 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced the appointment of Alan Glicklich, M.D. to the Company's Board of Directors effective on January 15,...Read more
A 212-patient Confirmatory Registration Study for Multikine in PD-L1 low newly diagnosed head and neck cancer patients is currently in final stage of start-up preparations - full enrollment expected by Q2 2026 Plans to seek early approval based on pre-surgical response rates A positive study outcome will position Multikine as the first treatment in over 50 years for newly diagnosed locally advanced head and neck cancer patients – a...Read more
CAMBRIDGE, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Eterna Therapeutics (Nasdaq: ERNA), a leader in cell therapies for the treatment of advanced solid tumors, today announced positive results from a preclinical study on the company’s lead cell therapy product, ERNA-101, which is designed to activate and regulate the immune system's response to recognize and attack ovarian cancer cells. This successful proof-of-concept study demonstrated...Read more
VANCOUVER, British Columbia, Jan. 14, 2025 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic derivative of lysergic acid diethylamide (“LSD”), announced that the USPTO has granted the BETR-001 composition of matter patent US publication number US2023/0219955 with expiry in 2042....Read more
Highlights: Travelan® (IMM-124E) Phase 2 Clinical Study Report submitted to the FDA Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Immunology Results Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Microbiome Responses Travelan® P2TD (n=866) Uniformed Services University field study randomized 776 subjects MELBOURNE, Australia, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX:...Read more
SYDNEY, Jan. 14, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused drug development company, today announced that it has closed its previously announced registered direct offering with existing fundamental healthcare investor, Alumni Capital LP, of 1,333,333 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing 100...Read more
Study Supported by $2.6 Million FDA Orphan Products Development Grant PRINCETON, N.J., Jan. 14, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™...Read more
Marlborough, Massachusetts--(Newsfile Corp. - January 14, 2025) - 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 1,063,670 shares of its common stock...Read more
Continued Significant Improvement in Skin Appearance Observed in Study Subject’s Disease Classification Improved from “Severe” to “Mild” after 6 Weeks Dosing Treatment area expanded from 20% Body Surface Area to “Whole Body” ASHBURN, Va., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases,...Read more
Interim data from Cohort 4 expected Q1 2025 MIAMI, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced it has opened three clinical trial sites in Eastern Europe. These...Read more
Follows Safety Review Committee (SRC) approval based on safety data from patients in Cohorts 1 and 2 No significant safety or dose limiting toxicities reported in Cohorts 1 and 2 PK data from Cohorts 1 and 2 consistent with preclinical and Phase 0 trial results BOSTON, Jan. 14, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA...Read more
BRANFORD, Conn., Jan. 14, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that it has commenced a public offering of shares of its common stock (or pre-funded warrants in lieu thereof). All of the shares of common stock (or pre-funded warrants in lieu thereof) to be sold in the proposed offering...Read more
Primary endpoint of DFS met at first prespecified interim analysis, showing a 68% reduction in the risk of disease recurrence or death in patients with high-risk CSCC after surgery compared to placebo Libtayo is the first and only immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting; a recent Phase 3 trial with Keytruda® failed in the same setting1 Libtayo is...Read more
Dupixent® is now used to treat over a million patients globally, with continued growth and expansion in multiple indications for diseases in which type 2 inflammation plays a role EYLEA HD® and EYLEA® remained the U.S. anti-VEGF category leader in 2024; aggregate U.S. net product sales were $6 billion for full-year 2024, up 1% based on preliminary (unaudited) results EYLEA HD pre-filled syringe (PFS) submission completed; launch...Read more
The Truveta collaboration will extend Regeneron Genetics Center’s® (RGCTM) world-leading DNA sequence-linked healthcare database (now including almost three million de-identified patient volunteers) through genetic sequencing of up to ten million additional patient volunteers, all with linked electronic health records, creating the Truveta Genome Project Extensively expanded database effort is designed to dramatically accelerate...Read more
2025 will be a transformational year for Incyte with multiple significant milestones, including four potential launches, four pivotal trial readouts, seven proof of concept data readouts and at least three Phase 3 study initiations Well-positioned for long-term growth, the Company has the potential to deliver more than 10 high impact launches across its portfolio by 2030 WILMINGTON, Del. / Jan 13, 2025 / Business Wire / Incyte...Read more
Achieved 2024 product sales of $3.0 to 3.1 billion (unaudited) and an ending cash balance of approximately $9.5 billion (unaudited) Updates 2025 expected revenue range to $1.5 to 2.5 billion Expects to reduce 2025 cash cost expenses by $1.0 billion with a plan for additional 2026 cost reductions of $0.5 billion Updates 2025 expected ending cash balance to approximately $6.0 billion Anticipates milestones across 10 prioritized...Read more
Preliminary total net product revenue of $638.2 million for the fourth quarter and $1.79 billion for full-year 2024, exceeding full-year guidance by over $100 million Preliminary ELEVIDYS net product revenue totaled $384.2 million for the fourth quarter, exceeding guidance by over $60 million, and $820.8 million for full-year 2024 Preliminary RNA-based PMO net product revenue for the fourth quarter and full-year of 2024 totaled $254.0...Read more
Preliminary fourth-quarter and full-year 2024 Rezdiffra™ (resmetirom) net sales ranges of $100 million to $103 million and $177 million to $180 million, respectively Preliminary year-end 2024 cash, cash equivalents, restricted cash and marketable securities of approximately $931 million As of year-end 2024, more than 11,800 patients on Rezdiffra Madrigal to present at the 43rd Annual J.P. Morgan Healthcare Conference at 2:15 p.m. PST...Read more
Remarkable early Attruby demand: 430 scripts written by 248 unique HCPs since FDA approval with broad uptake across academic centers and community centers in all patient types Fully enrolled three major market Phase 3 clinical trials: FORTIFY (BBP-418 for LGMD2I/R9); CALIBRATE (encaleret for ADH1); and PROPEL 3 (infigratinib for Achondroplasia) Well-financed to launch Attruby and read out major market Phase 3 trials: $406M in...Read more
Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively Sunosi preliminary 4Q and full year 2024 net product revenue of $25.7 million and $93.8 million, respectively NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced...Read more
Presents progress and new anticipated milestones across portfolio of more than 10 assets and 6 therapeutic areas. Announces multiple advancements across the MoDETM (molecular degraders of extracellular proteins) platform and the next generation TRAPTM (targeted removal of aberrant protein) degraders, including: IgA Nephropathy (IgAN) program: First-in-human dosing with BHV-1400, a next generation TRAP degrader, achieved rapid,...Read more
FY 2024 Preliminary Unaudited Total Revenue of Approximately $417-425 Million, Exceeding Previous Guidance of $415 Million YE 2024 Total Cash Grew to More than $100 Million, an Increase of Approximately $45 Million Q-o-Q, Notwithstanding $30 Million of Debt Organically Discharged During 4Q 2024 Newly Executed High Titer Plasma Supply Contracts Expected to Provide Foundation for Durable ASCENIV Revenue Growth Through Late 2030s PAS...Read more
Reports $709 million in preliminary1 full-year 2024 U.S. net product revenues $611 million in SYFOVRE® U.S. net product revenues, including $167 million in 4Q 2024 $98 million in EMPAVELI® U.S. net product revenues, including $23 million in 4Q 2024 Expects submission of EMPAVELI sNDA for C3G and primary IC-MPGN in early 2025; U.S. launch anticipated in 2H 2025, if approved Plans initiation of Phase 3 studies of...Read more
NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that it has agreed to sell an aggregate of 22,500,000 shares of common stock at a purchase price of $20.00 per share to three institutional accredited investors in a private investment in public equity (PIPE). Immunovant anticipates...Read more
Achieved $61.5 million and $172.0 million in preliminary fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively Ended 2024 with approximately $462 million in cash, cash equivalents, and marketable securities Additional updates across Company’s commercial portfolio and investigational pipeline to be provided during J.P. Morgan Healthcare conference presentation today at 11:15 a.m....Read more
2024 net product sales of approximately $336 million exceeds upper end of guidance range; preliminary and unaudited estimate 2025 expected global net product sales of $420 million to $435 million VISTAS study of volixibat in primary sclerosing cholangitis expected to complete enrollment in second half 2025; topline data expected 2026 FOSTER CITY, Calif. / Jan 13, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today...Read more
WAKIX® (pitolisant) Preliminary Net Revenue of ~$201 Million for Fourth Quarter and ~$714 Million for Full Year 2024; Representing Growth of ~23% in Year-Five of Launch 2025 WAKIX Net Revenue Guidance Between $820 - $860 Million; On Track to a Potential $1 Billion+ Opportunity Value-Creating Catalysts Anticipated Every Quarter in 2025: - Q1 – FDA Decision on File Acceptance of Pitolisant sNDA...Read more
BRISBANE, Calif., Jan. 13, 2025 (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 diseases, today announced an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic...Read more
601 patients have been enrolled in the double-blind portion of the SYNCHRONY Real-World study since initiation in November 2023 Data from SYNCHRONY Real-World study anticipated in the first half of 2026 SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked...Read more
Preliminary 2024 HEPLISAV-B® net product revenue grew 26% year-over-year to approximately $268 million Enrollment completed in Phase 1/2 shingles trial; top line results expected in Q3 2025 New $30 million contract with U.S. Department of Defense to advance plague vaccine program Cash, cash equivalents and marketable securities were approximately $714 million as of December 31, 2024 EMERYVILLE, Calif., Jan. 13, 2025 /PRNewswire/...Read more
Preliminary 2024 OJEMDA™ (tovorafenib) net product revenue of approximately $57.2 million (unaudited) First dose cohort cleared in Phase 1a/b clinical trial of DAY301 (PTK7-targeted ADC) Ended 2024 with approximately $531.7 million in cash, cash equivalents and short-term investments (unaudited) Company to present at 43rd Annual J.P. Morgan Healthcare Conference today at 3:45 p.m. Pacific Time (6:45 p.m. Eastern Time)...Read more
Preliminary fourth quarter neffy® net product revenue of approximately $6.5 million Preliminary cash, cash equivalents and short-term investments of $314.0 million at year-end 2024 to support an operating runway of at least three years Company to present at 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025 at 7:30am PT SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY),...Read more
VANCOUVER, British Columbia / Jan 13, 2025 / Business Wire / AbCellera (Nasdaq: ABCL) announced today that it has expanded its existing collaboration with AbbVie Inc. (NYSE: ABBV) to include the discovery of T-cell engagers (TCE) in oncology. The expansion builds upon the successful partnership established in December 2022 and includes access to AbCellera’s TCE platform to develop therapeutic antibodies for tumor targets. “We are pleased...Read more
| Company | Change | Last Trade |
|---|---|---|
| Madrigal Pharmaceuticals | 20.85 7.64 | $293.64 |
| Blueprint Medicines | 6.10 5.87 | $110.05 |
| Vertex Pharmaceuticals | 5.04 1.21 | $422.00 |
| MoonLake Immunotherapeutics | 4.29 10.34 | $45.76 |
| Krystal Biotech | 3.58 2.47 | $148.39 |
| Belite Bio | 3.17 5.98 | $56.21 |
| Rigel Pharmaceuticals | 2.78 16.02 | $20.13 |
| Vericel | 2.72 4.83 | $59.07 |
| Aligos Therapeutics | 2.64 8.35 | $34.25 |
| Biohaven | 1.74 4.85 | $37.59 |
| Neurocrine Biosciences | 1.34 0.94 | $143.26 |
| Legend Biotech | 1.23 3.91 | $32.66 |
| Exicure | 1.18 13.27 | $10.07 |
| Akero Therapeutics | 1.13 4.71 | $25.14 |
| Mirum Pharmaceuticals | 1.12 2.44 | $46.95 |
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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