Results from MIRASOL Also Show ELAHERE is the First Treatment to Demonstrate an Overall Survival Benefit in a Phase 3 Trial in Platinum-Resistant Ovarian Cancer Compared to Chemotherapy Clinically Meaningful Improvements in Progression Free Survival and Overall Survival Observed with ELAHERE Regardless of Prior Bevacizumab Status Data Further Support Potential of ELAHERE to Become the New Standard of Care for Patients with FRα-Positive...Read more
Phase 2 Mechanism of Action Trial Results Demonstrate the Immunomodulatory Effects of Trilaciclib in the Tumor Microenvironment Trilaciclib Enhances Expression of Genes Associated with Memory T Cells Trilaciclib Increases Multiple Surrogate Immune Markers for Memory CD8+ T Cell Differentiation, Infiltration,and Function RESEARCH TRIANGLE PARK, N.C., June 04, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a...Read more
Overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated RANO-HGG evaluable patients The Company expects to complete rolling NDA submission in October 2023 Conference call and webcast today at 6:00 p.m. CT BRISBANE, Calif., June 04, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical Company dedicated to...Read more
LOS ANGELES / Jun 04, 2023 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of biomarker findings from a Phase II study of alisertib plus paclitaxel versus paclitaxel alone (Clinicatrials.gov identifier NCT02187991) in metastatic hormone receptor positive (HR+) and triple negative (TN) breast cancer at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held...Read more
Data Supporting Summit’s Planned Phase III Trial for First-line Metastatic Squamous NSCLC Patients on Display Phase II ORR of 67% with a mDOR of 15 months in 1L SQ-NSCLC Patients MENLO PARK, Calif. / Jun 04, 2023 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is...Read more
Data presented at ASCO annual meeting demonstrate 55% Disease Control Rate (DCR) in heavily pre-treated GIST patients, including 100% DCR and 17% overall response rate (ORR) in efficacy evaluable 2nd-line GIST patients; data immature to estimate progression free survival (PFS) Combination of bezuclastinib and sunitinib is well-tolerated and consistent with published sunitinib monotherapy safety profile Cogent to...Read more
Clinically Meaningful Reduction in Risk of Progression or Death Was Observed in the Domvanalimab-Containing Study Arms Compared to Zimberelimab Monotherapy in First-Line, PD-L1-High NSCLC Objective Response Rate (ORR) Improved in Both Domvanalimab-Containing Study Arms Compared to Zimberelimab Monotherapy Results Will Be Presented Today During the American Society of Clinical Oncology (ASCO) Annual Meeting FOSTER CITY, Calif., &...Read more
Met Primary Endpoint with 63.4% Median Reduction in LDL-C (p<0.0001) 87.1% of Patients Treated with Combination of Obicetrapib and Ezetimibe Met Guideline-Recommended LDL-C Goal of <55 mg/dL compared to 0% of Patients Treated with Placebo (p<0.05) New Data Demonstrate Statistically Significant and Clinically Meaningful Improvements in Additional Lipid and Lipoprotein Parameters Predictive of Cardiovascular Disease Risk, Such...Read more
PRGN-2009 combined with an investigational checkpoint inhibitor resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers that were naïve or resistant to checkpoint blockade with prolonged duration of responses Recurrent/metastatic HPV-associated cancers (cervical, anal, oropharyngeal, etc.) are incurable by current therapies PRGN-2009 was safe and well-tolerated with only Grade 1 or 2 treatment related adverse...Read more
The clinical trial of the personalized cancer vaccine EVX-01 met its primary endpoints of safety and tolerability Positive clinical responses were reported in 8 out of 12 EVX-01 treated patients High-quality neoantigens, predicted by AI technology, were associated with longer progression-free survival Strong vaccine-specific immune responses were induced in all 12 EVX-01 treated patients Higher EVX-01 dose induced a stronger...Read more
Breadth of pipeline featured in multiple early clinical data presentations, reflecting diversity of fundamental growth drivers across development programs CAMBRIDGE, Mass., June 3, 2023 /PRNewswire/ -- Blueprint Medicines Corporation (Nasdaq: BPMC) today announced clinical data for multiple programs across its precision therapy portfolio at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentations...Read more
Initial data showed promising signs of efficacy, including a 47.1% ORR in patients with resistant/refractory gastric cancer expressing Claudin 18.2, with a well-tolerated safety profile Elevation Oncology on track to initiate Phase 1 clinical trial in the US in the second half of 2023 NEW YORK, June 3, 2023 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and...Read more
Long Term Follow Up Data from Phase 1 ALPHA/ALPHA2 Trials Demonstrate Potential of Allogeneic CD19 CAR T to Generate Durable Complete Responses Similar to Approved Autologous Therapies Presentation Focused on Patients (n=12) Treated with Phase 2 Regimen 67% Overall Response Rate (ORR) and 58% Complete Response (CR) Rate Five Patients (42%) Maintained a CR at Month 6; Four of Five CRs (80%) Ongoing Beyond Six Months, Including Two...Read more
Updated data from ongoing IGNYTE anti-PD1 failed melanoma cohort shows RP1 combined with nivolumab continues to demonstrate deep and durable responses with a well-tolerated safety profile; no progression in responding patients since the data snapshot presented in December 2022 Overall response rate (ORR) of 37.4%, with clinically meaningful activity across the range of anti-PD1 failed cutaneous melanoma settings enrolled, including in...Read more
Marked increases in overall survival observed across soft tissue sarcoma patients Demonstrated improvement of median progression free survival in patients with dedifferentiated liposarcoma (DDLPS) DDLPS expansion cohort enrolling to inform a potential Phase 3 registration trial SAN CARLOS, Calif., June 03, 2023 (GLOBE NEWSWIRE) -- Apexigen, Inc. (Nasdaq: APGN) a clinical-stage company focused on developing innovative antibody-based...Read more
Zevra is a corporate sponsor of the Hypersomnia Foundation and Beyond Sleepy Conference CELEBRATION, Fla., June 03, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly Zevra.), a rare disease therapeutics company, today announced that an oral presentation featuring the Phase 2 clinical trial design evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological...Read more
ELI-002 was shown to be well-tolerated with no dose limiting toxicity or cytokine release syndrome A high proportion of patients had tumor biomarker reduction (77%) with 32% having complete clearance Robust mKRAS-specific T cell responses induced in 87% of patients BOSTON, June 03, 2023 (GLOBE NEWSWIRE) -- Elicio Therapeutics (Nasdaq: ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for...Read more
Consistent with data shared in January 2023, the presentation at ASCO 2023 highlights data from the Phase 1 dose-expansion study for luveltamab tazevibulin, or luvelta, in ovarian cancer, demonstrating that FolRα-selected patients, who represent 80% of the patient population, experienced substantial clinical benefit REFRaME-O1, the Phase 2/3 pivotal study of luvelta for patients with platinum-resistant ovarian cancer has been initiated...Read more
CYT-0851 has demonstrated early activity in combination with capecitabine or gemcitabine in advanced solid tumors and a generally well tolerated safety profile in a heavily pretreated population of patients Overall disease control rate was 71.4% with the capecitabine combination and 87.5% with the gemcitabine combination Enrollment in the Phase 1 dose escalation study continues with preliminary data expected in mid-2023 LEXINGTON,...Read more
Early on-treatment ctDNA reduction in stable disease patients treated with KIMMTRAK was associated with longer overall survival (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md, 3 June 2023) Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases,...Read more
Data on BCMA/CD19 dual-targeting FasTCAR-T GC012F showed 100% minimal residual disease (MRD) negativity and 82.8% MRD negative stringent complete response (sCR) in a predominantly high-risk relapsed/refractory multiple myeloma (RRMM) population Data on GC012F for treatment of B-NHL will be presented on June 5 in a poster presentation at 2023 ASCO Annual Meeting SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China, June 3, 2023...Read more
Data update from AFM24-101 phase 1/2 monotherapy study includes 15 patients from the EGFR mutant non-small cell lung cancer (NSCLC) cohort AFM24 showed clinical activity in 7 out of 15 heavily pre-treated patients with tumor reductions, including 2 confirmed partial responses and 5 patients exhibiting stable disease In line with previous results, the majority of patients experienced only mild to moderate treatment-related adverse...Read more
Results presented today at ASCO 2023 and concurrently published in The Lancet Oncology demonstrate meaningful clinical benefit including antitumor activity, confirmed objective response rate (cORR) of 41.3%, median duration of response (DOR) of 12.9 months, and median progression-free survival (PFS) of 5.5 months (median study follow-up time of 12.4 months) Biliary tract cancers (BTC) are an aggressive group of cancers with no...Read more
Additional data from Phase 1 combination with FOLFIRI continues to show encouraging activity in median third-line metastatic colorectal cancer patients Progression-free survival of 5.6 months in median third-line colorectal cancer patients without bevacizumab Promising safety profile in combination with FOLFIRI and bevacizumab Randomized combination trial in second-line colorectal cancer patients initiated in Q1 2023 MOUNTAIN...Read more
BNT316/ONC-392 is a next-generation anti-CTLA-4 monoclonal antibody candidate jointly developed by BioNTech and OncoC4 as monotherapy or combination therapy in a range of solid tumor indications, including non-small cell lung cancer (NSCLC) Interim data of BNT316/ONC-392 from the ongoing Phase 1/2 trial to be presented at this year’s ASCO Annual Meeting demonstrate encouraging signs of clinical anti-tumor activity and a manageable...Read more
NEW YORK, June 02, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. A link to the oral presentation is included below. Michael S. Weiss, Chairman and Chief...Read more
76% of patients treated with obe-cel in the FELIX study achieved a response (CR/CRi), primary endpoint has been met based on previously communicated interim analysis Potential best in class tolerability, with very low levels of high-grade CRS and ICANS Robust and reliable manufacturing and logistics, with 84% of enrolled patients receiving obe-cel Analyst call to be held today, June 2, 2023 at 4.00 pm ET/9.00 pm BST LONDON, June...Read more
Tel-Aviv, June 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), today announced positive topline results from its investigator-initiated Phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center (“IMCA”), which suggest that the...Read more
VANCOUVER, BC, June 2, 2023 /CNW/ - Asep Medical Holdings Inc. ("Asep Inc." or the "Company") (CSE: ASEP) (OTCQB: SEPSF) (FSE: JJ8) announces the ground-breaking use of artificial intelligence (AI) to rapidly identify infections at increased risk of severe sepsis. The method was developed by the Hancock Lab, under the guidance of Dr. Robert E.W. Hancock, Killam Professor at the University of British Columbia (UBC), and analyzes the...Read more
Skye plans to complete enrollment of Phase 1 study in June San Diego, California--(Newsfile Corp. - June 2, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, reports that the safety review committee for its Phase 1 clinical trial of SBI-100 Ophthalmic Emulsion ("OE") has reviewed the data from the trial's fifth...Read more
LMNL6326 nominated as lead preclinical candidate for OXER1 antagonist development program, targeting the treatment of eosinophil-driven diseases Advancement of clinical trial application (CTA) enabling preclinical studies of LMNL6511 to support CTA filing for Phase 1 clinical trial in H2 2023 Insights gained from In Vivo preclinical studies of LMNL6511 to further refine potential indications' spectrum GPR40 agonist development...Read more
SAN DIEGO, June 2, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented findings from a meta-analysis of three long-term studies evaluating INGREZZA® (valbenazine) capsules that demonstrated substantial and sustained improvements in tardive dyskinesia (TD) in adults with or without concomitant antipsychotic therapy. The data (Poster #4) were presented at 2023 Psych Congress Elevate in Las Vegas. The...Read more
New data emphasizes the value of MRD testing in predicting survival outcomes and informing the personalized treatment of patients with hematologic cancers clonoSEQ continues to be the MRD test of choice for biopharma companies as evidenced in over a dozen investigational studies across multiple therapeutic approaches SEATTLE, June 02, 2023 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage...Read more
Event to be webcast live on Wednesday, June 7, 2023 at 4:30 p.m. ET CAMBRIDGE, Mass. & MONTREAL / Jun 02, 2023 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced it will host a conference call and live webcast to present initial monotherapy data from its Phase 1 MYTHIC clinical trial evaluating RP-6306, as well as to provide early...Read more
CAMBRIDGE, Mass. / Jun 02, 2023 / Business Wire / Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that Eric Shaff, President and Chief Executive Officer of Seres Therapeutics, will provide a corporate presentation at the Jefferies Healthcare Conference on Wednesday, June 7, 2023 at 8:00 a.m. ET in New York City. An audio webcast of the presentation will be available under the “Investors...Read more
Primary endpoint of 8-week transfusion independence (TI) significantly higher with imetelstat vs. placebo (P<0.001), with median TI duration approaching one year for imetelstat 8-week TI responders Statistically significant and clinically meaningful efficacy results achieved across key MDS subgroups: ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category Safety results consistent with prior imetelstat...Read more
CAMBRIDGE, Mass. & SALISBURY, England / Jun 02, 2023 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the acceptance of multiple abstracts at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) Congress, taking place in Hamburg, Germany and...Read more
BOSTON, June 02, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced Douglas A. Treco, Ph.D., the company’s chief executive officer and chairman of the board, will present at the Jefferies Healthcare Conference on Friday, June 9, 2023, from 9:30-9:55 a.m....Read more
AUSTIN, Texas / Jun 02, 2023 / Business Wire / Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that its management team will participate in a fireside chat at the Jefferies Healthcare Conference on June 9, 2023 at 10:30 am ET/7:30 am PT. A live webcast of the fireside chat will be available on Savara’s website at www.savarapharma.com/investors/events-presentations/...Read more
PRINCETON, N.J. / Jun 02, 2023 / 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 it will present at the following investor conferences in June: Jefferies 2023 Healthcare Conference — June 7-9, 2023 Fireside Chat Date: Friday, June 9th from 12:45-1:10pm ET Webcast Link:...Read more
BOSTON, MA / ACCESSWIRE / June 2, 2023 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory and cancer diseases, today announced that Stephen Yoder, president and chief executive officer of Pieris, will participate in a fireside chat at the Jefferies Healthcare Conference on Friday, June 9, 2023 at 10:00...Read more
CAMBRIDGE, Mass., June 2, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that John Butler, Chief Executive Officer, will present at the Jefferies Healthcare Conference on Wednesday, June 7, 2023 at 8:30 a.m. ET. In his presentation, Mr. Butler will discuss recent regulatory updates regarding...Read more
WATERTOWN, Mass., June 02, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage biotechnology company developing innovative therapies for the localized treatment of patients with chronic rhinosinusitis (CRS), today announced that Maria Palasis, Ph.D., President and Chief Executive Officer, will present at the Jefferies Healthcare Conference in New York, NY on Wednesday, June 7, 2023, at 10:30 a.m. ET. A live...Read more
CAMBRIDGE, Mass. and NEW YORK, June 02, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today announced that its President and Chief Executive Officer, David M. Epstein, Ph.D.,...Read more
IRVINE, Calif., June 02, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that David-Alexandre C. Gros, M.D., Chief Executive Officer, will present a company overview at the upcoming Jefferies Healthcare Conference on Friday, June 9, 2023, at 9:00 a.m. ET. To register in advance for the presentation webcast, sign up here. A webcast replay will be accessible following the live session on the...Read more
New Patient Data Further Implicates CCL24 in Fibrotic Disease Pathology and Prognosis and Supports Rationale for the Role of Chemomab's CCL24-Neutralizing Antibody CM-101 in Systemic Sclerosis and Other Fibro-inflammatory Diseases MILAN and TEL AVIV, Israel, June 2, 2023 /PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of...Read more
ARLINGTON, Mass., June 02, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced that it will present at the Jefferies Healthcare Conference being held in New York, NY. Members of Kala’s management team will participate in a fireside chat on...Read more
BOSTON, June 02, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that management will present at the 2023 Jefferies Healthcare Conference on Friday, June 9, 2023 at 8:00 a.m. ET. The event...Read more
SAN DIEGO, June 02, 2023 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with other life science companies to develop and commercialize innovative products in the United States, today announced that Charles...Read more
LONDON, June 02, 2023 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today announced that its Chief Executive Officer Michael Parini will present at the 2023 Jefferies Healthcare Conference being held in New York on June 7-9, 2023. The presentation will take place at 8 a.m. ET on June 9, 2023. Senior management will also participate in one-on-one investor meetings during the conference. A live webcast of...Read more
RADNOR, Pa., June 2, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced it will host a corporate and strategic update conference call on Monday, June 5, 2023 at 8:30 a.m. EDT. A live webcast of the conference call will be available on the Company's website at https://ir.nrxpharma.com/news-events/ir-calendar. An archive of...Read more
WATERTOWN, Mass., June 02, 2023 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, today announced the company’s president...Read more
Sydney, Australia, June 02, 2023 (GLOBE NEWSWIRE) -- Immutep Limited, an Australian company (ASX: IMM) (Nasdaq: IMMP) (Immutep or the Company), is pleased to announce the successful completion of an institutional placement (Placement) and the institutional component (Institutional Entitlement Offer) of its 1 for 7.6 pro rata accelerated non-renounceable entitlement offer (Entitlement Offer and, together with the Placement, the Offer) of...Read more
MARLBOROUGH, Mass., June 2, 2023 /PRNewswire/ -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced the closing of its previously announced registered direct offering of 233,646 shares of common stock, at a purchase price of $4.28 per share. In a concurrent private...Read more
SAN DIEGO / Jun 02, 2023 / Business Wire / MEI Pharma, Inc. (NASDAQ: MEIP) (the “Company”), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that, in connection with the Company’s previously announced succession plan, Daniel P. Gold, Ph.D’s tenure as the president and chief executive officer of MEI will end on June 2, 2023 and the Company’s board of directors has appointed David M. Urso...Read more
WASHINGTON, June 1, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VCA-894A for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), caused by cryptic splice site variants within IGHMBP2. CMT2S is a rare subtype of Charcot-Marie-Tooth disease (CMT), an inherited peripheral neuropathy for which...Read more
CLEVELAND / Jun 01, 2023 / Business Wire / Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine company developing MultiStem® (invimestrocel) cell therapy for critical care indications, announces patient enrollment has begun in the third and final cohort in MATRICS-1, the Phase 2 clinical study evaluating MultiStem® in patients following resuscitation from hemorrhagic trauma. This study is being conducted at The University of Texas Health...Read more
SOUTH SAN FRANCISCO, Calif., June 01, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, will hold an investor conference on Monday, June 5 at 8:00 a.m. ET to share results from Cohort D of the Phase 2b SYMMETRY study. The primary aim of the 12-week study was to assess the safety and...Read more
Icanbelimod demonstrated sustained clinical remission, a regulatory relevant efficacy endpoint, through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period. Icanbelimod continued to be well-tolerated, consistent with observed induction period safety data. SAN DIEGO, CA and TAICANG, China, June 01, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma”...Read more
First marketed engineered T-cell therapy for a solid tumor; BLA for afami-cel on track to complete submission in mid-2023 Compelling clinical data with late-stage programs targeting MAGE-A4 and mesothelin Preclinical programs targeting PRAME and CD70 in IND-enabling studies Adaptimmune funded into early 2026 with multiple value creating catalysts Webcast to be held tomorrow, June 2nd at 8 a.m. EDT:...Read more
Through a research collaboration with Janssen, a lead candidate was identified for further development towards clinical studies. In May 2020, LAVA entered into a research collaboration and license agreement with Janssen for the discovery and development of novel bispecific antibody-based gamma delta T cell engagers for the treatment of cancer. The agreement was facilitated by Johnson & Johnson Innovation. LAVA is also eligible to...Read more
Scientific Advisory Board members bring significant global expertise in oncology drug and clinical development NEW YORK / Jun 01, 2023 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the formation of a Scientific Advisory Board. The Scientific Advisory Board will work...Read more
Shares of Elicio to commence trading on Nasdaq under the ticker symbol “ELTX” on June 2, 2023 First in human Phase 1 data on lead candidate ELI-002 to be presented at 2023 American Society of Clinical Oncology (ASCO) BOSTON, June 01, 2023 (GLOBE NEWSWIRE) -- Elicio Therapeutics (Nasdaq: ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the...Read more
Dr. Loew to Assume New Leadership Role Upon Completion of the Planned Separation of Alkermes' Oncology Business Planned Separation Remains on Track to be Completed in Second Half of 2023 DUBLIN, June 1, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that Caroline J. Loew, Ph.D., has been appointed as the chief executive officer designate of Mural Oncology plc (Mural Oncology), the new independent...Read more
EDEN PRAIRIE, Minn., June 01, 2023 (GLOBE NEWSWIRE) -- Miromatrix Medical Inc. (NASDAQ: MIRO), a life sciences company pioneering a novel technology for bioengineering fully transplantable organs to help save and improve patients’ lives, today announced that Miromatrix and John Barry have mutually agreed to end his employment as Vice President of Research and Development ("R&D") effective on or around June 13, 2023, and that Jeff...Read more
Two-year treatment with donidalorsen in the Phase 2 open label study resulted in consistent, sustained protection from HAE attacks Completed enrollment in the Phase 3 OASIS-HAE study Topline Phase 3 results expected in H1 2024 CARLSBAD, Calif., June 1, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive clinical progress with donidalorsen, its late-stage investigational prophylactic therapy for...Read more
Topline Phase 1 monotherapy and initial combination data expected in 2024 BOSTON, June 01, 2023 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced that the first patient has been dosed in its Phase 1/2 clinical trial evaluating SNS-101 for the treatment of advanced...Read more
EDMONTON, Alberta / Jun 01, 2023 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced the results of a post-hoc, pooled analysis of the Phase 2 AURA-LV (NCT02141672) and Phase 3 AURORA 1 (NCT03021499) studies, which found that LUPKYNIS® with mycophenolate mofetil (MMF) and low-dose steroids resulted in earlier and greater reductions in proteinuria in lupus nephritis (LN) patients with high...Read more
U.S. Clinical Sites Screening Treatment-Experienced Participants with Wet AMD ODYSSEY Topline Results Expected in Q3 2024 ALPHARETTA, Ga., June 01, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that enrollment has opened in ODYSSEY, its Phase 2b...Read more
Patient in 520 mg/m2 cohort, previously unresectable, experienced tumor shrinkage and had tumor resected following camsirubicin treatment 3 of 3 patients in the 520 mg/m2 cohort achieved stable disease WILMETTE, Ill., June 01, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, today announced an update...Read more
Study is Investigating RenovoGem™ as Potential New Option for Pancreatic Cancer Treatment Recent Positive Interim Data Analysis from Study Revealed 60% Survival Benefit and 65% Side Effect Reduction Versus Systemic Chemotherapy LOS ALTOS, Calif. & DALLAS / Jun 01, 2023 / Business Wire / RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies,...Read more
HAT-301 is the Pivotal Efficacy Study to Support Upcoming NDA Filing Top Line Results Planned for Release in July 2023 TARRYTOWN, NY, June 01, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD), and other serious conditions with intractable...Read more
SAN DIEGO / Jun 01, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company’s mRNA...Read more
Submitted four efficacy supplements seeking inclusion of CV risk reduction and expansion of LDL-C lowering Anticipated approvals in U.S. in the first half of 2024 ANN ARBOR, Mich., June 01, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has submitted Supplemental New Drug Applications (sNDA) to the U.S. Food and Drug Administration (FDA) for the Company’s oral non-statin products NEXLETOL and...Read more
AUSTIN, Texas, June 01, 2023 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (“ETBs”), to create novel therapies with potent differentiated mechanisms of action for cancer, announced today that the U.S. Food and Drug Administration...Read more
GAITHERSBURG, Md., June 1, 2023 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that its PIKA Rabies Vaccine (the "Vaccine") was granted Phase 3 clinical trial approval from the Food and Drug...Read more
NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the European Commission (EC) has granted approval of BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. BRIUMVI was granted approval by the U.S. Food and Drug Administration on December 28, 2022, for the...Read more
Reaffirms Full Year 2023 Total Revenue Guidance of Between $375 Million and $385 Million Forecasts FIRDAPSE® 2023 Net Product Revenue Guidance of Between $245 Million and $255 Million, an Increase of 17% YoY Forecasts FYCOMPA® 2023 Net Product Revenue of Approximately $130 Million for 11 Months Reaffirms Full Year 2023 Non-GAAP Net Income Forecast of Between $195 Million and $205 Million CORAL GABLES, Fla., June 01, 2023 (GLOBE...Read more
VASCEPA Approved by the National Medical Products Administration (NMPA) as an Adjunct to Diet to Reduce Triglyceride Levels in Adult Patients with Severe Hypertriglyceridemia (≥ 500 mg/dL) EddingPharm Now Working Towards Preparing for Commercial Launch of VASCEPA Across Mainland China Expected by Year-End DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today...Read more
YUSIMRY™ (adalimumab-aqvh) will be the first biologic product offered by the Mark Cuban Cost Plus Drug Company YUSIMRY will be available on costplusdrugs.com for $569.27 plus dispensing and shipping fees DALLAS, Texas and REDWOOD CITY, Calif., June 01, 2023 (GLOBE NEWSWIRE) -- Mark Cuban Cost Plus Drug Company, PBC (“Cost Plus Drugs” or “Mark Cuban Cost Plus Drug Company”) and Coherus BioSciences, Inc....Read more
NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was awarded new U.S. Patent No....Read more
REDWOOD CITY, Calif., June 01, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced that the company plans to launch YUSIMRY™ (adalimumab-aqvh) in July 2023* with a list price of $995 per carton (2 x 40 mg/0.8 mL autoinjectors), the lowest price announced to date of any adalimumab offering in the United States. With Humira® currently priced at $6,922 per carton of two autoinjectors, the YUSIMRY...Read more
LEIDEN, The Netherlands, June 1, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that it has entered into a definitive agreement with Novartis Pharma A.G. ("Novartis") to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to Novartis for a pre-agreed, one-time payment of approximately US$21.1 million shortly after closing. Pharming was granted the PRV by...Read more
Cutting-edge spatial omics technologies to map cancer cells and their immune environment in high resolution, allowing AI to unlock potential for new breakthrough treatments Landmark research project is 100x larger than existing efforts Data will be generated from thousands of patients across multiple cancers University of Pittsburgh, Gustave Roussy, Lausanne University Hospital, Uniklinikum Erlangen/Friedrich-Alexander-Universität...Read more
Reunion Common Shareholders to Receive Consideration of US$1.12 Per Share in Cash Represents a 43.1% Premium to the 30-Day Volume Weighted Average Price Reunion Presents Encouraging Phase 1 Final Analysis at American Society of Clinical Psychopharmacology Annual Meeting, Enabling Advancement into Phase 2 in 2H 2023 TORONTO, June 01, 2023 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc. (NASDAQ: REUN, TSX: REUN) (“Reunion” or the...Read more
Data published online in the journal Cytotherapy demonstrate that CRISPR-mediated tissue factor gene knockout (TFKO) in allogeneic stromal cells (ASCs) leads to significantly lower tissue factor (TF) expression, activity, and thrombotic effects, providing a feasible strategy potentially to improve the safety of ASC-based cell therapy FLORHAM PARK, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”),...Read more
REDWOOD CITY, Calif., June 01, 2023 (GLOBE NEWSWIRE) -- Seer Inc. (NASDAQ: SEER), a life sciences company commercializing a disruptive new platform for proteomics, today announced the launch of the Proteograph XT Assay Kit, the latest proteomics assay workflow for the Proteograph Product Suite. This new product increases throughput without compromising performance, making it possible for a single user to process hundreds of samples per...Read more
MUNICH, Germany and TEL AVIV, Israel, June 01, 2023 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (the "Company" or "NurExone") (TSXV: NRX) (FSE: J90), a biopharmaceutical company developing biologically-guided exosome therapy ("ExoTherapy") for patients with traumatic spinal cord injuries, is pleased to announce a pioneering collaboration with the German company, Particle Metrix, a leading provider of particle analysis devices. In...Read more
BOSTON, June 01, 2023 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced that the Company will participate in the following investor events during the month of June 2023. Details are as follows: Jefferies Global Healthcare Conference Location: New York, NYFormat:...Read more
CAMBRIDGE, MA / ACCESSWIRE / June 1, 2023 / Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced its participation in the following upcoming investor conferences: 2023 Jefferies Healthcare Conference on Thursday, June 8th at 10:30 a.m. ET 44th Annual Goldman Sachs Global Healthcare Conference on Wednesday, June 14th at 4:40 p.m. PST A live webcast of each...Read more
| Company | Change | Last Trade |
|---|---|---|
| Vertex Pharmaceuticals | 10.16 3.14 | $333.78 |
| Regeneron Pharmaceuticals | 8.78 1.20 | $739.95 |
| Krystal Biotech | 7.36 6.30 | $124.20 |
| BioMarin Pharmaceutical | 5.10 5.78 | $93.36 |
| Alnylam Pharmaceuticals | 5.00 2.65 | $193.67 |
| Karuna Therapeutics | 4.39 1.91 | $233.65 |
| Relief Therapeutics | 4.18 19,434.90 | $4.20 |
| Ligand Pharmaceuticals | 4.11 5.77 | $75.31 |
| BioNTech | 4.01 3.85 | $108.13 |
| BeiGene | 3.88 1.74 | $227.36 |
| United Therapeutics | 3.74 1.75 | $217.22 |
| Ascendis Pharma | 3.34 3.80 | $91.30 |
| Intellia Therapeutics | 2.80 7.34 | $40.96 |
| Zai Lab | 2.70 8.18 | $35.70 |
| Prothena | 2.62 3.95 | $69.01 |
Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic immunoassay tests and microarrays. Surmodics is pursuing highly differentiated whole-product solutions that are designed to address...
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