European Hematology Association

U.S. FDA Approves Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions

Retrieved on: 
Tuesday, August 29, 2023
Biotechnology, General Health, FDA, Health, Pharmaceutical, Myelodysplastic syndrome, Epoetin alfa, Bristol Myers Squibb, RBC, European Hematology Association, ESA, Diarrhea, Hematology, Cell therapy, American Society of Clinical Oncology, Multimedia, BMY, MD Anderson Cancer Center, ASCO, MDS, Congress, Hypertension, Peripheral edema, HB, Phase 3, Patient, University, Anemia, Annual general meeting, EHA, Nausea, Periodic breathing, Merck, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, NYSE, Society, Food, Fatigue, Pharmaceutical industry, Medical device, Lancet

These results underscore Reblozyl’s ability to address chronic anemia earlier in the treatment journey in a broader range of patients.

Key Points: 
  • These results underscore Reblozyl’s ability to address chronic anemia earlier in the treatment journey in a broader range of patients.
  • HI-E increase of at least 8 weeks was achieved by 74.1% (n=109) of Reblozyl patients vs. 51.3% (n=79) of epoetin alfa patients (p
  • RBC-TI of at least 12 weeks was achieved by 66.7% (n=98) of Reblozyl patients vs. 46.1% (n=71) of epoetin alfa patients (p=0.0003).
  • Patients treated with Reblozyl demonstrated durable responses with nearly 2.5 years of median RBC-TI ≥12 weeks (126.6 weeks, week 1 to end of treatment).

Mustang Bio Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, August 14, 2023
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WORCESTER, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2023.

Key Points: 
  • WORCESTER, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2023.
  • Research and development expenses were $10.8 million for the second quarter of 2023, compared to $15.2 million for the second quarter of 2022.
  • Non-cash, stock-based expenses included in research and development were $(0.1) million for the second quarter of 2023, compared to $0.4 million for the second quarter of 2022.
  • General and administrative expenses were $3.1 million for the second quarter of 2023, compared to $3.1 million for the second quarter of 2022.

2seventy bio Reports Second Quarter Financial Results and Recent Operational Progress

Retrieved on: 
Monday, August 14, 2023
Biotechnology, General Health, Health, Oncology, Abstract, Maintenance, Communication, Partnership, Gene, European Hematology Association, Regeneron Pharmaceuticals, Multiple myeloma, American Society of Clinical Oncology, Cancer, Toxicity, Bristol Myers Squibb, American Society of Gene and Cell Therapy, Trial of the century, TCR, ASCO, Congress, AML, SAE, Investigational New Drug, Patient, S12, EHA, Annual general meeting, Root cause analysis, PDUFA, Webcast, Cell, BMS, RRMM, Research, FDA, Ovarian cancer, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, IND, Food, Pharmaceutical industry, Rare-earth element, Vaccine, Cryptocurrency, Idecabtagene vicleucel

(Nasdaq: TSVT), a leading immuno-oncology cell therapy company, today reported financial results and recent highlights for the second quarter ended June 30, 2023.

Key Points: 
  • (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, today reported financial results and recent highlights for the second quarter ended June 30, 2023.
  • The Company ended the second quarter of 2023 with cash, cash equivalents and marketable securities of $307 million.
  • 2seventy bio believes that this cash position, combined with growing Abecma cashflow and disciplined expense management, provides financial runway into 2026.
  • ET to discuss 2Q 2023 financial results and recent business highlights.

Disc Medicine Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, August 11, 2023
Sodium- and chloride-dependent glycine transporter 1, Ruxolitinib, Chronic kidney disease, European Hematology Association, EPP, AURORA, G&A, Porphyria, Inflammation, MF, Dialysis, Congress, IRON, Development, Erythropoiesis, Glycine, Patient, Administration, Anemia, EHA, Mab, XLP, Research, Polycythemia, Technology transfer, Safety, Pharmaceutical industry, Nursing, Cryptocurrency, Vaccine, Disc

Disc plans to initiate a Phase 1 study in healthy volunteers during the second half of 2023.

Key Points: 
  • Disc plans to initiate a Phase 1 study in healthy volunteers during the second half of 2023.
  • Second Quarter 2023 Financial Results:
    Cash Position: Cash and cash equivalents were $377.6 million as of June 30, 2023, which are expected to fund our operational plans well into 2026.
  • Research and Development Expenses: R&D expenses were $12.1 million for the quarter ended June 30, 2023, as compared to $7.7 million for the quarter ended June 30, 2022.
  • Net Loss: Net loss was $15.9 million for the quarter ended June 30, 2023, as compared to $9.6 million for the second quarter of 2022.

Vor Bio Reports Second Quarter 2023 Financial Results and Provides Company Update

Retrieved on: 
Thursday, August 10, 2023
Research and development, European Hematology Association, Bone marrow, Clinical trial, Passive treatment system, G&A, Toxicity, HCT, Editas Medicine, Trial of the century, Acute myeloid leukemia, Health, U.S. FDA, CAR, AML, CD33, Patient, CGMP, Administration, Engineering, HSC, R, FDA, General Administration of Press and Publication, Pharmaceutical industry, Nursing, Medical device, Dentistry, Vaccine, Fine chemical, Gemtuzumab ozogamicin, IND

VCAR33ALLO IND cleared by U.S. FDA; Rapidly activating sites toward study initiation

Key Points: 
  • VCAR33ALLO IND cleared by U.S. FDA; Rapidly activating sites toward study initiation
    CAMBRIDGE, Mass., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today reported financial results for the three-month period ended June 30, 2023, and provided a business update.
  • Research & Development (R&D) Expenses: R&D expenses for the second quarter of 2023 were $23.9 million, compared to $15.3 million for the second quarter of 2022.
  • General & Administrative (G&A) Expenses: G&A expenses for the second quarter of 2023 were $8.3 million, compared to $6.5 million for the second quarter of 2022.
  • Net Loss: Net loss for the second quarter of 2023 was $30.0 million, compared to $21.7 million for the second quarter of 2022.

Salarius Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Thursday, August 10, 2023
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HOUSTON, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today reported financial results for the three and six months ended June 30, 2023 and provided a business update.

Key Points: 
  • Research and development expenses declined to $2.4 million for the second quarter of 2023 from $2.9 million for the second quarter of 2022, primarily due to lower spending on seclidemstat offset by higher spending on SP-3164.
  • Spending associated with seclidemstat and SP-3164 for the second quarter of 2023 was $1.1 million and $1.3 million, respectively, compared with $2.1 million and $0.8 million, respectively, for the second quarter of 2022.
  • General and administrative expenses were $1.6 million for the second quarter of 2023, compared with $1.8 million for the second quarter of 2022, with the decline due to lower annual shareholder meeting expenses and overall compensation and benefit costs.
  • As of June 30, 2023, Salarius had cash, cash equivalents and restricted cash of $11.5 million, compared with $12.1 million as of December 31, 2022.

Nkarta Reports Second Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Thursday, August 10, 2023
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As previously announced, Nkarta plans to present updated results from its ongoing clinical trial of NKX019 in the second half of 2023.

Key Points: 
  • As previously announced, Nkarta plans to present updated results from its ongoing clinical trial of NKX019 in the second half of 2023.
  • In July 2023, Nkarta announced the appointment of Alyssa Levin, CPA, CA, as Chief Financial and Business Officer.
  • Non-cash stock-based compensation expense included in R&D expense was $2.1 million for the second quarter of 2023.
  • Net loss was $33.3 million, or $0.68 per basic and diluted share, for the second quarter of 2023.

X4 Pharmaceuticals Reports Second-Quarter 2023 Financial Results, Provides Corporate Updates, and Reports Emerging Data from Chronic Neutropenia Clinical Program

Retrieved on: 
Thursday, August 10, 2023
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Additional data from this ongoing Phase 2 trial are expected to be shared in the fourth quarter of 2023.

Key Points: 
  • Additional data from this ongoing Phase 2 trial are expected to be shared in the fourth quarter of 2023.
  • X4 is planning to initiate a Phase 3 clinical trial evaluating mavorixafor in certain chronic neutropenic disorders in the first half of 2024.
  • X4 will host a conference call and webcast today at 8:30 am ET to discuss these financial results and business highlights.
  • The live webcast and slide presentation can be accessed on the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com .

EQS-News: MorphoSys AG Reports Second Quarter and First Half 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
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Minjuvi royalty revenue of € 2.2 million for sales outside of the U.S. in the second quarter 2023 and € 2.9 million for the first half of 2023.

Key Points: 
  • Minjuvi royalty revenue of € 2.2 million for sales outside of the U.S. in the second quarter 2023 and € 2.9 million for the first half of 2023.
  • The MorphoSys AG Annual General Meeting on May 17, 2023 re-elected Mr. George Golumbeski, Ph.D., and Mr. Michael Brosnan to the Company’s Supervisory Board.
  • Events After the End of the Second Quarter of 2023:
    On August 1, 2023, Incyte announced the full enrollment of the Phase 3 study inMIND.
  • Total revenues for the second quarter 2023 were € 53.2 million compared to € 59.4 million for the same period in 2022.

Omeros Corporation Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
Neurology, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Other Health, DSM-IV codes, Survival, Tardive dyskinesia, Bangladesh Technical Education Board, Data analysis, Patent, Investment, Patient, Congress, BLA, Inflammation, Emory University, Therapy, Paroxysmal nocturnal hemoglobinuria, European Hematology Association, Research, Emory, Government, Proteinuria, Kidney International, CUD, Glomerulus, Manuscript, L-DOPA, Hematuria, Safety, Omeros, COVID-19, Inflammation Research, Immunoglobulin A, Fibrosis, PIN, Cancer, PNH, National Institute on Drug Abuse, LID, PDE7, Hemolysis, Complement, Clinical trial, Mannan-binding lectin, Sale, Trial of the century, IgA nephropathy, Corporation, NIDA, Society, C5, Pharmaceutical industry, Reinsurance, Music, Security (finance), Vaccine, Video game, Frontiers, Hematology, Immunology, Agency

“Our team continued building significant shareholder value throughout the second quarter of 2023,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer.

Key Points: 
  • “Our team continued building significant shareholder value throughout the second quarter of 2023,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer.
  • Total costs and expenses for the second quarter of 2023 were $40.9 million compared to $37.4 million for the second quarter of 2022.
  • Interest expense during the second quarter of 2023 was $7.9 million compared to $4.9 million during the prior year quarter.
  • During the second quarter of 2023, we earned $4.5 million in interest and other income compared to $0.7 million in the prior year quarter.