RBC Capital Markets to hold a virtual conference » 09:5205/1705/17/21
AEGXF, BYDGF, CNI, CP, GBT, GDRX, GILD, IONS, MRETF
Passage Bio to host research and development day » 09:2005/1705/17/21
Research and Development…
Research and Development Day to be held on May 17 at 9:30 am. Webcast Link
OrthoPediatrics continues Double Diamond Sponsorship for POSNA meeting » 09:2005/1705/17/21
Gracell reports Q1 EPS (5c), consensus (21c) » 08:0605/1705/17/21
"We are thrilled to…
"We are thrilled to have ushered in the new year as a public company following a successful initial public offering that was supported by top-tier institutional investors," commented Dr. William Cao, founder, Chairman, and CEO of Gracell. "We have made significant advancements during the first quarter regarding our pipeline of innovative autologous and allogeneic CAR-T cell therapies. Recently, we announced dosing the first patient in the Phase 1/2 registrational study of GC007g, an allogeneic CAR-T cell therapy derived from HLA-matched donors for the treatment of r/r B-ALL. At the AACR 2021 Annual Meeting last month, we presented follow-up data on our off-the-shelf stand-alone allogeneic CAR-T cell therapy GC027 for the treatment of r/r T-ALL. With a patient maintaining minimal residual disease negative complete remission through 16.8 months, we are very encouraged by the potential of GC027 in this hard-to-treat indication. We are pleased to announce that we are expanding our leadership team with Jenny Ni, Ph.D., M.D., as Chief Technology Officer. Dr. Ni brings extensive experience in developing CAR-T cell therapies, including having successfully lead process development at both Pfizer and Allogene Therapeutics. We look forward to her contributions, including leading our technical operations teams including Chemistry, Manufacturing and Control and manufacturing to ensure a smooth technology transfer to Lonza for our FasTCAR-enabled product candidate GC012F. We plan to build on the momentum achieved during the first quarter with several near-term catalysts expected during 2021. As we continue to ramp up clinical development efforts, we continue to expand our team in the U.S. and preparing to expand our GMP manufacturing facility in China. We also look forward to providing updates at the ASCO and EHA 2021 annual meetings on the FasTCAR-enabled BCMA/CD19 dual-targeting candidate GC012F for the treatment of r/r multiple myeloma, which has demonstrated fast, deep, and durable responses in a predominantly high-risk multiple myeloma patient population. We are excited to begin collaborating with Lonza to manufacture our FasTCAR-enabled product candidate GC012F as we work towards the U.S. IND filing in the first half of 2022. We believe the potential of our proprietary FasTCAR and TruUCAR platforms is vast, and we are working expeditiously to bring new product candidates into clinical development," Dr. Cao concluded.
Cytokinetics announces presentation of data from GALACTIC-HF » 08:0305/1705/17/21
Cytokinetics announced that data from a secondary analysis of GALACTIC-HF assessing the effect of omecamtiv mecarbil on clinical outcomes in relationship to patient baseline ejection fraction were presented by John Teerlink, Professor of Medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center and Executive Committee Chair, GALACTIC-HF in a Late Breaking Clinical Trial session at the American College of Cardiology 70th Annual Scientific Session & Expo and were simultaneously published in the Journal of the American College of Cardiology.
Veracyte announces data showing Percepta Genomic Atlas detects gene alterations » 12:4605/1405/14/21
Veracyte announced new…
Veracyte announced new data demonstrating the ability of the Percepta Genomic Atlas to detect alterations that may inform lung cancer treatment decisions for patients from the same small biopsy that was used for diagnosis. Study findings presented today at the American Thoracic Society 2021 International Conference show that the test accurately detects known lung-cancer gene variants using small biopsy samples, which may help guide treatment with targeted therapies. For the analyses presented at the ATS Conference, researchers evaluated the feasibility of detecting National Comprehensive Cancer Network-recommended gene alterations with the Percepta Genomic Atlas, using samples from 25 patients obtained during initial bronchoscopy procedures. Results show that the in-development test accurately detected the gene variants in these samples with over 95% concordance to a reference next-generation sequencing assay.
Fly Intel: Pre-market Movers » 09:0905/1405/14/21
VVNT, SNOW, PLUG, ITRM, FREE, SLDB, DASH, COIN, BPTH, DIS, CRMD, PTE, MKGI
Check out this morning's…
TCR2 Therapeutics price target lowered to $45 from $57 at Wedbush » 07:2705/1405/14/21
Wedbush analyst David…
Wedbush analyst David Nierengarten lowered the firm's price target on TCR2 Therapeutics to $45 from $57 and keeps an Outperform rating on the shares. The company reaffirmed that it is on track todetermine a recommended Phase 2 dose of gavo-cel for treatment-refractory mesothelin-expressing solid tumors and expects to initiate its Phase 1/2 expansion trial this year, Nierengarten tells investors in a research note. The analyst expects continued updates from treated patients over the rest of the year.
Iterum Therapeutics reports Q1 adjusted EPS (5c), consensus (7c) » 07:0505/1405/14/21
As of March 31, 2021,…
As of March 31, 2021, Iterum had cash, cash equivalents and short-term investments of $100.5M. Based on its current operating plan, Iterum expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into the first half of 2023. "We continue to prepare for a U.S. Food and Drug Administration advisory committee meeting and look forward to clarity from the FDA on timing. In the meantime, the FDA continues its review of our new drug application for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible organism and has not advised us of any change to the current PDUFA goal date of July 25, 2021," said Corey Fishman, CEO. "With an FDA decision on oral sulopenem expected in the second half of 2021 and a strong cash position, we are preparing for a launch of oral sulopenem into the community in the fourth quarter of 2021, if approved."
Morgan Stanley to hold a virtual conference » 04:5505/1405/14/21
GRCL, HOOK, HCM
Asia Healthcare Virtual…
Asia Healthcare Virtual Conference 2021 will be held on May 13-14.