$ALLO $13.28 Allogene Therapeutics, Announces Removal of FDA Clinical Hold on their Clinical Trials • Allogene reported that Chromosomal Abnormality Was Not the Result of TALEN® Gene Editing or Allogene's Manufacturing Process • Allogene to Initiate a Phase 2 Pivotal Clinical Trial of ALLO-501A in Relapsed/Refractory Large B-cell Lymphoma Mid-year 2022 Pending FDA Discussion NEW YORK, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Cellectis (NASDAQ:CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today stated that its licensed partner, Allogene Therapeutics, Inc. (NASDAQ:ALLO) announced that the U.S. Food and Drug Administration (FDA) has lifted the hold on its clinical trials. The FDA had placed a clinical hold on all five of Allogene's clinical trials on October 7, 2021 following a report of a chromosomal abnormality detected in ALLO-501A CAR+ T-cells from a single patient enrolled in Allogene's ALPHA2 study. Allogene reported today that the investigations concluded that the chromosomal abnormality was unrelated to TALEN® gene editing or Allogene's manufacturing process and had no clinical significance. The abnormality was not detected in any manufactured AlloCAR T™ product or in any other patient treated with the same ALLO-501A lot. The abnormality occurred in the patient after the cell product was administered. It involved regions of the T cell receptor and immunoglobulin genes known to undergo rearrangement as part of the natural T cell or B cell maturation process. "We are very pleased that our licensed partner Allogene is now able to resume its clinical trials, bringing us one step closer to delivering these innovative therapies to patients with unmet medical needs," said Dr. André Choulika, CEO of Cellectis. "TALEN® gene editing technologies were not involved in the findings leading to the clinical hold. More than 170 patients with relapsed or refractory malignancies have been administered TALEN®-edited allogeneic CAR-T cell product candidates with a favorable safety profile, making it the largest and most robust disclosed clinical dataset of any gene editing technology in the world." Allogene also announced that following the lift of the clinical holds and pending final discussions with the FDA, Allogene intends to initiate a Phase 2 pivotal trial of ALLO-501A in relapsed/refractory large B-cell lymphoma mid-year 2022. Allogene's allogeneic CAR-T programs utilize Cellectis' technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries. Allogene has an exclusive license to Cellectis' technologies for ALLO-715, ALLO-605 (both directed at BCMA) and ALLO-316 (directed at CD70) and holds development and commercial rights for these investigational product candidates. About Cellectis Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 22 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs. As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing lifesaving UCART product candidates for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM). HEAL is a new platform focusing on hemopoietic stem cells to treat blood disorders, immunodeficiencies and lysosomal storage diseases. Cellectis' headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.
33 minutes left in the after-hours session. Another one of these earning reports that apparently no one pays attention to. This one, take it long. As I type it's $45.75 on the offer. PRGS Little risky, but it should be ok.
Draganfly partners with Women and Drones 07:48 DPRO Draganfly is pleased to announce a partnership with Women And Drones, a global platform for women who are disrupting, innovating and shaping the future of STEM and aviation. Women And Drones is the leading membership organization dedicated to driving excellence in the uncrewed aircraft systems and Advance Air Mobility industry by advocating for female participation in this dynamic segment of the global economy. Ok- Women and Drones is a great name!
Cryoport upgraded to Buy from Neutral at Roth Capital 07:39 CYRX Roth Capital analyst Richard Baldry upgraded Cryoport to Buy from Neutral with a $90 price target. ooopha this is an aggressive price target to come out during a correction there must be meat on this bone. CYRX- $43.50
Affirm price target lowered to $70 from $170 at Deutsche Bank 06:56 AFRM Deutsche Bank analyst Bryan Keane lowered the firm's price target on Affirm to $70 from $170 and keeps a Hold rating on the shares. The analyst sees "mounting worries" about the company's volume but he sees potential for upside to the 112% year-over-year gross merchandise volume growth estimate for Q4. GBA SHORT CALL was @ $147 I don't think anyone on this site will top that....
Velodyne Lidar price target lowered to $4.50 from $8 at Citi 06:37 VLDR Citi analyst Itay… Genius Sports initiated with an Outperform at Credit Suisse 06:13 GENI Qualtrics upgraded to Outperform on recent selloff at Evercore ISI 06:11 XM Evercore ISI analyst Kirk Materne upgraded Qualtrics to Outperform from In Line with a $40 price target. The recent pullback in the shares creates a more attractive risk/reward when taking a 6-12 month view, Materne tells investors in a research note. The analyst believes Qualtrics is well positioned to benefit from a "strong demand environment as customers remain laser focused on delivering positive customer and employee experiences." He expects the company will continue to deliver "beat/raise" results in 2022. ABB upgraded to Outperform from Sector Perform at RBC Capital 06:09 ABB RBC Capital analyst Sebastian Kuenne upgraded ABB to Outperform from Sector Perform with a price target of CHF 41, up from CHF 30. The "leaner" company is in "far better position" to capture value in the electrification of transport and in the automation of industries, the analyst tells investors in a research note. Kuenne adds that while Q4 will be "tough" for ABB, he is positive on the stock offering a "buying opportunity".
Vicinity Motor nabs $14M order for VMC 1200 EV Trucks from Pioneer Auto Jan. 19, 2022 8:42 AM ETVicinity Motor Corp. (VEV) Vicinity Motor(NASDAQ:VEV)received a C$14Morderfrom Pioneer Auto, retail automotive dealer in British Columbia, for 100 VMC 1200 Class 3 electrictrucks. Post a prior letter of intent, The Pioneer Group has been appointed to act as the company's exclusive dealer in the province of British Columbia. With 17 locations across British Columbia, Canada, Pioneer retails 6K+ vehicles per year and carries 1.5K+ vehicles in its network including Mitsubishi, Honda, Chrysler, Dodge, Jeep and RAM models; VMC 1200 trucks are expected to arrive to Pioneer in 2Q22. The first VMC 1200 trucks will be delivered from our Canadian operations and then manufacturing will shift to the company's new Washington state facility that is scheduled to come online late in 2Q22.
Esports Technologies guides 10-month revenue outlook of $70M Jan. 19, 2022 8:33 AM ETEsports Technologies, Inc. (EBET) Esports Technologies(NASDAQ:EBET)announcesrevenue guidance of $70M for the 10-month period from December 2021 to September 2022. This revenueexpectation is derived primarily from the company's online sportsbook and casino brands including Karamba, Hopa, Griffon Casino, BetTarget, Dansk777 and GenerationVIP, which have over 1.25M deposited customers in more than 15 countries. Aaron Speach, CEO, Esports Technologies, said, "As we begin a successful 2022, we remain committed to increasing our operational and financial performance. We expect to deliver consistent cash flow for the remainder of 2022 by growing esports revenue in regulated markets, as well as continued growth from our portfolio of online sportsbook and casino brands." Read Now:Esports Technologies receives $30M senior secured term loan