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0.4560+0.0917 (+25.1716%)
At close: January 29 04:00PM EST
0.4701 +0.01 (+3.09%)
After hours: 08:00PM EST
Volume 13,862,883
Avg. Volume 3,371,643
Amazing trading both on price and volume on non real news!
0.4166+0.0523 (+14.3563%)
As of 10:52AM EST. Market open.
Volume 5,009,505
Avg. Volume 3,331,806
Volumewise, the market reaction to the (non) news is quite positive.
Agreed. Either implies desperation or they’re trying to telegraph that a deal is close.
If it’s the former, maybe an attempted pump to tap an ATM?
If the latter, just finish the deal and announce it!
Murocman
So what's new?
A very strange PR indeed to say the least.
Why distribute a non news PR i wonder?
Gamida Cell Actively Pursuing Strategic Alternatives
https://finance.yahoo.com/news/gamida-cell-actively-pursuing-strategic-110000992.html
BOSTON, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced it is actively pursuing strategic alternatives in order to maximize value for all stakeholders, focusing on an asset sale, merger or other strategic transaction. However, there can be no assurance that the company’s strategic alternatives process will result in any such transaction.
While pursuing strategic alternatives, the company continues to put its focus and resources behind the commercialization of Omisirge® (omidubicel-onlv), the first and only FDA-approved nicotinamide modified cell therapy donor source for allogeneic stem cell transplant.
Moelis & Company LLC is the company’s financial advisor for this process.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv), and the company’s pursuit of strategic alternatives. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and as to the pursuit of strategic alternatives, the risk that no transaction may result. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
OMISIRGE® is a registered mark of Gamida Cell Inc. © 2024 Gamida Cell Inc. All Rights Reserved.
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
Investor Contact:
Chuck Padala
LifeSci Advisors
Chuck@lifesciadvisors.com
1-646-627-8390
Methinks there were some expectations to this event:
Want to learn more about OMISIRGE® (omidubicel-onlv)?
Come visit our booth at Highlights of ASH in New York, NY on January 26-27!
See Full Prescribing Information, including Boxed Warning, at https://lnkd.in/etxVyNF2 or visit http://Omisirge.com
My theory is that the sp spike was due to some positive outcome from this event,
when non occured, price went down.
Comments?
GMDA................................https://stockcharts.com/h-sc/ui?s=GMDA&p=W&b=5&g=0&id=p86431144783
0.4078+0.0578 (+16.5143%)
At close: 04:00PM EST
0.4089 +0.0011 (+0.2697%)
After hours: 4:01PM EST
Hefty volume too:
Volume 6,810,221
Avg. Volume 3,137,781
It's getting better
0.4197+0.0697 (+19.9143%)
As of 02:10PM EST. Market open.
Volume 5,758,672
Avg. Volume 3,137,781
True! If nothing else, it’s nice to see some sustained upward momentum with decent volume.
Murocman
0.3710+0.0210 (+6.0000%)
As of 10:27AM EST. Market open.
Volume 2,097,310
Avg. Volume 3,137,781
I guess some day we shall know if there
was a reason for these upticks
0.3292+0.0165 (+5.2766%)
As of 09:33AM EST. Market open.
Seems like momentum continues!
0.3127+0.0287 (+10.1056%)
At close: January 23 04:00PM EST
0.3174 +0.00 (+1.50%)
After hours: 08:00PM EST
What do you guys think, is there any
chance there is something of substance
going on behind the scenes, and not
only futile day trading?
Yep, here we go again……
GMDA now looks more like a regular pk
stock swarmed by herds of day traders.
Day traders are having a great time with this stock!!
0.3323+0.0483 (+17.0070%)
As of 02:12PM EST. Market open.
Getting better
0.3193+0.0353 (+12.4296%)
As of 01:48PM EST. Market open.
Volume 1,942,878
Avg. Volume 3,003,216
Spinning Wheels.
0.2768-0.0281 (-9.2161%)
As of 12:55PM EST. Market open.
Just a shortlived sad episode on Friday
0.3049+0.0649 (+27.0417%)
At close: January 19 04:00PM EST
0.3128 +0.01 (+2.59%)
After hours: 08:00PM EST
Looking forwards to some good news to justify the uptick.
I have been investing in 4 companies all the
long and winding road till full FDA approval.
The companies are MDWD, PLX, BLRX and
GMDA.
Excellent science for them all, albeit very poor
financial performance for each of them since.
I wonder why?
Totally understand. I think we’re all a little crispy from being burned by this company on multiple occasions!
Murocman
I'd be more than happy to be proven wrong.
Right now i am in a 'lowering down expectations' mode.
At current price GMDA seems a
bargain, but i will not be adding.
I would have bought in at this point
as a starting investing point.
The risk reward ratio looks promising.
I’m not so sure. There is no good reason for the volume today and there aren’t any known catalysts pending.
Volume is over 2x normal and could easily approach 3x before the market closes.
Something going on but it remains to be seen if it’s something imminent we’ll find out about in the next few days.
There is the old wall street adage that volume precedes price, so I guess we’ll see?
Murocman
My speculation is the daytrading crowd stepped in.
Volume is robust, but with no news
i suppose it is a non event.
Something’s afoot on an otherwise nondescript Friday trading day!?
0.2900+0.0500 (+20.8333%)
As of 12:43PM EST. Market open.
Volume 4,545,715
Avg. Volume 2,821,290
Friday Night Fever
It's a Long, Long Way to Tipperary
0.2808+0.0408 (+17.0000%)
As of 10:25AM EST. Market open.
Volume 1,857,601
Avg. Volume 2,821,290
Huh?
Gamida Cell to Present at the 2024 Tandem Meetings of ASTCT® and CIBMTR®
https://finance.yahoo.com/news/gamida-cell-present-2024-tandem-130000730.html
BOSTON, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced it will present new data on its FDA approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings will take place virtually and in person at the Henry B. González Convention Center in San Antonio, Texas, February 21-24.
Additional details about the poster presentations are as follows:
Title: Omidubicel-onlv for Allogeneic Transplantation (allo-HCT) in Patients with Hematologic Malignancies: Results of a Multicenter Open-Label Expanded Access Program (EAP)
Abstract Number: 313
Lead Author: Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute
Time: February 22, 6:45-7:45 p.m. ET
Abstract highlights: An Expanded Access Program (EAP) evaluated outcomes in 29 patients with hematologic malignancies following allo-HCT with omidubicel. Eligible patients =12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards. Results demonstrated rapid hematopoietic recovery and low rate of infections. Safety and efficacy, including relapse, disease-free survival and overall survival, were similar to those observed in the Phase 3 study of omidubicel. Omidubicel was approved under the brand name Omisirge® (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant.
Title: A Phase I/II Study of GDA-201, Cryopreserved Nicotinamide-Enhanced Allogeneic Natural Killer Cells, in Patients with Relapsed/Refractory B-cell Lymphoma
Abstract Number: 255
Lead Author: Brian C. Shaffer, Associate Professor of Medicine and Head of the Adult Mismatched Donor Sub-Program at Memorial Sloan Kettering Cancer Center in New York
Date and Time: February 22, 6:45-7:45 p.m. ET
Abstract highlights: This is an ongoing multicenter Phase 1 study of allogeneic cryopreserved NK cell therapy candidate GDA-201 in patients with relapsed/refractory B-cell CD20 positive non-Hodgkin lymphoma. Preliminary data for the 10 patients enrolled in the first three of four total cohorts, who were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant, showed no infusion reactions, dose limiting toxicities or related serious adverse events reported in patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab. Marked shrinkage of target lesions was observed in five patients and efficacy evaluation showed two patients with complete response, two with partial response and one with stable disease. Two patients treated had cytokine release syndrome. There were no reported cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease.
About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024.
GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
Omisirge® (omidubicel-onlv) Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Important Safety Information for Omisirge
BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE
Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Contraindications
OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.
Warnings and Precautions
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.
Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.
Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.
Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.
Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.
Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.
Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction.
Please see full Prescribing Information, including Boxed Warning.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Facebook, X and Instagram.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv), and the Company’s cell therapy candidate, GDA-201. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
Omisirge® is a registered trademark of Gamida Cell Inc. © 2024 Gamida Cell Inc. All Rights Reserved.
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
Investor Contact:
Chuck Padala
LifeSci Advisors
Chuck@lifesciadvisors.com
1-646-627-8390
0.3315-0.0245 (-6.8820%)
As of 01:58PM EST. Market open.
Hopeless!
0.3700-0.0266 (-6.7070%)
As of 10:20AM EST. Market open.
Volume 1,532,565
Avg. Volume 2,452,220
Back to the graveyard!
Volume precedes price
0.3948-0.0073 (-1.8155%)
As of 10:08AM EST. Market open.
Volume 3,384,976
Avg. Volume 2,292,090
Sure, but in which direction?
Signs of life on strong volume and no news during a holiday week…hmmm!
0.4269+0.1051 (+32.6600%)
As of 02:00PM EST. Market open.
Looks serious!
0.3700+0.0482 (+14.9783%)
As of 10:07AM EST. Market open.
Getting better with robust volume.
Will it stick, i wonder?
0.3562+0.0344 (+10.6899%)
As of 10:00AM EST. Market open.
Misleading signs of life again?
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On December 14, 2023, Gamida Cell Ltd. (the “Company”) entered into a Second Amended and Restated Consulting Agreement, effective December 31, 2023 (the “Amended Consulting Agreement”), with Terry Coelho, the Chief Financial Officer of the Company, pursuant to which Ms. Coelho’s existing Amended and Restated Consulting Agreement, dated May 22, 2023, with the Company was extended through March 31, 2024. The Amended Consulting Agreement provides for Ms. Coelho to be compensated at an hourly rate of $500 for a minimum of 40 hours per week of services specified in the Amended Consulting Agreement. Ms. Coelho is also eligible to earn a retention bonus of $100,000 (the “Retention Bonus”) if she remains continuously engaged with the Company through March 31, 2024. If, prior to March 31, 2024, either Ms. Coelho provides notice of termination without cause, or the Company provides notice of termination for breach and Ms. Coelho fails to cure the breach, then the Retention Bonus will not be paid.
Resurrection from the dead?
It's about time!
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5 Nahum Heftsadie Street
Givaat Shaul
Jerusalem 91340
Israel
97222 659 666
http://www.gamida-cell.com
https://investors.gamida-cell.com/static-files/19b66eb5-8912-4828-a311-64227b63ec0f
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