Gamida Cell reports Q2 EPS (37c), consensus (30c) » 08:1208/1108/11/20
"The primary endpoint data for omidubicel underscore its potential to become an important treatment option for patients by providing a reliable graft source that can enable rapid neutrophil engraftment, which has been linked to other important outcomes such as fewer infections and hospitalizations," stated Julian Adams, Ph.D., CEO of Gamida Cell. "We look forward to reporting secondary endpoints from the study and to initiating the biologics license application, or BLA, for omidubicel to the FDA on a rolling basis, both in the fourth quarter of this year."
|Over a week ago|
Gamida Cell names Michele Korfin Chief Operating and Chief Commercial Officer » 08:1807/2107/21/20
Gamida Cell announced the…
Gamida Cell announced the appointment of Michele Korfin as chief operating and chief commercial officer. Gamida Cell said in a release, "Ms. Korfin brings over 20 years of experience in oncology, focused on business operations and commercialization of novel therapies. In this role, she will have oversight of manufacturing and commercialization as Gamida Cell advances its clinical development candidates: omidubicel, an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of bone marrow transplant, and GDA-201, an investigational, natural killer cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma. Prior to joining Gamida Cell, Ms. Korfin served as COO at TYME Technologies."
|Over a month ago|
Fly Intel: Top five analyst initiations » 10:0507/0107/01/20
PZZA, DKNG, WSC, GMDA, IHG
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Papa John's (PZZA) initiated with an Outperform at Wedbush. 2. DraftKings (DKNG) initiated with an Overweight at Stephens. 3. WillScot (WSC) initiated with a Buy at Stifel. 4. Gamida Cell (GMDA) initiated with an Outperform at Evercore ISI. 5. InterContinental (IHG) initiated with a Neutral at Credit Suisse. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Gamida Cell initiated with an Outperform at Evercore ISI » 16:2906/3006/30/20
Evercore ISI analyst…
Evercore ISI analyst Jonathan Miller initiated coverage of Gamida Cell with an Outperform rating.
Fly Intel: Top five analyst initiations » 10:0705/2605/26/20
GMDA, CGNX, PEGA, AMAT, DIOD
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Gamida Cell (GMDA) initiated with an Overweight at Piper Sandler. 2. Cognex (CGNX) initiated with a Hold at HSBC. 3. Pegasystems (PEGA) initiated with a Buy at Goldman Sachs. 4. Applied Materials (AMAT) initiated with an Equal Weight at Barclays. 5. Diodes (DIOD) initiated with a Buy at Loop Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Gamida Cell initiated with an Overweight at Piper Sandler » 18:2505/2505/25/20
Piper Sandler analyst…
Piper Sandler analyst Edward Tenthoff initiated coverage of Gamida Cell with an Overweight rating and $13 price target. The analyst notes that Gamida Cell recently reported positive Phase III data on omidubicel for patients receiving hematopoietic stem cell transplant showing 10 days faster neutrophil engraftment than standard umbilical cord blood transplant. Gamida Cell plans to report full Phase III data and file a BLA later this year, he adds. Tenthoff expects FDA approval next year with U.S. sales reaching $468M by 2028. Gamida Cell recently issued 15.3M shares at $4.50 raising gross proceeds of $69M, bringing pro forma cash to about $105M, the analyst points out.
Gamida Cell sees FY20 cash used for ongoing operating activities $60M-$70M » 08:1005/2105/21/20
Gamida Cell expects cash…
Gamida Cell expects cash used for ongoing operating activities in 2020 to range from $60M to $70M. Gamida Cell expects that, after accounting for the completion of its public follow-on offering, its current cash, cash equivalents and available-for-sale securities will support the company's ongoing operating activities into the second half of 2021. This cash runway guidance is based on the company's current operational plans and excludes any additional funding beyond the follow-on offering, or business development activities that may be undertaken.
Gamida Cell reports Q1 EPS (31c), consensus (45c) » 08:0905/2105/21/20
As of March 31, 2020,…
As of March 31, 2020, Gamida Cell had total cash, cash equivalents and available-for-sale securities of $40.3M, compared to $ 55.4M as of December 31, 2019. "Last week, we were extraordinarily pleased to report that our Phase 3 study of omidubicel met its primary endpoint of demonstrating a significant reduction in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. Shortening the time to engraftment is clinically meaningful, as it can reduce a patient's time in the hospital and decrease likelihood of infection. These positive study results represent an important step forward for Gamida Cell and the transplant community," stated Julian Adams, CEO of Gamida Cell. "Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. FDA and has the potential to be the first FDA-approved bone marrow transplant graft. Our dedicated team is working hard to begin submitting the biologics license application for omidubicel to the FDA on a rolling basis in the fourth quarter."
Fly Intel: Pre-market Movers » 08:5805/1905/19/20
ABUS, WMT, AAP, KSS, WB, RADA, HD, MUX, IQ, TMUS, MRNA, GMDA
Check out this morning's…
Gamida Cell 13.333M share Spot Secondary priced at $4.50 » 06:0105/1905/19/20
The deal range was…
The deal range was $4.50-$5.00. Piper Sandler and Evercore ISI acted as joint book running managers for the offering.