iBio announces resignation of CEO Thomas Isett » 16:3112/0212/02/22
iBio announced the Board…
iBio announced the Board of Directors and Thomas Isett, the company's CEO, have agreed that Isett will resign as a member of the Board and relinquish his duties, rights and obligations as an officer and CEO of the company, effective immediately. While the company continues its search for a successor, the leadership team will report to the current Chair of the Board, William Clark.
|Over a week ago|
BlackBerry expands work with AWS to elevate BlackBerry QNX software to cloud » 09:2011/2811/28/22
BlackBerry Limited announced an extension of its use of Amazon Web Services, AWS, that will make BlackBerry QNX technology available to embedded systems developers for the first time ever in the cloud, significantly reducing time to market for their products. At AWS re:Invent 2022, BlackBerry QNX will demonstrate the company's Real Time Operating System along with its artificial intelligence data platform - BlackBerry IVY - running natively on Amazon Elastic Compute Cloud instances, powered by AWS Graviton2 processors. The BlackBerry QNX RTOS running in the cloud functions as a cloud-native developer workbench and can be used independently - or in conjunction with - BlackBerry IVY, a cloud connected automotive AI platform co-developed by BlackBerry and AWS
Fly Intel: Pre-market Movers » 08:5611/2211/22/22
WBA, GME, ADI, BBY, AEO, MDT, DLTR, GMDA, SCPH, JACK
Check out this morning's…
Gamida Cell says FDA extends omidubicel's PDUFA date to May 1, 2023 » 16:5311/2111/21/22
Gamida Cell provided an…
Gamida Cell provided an update on recent interactions with the U.S. Food and Drug Administration relating to the company's Biologics License Application for omidubicel, the company's advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant. As part of its ongoing BLA review, FDA issued an information request and viewed the data in the response as a major amendment, resulting in an extension of the omidubicel Prescription Drug User Fee Act date from January 30, 2023 to May 1, 2023. The agency also rescheduled Gamida Cell's late-cycle meeting to the first quarter of 2023. The data FDA requested were laboratory results for intermediate time points for patients enrolled in the Phase 3 study. These additional data provided by Gamida Cell to FDA are consistent with prior data submissions. "We appreciate the FDA's collaboration as they conduct their review of omidubicel," said Abigail "Abbey" Jenkins, Gamida Cell's President and Chief Executive Officer. "If approved, omidubicel will be the first and only advanced cell therapy for patients with blood cancer in need of an allogeneic stem cell transplant. We are committed to bringing this potentially transformative therapy forward as quickly as possible."
Mind Medicine price target lowered to $18 from $22 at Canaccord » 07:5111/2111/21/22
Canaccord analyst Tania…
Canaccord analyst Tania Armstrong-Whitworth lowered the firm's price target on Mind Medicine to $18 from $22 and keeps a Speculative Buy rating on the shares. The analyst said given ongoing capital constraints among biotechnology peers and considering their recent cost-cutting efforts, she has reduced her target.
Largest borrow rate increases among liquid names » 08:4511/1811/18/22
PHUN, NKLA, MNMD, QS, KOLD, AVDL, PTLO, QSR, SKLZ, EWH
Latest data shows the…
Latest data shows the largest indicative borrow rate increases among liquid option names include: Phunware (PHUN) 17.26% +1.39, Nikola (NKLA) 45.43% +0.82, MindMed (MNMD) 4.64% +0.82, Quantumscape (QS) 6.65% +0.73, ProShares UltraShort DJ-UBS Natural Gas (KOLD) 6.97% +0.40, Avadel Pharmaceuticals (AVDL) 5.78% +0.23, Portillo's (PTLO) 1.90% +0.21, Restaurant Brands (QSR) 0.44% +0.19, Skillz (SKLZ) 1.22% +0.18, and iShares Hong Kong (EWH) 5.21% +0.14.
Mind Medicine initiated with an Outperform at RBC Capital » 06:4011/1611/16/22
RBC Capital analyst Brian…
RBC Capital analyst Brian Abrahams initiated coverage of Mind Medicine with an Outperform rating and $5 price target. The analyst states that psychedelics, including LSD - which Mind Medicine lead drug MM-120 is a formulation of - have "shown increasing potential of late in treating mental health disorders". Abrahams adds that the company is taking a prudent and thoughtful approach to clinical development and scale-up that should maximize the potential they can capitalize on early promise shown for LSD in the high unmet need generalized anxiety disorder indication.
Gamida Cell price target lowered to $10 from $15 at Oppenheimer » 06:1311/1511/15/22
Oppenheimer analyst Mark…
Oppenheimer analyst Mark Breidenbach lowered the firm's price target on Gamida Cell to $10 from $15 and keeps an Outperform rating on the shares following the company's Q3 earnings and conference call. The analyst remains confident that omidubicel will receive FDA approval on or before its January 30 PDUFA date, but expects the product to face stiff competition from other graft sources upon launch. Pricing remains a key unknown that could help transplant centers and payers ascertain its cost-effectiveness relative to haplo-HSCT, which Breidenbach sees as omidubicel's primary competition. An upcoming ASH presentation suggests that omidubicel holds a slight edge over most competing grafts in terms of efficacy, safety, and long-term patient outcome-but, with uncertainty still surrounding Gamida's ex-U.S. regulatory and commercial strategy, the analyst has refined his model to focus on omidubicel's U.S. commercial potential.
Mind Medicine price target lowered to $8 from $22.50 at Maxim » 08:3211/1411/14/22
Maxim analyst Jason…
Maxim analyst Jason McCarthy lowered the firm's price target on Mind Medicine to $8 from $22.50 but keeps a Buy rating on the shares. The analyst is citing the company's equity financing and dilution in reducing his price target, though he also notes that it has significantly strengthened balance sheet to reach clinical milestones on its refocused pipeline. McCarthy further notes that Mind Medicine's lead program, MM-120 in generalized anxiety disorder, is expected to report data in late 2023, and its second MM-120 program, low dose for ADHD, is also expected to report topline data in the second half of next year.
Gamida Cell reports Q3 EPS (29c), consensus (31c) » 07:0711/1411/14/22
Net loss was $17.8M in…
Net loss was $17.8M in the third quarter compared to a net loss of $23.2M in the third quarter of 2021.