Fly Intel: Pre-market Movers » 09:0905/1405/14/21
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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.
Fly Intel: After-Hours Movers » 18:2105/1305/13/21
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CorMedix reports Q1 EPS (20c), consensus (18c) » 16:4305/1305/13/21
The Company reported cash…
The Company reported cash and short-term investments of $81.2 million at March 31, 2021, excluding restricted cash. The Company believes that, based on its current cash resources, it has sufficient resources to fund operations at least into the second half of 2022. approximately $1.3 million in net proceeds. Closing is anticipated in 2Q of 2021. Khoso Baluch, CorMedix CEO commented, "As we continue to work through the items required by FDA for resubmission of the NDA, we remain confident in our efforts to bring DefenCath to hemodialysis patients as an important novel antimicrobial catheter lock solution to reduce catheter related blood stream infections in patients receiving hemodialysis via central venous catheters. We believe we have the right team and resources to accomplish this as we advance DefenCath through the regulatory approval process."
Bolt Biotherapeutics reports Q1 EPS ($1.14), consensus (60c) » 16:3905/1305/13/21
Cash, cash equivalents,…
Cash, cash equivalents, and marketable securities were $302.9 million as of March 31, 2021, which is expected to fund operations into 2023 - Bolt is well positioned to continue to drive growth across the company and advance the pipeline through key milestones, with cash to fund operations into 2023. "Our successful IPO in the first quarter of 2021 places us in a position of strength to deliver on value-creating milestones in 2021 and 2022. We continue to advance our Phase 1/2 trial for our lead candidate, BDC-1001, for the treatment of patients with HER2-expressing solid tumors. We look forward to completing the monotherapy dose escalation and initiating the monotherapy Phase 2 dose expansion cohorts as well as the evaluation of combining BDC-1001 with an anti-PD-1 antibody later in 2021," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt. "Beyond BDC-1001, we continue to advance our pipeline and are on track to initiate clinical trials for CEA-targeted ISAC BDC-2034 in 2022 and we expect to designate our third clinical candidate later this year."
CorMedix appoints Thomas Nusbickel as Chief Commercial Officer » 08:3205/1305/13/21
CorMedix (CRMD) announced…
CorMedix (CRMD) announced the appointment of Thomas Nusbickel to the newly created position of Chief Commercial Officer. Tom will be responsible for advancing the commercial strategy needed to bring DefenCath to patients in the U.S. when approved by FDA for commercial distribution. Tom most recently served as Vice President of Market Access and Government Affairs at Coherus Biosciences (CHRS).
Frequency Therapeutics reports Q1 EPS (60c), consensus (28c) » 07:4105/1305/13/21
Reports Q1 revenue…
Reports Q1 revenue $4.65M, consensus $8.13M. "As we work to develop a novel medicine for the treatment of the most common form of hearing loss, our initial focus has been to investigate the broadest set of potential conditions and severities through a comprehensive series of probing studies. With data from all of our single administration studies, we have been able to better define the groups of patients that we believe are responding to FX-322, while also informing the optimal study design for new placebo-controlled Phase 2 trials," said David Lucchino, Frequency's CEO.
Akouos expects cash to fund operations for at least next two years » 07:1805/1305/13/21
Cash, cash equivalents,…
Cash, cash equivalents, and marketable securities were $286.6 million as of March 31, 2021, as compared to $308.0 million as of December 31, 2020. Akouos expects its cash balance to fund operations for at least the next two years.
Akouos reports Q1 EPS (47c), consensus (38c) » 07:1805/1305/13/21
"We continue to…
"We continue to demonstrate our leadership in the field of inner ear genetic medicines. Recently, FDA granted AK-OTOF, our lead product candidate, what we believe are the first Orphan Drug and Rare Pediatric Disease designations for a genetic form of hearing loss. At the ASGCT Annual Meeting, our team presented nonclinical data demonstrating the unique applicability of our genetic medicine platform to potentially restore, improve, and preserve physiologic hearing for a monogenic condition and a condition of complex etiology," said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos. "These accomplishments have been made possible by our team of leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy, including the recent addition of Dr. Kathy Reape as chief development officer. We continue to build our team's capabilities, infrastructure, and facilities to support our planned IND submissions for AK-OTOF and AK-antiVEGF in 2022, and are progressing our earlier stage programs towards candidate selection or target announcement."
Liquidia Technologies reports Q1 EPS (21c), consensus (21c) » 07:1105/1305/13/21
Reports Q1 revenue…
Reports Q1 revenue $3.08M, consensus $870,000. Damian deGoa, Liquidia's CEO, said: "This first quarter has been an important time of transition and re-structuring for the company as it strengthens its position and commitment to the products and patients that we support. We believe that our renewed focus and financial discipline are essential in order for the company to achieve its objectives in 2021 and beyond."