Kala Pharmaceuticals (KALA) recently reported its fourth-quarter earnings, which missed estimates, causing some concern among investors. The company reported a loss of $0.32 per share, missing the consensus estimate of a loss of $0.29 per share. Despite the miss, the company's revenue beat expectations, coming in at $14.6 million compared to the expected $13.8 million. The Q4 earnings miss is...
Chemomab Therapeutics Ltd shares jumped on Tuesday, after it reported topline results from its Phase 2a trial assessing CM-101 in non-alcoholic steatohepatitis (NASH) patients. While the trial met its primary endpoint of safety and tolerability, CM-101 achieved reductions in secondary endpoints that include liver fibrosis biomarkers and physiologic assessments measured at baseline and week...
The U.S. Food and Drug Administration (FDA) approved TG Therapeutics Inc's Briumvi – a monoclonal antibody for treating patients with relapsing forms of multiple sclerosis (RMS). Briumvi is the first and only anti-CD20 monoclonal antibody approved for RMS that can be administered in a one-hour infusion following the first dose. The approval by the FDA may help offset the headwind to the...
Alzamend Neuro Inc .has partnered with the Miller School of Medicine, Interdisciplinary Stem Cell Institute at the University of Miami for its Phase 1/2A trial of ALZN002. ALZN002 is a patented immunotherapy method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine to combat Alzheimer’s. On October 5, Alzamend announced the addition of healthy adult subject to its...
Signals from Pattern Search Engine Tickeron is bringing high-powered Artificial Intelligence (A.I.) technology to the retail investment community that, in our opinion, rivals the technology and approach used at major Wall Street firms. The Ph. D founders of Tickeron have spent several years researching and building an Artificial Intelligence-based search engine that allows active investors to...
Avid Bioservices posted adjusted earnings of $0.04 per share for the quarter ending July 2022, exceeding the Zacks Consensus Estimate of $0.03 per share. Earnings were $0.10 per share in the year-ago quarter. Revenues of $36.69 million for the quarter also topped the Zacks Consensus Estimate by 7.92%. The figure is also higher than year-ago period’s $30.75 million. The current consensus EPS...
RVL Pharmaceuticals plc. announced its preliminary second quarter FY22 sales from Upneeq of $8.4 million. The figure represents a +42% growth sequentially. Upneeq is an approved ophthalmic solution for droopy eyelids. The company also mentioned that it had received orders from approximately 2,200 cumulative unique medical aesthetics practices from February through June of 2022. CEO Brian...
BioNTech SE reported growth in earnings and revenue for the fourth quarter, driven by the Covid-19 vaccine it produces in partnership with Pfizer Inc. The company also announced its program for repurchasing shares of up to $1.5 billion over the next two years. The company posted net profit of 3.17 billion euros ($3.51 billion) for the last quarter of the year, up from EUR3.66 million a year...
Moderna and Pfizer shares climbed, after the U.S. Food & Drug Administration authorized the use of a second shot of Covid boosters developed by the pharma companies. According to the FDA, adults over the age of 50, as well as those with compromised immune systems, can receive a booster dose of either the Pfizer or Moderna vaccine at least four months after receiving the first. Peter Marks,...
Moderna posted fourth quarter earnings that surpassed expectations. The pharma company also boosted its full-year revenue outlook for Covid vaccine sales. and unveiled a new $3 billion share repurchase plan. Moderna’s diluted GAAP earnings came in at $11.29 per share for the three months ending in December, beating the Street expectations of $9.90 per share. It incurred a loss of -69 cents...
Iterum Therapeutics plc said that it will not get approval for the current form of its new drug application for oral sulopenem.
According to the Food and Drug Administration (FDA), additional data are required and the company should conduct at least one more well-controlled clinical trial for its treatment of adult women with uncomplicated urinary tract infections.FDA mentioned that it is willing to work with Iterum on the design of clinical trials in order to address the issues the FDA identified.
However, Iterum CEO Corey Fishman said the company is “disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem,” .
Myron Holubiak, president and chief executive mentioned that this would be the third recommendation by the DMC supporting the continuation of the Mino-Lok trial.He said the outcome indicates that “based on our predefined parameters, it would be possible to achieve our primary endpoint by continuing the trial as planned, and is an encouraging signal when combined with the results of our prior studies.
Shares of Clearside Biomedical climbed on Thursday, following a price target hike from analysts at Wedbush. Wedbush analyst Liana Moussatos tripled her price target on the biopharmaceutical company’s shares to $18 a share. Moussatos has an outperform rating on the stock. This follows positive data from a early stage eye treatment study at Clearside. "We find these initial results encouraging...
Sage Therapeutics shares fell on Tuesday, following disappointing results of its Phase 3 test results for its depression drug Zuranolone. The biotech company is producing this drug with Biogen. The late-stage study revealed that while Zuranolone did lead to improvement on depression symptoms, there are doubts about the longer-term efficacy of the treatment. According to Sage, the drug’s...
Shares of Ocugen Inc. in premarket trading on Tuesday, after the company said it chose privately held pharmaceutical contract manufacturer Jubilant HollisterStier, to produce its COVID-19 vaccine (which is still in investigational stage) for the U.S. and Canada. The vaccine, called COVAXIN is not authorized in either country at this time. “We are fully committed to bringing COVAXIN to the US...
Editas Medicine shares got a sell rating from Goldman Sachs as the latter initiated coverage on the stock.
Goldman Sachs analysts set a price target of $20 a share, a Wall Street low, on the biotech shares.According to the analysts, the risk-reward dynamic was skewed negatively for the company.
Goldman analyst Madhu Kumar mentioned in a note that initial results from Editas’ experimental Crispr gene editing product EDIT-11 in a rare eye disease may not lead to adequate productive editing to meaningfully improve patients' vision.
Novavax is reportedly delaying signing a contract to supply its COVID-19 vaccine to the EU due to production issues. According to a Reuters report, the company is struggling to source some of the raw materials for the vaccine. Earlier this year, the EU was planning to a sign a deal for at least 100 million doses of Novavax's vaccine, with an option to buy another 100 million doses. The...
Biotech company Seneca Biopharma, Inc. reported its financial results for the year ended December 31, 2020. The year saw the company entering into a definitive Merger Agreement with private company Leading BioSciences, Inc. , which specializes in developing novel therapeutics to improve human health through therapeutic protection of the gastrointestinal mucosal barrier. Net loss for 2020 came...
Novavax posted a fiscal fourth-quarter loss that’s wider than anticipated by analysts. However, the vaccine development company’s revenue came in higher than expected. The net loss for the quarter widened to -$2.70 a share from -$1.13 in the year-earlier quarter. FactSet poll shows consensus estimates of a GAAP net loss of -$2.23 a share Revenue rose $279.7 million from $8.8 million. That's...
Biotech company Moderna said it was seeking approval from regulators around the globe to pack 50 per cent more coronavirus vaccine into each of its vials, in order to boost current supply levels. The company gave a statement after The New York Times first reported that the US Food and Drug Administration (FDA) had already given permission to it to increase the amount by 40 per cent. A...