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...

While the decision will need a confirmation by the European Commission, it still leads to region-wise vaccine distribution in the coming days.

Ursula von der Leyen, president of the European Commission, said in a statement that the Moderna vaccine would allow the EU to have an additional 160 million doses.The European Medicines Agency said the biotech's mRNA 1273 vaccine is "another tool to overcome the current emergency", after the Pfizer-BioNTech Covid vaccine.

The decision will need a confirmation by the European Commission

 

It also suggested a good tolerance generally.

Novavax is also currently conducting a large Phase 3 clinical study in the United Kingdom (U.K.), a Phase 2b safety and efficacy study in South Africa, and an ongoing Phase1/2 trial in the U.S. and Australia.Results from these trials are expected to come in as soon as early first quarter 2021, although timing could depend on transmission rates in the regions.

This surge followed an announcement of Ampio’s new COVID 19 treatment successfully moving toward a Phase 2 clinical trial after the Safety Monitoring Committee gave it the green light.Although the stock showed incredible results from December 20, 2019 to December 20, 2020 with a $2.30 (+370.77%) surge in price, a huge 6.613M (+312.41%) rise is volume, and an impressive $445.98M (+476.66%) change in market capitalization, the jury is still out.

Novavax   reported  revenue that increased substantially year-over-year, but was lower than analysts' expectations. The vaccine development company’s revenue of $35.5 million in the latest quarter, compared to $3.4 million in the year-ago quarter.The odds of a continued Downtrend are 79%. The Stochastic Indicator may be shifting from an Uptrend to a Downtrend.

Yee gave  the biopharmaceutical company a share-price target of $90. Last week, Moderna said it completed enrolling patients for a Phase II study of the vaccine candidate, mRNA-1273. Yee predicts that mRNA-1273 will have at least an emergency-use authorization by early next year. Moderna said that it’s on track to deliver 500 million doses per year, and possibly up to 1 billion doses per year, starting 2021. According to Tickeron, MRNA enters an Uptrend because Momentum Indicator exceeded the 0 level on July 09, 2020 This indicator signals that MRNA's price has momentum to move higher, since its current price moved above its price 14 days ago.

Regeneron   shares climbed Tuesday, following news of the company being awarded a $450 million contract with the U.S. government, for developing coronavirus treatment. The biotechnology company said that the contract will support it in boosting production of the REGN-COV2, conditional upon the success of clinical trials and Emergency Use Authorization or product approval from the Food and Drug Administration grants REGN-COV2 is involved in two different clinical trials for both the treatment and prevention of the COVID-19. Another biotech company Novavax  also received a government contract, worth $1.6 billion from the federal government, to complete late-stage development of its NVX‑CoV2373 Covid-19 vaccine candidate, and to begin large-scale manufacturing and delivery of the drug by next year. Tickeron's Comparison of Novavax, Inc. (NVAX) vs Regeneron Pharmaceuticals, Inc. (REGN) : [NVAX & REGN] are closely correlated. Both companies

Preliminary results are expected at the end of this month. According to Novavax, the $1.6 billion from Operation Warp Speed will help towards a more widespread phase 3 trial as well as support the company stockpile and build out a distribution network for the drug. Tickeron's AI-powered scorecard rates NVAX a BUY. NVAX's Aroon indicator reaches into Uptrend on July 06, 2020 For traders, this could mean going long on the ticker or exploring call options in the next month.The odds of a continued Uptrend are 78%. The Moving Average Convergence Divergence (MACD) just turned positive.

Biotech company Moderna   has reportedly delayed the start of a Phase III trial of its coronavirus vaccine. The healthcare website Stat News reported that Moderna was making changes to the trial plan, and therefore the start date of the Phase III study has been pushed back, according to investigators who did not want to be named. “My understanding was that they wanted to get the first vaccines given in July, and they say they’re still committed to do that,” one investigator said, according to Stat News.“As best I can tell, they’re close to being on target for that.” Moderna wrote on Twitter that "the trial is still expected to begin in July and we expect to be the first to start a Phase 3 trial.

The current health crisis has created a lot of buzz around the biotech sector as several companies from the sector are working on potential vaccines against the COVID-19 virus.Many of the companies are overvalued at this time, but the fundamentals of many are really good. I looked at the SPDR S&P Biotech ETF (NYSE: XBI) and its components.