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.

Initial biochemical and biophysical analyses also indicate STI-1499 is a potentially strong antibody drug candidate.", the company mentioned in its statement. Sorrento's findings are subject to  peer review by other scientists, and the research has not been tested on human beings, according to reports. Sorrento also claims that this newly discovered antibody, labelled the STI-1499, could be developed and made available before a vaccine enters the market. Meanwhile, the company continues to work on production of a separate, antibody “cocktail” that could provide protection against SARS-CoV-2 even in case of mutations in the virus.    

Novavax  said it would be receiving up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations for development of its coronavirus vaccine candidate. The biotechnology company mentioned that the additional funding will support a rapid scale-up of the NVX-CoV2373 vaccine antigen and therefore allow the company to boost its large-scale manufacturing capacity. According to Novavax,  a Phase 1/2 clinical of the vaccine candidate will begin this month in Australia.The company said the funding would allow it to potentially produce up to 100 million vaccine doses by end of 2020.

Inovio Pharmaceuticals  shares climbed around +20% Tuesday, following the company’s announcement about its progress on developing a coronavirus vaccine. The biotech company revealed that it has sped its timeline for developing the vaccine, and is planning human trials beginning April.  Inovio  plans to start human clinical trials in the U.S. in April, followed by trials in China and South Korea. The company intends to  implement  1 million doses by the end of the year. But J. Joseph Kim, president and CEO, added that Inovio would need to expand resources to make enough doses to help protect Americans from Covid-19 as well as to lead global efforts to combat this virus.  

Pharmaceutical companies Nektar Therapeutics and  Bristol-Myers Squibb have expanded their collaboration to develop an anti-cancer treatment. The treatment comprises Nektar’s bempegaldesleukin (bempeg) and Bristol-Myers' Opdivo (nivolumab).  The expansion would go beyond the three pivotal studies in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) - to include additional trials in adjuvant melanoma and in muscle-invasive bladder cancer.  Nektar and Bristol-Myers will also begin phase 1/2 dose escalation studies in first-line RCC.  The two companies began the partnership in 2016.The cost-sharing conditions won’t change in the expanded accord. Bristol-Myers will  also fund a Phase 1/2 dose optimization and expansion trial assessing the combo in first-line non-small cell lung cancer. Nektar will be able to receive up to $125 million total once the fi

Incyte Corporation shares took a hit late trading Thursday, after news of disappointing results on one of its clinical trials. The pharmaceutical  company revealed that one of its drugs fell short of meeting its primary endpoint in a phase 3 trial.That is, it did not meet the primary endpoint of a statistically significant improvement in overall response rate (ORR) at Day 28 compared to placebo plus corticosteroids; also, no difference was found in non-relapse mortality at month 6, which is a crucial secondary endpoint. The above-mentioned disease is often seen in patients undergoing bone marrow or organ transplants.

Biotech company Wave Life Sciences’ shares plummeted , after clinical test results on a anti-Huntington disease drug turned out to be a bit disappointing. The trial, which compared the results from oligonucleotide therapeutic WVE-120102 with a placebo, showed a statistically significant 12.4% reduction in a disease-causing mutant huntingtin protein, at the highest doses tested ( as indicated in the Wave Life’s statement).However,  “there was no difference" in total huntingtin protein compared with placebo, the company said. The drug was generally safe and “well tolerated among patients receiving doses up to 16 mg in both single and multidose portions of the study,” according to Wave Life. Wave Life conducted a Phase 1b/2a Precision-HD2 trial.

Nektar Therapeutics (Nasdaq: NKTR) is a biopharmaceutical company that drugs for cancer, autoimmune diseases, and chronic pain.The company’s fundamental indicators are all over the place, but the stock has been trending lower since September. If we connect the closing high from September with intraday high from February, it creates a trend line that the stock just hit in the last few days.

Regeneron Pharmaceuticals’ first-quarter earnings came in lower  than what analysts expected. Regeneron raked in adjusted earnings of $4.45 per share, missing Wall Street's expectation of $5.52.Revenue of $1.71 billion also was lower than analysts' $1.76 billion expectations.  CEO Leonard Schleifer emphasized that the company is optimistic about the potential of its  product Dupixent, which is now FDA-approved in atopic dermatitis and asthma in both adults and adolescents and is currently under Priority Review by the FDA for chronic rhinosinusitis with nasal polyps.

Celgene Corporation says that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for label expansions of its oncology drug, Revlimid and Imnovid. The CHMP recommended approval of the triplet regimen of Revlimid as combination therapy with Velcade and dexamethasone (RVd) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.The committee is expected to make its final decision in approximately two months. 

Durham, NC-based biotech Precision Biosciences has filed a prospectus for a $100 million IPO. Next year, the company should launch a Phase 1/2a clinical trial evaluating a gene-edited allogeneic CAR T candidate targeting CD18 in acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL) patients.The company believes that this is the first allogeneic CAR T for NHL.