Medigen-Dynavax Vax Combo Starts Phase 2

 Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO) a biopharmaceutical company focusing on the development and production of vaccines and biologics, and Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that the first participant has been dosed in the Phase 2 clinical trial evaluating MVC's COVID-19 vaccine candidate, MVC-COV1901.  MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax.

MVC's Phase 2 clinical trial is a randomized, double-blinded, multi-center clinical trial, expecting to enroll 3,700 healthy subjects, 20 years of age and above. The trial will evaluate MVC-COV1901 safety and endurance of immunogenicity. The proposed dosing regimen is two doses administered intramuscularly one month apart. Based on MVC's Phase 1 interim data, MVC-COV1901 has demonstrated a good safety profile and encouraging immunogenicity performance.

https://www.prnewswire.com/news-releases/medigen-vaccine-biologics-covid-19-vaccine-adjuvanted-with-dynavaxs-cpg-1018-announces-first-participant-dosed-in-phase-2-clinical-trial-in-taiwan-301213721.html

Aurinia gains after Wainwright upgrade

 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSE:AUP)'s stock price reached a new 52-week high during mid-day trading on Monday after HC Wainwright raised their price target on the stock from $30.00 to $35.00. HC Wainwright currently has a buy rating on the stock. Aurinia Pharmaceuticals traded as high as $23.80 and last traded at $20.60, with a volume of 387735 shares trading hands.

https://www.marketbeat.com/instant-alerts/nasdaq-auph-price-alert-2021-01/

Regeneron Upgraded as BMO Sees Potential for Eye, Skin Drugs

 Regeneron  (REGN)  shares rose Monday after BMO Capital Markets analyst Matthew Luchini raised his rating on the biotech company to outperform from market perform and affirmed his price target at $630.

Regeneron "is well positioned heading into 2021," Luchini wrote in a commentary cited by Barron’s.

Regeneron shares recently traded at $547.06, up 1.7%. They surged 11% in 2021 through Friday's trading, and they leaped 59% over the past year amid optimism over its coronavirus antibody treatment.

While the company’s Eylea eye drug faces some headwinds, it still has room to grow, as does its Dupixent skin drug, he said. Luchini also is impressed with Regeneron’s cancer-drug pipeline.

“Given our positive view on Regeneron’s fundamentals and optionality provided by the pipeline, ... current levels provide an attractive entry point,” he said.

As for the covid treatment, “monoclonal antibody usage has been slow, even during the continuing surge,” Luchini said. 

“Given our expectation that the broader focus remains on expanding vaccine distribution, we expect demand to meaningfully decline as we move through the second half of 2021.”

Earlier this month, Citi analyst Mohit Bansal upgraded Regeneron to buy from neutral on optimism about Dupixent. 

Bansal says investors are focusing too much on weakness in Eylea and not enough on Dupixent.

The “recent weakness in the name is overlooking the pace of Dupixent’s growth and expansion potential,” he said, according to Seeking Alpha. 

Dupixent has plenty of potential for growth beyond its current label, Bansal said, according to Dow Jones.

His price target is $575.

https://www.thestreet.com/investing/regeneron-upgraded-at-bmo-stock-rises

iRobot: Delayed reaction to tout?

 Shares of Roomba maker iRobot (NASDAQ:IRBT) roared out of the gate Monday, climbing 51.5% through 10:45 a.m. EST in apparent delayed reaction to an endorsement from Investor's Business Daily.

On Thursday last week, IBD reported that iRobot stock has improved its "relative strength" rating from 61 to 72. Citing "over 100 years of market history," the paper noted that "the market's biggest winners" are those that score "north of 80" on IBD's 1-99 relative strength scale.  

iRobot, in the paper's estimation, was approaching a "buy point" and should be bought just as soon as it crosses a share price of $98.65.

iRobot shares passed that buy point in the final minutes of trading Friday. Today, as trading resumes, the stock took off like a starter pistol had been fired. Already ranked No. 1 among its peers in the Household-Appliances/Hardware industry group last week, iRobot appears to be off to the races now, and unlikely to give up its title any time soon -- at least so far as IBD's RS ratings go.

And that's fine -- if "technical analysis" and following the trading patterns of various ticker symbols is your thing. It certainly seems to be working out for momentum traders today! But what about value investors? Is there anything for us to like about iRobot stock?

As a matter of fact, there is. From a valuation perspective, iRobot stock at $3.9 billion sells for a reasonable 25.5 times trailing earnings, even after today's astounding run-up. Moreover, when you value the stock on its much stronger free cash flow -- the company generated $225 million in real cash profits over the past year -- iRobot's price-to-FCF ratio drops to an even more attractive 17.5, a valuation that looks to be less than half the average P/E of the stock market as a whole.

In short, there are arguments to buy iRobot stock on both the technical and the fundamental sides -- and that's at least two good reasons why this stock is rocketing today.

https://www.fool.com/investing/2021/01/25/why-irobot-stock-just-rocketed-515/

Markets Are Breaking Left And Right As Stocks Tumble

 Whether it is due to the absolute insanity taking place among the most shorted names, or the broader market suddenly tumbling (perhaps as the PPT forgot to keep an eye on the S&P transfixed by the action in GME), Downdetector and Bloomberg report that a slew of trading platforms are reporting problems on Monday, and while some have been resolved while others are ongoing.

• Robinhood is experiencing issues with crypto trading
• Vanguard tweeted it understands some clients are experiencing issues accessing their accounts
• TD Ameritrade says it is aware of an issue impacting a small number of clients on the thinkorswim platform, a company spokesperson said
• Charles Schwab announced it worked to resolve an issue
• There was a slowdown in Merrill logins earlier Monday, but the situation has been resolved, according to a Bank of America spokesperson
• E*Trade users reported problems Monday, according to Downdetector

Meanwhile, aside from the ridiculous action in penny stocks and supershorts, the broader market has just tumbled...

... the VIX is surging...

... and the 10Y has slumped to session lows.

https://www.zerohedge.com/markets/markets-are-breaking-left-and-right-stocks-tumble

Moderna: working on Covid booster for South Africa variant, current vax some protection

 

• Moderna said it’s accelerating work on a Covid-19 booster shot to guard against the recently discovered variant in South Africa.
• Its researchers said its current coronavirus vaccine appears to work against the two highly transmissible strains found in the U.K. and South Africa, although it looks like it may be less effective against the latter.
• https://www.cnbc.com/2021/01/25/covid-vaccine-moderna-working-on-covid-booster-shots-for-south-african-strain.html

Humanigen, Emergent Bio in Agreement on Phase 3 COVID-19 Therapy Lenzilumab

Emergent BioSolutions Inc. (NYSE:EBS) (Emergent) and Humanigen, Inc. (NASDAQ:HGEN) (Humanigen) today announced that they have entered into a contract development and manufacturing (CDMO) services agreement to accelerate the drug product manufacturing of lenzilumab™, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called "cytokine storm." Emergent will provide access to manufacturing capacity reserved for and provided by the U.S. government under Humanigen’s Cooperative Research and Development Agreement (CRADA) with the Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for emergency use authorization (EUA) in the first quarter of 2021.

Under the terms of the agreement, Emergent will provide its integrated CDMO services for the manufacturing of drug product batches to support Humanigen’s efforts to increase supply of lenzilumab in anticipation of a potential EUA beginning in the first quarter of 2021, including utilization of a new state-of-the-art flex fill line at Emergent’s Baltimore, MD (Camden) drug product manufacturing facility. This newly expanded facility was built to provide increased capacity and flexibility to support companies in need of clinical and commercial manufacturing capabilities. The parties intend to negotiate a commercial manufacturing services agreement that could include future fill batches for a biologics license application (BLA).

This agreement marks Emergent’s seventh CDMO collaboration with government and industry partners working to deliver COVID-19 vaccine and therapeutic solutions.

https://finance.yahoo.com/news/humanigen-emergent-biosolutions-announce-contract-133000441.html