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CRVS, HEPA Jump On COVID-19 Drug Bandwagon, LVGO In Good Health, NVAX Joins $100 Stock Price Club

pharma 032117 08jul20 lt

Today's Daily Dose brings you news about the pipeline progress of Annovis Bio, new entrants in the COVID-19 drug development space, Livongo Health's upbeat preliminary Q2 revenue, Regeneron's BARDA contract, Novavax stock price touching new high and Mallinckrodt's near-term regulatory catalyst.

Read on…

1. Annovis To Advance ANVS401 Into Parkinson's/ Alzheimer's Study

Annovis Bio Inc. (ANVS) has received clearance from the Central Institutional Review Board to begin a phase II study of its lead compound ANVS401 in early Parkinson's disease and early Alzheimer's disease patients.

The two-part phase II study, which will be conducted at 15 sites across the U.S., will treat a combined total of 68 Parkinson's disease and Alzheimer's disease patients for 4 weeks with ANVS401.

The study is expected to be completed by the first quarter of 2021.

ANVS closed Tuesday's trading at $6.78, up 76.56%.

2. Corvus Jumps On COVID-19 Drug Bandwagon

Corvus Pharmaceuticals Inc. (CRVS) has initiated a phase I study of CPI-006, which represents a novel immunotherapy approach, in patients with COVID-19.

CPI-006 has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer, according to the Company.

In both in vitro and in vivo studies in cancer patients, CPI-006 has demonstrated binding to various immune cells and the inducement of a humoral adaptive immune response - B cell activation and lymphocyte trafficking leading to the production of antigen-specific immunoglobulin (IgM and IgG) antibodies.

The phase I study of CPI-006 is expected to enroll up to 30 COVID-19 patients with mild to moderate symptoms. Data from this study is scheduled to be available later this year.

CPI-006 is also being studied in a phase 1/1b clinical trial as monotherapy and in combination with investigational Ciforadenant or Merck's Keytruda in patients with a variety of cancers who have failed standard therapies. Updated clinical data from the phase 1/1b clinical trial is targeted to be presented at the Society for Immunotherapy of Cancer (SITC) annual meeting in November 2020.

CRVS touched a new 52-week high of $6.88 in intraday trading on Tuesday, before closing at $4.95, up 80.84%.

3. 89bio Prices Upsized Offering

89bio Inc. (ETNB) has priced an upsized underwritten public offering of 2.65 million shares of its common stock at a public offering price of $27.50 per share. The gross proceeds of the offering are expected to be approximately $72.9 million.

The offering is expected to close on July 10, 2020. The underwriters have a 30-day option to purchase up to an additional 397,440 shares of common stock.

89bio is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of liver and cardio-metabolic diseases.

The Company's lead drug candidate is BIO89-100, under a phase 1b/2a trial in nonalcoholic steatohepatitis. Topline results from this study are expected in the second half of 2020.

ETNM closed Tuesday's trading at $33.05, up 24.81%.

4. Hepion Eyeing Coronavirus Treatment

Hepion Pharmaceuticals Inc.'s (HEPA) anti-fibrotic drug candidate, CRV431, has demonstrated positive results in models of acute pulmonary injury and SARS-CoV-2 viral replication.

According to the 'in vitro' results, CRV431 attenuated lung inflammation and damage similar to or better than Dexamethasone, including reductions in neutrophils and IL-6, besides decreasing SARS-CoV-2 replication and production of infectious virus.

CRV431 is already being studied as a treatment for non-alcoholic steatohepatitis, or NASH. This compound is under a phase IIa trial for NASH fibrosis, dubbed AMBITION. Results from this study are expected by the end of this year.

HEPA closed Tuesday's trading at $4.12, up 43.06%.

5. Livongo Reports Upbeat Preliminary Q2 Revenue

Shares of Livongo Health Inc. (LVGO) touched a new high on Tuesday, following upbeat preliminary revenue for the second quarter of fiscal 2020.

For the second quarter, the Company expects revenue to be in the range of $86 million to $87 million, up from prior guidance of $73 million to $75 million. Analysts polled by Thomson Reuters have a consensus revenue estimate of $77.57 million for the quarter.

The Company is slated to report second-quarter financial results on August 5, 2020.

LVGO closed Tuesday's trading at $93.76, up 20.78%.

6. Mallinckrodt Faces FDA Panel On Jul.15

Mallinckrodt plc's (MNK) Terlipressin, an investigational agent being evaluated for the treatment of hepatorenal syndrome type 1, is slated to be reviewed by an FDA panel on July 15, 2020.

Hepatorenal syndrome type 1 (HRS-1) is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis, which affects an estimated 30,000 to 40,000 people in the U.S. annually. The condition has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated. Currently, there are no FDA-approved drug therapies for HRS-1 in the U.S.

The final decision on Terlipressin is expected by September 12, 2020.

MNK closed Tuesday's trading at $2.44, down 2.01%.

7. Novavax Joins Elite $100 Stock Price Club

Shares of Novavax Inc. (NVAX) climbed more than 30 percent on Tuesday, following news that the Company has been selected to participate in Operation Warp Speed, a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021.

The Company's COVID-19 vaccine candidate NVX-CoV2373 is under a phase I/II trial, with preliminary immunogenicity and safety results from the phase I portion of the trial expected in July 2020. If the results are promising, the phase II portion of the trial will be initiated quickly. The Coalition for Epidemic Preparedness Innovations has provided up to $388 million in funding to support the phase I/II trial.

A pivotal phase III trial of NVX-CoV2373 with up to 30,000 subjects is expected to commence beginning in the fall of 2020.

Under the Operation Warp Speed program, Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including completion of the pivotal phase III trial, establishing large-scale manufacturing and delivery of 100 million doses of NVX-CoV2373, as early as late 2020.

NVAX closed Tuesday's trading at $104.56, up 31.62%. The stock touched a new high of $111.77 in intraday trading.

8. Regeneron Rallies On BARDA Contract

As part of Operation Warp Speed, the Biomedical Advanced Research and Development Authority has granted Regeneron Pharmaceuticals Inc. (REGN) a $450 million contract to manufacture and supply REGN-COV2, an investigational anti-viral cocktail in the treatment and prevention of COVID-19.

REGN-COV2 is currently in two phase II/III clinical trials for the treatment of COVID-19 and in a phase III trial for the prevention of COVID-19 infection.

Preliminary data from the phase II/III trials are expected later this summer.

REGN closed Tuesday's trading at an all-time high of $640.88, up 2.17%. In intraday trading, the stock had touched $653.49.

9. Stocks That Moved On No News

VBI Vaccines Inc. (VBIV) closed Tuesday's trading at $3.36, up 21.30%.

Inovio Pharmaceuticals Inc. (INO) closed Tuesday's trading at $24.09, up 15.10%.

Cardiff Oncology, Inc. (CRDF) closed Tuesday's trading at $4.86, up 14.35%.

Trevi Therapeutics Inc. (TRVI) closed Tuesday's trading at $5.49, down 21.35%.

Interpace Biosciences Inc. (IDXG) closed Tuesday's trading at $5.53, down 13.05%.

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