Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of assets with different modes of action to provide a cure for people with chronic hepatitis B virus (cHBV) infection and to treat coronaviruses (including COVID-19), today announced preliminary data from its on-going Phase 1a/1b clinical trial demonstrating that its next generation capsid inhibitor, AB-836, is generally safe and well-tolerated in both healthy subjects and patients with cHBV and provides robust antiviral activity.
Gaston Picchio, Ph.D., Chief Development Officer at Arbutus, commented, “These preliminary results demonstrate that AB-836 is generally safe and well-tolerated in both single- and multiple-doses in healthy subjects and at doses up to 100mg administered once daily for 28 days in cHBV patients. In addition, the mean Day 28 drop in HBV DNA observed to date with a relatively low dose suggests that AB-836 is a very potent inhibitor of HBV replication making it an ideal candidate to potentially completely suppress viral replication. We look forward to continuing to evaluate the safety and efficacy of AB-836 in Part 3 of this trial.”
The Phase 1a/1b clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of single and multiple doses of AB-836 in healthy subjects and patients with cHBV. The trial consists of three parts. Part 1 evaluated alternating single doses of AB-836 or placebo ranging from 10mg to 175mg in a fasted or fed state in healthy subjects. Part 2 evaluated multiple ascending doses of 50mg, 100mg or 150mg of AB-836 or placebo once daily for 10 days in healthy volunteers. Part 3, which is still on-going, is currently randomizing HBV DNA positive cHBV patients who are HBeAg positive or negative to receive either 50mg or 100mg of AB-836 or placebo once daily for 28 days.
Moderna( MRNA -9.62% )andPfizer( PFE 0.24% )dominate the coronavirus vaccine market. Each has generated quarterly vaccine revenue in the billions. And they expect to report annual vaccine revenue of as much as $18 billion and $36 billion, respectively.Johnson & Johnsonalso sells a coronavirus vaccine. But the company has remained a distant rival since that product's authorization.
But the vaccine market soon may welcome another competitor. And that competitor has a potential vaccine that could carve out a decent share of the market. Now, the question is whether, right now, this latecomer represents a better buy than today's leaders. Let's find out.
So, which player am I talking about? None other thanNovavax( NVAX -7.19% ). The company is far from a stranger to the spotlight. The U.S. awarded the biotech $1.6 billion in funding in the early days of the vaccine race -- and a contract for the delivery of 100 million vaccine doses. Novavax fell behind due to struggles with its manufacturing ramp up. But in recent weeks, the company completed regulatory filings to various countries. And it's even won authorization from Indonesia and the Philippines.
Novavax plans on filing for authorization in the U.S. before the end of the year. A decision could come a few weeks later. But can Novavax still benefit this late in the game?
I think so. And here's why. Novavax's potential product is different from the Moderna and Pfizer vaccines. The candidate isn't an mRNA vaccine. That means it doesn't include mRNA to instruct the body to produce a copy of the coronavirus spike protein -- that's the protein used to infect. Instead, Novavax's candidate falls into the category of protein subunit vaccines. It includes a genetically engineered spike protein in nanoparticle form along with an adjuvant to boost immune response.
Some healthcare providers and individuals hesitate to go for a new technology like mRNA. And this is where Novavax can gain market share. Subunit vaccines already are on the market -- an example is the hepatitis B vaccine. This is a long-proven technology. So those who are hesitant about going for a coronavirus jab may more easily opt for Novavax.
The temperature difference
Also, Novavax's candidate is stable at refrigerator temperatures. Moderna and Pfizer vaccines can only be stored at those levels for a month. After that, they require freezer temperatures.
Novavax also may get a lift from the U.S. Food and Drug Administration's authorization of vaccine "mixing and matching." That means anyone who has received a primary series of one authorized vaccine brand may choose the same brand or another when it's time for a booster.
And finally, Novavax won't be left behind when it comes to dealing with variants of concern. A Novavax spokesperson told The Hill that the company has begun development of a candidate targeting the omicron variant. Health officials first detected omicron in South Africa early last month. Since, it's spread to other areas including Europe and North America.
Now, let's look at Novavax's stock price. It climbed more than 12% last month. From here, Wall Street predicts the stock could increase 30%, according to the average 12-month price forecast.
Year-to-date, Moderna has soared past Novavax. Pfizer remains the laggard. (That's almost expected. Pharmaceutical companies aren't as sensitive to vaccine news as their biotech rivals. That's because they depend on the sales of many products -- so they aren't as reliant on just one.)
Novavax is particularly interesting at today's level. That's because several catalysts lie ahead: regulatory authorization in various markets including the U.S., vaccine rollout, and real-world data once a product is on the market. Any positive data on how Novavax fares against the omicron variant also could offer a lift.
I'm positive on Moderna and Pfizer over the long term. But they've already been through the vaccine authorization and launch stage -- and reaped the rewards of share performance. In the coming months, it may be Novavax's turn. That's why this biotech stock may represent a better buy right now.
PDUFA date extended by three months to April 5, 2022
No Additional Data Requested Following Meeting with FDA
BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.
In connection with the FDA’s ongoing review, BioXcel Therapeutics responded to the agency’s information request pertaining to analyses of clinical data, and was recently informed the application would require additional time for review. As a result, the FDA extended the previously disclosed PDUFA date of January 5, 2022 to April 5, 2022. BioXcel Therapeutics and the FDA met on November 30. No additional data has been requested.
“Following our meeting with the FDA, we remain committed to working closely with the agency to facilitate a review of our NDA for BXCL501 and excited about making this potential therapy available to patients and caregivers as soon as possible,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “As we prepare for anticipated FDA approval, we are confident in BXCL501’s broad potential to treat the millions of patients suffering from agitation associated with schizophrenia and bipolar disorders.”
BeyondSpring Pharmaceuticals (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). The FDA issued the CRL to indicate that they have completed their review of the application and have determined that it cannot be approved in its present form.
The FDA’s CRL indicated that the results of the single registrational trial (106 Phase 3) was not sufficiently robust to demonstrate benefit and that a second well controlled trial would be required to satisfy the substantial evidence requirement to support the CIN indication.
“BeyondSpring strongly believes that plinabulin in combination with G-CSF has significant potential to raise the standard of care in CIN, a devastating side effect of chemotherapy,” said Dr. Lan Huang, BeyondSpring’s co-founder, chief executive officer and chairwoman. “The Company plans to request a meeting with the FDA and remains committed to its goal of bringing plinabulin to cancer patients in need globally.”
BeyondSpring remains confident in the efficacy and safety data for plinabulin in combination with G-CSF for the prevention of CIN. The Company expects to work closely with the FDA to consider the possible future clinical pathway for CIN, which may include a second study.
Sensus to Bring FDA-cleared Non-invasive Drug-delivery System and Treatment Alternative to Needles to Dermatologists Beginning [Immediately/Date]
Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces the signing of an exclusive U.S. distribution agreement with Mattioli Eng. Italia S.P.A. for its TransDermal Infusion System non-invasive drug delivery system. Sensus plans to begin marketing this System to dermatologists nationwide beginning immediately.
The TransDermal Infusion System is cleared by the U.S. Food and Drug Administration (FDA) for the local administration of ionic drug solutions into the body for medical purposes, and can be used as an alternative to injections. Sensus’ sales organization will market the system to dermatologists for skin rejuvenation treatments, pre-laser treatments, pre- and post-plastic surgery and other applications. In addition, Sensus plans to make rental programs and leasing facilities available, similar to current programs for its superficial radiation therapy and aesthetic lasers.
The System allows drugs to penetrate the skin’s innermost, hypodermic layer by increasing permeability. Faster than traditional iontophoresis, the TransDermal Infusion System allows delivery of drugs that are otherwise not able to be absorbed including Botox®, hyaluronic acid, lidocaine, collagen and others typically used in aesthetic procedures.
