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ABIO To Start Phase 2 COVID-19 Trial In Q4, ACIU On Track, BCLI Expects ALS Trial Data In Nov.

pfizer aug06 lt

Today's Daily Dose brings you news about ARCA biopharma's progress in its COVID-19 drug candidate, AC Immune' upcoming milestones, BrainStorm Cell's November catalyst, Bristol-Myers/Pfizer's Eliquis patent suit ruling, and Novavax's positive phase I data from its COVID-19 vaccine trial.

Read on…

1. ARCA biopharma To Explore AB201 for COVID-19

ARCA biopharma Inc. (ABIO) is planning to file an Investigational New Drug application for AB201 as a potential treatment for COVID-19 in the third quarter of this year, seeking clearance to initiate a phase II trial.

If the company gets the go-ahead from the FDA, the phase II trial of AB201 is expected to be initiated in the fourth quarter of this year.

Gencaro, the company's lead investigational drug, is being developed for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population. Initiation of a phase III trial of Gencaro, dubbed PRECISION-AF, is on hold due to the ongoing COVID-19 pandemic.

The enrollment in the PRECISION-AF trial could start in 2021, according to ARCA.

ABIO closed Wednesday's trading at $6.77, down 0.15%.

2. AC Immune to Report Alzheimer's Trial Data in 2H20

AC Immune SA (ACIU) has an important catalyst to watch out for in the second half of this year.

The company's lead anti-Tau antibody is Semorinemab - being co-developed in collaboration with Roche's Genetech. Semorinemab is under a phase II trial for the treatment of patients with prodromal to mild Alzheimer's. The topline data from this trial is expected in the second half of 2020.

As recently as last month, the company advanced its anti-Tau Alzheimer's vaccine ACI-35.030 into a phase 1b/2a clinical trial.

ACIU closed Wednesday's trading at $6.57, down 6.81%.

3. BrainStorm Getting Ready to Reveal ALS Trial Results

BrainStorm Cell Therapeutics Inc. (BCLI) has a couple of catalysts lined up for the coming months.

A phase III pivotal trial investigating NurOwn in amyotrophic lateral sclerosis is underway, with topline data readout expected by the end of November this year.

A phase II clinical trial of NurOwn is ongoing in progressive multiple sclerosis and is expected to complete dosing by the end of 2020.

The company is planning a phase II proof-of-concept clinical trial of NurOwn in Alzheimer's disease at several leading AD centers in the Netherlands and France.

BCLI closed Wednesday's trading at $13.11, down 2.09%.

4. Bristol-Myers/Pfizer Prevail in Eliquis Patent Challenge

In a patent suit filed by Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) against Sigmapharm Laboratories LLC, Unichem Laboratories Ltd. and Sunshine Lake Pharma Co. Ltd over blood thinner Eliquis, the Court has ruled in favor of the two big pharma companies.

Pfizer and Bristol-Myers Squibb have a worldwide collaboration to develop and commercialize Eliquis that was discovered by Bristol-Myers.

Sigmapharm Labs, Unichem Labs, and Sunshine Lake are some of the generic drug makers that have been seeking to get FDA approval for their generic versions of Eliquis.

According to Bristol-Myers and Pfizer, the key composition of matter patent on Eliquis in the U.S. expires only in 2031. So, now that the Court has ruled in favor of Pfizer and Bristol-Myers, the three generic manufacturers currently involved in the case, will not be able to launch the generic versions of Eliquis until 2031.

However, based on settlement agreements reached with other generic manufacturers, it is expected that the generic entry could occur after 2026 but before 2031, subject to appeals and future challenges.

The FDA approved generic versions of Eliquis, made by Mylan and Micro Labs last December, which marked the first-ever generic versions of that drug.

In the first quarter of 2020, Eliquis brought in global revenue of $2.64 billion for Bristol-Myers and $1.30 billion for Pfizer.

BMY closed Wednesday's trading at $59.69, up 0.37%. In after-hours, the stock was up 4.21% at $62.20.

5. Novavax Rallies On Positive Phase I trial results of COVID-19 Vaccine

Shares of Novavax Inc. (NVAX) touched an all-time high of $189.40 in intraday trading on Wednesday, following positive phase I data from its phase I/II trial of its COVID-19 vaccine candidate NVX-CoV2373.

In the phase I part, which evaluated NVX-CoV2373 adjuvanted with Matrix-M, the vaccine candidate was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

"All subjects developed anti-spike IgG antibodies after a single dose of the vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses", noted the company.

The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and was conducted at two sites in Australia.

NVAX closed Wednesday's trading at $173.49, up 10.38%.

6. Stocks That Moved On No News

Biofrontera AG (BFRA) closed Wednesday's trading at $26.80, up 378.57%.

Alimera Sciences Inc. (ALIM) closed Wednesday's trading at $6.98, up 27.84%.

Iteos Therapeutics Inc. (ITOS) closed Wednesday's trading at $28.88, up 17.21%.

Alterity Therapeutics Limited (ATHE) closed Wednesday's trading at $2.91, down 15.16%.

Inozyme Pharma Inc. (INZY) closed Wednesday's trading at $22.43, down 9.30%.

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