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BNTX On Fire, QDEL's Coronavirus Test Gets FDA's EUA, CureVac Back In The News

pharma 050517 18mar20 lt

Today's Daily Dose brings you news about BioNTech's deal with Pfizer for developing coronavirus vaccine, the curious case of CureVac's CEO exit, Regeneron's progress in COVID-19 vaccine development, and FDA's Emergency Use Authorization of Quidel's coronavirus test.

Read on…

Shares of BioNTech SE (BNTX) continued the rally for the second day on Tuesday, following a deal with Pfizer Inc. (PFE) for the co-development and distribution, excluding China, of BNT162 to prevent COVID-19 infection.

BNT162 is BioNTech's potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection. The vaccine is expected to enter clinical testing by the end of April 2020.

BioNTech already has a research and development collaboration with Pfizer that was signed in 2018 to develop mRNA-based vaccines for the prevention of influenza.

On Tuesday, BioNTech and China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd. agreed to work jointly on the development of BNT162 in China for the prevention of COVID-19 infections.

BNTX closed Tuesday's trading at $66.60, up 66.50%. in after-hours, the stock gained another 8.11% to $72.

German biotech company CureVac AG has announced that its CEO Ingmar Hoerr will take a temporary leave of absence for medical reasons. His leave is not caused by coronavirus, the Company added.

It was only as recently as March 11, 2020, did Ingmar Hoerr take over as CEO, replacing Daniel Menichella. The resignation of Hoerr comes at a time when the exit of Daniel Menichella itself is shrouded in mystery.

Early this month, Daniel Menichella was one of the few high-ranking representatives of pharmaceutical and biotech companies who was invited to the White House to discuss strategies and opportunities for the rapid development and production of a coronavirus vaccine with U.S. President Donald Trump, Vice President Mike Pence, and members of the White House Coronavirus Task Force.

The German newspaper Welt am Sonntag on Sunday reported that the U.S. president allegedly offered CureVac, which is developing a potential coronavirus vaccine, billion dollars to "secure its exclusivity", and that Trump wanted that vaccine "only for the United States."

CureVac is a clinical-stage company developing mRNA-based vaccines. In a phase I rabies study reported in January, CureVac was able to induce immune responses in humans with the extremely low dose of only 1 microgram. If this is shown to apply to a coronavirus vaccine, millions of vaccine doses could potentially be produced at low costs in its existing production facilities, according to the Company.

Refuting the allegations raised in the newspaper, CureVac says that it has not received from the US government or related entities an offer before, during and since the Task Force meeting in the White House on March 2.

Quidel Corp. (QDEL) has received FDA's Emergency Use Authorization to market its Lyra(r) SARS-CoV-2 Assay, a real-time RT-PCR test intended to detect the coronavirus from nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19 infection.

Hologic Inc. (HOLX), LabCorp (LH), Roche and Thermo Fisher Scientific Inc. (TMO) are the other companies that recently received Emergency Use Authorization from the FDA for their COVID-19 tests.

As of this writing, worldwide, the number of confirmed cases is 198,215 and the death toll is 7,955.

QDEL closed Tuesday's trading at $93.64, up 26.20%.

Shares of Regeneron Pharmaceuticals Inc. (REGN) touched a two-year high of $512.98 in intraday trading on Tuesday, following an update on its efforts to discover and develop a novel multi-antibody cocktail that can be administered as prophylaxis before exposure to the SARS-CoV-2 virus or as a treatment for those already infected.

The Company announced that it has now isolated hundreds of virus-neutralizing, fully human antibodies from its VelocImmune mice, which have been genetically-modified to have a human immune system. Regeneron has also isolated antibodies from humans who have recovered from COVID-19, in order to maximize the pool of potentially potent antibodies.

Out of the large pool of candidates, the top two antibodies for a 'cocktail' treatment will be selected based on their desirable qualities, the Company added.

In other related news, Regeneron and its collaborator Sanofi has initiated a phase II/III clinical trial evaluating Kevzara in patients hospitalized with severe COVID-19. Kevzara is approved for the treatment of adults with rheumatoid arthritis.

REGN closed Tuesday's trading at $491.69, up 11.54%.

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