Get the Latest Investment Ideas Delivered Straight to Your Inbox.

TICKERS: BNTX, PFE

BioNTech Shares Rise as FDA Grants It and Partner Pfizer Fast Track Status for Two Covid-19 Vaccine Candidates

Source:

Shares of BioNTech SE traded 15% higher after the company reported that, together with its partner Pfizer, it has received FDA Fast Track designation for two separate mRNA-based vaccine candidates against SARS-CoV-2.

Clinical-stage biotechnology company BioNTech SE (BNTX:NASDAQ) and pharmaceutical giant Pfizer Inc. (PFE:NYSE) today announced that "two of the companies' four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA)." The companies stated that BNT162b1 and BNT162b2 are presently being evaluated in ongoing Phase 1/2 clinical trials in the U.S. and Germany and are the two most advanced vaccine candidates in the collaborative BNT162 program.

The firms explained that the FDA's Fast Track program is designed to expedite the development and review of new drugs and vaccines and that the Fast Track designation was granted based upon preliminary data from ongoing Phase 1/2 trials in Germany and the U.S. and also from additional animal immunogenicity studies.

The company pointed out that "the BNT162 program is evaluating at least four experimental vaccines, each of which represent a unique combination of messenger RNA (mRNA) format and target antigen."

Pfizer's SVP of Global Regulatory Affairs Peter Honig commented, "The FDA's decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2...We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates."

BioNTech's Chief Medical Officer Özlem Türeci remarked, "We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward."

The company noted that "the Project Lightspeed vaccine development program is based on BioNTech's proprietary mRNA-based technology platforms and supported by Pfizer's global vaccine development capabilities." Subject to regulatory approval, the companies hope to enroll up to 30,000 patients in a Phase 2b/3 trial possibly as early as later this month. If the Phase 2b/3 study produces successful results and the vaccine candidate is granted regulatory approval, the companies stated that they plan to manufacture up to 100 million doses of the vaccine by December 2020 and as many as 1.2 billion doses by the end of 2021.

BioNTech is based in Mainz, Germany, and is focused on providing next generation immunotherapies for cancer and other serious diseases. The firm stated that "its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules."

Pfizer is a research-based global biopharmaceutical company headquartered in New York, that is engaged in the discovery, development and manufacture of healthcare products. Its global portfolio is composed of many household name brand prescription medications including Prevnar 13, Xeljanz, Eliquis, Lipitor, Celebrex, Pristiq and Viagra. The firm's shares trade on the NYSE and it has a market cap of approximately $188 billion.

BioNTech began the day week with a market capitalization of around $16.1 billion with approximately 228.6 million shares outstanding. BNTX shares opened 11.5% higher today at $78.47 (+$8.11, +11.53%) over Friday's $70.36 closing price. The U.S. ADR stock has traded today between $75.75 and $84.89 per share and is currently trading at $81.19 (+$10.83, +15.39%).

[NLINSERT]

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.




Learn More about Streetwise Reports Live

Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe