The biotech industry continues to witness developments and improvements in drug research in 2021 while withstanding the impact of the pandemic remarkably well. While development updates related to COVID-19 medicines/vaccines continued to take center stage this year, there were positive developments in the biotech sector in other pipeline areas too.
In this article, we discuss four companies, whose stocks have already doubled this year. Let us understand the factors, which drove these stocks.
BioNTech ( BNTX Quick Quote BNTX - Free Report)
BioNTech has a Zacks Rank #1 (Strong Buy) and its stock is up 143.2% this year so far. You can see
the complete list of today’s Zacks #1 Rank stocks here.
BioNTech has been riding high on the success of it and partner Pfizer’s two-shot vaccine for COVID-19, BNT162b2/Comirnaty. The vaccine was developed in record time and is now approved for emergency/temporary use in individuals 16 years of age and older in 91 countries worldwide. As of May 3, 2021, Pfizer/BioNTech had shipped approximately 430 million doses of the vaccine to 91 countries, bringing in significant revenues for BioNTech and Pfizer. Moreover, Pfizer/BioNTech have signed agreements to deliver over 1.8 billion doses of BNT162b2 in 2021.
Last week, the FDA expanded BNT162b2’s Emergency Use Authorization (EUA) to allow vaccinating adolescents aged 12-15 years old. Meanwhile studies are ongoing to expand the authorization of BNT162b2 to additional population groups.
Meanwhile, BioNTech is moving into later stage testing for three cancer programs in the near term and plans to launch multiple new products over the next five years.
Ocugen ( OCGN Quick Quote OCGN - Free Report)
This #3 (Hold) Ranked stock is up 369.9% this year so far.
In February, Ocugen entered into a definitive agreement with India-based Bharat Biotech to co-develop and commercialize the latter’s COVID-19 vaccine, COVAXIN, for the U.S. market. This collaboration,which gave Ocugen U.S. rights to this lucrative vaccine candidate, has driven the stock’s price this yearso far. Ocugen is making progress toward EUA for COVAXIN in the United States. Ocugen is also in discussions with BARDA, regarding the U.S. government’s support of COVAXIN.
The company is also simultaneously driving its ophthalmology gene therapy pipeline toward clinical studies. It plans to submit an investigational new drug (“IND”) application for its gene therapy candidate, OCU400, in the second half of this year. The IND application is seeking FDA’s approval to initiate two early-stage studies, anticipated to start by the end of 2021.
Rubius Therapeutics ( RUBY Quick Quote RUBY - Free Report)
Rubius Therapeutics has a Zacks Rank #3. Its stock has risen 242.7% this year so far.
Rubius Therapeutics’ stock got an impetus from positive initial data announced from a phase I/II study of its pipeline candidate, RTX-240 in advanced solid tumors in March. The data demonstrated RTX-240’s single-agent activity providing initial validation of the Rubius Therapeutics’ RED PLATFORM
Its other clinical programs in cancer and autoimmune diseases are also progressing. Enrolment is ongoing in phase I studies on RTX-240 in acute myeloid leukemia and RTX-321 in advanced HPV 16-positive cancer. Several data readouts are expected this year,which could be catalysts for the stock.
Entera Bio ( ENTX Quick Quote ENTX - Free Report)
Entera Bio has a Zacks Rank #3. Its stock has risen 180.5% this year so far.
Entera Bio’s stock gained this year following announcement of positive final three-month biomarker data from phase II study of its orally delivered human parathyroid hormone (1-34) or PTH, drug candidate, EB613 in osteoporosis in March.
The study met the primary endpoint showing a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months of treatment compared to placebo. P1NP is a biomarker that indicates the rate of new bone formation. Patients in the 2.5 mg dose group also experienced a significant reduction in CTX, a biomarker that indicates the rate of bone resorption. The data, overall, supported the osteoanabolic or bone building effects of EB613 as well as its potential to produce meaningful increases in bone mineral density at six months.
EB613, if approved, will provide an oral alternative to daily injections to osteoporosis patients, thereby improving patient convenience.
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