The drug/biotech sector has delivered on investor expectations by making medicines/vaccines for COVID-19 in record time. Rapid development and regulatory approvals of some medicines and vaccines put the drug/biotech sector back on track after companies reported soft third-quarter results and maintained a cautious outlook for the rest of the year due to rising cases of infections. The FDA, this month, granted emergency use authorization (EUA) to Pfizer/BioNTech’s and
Moderna’s ( MRNA Quick Quote MRNA - Free Report) mRNA-based COVID-19 vaccines.
While the development of a vaccine has definitely taken center stage, regular pipeline and regulatory events are now more or less back on track. The outbreak had resulted in a delay in key FDA decisions and the postponement of important studies.
Meanwhile, after a flurry of deals in 2019, M&A activity significantly slowed down in 2020, mainly due to the impact of the pandemic. Nonetheless, AstraZeneca’s recent offer to buy biotech giant, Alexion indicates that M&A activity might pick up once again in 2021. Collaborations and partnerships with smaller companies were in full swing this year, mainly for making antivirals and vaccines for COVID-19.
industry is up 9.2% this year compared with the S&P 500 Index’s 16.9% rise.
Some industry participants have risen more than 200% this year. While some soared due to COVID-19 related developments, others rose on positive pipeline or regulatory progress. Here we discuss five such stocks.
A chart showing the share price movement of the five stocks is given below
Shares of this biotech have risen 469.5% this year due to the rapid development of its coronavirus vaccine candidate, mRNA-1273, which is now approved for emergency use in the United States and Canada. Applications seeking emergency use have been filed in other countries including EU. Moderna is one of two early entrants in the COVID-19 vaccine space, and it can reap in some early profits. Moderna’s candidate achieved an impressive efficacy rate of 94.1% in primary efficacy analysis.
It is also developing several promising mRNA-based pipeline candidates, targeting a wide range of indications. These candidates also attract partnerships with big pharma companies, thus generating funds through upfront and milestone payments, and reducing research and marketing costs.
Moderna has a Zacks Rank of 3.
Ultragenyx Pharmaceutical ( RARE Quick Quote RARE - Free Report)
This year has been fruitful for Ultrageny as it gained several new drug/line extension approvals. It gained FDA approval for Dojolvi for long-chain fatty acid oxidation disorders, which are life-threatening genetic disorders
In June, FDA approved a second indication for its key drug, Crysvita for tumor-induced osteomalacia (TIO). Crysvita was also approved in the EU for the treatment of X-linked hypophosphatemia (XLH). Crysvita is generating meaningful revenue growth and with the launches of Dojolvi and Crysvita for TIO, the company now has three marketed products across four indications in its portfolio, which can drive revenues in the future quarters.
In October, it signed a strategic collaboration with Solid Biosciences, which added a potential Duchenne therapy to its gene therapy pipeline. Ultragenyx has six gene therapy candidates in its pipeline.
Shares of this #3 Ranked company have risen 297.7% this year.
Fate Therapeutics ( FATE Quick Quote FATE - Free Report)
Positive pipeline updates related to its innovative immunotherapies have boosted Fate Therapeutics’ share price in 2020. It recently released encouraging data from its phase I study of FT596, its universal, off-the-shelf, CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell product candidate. Fate also announced positive interim data from its dose-escalation phase I study of FT516 in combination with rituximab for patients with relapsed/ refractory B-cell lymphoma. In April, Fate entered into a global collaboration and option agreement with J&J to develop iPSC-derived CAR NK and CAR T-cell product candidates targeting up to four tumor-associated antigens. Shares of the company have surged 391.6% in the year. Fate Therapeutics has a Zacks Rank of 3.
Intellia Therapeutics ( NTLA Quick Quote NTLA - Free Report)
In November, Intellia Therapeutics dosed the first patient in a phase I study on its lead CRISPR/Cas9-based pipeline candidate NTLA-2001 for the treatment of transthyretin amyloidosis (ATTR). Intellia received regulatory authorization to initiate a phase I study on NTLA-2001 in October. This marked the company’s transition to a clinical stage biotech. Simultaneously, the company is progressing on its development plans for its other two candidates, NTLA-5001 and NTLA-2002 for the treatment of acute myeloid leukemia (AML) and hereditary angioedema (HAE), respectively. It plans to file investigational new drug application (IND) to begin clinical studies for both candidates next year.
Shares of this #3 Ranked stock have risen 315.3% this year so far.
Mersana Therapeutics ( MRSN Quick Quote MRSN - Free Report)
Mersana Therapeutics focuses on the development of antibody drug conjugates (ADC) for cancer patients. Data from the company’s early-stage study on its promising therapy XMT-1536 showed significant anti-tumor activity in heavily-pretreated ovarian cancer patients with response rates far exceeding standard of care. Meanwhile, the company has encouraging pipeline candidates derived from its multiple innovative ADC platform.
The company has a Zacks Rank #3 and its stock has risen 375% this year.
Zacks Top 10 Stocks for 2021
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