With 2019 coming to a close, that means it’s time to look back on the top-performing NASDAQ biotech stocks of the year.
It’s been a bumpy ride so far this year for the NASDAQ Biotechnology Index (INDEXNASDAQ:NBI), which started at 3,061.26 points in January and reached a high of 3,750 points on November 30.
While the index has certainly had its share of ups and downs during the year, overall it has increased over 21 percent since the start of the year — even soaring past the S&P 500 (INDEXSP:.INX).
According to a report from Technavio, the biotechnology market will grow at a compound annual growth rate of 7 percent between now and 2023 to reach a valuation of US$1.77 billion.
Driving that growth will be an increase in both cancer diagnoses and demand for alternative treatment options, among other things.
As the year comes to a close, here the Investing News Network profiles the five top NASDAQ biotech stocks of the year and what drove their share prices over the course of 2019. Data was compiled on December 3, 2019, using TradingView’s stock screener. All companies had market caps between US$50 million and US$500 million at that time.
1. Enlivex Therapeutics (NASDAQ:ENLV)
Market cap: US$83.5 million; current share price: US$8.08; year-to-date gain: 944.2 percent
Enlivex Therapeutics is developing products for cell immunotherapy. In particular, its Allocetra product can treat a range of conditions by using the body’s mechanisms to rebuild immune balance.
The company currently has three clinical trials in different stages of development in its pipeline. The first is indicated for preventing complications following bone marrow transplantation; it is in a Phase 2a trial, with Phase 2/3 set to begin in Q1 2020. The second is for prevention of cytokine storms and organ dysfunction in sepsis; it is currently in an ongoing Phase 1b trial with Phase 2 slated for the start of 2020.
The third is for solid tumor immune checkpoint microenvironment modulating. It has completed preclinical trials, with the company now looking for partners to begin a Phase 1 trial.
Enlivex announced in late March that it had officially begun trading on the NASDAQ. In August, the company shared positive data from a review of its ongoing Phase 1b clinical trial for severe sepsis. According to the announcement, a safety committee recommended that patient enrolment continue with the addition of four more patients.
At the end of August, Enlivex provided an update on its Allocetra-OTS immunotherapy and CAR-T therapy to treat solid tumors at the Joint IIS-ISCR Special 2019 conference. The preclinical study results indicated that the method increased anti-tumor macrophage population around the solid tumor microenvironment in patients that were treated with the combination therapy.
Other big news for Enlivex came in mid-November, when the company said it had finished recruiting patients for its Phase 1b trial testing the safety and efficacy of Allocetra in severe sepsis patients.
2. Relmada Therapeutics (NASDAQ:RLMD)
Market cap: US$342.37 million; current share price: US$33.32; year-to-date gain: 624.13 percent
Clinical-stage Relmada Therapeutics is developing treatments for depression, central nervous system disorders and ophthalmological conditions, among others.
The company’s most advanced product is REL-1017 (dextromethadone), which is in various stages of development for major depressive disorder, Rett syndrome, ophthalmological disorders and mitochondrial diseases.
In April, Relmada announced that results from REL-1017 had been accepted into the peer-reviewed Journal of Clinical Psychopharmacology for publication. At the time, the candidate was in a Phase 2 study for major depressive disorder for patients who had not responded to other antidepressants.
By mid-October, the company had released topline results from the Phase 2 study. They indicated that REL-1017 had sustainable efficacy and noticeable differences compared to a placebo. Relmada will now be discussing what the next steps will be with the US Food and Drug Administration (FDA).
3. Provention Bio (NASDAQ:PRVB)
Market cap: US$479.66 million; current share price: US$10.21; year-to-date gain: 479.66 percent
Provention Bio’s area of focus is developing products for immune-mediated diseases, such as autoimmune diseases, allergies and asthma. Its most advanced product is PRV-031 — or teplizumab — which is being developed to prevent type 1 diabetes. The company’s second product is PRV-015, which the company is developing to treat gluten-free diet non-responsive celiac disease. Provention Bio anticipates it will be able to move this product into a Phase 2 clinical trial for the condition.
The remainder of the company’s pipeline includes candidates to treat inflammatory bowel diseases, auto-antibody-mediated diseases and acute coxsackie B virus.
In April, the company began a Phase 3 clinical trial of PRV-031, called PROTECT, in patients with recent onset type 1 diabetes. That same month, Provention Bio finished enrolling patients in a Phase 2a clinical trial of another product, called PRV-6527, in patients with Crohn’s disease.
Other highlights of the year include breakthrough therapy designation from the FDA for PRV-031 to prevent type 1 diabetes in people at risk of contracting the condition. PRV-031 was also granted PRIME designation from the European Medicines Agency in late October.
Finally, the company announced topline results from its Phase 2a clinical trial of PRV-6527 in Crohn’s disease. Although patient symptoms improved at the 12 week mark, changes were not substantially different from those seen with a placebo.
4. Durect (NASDAQ:DRRX)
Market cap: US$426.08 million; current share price: US$2.22; year-to-date gain: 357.46 percent
Durect is developing treatments based off of its epigenetic regulator program and drug delivery platforms. The company’s lead candidate, DUR-928, is in a Phase 2 clinical development trial and has demonstrated its effectiveness in lipid homeostasis, inflammation and cell survival.
To date, more than 200 people have been dosed with DUR-928, which is currently in clinical trials for alcoholic hepatitis, non-alcoholic steatohepatitis and psoriasis.
In September, Durect announced positive data from its Phase 2a clinical trial of DUR-928 in patients with alcoholic hepatitis. Roughly 19 patients — 12 with severe alcoholic hepatitis and seven with moderate alcoholic hepatitis — were enrolled. According to the results, DUR-928 was tolerated in all patients with no adverse side effects.
By early October, the company announced it had finished enrolling patients in its Phase 2a clinical trial in patients with psoriasis, while 50 percent enrolment in its Phase 1b clinical trial in patients with non-alcoholic steatohepatitis had been completed.
5. Ardelyx (NASDAQ:ARDX)
Market cap: US$496.34 million; current share price: US$7.92; year-to-date gain: 321.79 percent
Ardelyx’s area of focus is on cardiorenal diseases, which are conditions primarily affecting the heart and kidneys. The company currently has three cardiorenal programs in different stages of development. The most advanced is its treatment tenapanor, which is in a Phase 3 clinical trial for hyperphosphatemia, an electrolyte disorder in which phosphate levels in the blood are elevated.
Some of the company’s notable announcements in the year include topline results from its Phase 3 study of tenapanor in patients on dialysis with hyperphosphatemia, and the FDA’s approval of tenapanor in September to treat irritable bowel syndrome with constipation. In December, Ardelyx released topline results from its Phase 3 PHREEDOM study of tenapanor in chronic kidney disease patients on dialysis.
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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.