8 Biotech Companies with Upcoming Catalysts
Decisions by the U.S. Food and Drug Administration (FDA) don’t necessarily make or break a biopharma company—although they can, depending on the decision—but they often have at least a short-term impact on the company’s stock. Not all catalysts are necessarily regulatory decisions, but many are. Here’s a look at eight biopharma companies with upcoming catalysts.
#1. Mylan. Headquartered in Canonsburg, Pennsylvania, Mylan is holding its investor day on April 11 in New York City. In addition to providing updates about its platform and pipeline, investors will be looking for more information about its plans, with Revance Therapeutics, Inc., to develop and commercialize a biosimilar to Allergan, Inc.’s Botox (onabotulinumtoxinA). This was announced on February 28. Mylan paid Revance $25 million upfront, and there are various milestones and royalties included, but no details were provided.
Benzinga also pointed out that, “A U.S. Patent Trial and Appeal Board oral hearing for Allergan’s Restasis is scheduled for April 3. The PTAB denied St. Regis Mohawk Tribe’s motion to terminate Mylan’s Restasis challenge over six Restasis-related patents, according to a Feb. 26 release from Mylan. A final decision on the challenged patents is scheduled for June 6.”
#2. Horizon Pharma . Based in Dublin, Ireland, Horizon will begin enrolling patients in its clinical RECIPE trial for Krystexxa, the first and only biologic for uncontrolled gout. The company has projected possible net sales growth of Krystexxa of over 50 percent in 2018. The drug was approved by the FDA as a third-line treatment for gout in 2010. The drug’s use has been limited by immune reactions. The RECIPE trial will evaluate whether a short course of immune modulating treatment with myclophenolate moefitil can reduce the immune response.
#3. Heron Therapeutics. Located in Redwood City, California, Heron is expected to announce positive data from its Phase III clinical trial of HTX-011 for postoperative pain. HTX-011 is combination of bupivacaine, a local anesthetic, with meloxicam, an anti-inflammatory.
#4. Cidara Therapeutics. The company is expected to release data from its Phase II trial of CD101 IV/Rezafungin next week. The drug is being evaluated as an antifungal for candidemia and invasive candidiasis. Rezafungin is a novel antifungal echinocandin and the only product candidate for the fungus that could be taken once a week.
#5. NEOS Therapeutics. Headquartered in Grand Prairie, Texas, the company is hosting its investor day on March 22. It is also released its fourth-quarter and year-end financials tomorrow, March 15. The company focuses on developing, manufacturing and marketing extended-release products using a proprietary modified-release drug delivery and orally disintegrating tablet technology platform.
#6. Revance Therapeutics, Inc.. In addition to the biosimilar it is developing with Mylan, mentioned earlier, Revance Therapeutics, based in Newark, California, is expecting to wrap up its Phase IIa trial for RT002 to treat plantar fasciitis in this quarter. Interim data was released on January 8. The company put a positive spin on the interim data, although it failed to meet its primary endpoint. The company stated, “While not statistically significant, RT002 did outperform placebo, providing patients with considerable pain relief. Similar numeric trends were seen in the secondary and exploratory endpoints.” The company and investors are hoping that a more thorough analysis provides more definitive positive data.
#7. Evolus. Located in Irvine, California, Evolus is a medical aesthetics company. In April, it plans to release data from its EVB-003 trial for botulinum toxin DWP-450 at the Australasian Society of Aesthetic Plastic Surgery and the Aesthetic & Anti-Aging Medicine World Congress meeting. On February 16, it presented data of its prabotulinumtoxinA neuromodulator at the American Academy of Dermatology meeting.
#8. Paratek Pharmaceuticals, Inc.. Based in Boston, Paratek focuses on anti-infectives. On February 5, it completed two New Drug Applications (NDA) to the FDA for its once-daily oral and IV formulations of its broad-spectrum antibiotic, omadacycline. It is first in a new class of tetracycline antibiotics called aminomethylcyclines. The submission is for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Whether the FDA accepts the applications will be announced in April, and approval is likely to happen in early October.