Biotech stocks are at the mercy of market-moving catalysts, and Cantor Fitzgerald analyst Louise Chen outlined potential outlined potential stock-moving events for eight biotech names in a Monday report.
Mylan: Pipeline Update, Patent Challenge
Mylan N.V. MYL is scheduled to hold its investor day in New York City on April 11. The company is expected to shed light on the following:
- A recently announced biosimilar Botox program with Revance Therapeutics Inc RVNC.
- A Humira biosimilar program.
- Its platform and pipeline.
A U.S. Patent Trial and Appeal Board oral hearing for Allergan plc Ordinary Shares AGN'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.
Horizon: Enrolling For RECIPE, TRIPLE Trials
Horizon Pharma PLC HZNP plans to begin enrolling patients in the RECIPE trial for krystexxa. Krystexxa is the first and only biologic for uncontrolled gout — the most common form of inflammatory arthritis — that rapidly reverses disease progression, according to a company presentation. Horizon expects krystexxa net sales growth of over 50 percent in 2018.
The biotech firm plans to start the immunomodulation arm of its TRIPLE study in the first quarter.
Positive Trial Results Expected For Heron's Postoperative Pain Med
Cantor Fitzgerald expects Heron Therapeutics Inc HRTX to announce positive Phase 3 trial results for HTX-011 as early as April. HTX-011 combines the local anesthetic bupivacaine in a fixed dose with anti-inflammatory meloxicam for postoperative pain.
Midstage Trial Results For Cidara's Antifungal
Cidara Therapeutics Inc CDTX is expected to release positive results for its Phase 2 study of CD101 IV/Rezafungin for systemic infections early in the week of March 19, according to Cantor Fitzgerald.
Watch For Positive Neos News
Neos Therapeutics Inc NEOS is scheduled to host its investor day March 22, which Cantor Fitzgerald projects will be incrementally positive for the company's stock.
Twin Catalysts For Revance
Revance is due to complete its Phase 2a trial for its RT002 for the treatment of plantar fasciitis in the first quarter of 2018. Although interim results from the study did not meet the primary endpoint, Revance plans to review full data from the study and conduct another Phase 2a trial with a modified design, analyst Chen said.
Revance hosts its analyst day April 19.
Evolus Presents At Two Conferences
Evolus Inc EOLS is due to present data from its EVB-003 study for botulinum toxin DWP-450 at the Australasian Society of Aesthetic Plastic Surgery and the Aesthetic & Anti-Aging Medicine World Congress meetings in April.
Paratek Awaits FDA Acceptance
Chen said she expects FDA acceptance for Paratek Pharmaceuticals Inc PRTK's NDA filing for omadacycline, indicated for acute bacterial infections, in early April, with approval likely to come in early October. The NDA was filed in early February.
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