Supernus (SUPN) Receives FDA Approval for ADHD Treatment

Supernus Pharmaceuticals (NASDAQ:SUPN), Inc. SUPN announced that the FDA approved its pipeline candidate, SPN-812, (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. The candidate was approved under the brand name, Qelbree.

The approval was supported by data from an extensive development program consisting of four phase III clinical studies, which evaluated more than 1000 pediatric patients aged 6 to 17 years.

We remind investors that the FDA accepted for review the NDA for SPN-812 for the treatment of ADHD in the above-mentioned patient population in January 2020 and assigned a Prescription Drug User Fee Act (PDUFA) target action date of Nov 8, 2020.

However, in November 2020, the regulatory body issued a Complete Response Letter (CRL) for the NDA. The CRL indicated that the review cycle for the NDA was complete but was not ready for approval in its present form. The primary issue cited in the CRL was related to the company’s in-house laboratory that conducts analytical testing, which recently moved to a new location.

Thereafter, in January 2021, Supernus met with the FDA in a Type A meeting to discuss the CRL and the requirements for the NDA resubmission. In February 2021, the company resubmitted the SPN-812 NDA and removed the reference to its in-house laboratory, and addressed other contents of the CRL.

The approval strengthens Supernus’ portfolio for the treatment of central nervous system (CNS) diseases, which include epilepsy treatments (Trokendi XR and Oxtellar XR) and Parkinson’s Disease treatment (Apokyn).

Meanwhile, in December 2020, Supernus announced positive results from a phase III study in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.

Shares of Supernus have gained 14.5% so far this year compared with the industry’s increase of 5.2%.

Competition is stiff in the ADHD space from Adderall XR, Johnson & Johnson’s JNJ Concerta (methylphenidate) and Takeda’s TAK Vyvanse, among others.

Supernus currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare space is Repligen (NASDAQ:RGEN) Corp. RGEN, which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Earnings estimates for Repligen have moved up 25 cents for 2021 in the past 60 days.

Bitcoin, Like the Internet Itself, Could Change Everything

Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix (NASDAQ:NFLX) did to Blockbuster and Amazon (NASDAQ:AMZN) did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.

Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.

See 3 crypto-related stocks now >>