Vitamin Shoppe shares jump 32% after earnings beat

Shares of Vitamin Shoppe soared 32.1 percent at $10.70 per share on Wednesday after the company reported better-than-expected earnings for its second quarter.

The nutritional supplement company reported adjusted earnings of 31 cents per share versus the 5 cents per share consensus estimate from analysts, according to Thomson Reuters.

Vitamin Shoppe’s digital commerce sales increased 37 percent, however its same store sales fell 1.1 percent contributing to its total sales fall of 1 percent in the quarter, compared to last year.

Alex Smith, the Chairman of the Vitamin Shoppe stated, “Our focus on retail fundamentals is starting to deliver improved performance. In the second quarter we saw improvement across all key metrics including: comp sales, customer acquisition and product margin.”

Vitamin Shoppe also announced last month the appointment of Sharon Leite as the company’s new CEO.

https://cnb.cx/2Pfr39q

Invitae May Become The Amazon Of Genetics

Invitae beat earnings, revenue and guidance estimates.

The company is set to hit over $500 million in revenue by the end of 2020 with 50% gross margins and a market cap today of $750M.

The company is on track to cut cash burn from Q1:18 by 40-50% by year-end.

The industry is going through “unqualifiedly the most unprecedented change in the history of our space”.

Invitae CEO believes there is a network effect that will be put in place, where there will be no catching them with a TAM of 1B+ people.

https://bit.ly/2MmzkdZ

Regeneron’s fasinumab safety remains ‘open question,’ says Piper Jaffray

Piper Jaffray analyst Christopher Raymond backed an Overweight rating on Regeneron Pharmaceuticals (REGN) shares following this morning’s release of fasinumab results, saying the drug and partner Teva’s (TEVA) anti-NGF antibody met its primary and secondary efficacy pain and functional endpoints in a Phase 3 trial of patients with chronic pain from osteoarthritis of the knee or hip. Raymond says the efficacy “was never really in doubt,” but the bigger focus for the drug is safety, and will wait for detailed data at an upcoming medical meeting, but notes that fasinumab’s arthropathy rate appears “slightly higher” than that of tanezumab. Given the severity of the ongoing opioid epidemic and relative lack of alternatives for these patients outside of total joint replacement, the analyst thinks the appetite of regulators and potential market for new effective, non-opioid chronic pain therapies like anti-NGF clearly exists, though he will leave this as an unmodeled potential source of upside for now

https://bit.ly/2w9q2qO

Sun Pharma: U.S. FDA Approval of CEQUA™ to Treat Dry Eye Disease

Sun Pharmaceutical Industries Ltd.(Reuters:SUN.BO, Bloomberg:SUNP IN, NSE:SUNPHARMA, BSE:524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that Sun Pharma has received approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration (FDA). CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

CEQUA provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The innovative nanomicellar formulation allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration. In the Phase 3 confirmatory trial on CEQUA, after 12 weeks of treatment, as compared to vehicle, CEQUA showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production) (p<0.01). Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment. CEQUA is dosed twice daily and will be available as a single-use vial.

The nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA.

“Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” said Abhay Gandhi, CEO, North America, Sun Pharma. “The U.S. FDA approval of CEQUA represents a long-awaited dry eye treatment option and is an important milestone in the development of Sun’s Ophthalmics business. CEQUA, with its novel nanomicellar formulation for a proven dry eye medication, delivers a lipophilic molecule in a clear solution form.”

Additionally, Jodi Luchs, MD, the principal investigator behind the CEQUA confirmatory Phase 3 trial, noted: “Dry eye is a complex disease that lacks a ‘one-size-fits-all’ approach. As a clinician treating a high volume of dry eye patients, it’s important to have multiple treatment modalities available at my disposal. Given its strong clinical trial performance, the approval of CEQUA is welcomed news, and I look forward to offering my patients this compelling new option.”

CEQUA (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.

https://bit.ly/2MwheVY

FDA Clears SPR Non-opioid Peripheral Nerve Stimulation for Pain Management

 SPR Therapeutics, Inc., a leader in neurostimulation technology for pain, today announced that the U.S. Food and Drug Administration (FDA) has cleared its SPRINT^®endura™ (single lead) and extensa™ (dual lead) Peripheral Nerve Stimulation (PNS) Systems. The SPRINT System is the only percutaneous PNS System cleared by the FDA and indicated for up to 60 days in the back and/or extremities for both chronic and acute pain and is the industry’s only dual lead capable PNS platform.

“Our SPRINT PNS platform is designed to deliver the least invasive and most user-friendly PNS therapy experience for physicians and their patients. With the ease of use and dual lead capabilities we’ve built into the SPRINT System we look forward to advancing the early use of neurostimulation as a non-opioid alternative for more patients while we continue to generate data that demonstrate significant and sustained pain relief following our 60-day therapy,” said Maria Bennett, Founder, President and CEO of SPR Therapeutics.

“The SPRINT PNS system provides a non-opioid therapy alternative that we have used successfully with many of our pain patients,” said interventional pain management physician Chris Gilmore, MD, of Carolinas Pain Institute in Winston-Salem, NC. “In my experience, most patients prefer a non-permanent, non-destructive and non-surgical option for pain management when possible. The minimally invasive nature of the SPRINT System allows us to introduce peripheral nerve stimulation therapy early in the care continuum, including its use in well-selected patients with back pain.”

This SPRINT PNS platform offers several new benefits:

• Dual lead capability allows physicians to implant two leads connected to a single wearable pulse generator
• Rechargeable batteries allow continuous stimulation delivery
• Bluetooth^® enabled controller fosters patient-specific customization and ease of use

Multiple clinical trials evaluating SPRINT have demonstrated its ability to reduce pain and improve quality of life. Preliminary results from a Federally-funded multicenter study of SPRINT for the treatment of chronic post-amputation pain demonstrate that significant reductions in pain or pain interference (≥50 percent) were reported among two-thirds of subjects following the 8-week treatment period.  Enduring and significant pain relief (≥50 percent) was reported by four of the five patients (80 percent) who have completed the entire 12-month study according to data being presented at the Napa Pain Conference, August 16-19, 2018. The vast majority of these subjects were implanted with dual (femoral and sciatic) leads.

To learn more about SPRINT, visit SPR Therapeutics at the Napa Pain Conference from August 16-19 and at the Military Health System Research Symposium from August 20-23.

https://bit.ly/2MUt1KD

Evoke: New drug application accepted for review by FDA

Evoke Pharma announced that the company’s 505 new drug application, or NDA, for Gimoti, the company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis, has been accepted for review by the FDA. In its filing communication, FDA stated that the NDA received on June 1, is sufficiently complete to permit a substantive review and set a target goal date under the Prescription Drug User Fee Act, or PDUFA, of April 1, 2019. If approved, Gimoti will be the first new non-oral drug treatment option for diabetic gastroparesis in four decades. Additionally, the Day-74 letter did not indicate that FDA is planning to hold an advisory committee meeting to discuss the NDA. In a separate written communication, the agency responded to the NDA request for proprietary name review by conditionally accepting the proprietary brand name, Gimoti. This review and conditional acceptance validate that Gimoti is a proprietary name consistent with FDA’s goal of preventing medication errors and potential harm to the public associated with product misidentification or confusion.

https://bit.ly/2MmjWxY

Rite Aid faces challenges ahead as standalone business, says Deutsche Bank

Deutsche Bank analyst Glen Santangelo maintained a Hold rating on Rite Aid but cut his price target to $1.60 from $2.25 after re-evaluating the company as a standalone business following the termination of the merger agreement with Albertsons. In a research note to investors, the analyst says he believes the outlook will continue to be weighed down by the challenges facing the retail pharmacy industry such as declining volume and reimbursement pressure, and thinks that the fundamental challenges ahead for Rite Aid will make it difficult for the company to find a sustainable growth path on a standalone basis.

https://bit.ly/2nHQkMM