What To Watch In Q2: Upcoming Healthcare Regulatory Events

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SLINGSHOT INSIGHTS CONTRIBUTOR: Phil Loria

The current political atmosphere around healthcare in the U.S has investors particularly concerned with regulatory events in the space. Uncertainty is at an all time high, allowing diligent investors to capitalize on numerous opportunities.

Before diving into the key regulatory events to watch, I will quickly recap what happened with the catalysts we highlighted in our Q1 article. The FDA approved Synergy’s (NASDAQ:SGYP) Trulance [plecanatide] for chronic idiopathic constipation [CIC] on January 19th, and the company submitted their sNDA in irritable bowel syndrome with constipation [IBS-C] last week. Their stock peaked at a closing price of $7.07 following approval, but has since dropped to $4.65. Rigel (NASDAQ:RIGL) has increased more than 25% since early March when they announced plans to submit their NDA for Fostamatinib in ITP before the end of Q1. Aerie (NASDAQ:AERI) has traded near all time highs through Q1, but declined about 5% since their NDA submission on March 1st. Here is a list of 9 important regulatory decisions coming in Q2.

REGULATORY EVENTS TO WATCH:

FDA Decision Expected by April 5th for Merck’s Glargine [MK-1293] in Type 1 & 2 Diabetes

  • The estimated action date is based on the 10 month review period following a filing for a non-NME. Approval and the successful launch of Glargine are imperative in restoring investor confidence in the company. The drug is a biosimilar to Sanofi’s (NYSE:SNY) Lantus, which accounted for 16.9% of their net sales in 2016 [~$6.16B]. Merck (NYSE:MRK) is hoping to capture a significant chunk of this revenue, although the market for long-acting insulin is only getting more competitive. The company’s ability to capitalize on this opportunity will be very important to healthcare investors, and Slingshot Insights plans on conducting an Expert Interview to gauge the landscape of the injectable insulin market.

PDUFA date of April 11th for Neurocrine’s Ingrezza in Treatment of Tardive Dyskinesia [TD]

  • Neurocrine (NBIC) is at a critical time with their lead product Ingrezza after positive data in Q1 2017 for TD and Tourette Syndrome. The company is ready for commercialization and hoping to have its first profitable year if the drug is granted approval on April 11th. The price point is not clear; NBIX has stated a possible range of $20,000 to $60,000, and identified a possible patient population in the U.S of 500,000 for TD and 400,000 for Tourette syndrome. There are currently no FDA approved products for TD, and significant unmet needs within the Tourette syndrome population. The upcoming PDUFA date will give significant insight into the future of Ingrezza, and the other upcoming catalysts for the drug. Slingshot Insights is planning to conduct an expert interview following the PDUFA date to discuss the market potential of Ingrezza. You can add your own questions for the expert.

PDUFA Date of April 27th for BioMarin’s BLA for Brineura [Cerliponase Alfa] in Treatment of Batten Disease

  • With five approved products marketed today, BioMarin is hoping to add to its portfolio of treatments for rare genetic diseases. Brineura is indicated for CLN2 disease, a form of Batten disease with an estimated patient population of 1,200 to 1,600 in BMRN commercial territories. Children begin showing symptoms at ages two to four and have a life expectancy between eight and twelve years. Rapid neurodegeneration causes loss of motor ability, language delays and seizures, and can progress towards blindness and dementia. Despite trading around $40 a share, the company has yet to reach profitability. Approval of Brineura would be another step in that direction, and will be an indicator of how the CHMP and EU will act on the drug in Q3.

PDUFA Date of April 29th for Ariad’s Brigatinib in ALK-Positive Non-Small Cell Lung Cancer [NSCLC]

  • Ariad (NASDAQ:ARIA) was recently acquired by Takeda (OTCPK:TKPHF) for $5.2B in cash, a bet on the potential of their two main candidates Brigatinib and Iclusig. Iclusig is already commercialized for a high unmet need subpopulation in leukemia, bringing in $170-$180M in revenue last year. It has potential to expand use to earlier lines of treatment, although there are serious safety concerns including life-threatening blood clots and narrowing of blood vessels. The main point of the acquisition was to gain control of Brigatinib, which is awaiting regulatory decisions from the FDA and EU for the 2nd line treatment of ALK-positive NSCLC. The drug has an ongoing Phase 3 study in 1st-line indication, and Takeda believes it could peak with sales over $1B. Takeda’s experience should lead to a more successful launch for Brigatinib, and both of these drugs add significant future revenue potential to Takeda’s oncology pipeline. The PDUFA date will give investors a great idea of how the drug will be treated by regulators in the future. Slingshot Insights plans to conduct an Expert Interview before April 29th on the chances of approval and overall potential of Brigatinib; follow this link to join or add any questions.

PDUFA Date of May 7th for TherapeuticsMD’s Yuvvexy in Moderate-to-Severe Vaginal Pain

  • TXMD has two marketed prenatal vitamin regimens, and a pipeline of drug candidates focused on women’s health issues. Slingshot Insights recently conducted an interview with Dr. Mary Jane Minkin of Yale University School of Medicine in preparation for the Yuvvexy PDUFA date. The interview focused on the likelihood of FDA approval based on disclosed clinical data, as well as potential barriers to adoption and overall market opportunity. Yuvvexy is indicated for dyspareunia [pain during intercorse] in postemenopausal women, and it is estimated that over 50% of people suffering are currently not seeking treatment. Current products include creams and suppositories, but costs are frequently high due to lack of insurance coverage. Yuvvexy is a suppository, and will hope to take sales away from Vagifem and generic Yuvafem.

FDA Priority Review for Novartis’ Midostaurin in Treatment of Acute Myeloid Leukemia [AML] Expected By May 14th

  • Novartis’ (NYSE:NVS) Midostaurin is indicated for AML with an FLT3 mutation, and advanced systemic mastocytosis [SM], two devastating rare diseases. About 87,500 people worldwide have AML, and about one-third, 29,000, have an FLT3 mutation. SM affects about 20,000-40,000 people globally, and is a group of diseases characterized by uncontrolled growth and accumulation of mast cells. Approval of the product would add to the impressive portfolio of NVS, and cement their position in the evolving AML landscape. Edison Group and Slingshot Insights recently conducted an Expert Interview with Dr. Douglas Smith of John Hopkins discussing Midostaurin and other interesting pipeline candidates for AML. You can access the full transcript on Seeking Alpha here.

PDUFA Date of June 5th for Alkermes’ sNDA for Two-Month Dosing of Aristada in Treatment of Schizophrenia

  • Alkermes’ (NASDAQ:ALKS) Aristada is already approved by the FDA for the treatment of schizophrenia, and is available with once-monthly dosing and six-week dosing in three strengths. The injectable drug had $47.2 million in net sales in 2016, and ALKS predicts this will increase by at least 100% in 2017. If approved this will be the only two-month offering on the LAI market, and will help the company move towards profitability after losing around $208 MM last year. Their pipeline includes products for major depressive disorder, transition from opioid dependence, schizophrenia, and multiple sclerosis. Follow this link to access projects executed by Slingshot Insights discussing ALKS-5461 in major depressive disorder, ALKS-3831 in schizophrenia, and Vivitrol in opioid abuse treatment.

PDUFA Date of June 24th for Portola’s Betrixaban in VTE Prevention

  • With no approved products Portola (NASDAQ:PTLA) has not reached profitability, but the company sees an addressable market of $3-4B for Betrixaban, and $2B for their anticoagulant antidote Andexxa. They are also developing Cerdulatinib for relapsed and refractory hematologic cancers, but regulatory events for Betrixaban and Andexxa will be the most significant catalysts in 2017. Given the failed Phase 3 APEX study and lack of advisory committee meeting this PDUFA is particularly interesting, and PTLA investors should be watching closely.

PDUFA Date of June 30th for Radius’ Abaloparatide-SC in Treatment of Postmenopausal Women with Osteoporosis

  • Radius (NASDAQ:RDUS) trades more than 50% below their all time high, and has declined about 28% since they failed to impress investors with Phase 1 data evaluating RAD1901 in December. The PDUFA for their main product, Abaloparatide-SC, was originally planned for March 30th, before the FDA recently requested more information and pushed it back until the end of June. The drug is also being tested in the form of a transdermal patch, but the subcutaneous injection is further in development and also expects a decision from the CHMP in 2017. The FDA decision will give valuable insight into future regulatory decisions for Abaloparatide, and RDUS investors should be watching closely. Slingshot Insights hopes to conduct an Expert Interview evaluating chances of approval and market potential before the PDUFA, where you can add your own questions for the Expert.

Slingshot Insights has an extensive, searchable database of all the key value driving events for the sector. These are just some of the key catalysts that are coming up for the biotech sector in the second quarter of 2017. Keep an eye out for our article covering important data releases in Q2 coming next week.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

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What To Watch In Q2: Upcoming Healthcare Regulatory Events

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