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Top 5 Losers In Healthcare Sector (CYCN, AMAG, ELGX…)

pharmadown oct30 lt

The following are some of the healthcare stocks that posted the biggest percentage decline on Wednesday.

1. Cyclerion Therapeutics Inc. (CYCN)

Cyclerion Therapeutics is a clinical-stage biopharmaceutical company focused on the development of soluble guanylate cyclase (sGC) stimulators for the treatment of serious and orphan diseases.

Lost 79.52% to close Wednesday's (Oct.30) trading at $2.75.

News: The Company announced topline results from its phase II proof-of-concept studies of Praliciguat in heart failure with preserved ejection fraction and in diabetic nephropathy, both of which did not reach statistical significance on the respective primary endpoints.

The phase II proof-of-concept study of Praliciguat in heart failure with preserved ejection fraction, dubbed CAPACITY, did not meet statistical significance on its primary endpoint of improved exercise capacity from baseline as compared to placebo, measured by cardiopulmonary exercise testing.

The phase II proof-of-concept study of Praliciguat in diabetic nephropathy did not meet statistical significance on its primary endpoint of reduction in albuminuria from baseline as compared to placebo, measured by urine albumin creatinine ratio.

2. AMAG Pharmaceuticals Inc. (AMAG)

AMAG is a revenue-generating pharmaceutical company.

Lost 22.36% to close Wednesday's trading at $10.35.

News: An FDA panel, which reviewed whether or not to allow AMAG Pharmaceuticals Inc.'s (AMAG) Makena, a drug indicated for the prevention of preterm birth in pregnant women, to remain in the market, has voted 9-7 recommending withdrawal of the drug.

However, seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial. Now that the panel has made its recommendation, it is for the FDA to make a final decision.

Makena received accelerated approval from the FDA in 2011 for the prevention of preterm birth in pregnant women. Companies whose drugs are approved under the "accelerated approval pathway" are required to conduct a post-approval confirmatory clinical trial to verify and describe clinical benefit. Only then, will the accelerated approval be converted into a full approval.

In the case of Makena, the completed confirmatory trial, dubbed PROLONG, has not demonstrated a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity.

Sales of Makena in 2018 were $322 million - down from $387 million in 2017. In the first half of 2019, sales of the drug slipped to $62 million from $195 million in the comparable year-ago period.

3. Endologix Inc. (ELGX)

Endologix develops and manufactures minimally invasive treatments for aortic disorders.

Lost 21.23% to close Wednesday's trading at $2.30.

News: The stock took a hit, following an update regarding Type III endoleaks with the Company's AFX Endovascular AAA System, which the FDA issued as a Safety Communication response.

In this most recent update on October 28, 2019, the FDA notes that there may be a higher than expected risk of Type III endoleaks occurring with the use of Endologix's AFX Strata System. The update was based on the Kaiser Integrated Health System, published in the Journal of the American College of Surgeons (Rothenberg et. al.).

Endologix has clarified that its current commercially available versions of the AFX System - the AFX Duraply and AFX2TM products, are manufactured using a different processing methodology than AFX Strata and include additional product improvements.

4. Iterum Therapeutics plc (ITRM)

Iterum Therapeutics is a clinical-stage pharmaceutical company developing next-generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings.

Lost 21.71% to close Wednesday's trading at $2.74.

News: No news

Clinical Trials:

Three phase III trials are underway namely, SURE 1, SURE 2, and SURE 3.

-- In SURE 1, oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) is compared to oral ciprofloxacin in women with uncomplicated urinary tract infections (uUTI).
-- In SURE 2, IV sulopenem followed by oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) is compared to IV ertapenem followed by oral ciprofloxacin in adults with complicated urinary tract infections (cUTI). Topline data from this trial is expected this quarter (Q4,2019).
-- In SURE 3, IV sulopenem followed by oral sulopenem is compared to IV ertapenem followed by a combination of oral ciprofloxacin and oral metronidazole in adults with complicated intra-abdominal infections (cIAI).

5. Cardiovascular Systems, Inc. (CSII)

Cardiovascular Systems is a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease.

Lost 16.80% to close Wednesday's trading at $43.43.

News: No news

Recent event:

On October 29, 2019, the Company reported financial results for its fiscal first quarter, ended September 30, 2019.

The net loss for the fiscal first-quarter widened to $5.8 million or $0.17 per share from $2.9 million or $0.09 per share in the year-ago quarter. Analysts were expecting a loss of $0.08 per share. The fiscal 2020 first-quarter revenues were $64.5 million, an increase of $8.2 million, or 14.6%, from the first quarter of fiscal 2019.

For fiscal 2020 ending June 30, 2020, the Company expects net income (loss) of approximately breakeven, excluding approximately $1 million of intangible asset amortization and an additional $1 million of direct expenses related to the WIRION acquisition. Cardiovascular Systems acquired the WIRION Embolic Protection System and related assets from Gardia Medical Ltd., a wholly-owned Israeli subsidiary of Allium Medical Solutions Ltd. in August of this year.

Revenue for the year is expected to be in the range of $278 million to $283 million, representing 12% to 14% growth compared with fiscal 2019.

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