AXON Depressed By MINDSET, CDNA On Track, PTCT On A Sticky Wicket?

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of September 26, 2017.

GAINERS

1. CareDx Inc (CDNA)

Gained 23.72% to close Tuesday's (Sep.26) trading at $4.12.

News: Molecular Diagnostics Services (MolDX) Program developed by Palmetto GBA has set AlloSure reimbursement at $2,840.75, which is same reimbursement as AlloMap in 2017.

AlloSure, which is on track for launch in October, is the Company's proprietary next-generation sequencing test for measuring the percentage of donor-derived cell-free DNA (dd-cfDNA) in solid organ transplant recipients. AlloMap is a non-invasive blood test for heart transplant patients.

AlloSure will be reimbursed for kidney transplant patients covered by Medicare across the United States starting October 9, 2017. About 80% of kidney transplant patients are covered by Medicare, so many patients will have access to AlloSure, according to the Company.

The Company estimates that AlloSure could bring home revenue of $200 million per year.

2. Versartis Inc. (VSAR)

Gained 14.29% to close Tuesday's trading at $2.80 after 2 down days of trading.

News: No news

Recent event:

Last Thursday (Sep.21, 2017) after the bell, the Company announced that its phase III study of Somavaratan in pre-pubertal children with Growth Hormone Deficiency, dubbed VELOCITY, did not meet the trial goals. The news sent the stock tumbling nearly 88% on Sep.22, 2017.

3. Surgery Partners Inc. (SGRY)

Gained 10.33% to close Tuesday's trading at $10.15.

News: No news

Recent event:

On August 8, 2017, the Company reported disappointing Q2, 2017 financial results and trimmed its revenue outlook for the year.

In the second quarter of 2017, the Company's net loss attributable to Surgery Partners was $4.5 million or $0.09 per share compared to net income of $2.1 million or $0.04 per share for the same period last year. Total revenues for the recent second quarter decreased 0.5% to $288.4 million from $289.7 million for the second quarter of 2016.

Looking ahead to full year 2017, the Company expects revenue in the range of $1.18 billion to $1.20 billion, which reflects 7% to 9% growth over 2016. Previously, the Company was expecting 2017 revenue growth of 9% to 11%. The revised outlook of this year reflects the recent softness in healthcare utilization and payor mix shift experienced during the second quarter.

4. AcelRx Pharmaceuticals Inc. (ACRX)

Gained 8.97% to close Tuesday's trading at $4.25.

News: No news

Near-term catalyst:

-- The FDA decision on the Company's investigational product Dsuvia for the treatment of moderate-to-severe acute pain in a medically supervised setting is expected to be announced on October 12, 2017.

Dsuvia, formerly known as ARX-04, consists of 30 mcg sufentanil in very small sublingually absorbed tablets that are delivered via a disposable, pre-filled, single-dose applicator.

AcelRx estimates that the market potential of Dsuvia in the U.S. will be roughly $1.1 billion.

5. Kala Pharmaceuticals Inc. (KALA)

Gained 8.16% to close Tuesday's trading at $23.45.

News: No news

Recent events:

-- On July 20, 2017, the Company made its stock debut on The NASDAQ Global Select Market at an offering price of $15.00 per share. -- On May 1, 2017, the Company reported positive results from its confirmatory phase III trial of KPI-121 1% for the treatment of inflammation and pain in patients who have undergone cataract surgery.

Near-term catalysts:

-- The two ongoing phase III trials of KPI-121 1% in dry eye disease are expected to complete in late 2017.

6. Amphastar Pharmaceuticals Inc. (AMPH)

Gained 7.44% to close Tuesday's trading at $17.48.

News: The Company's abbreviated new drug application for Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10mL, and 0.5mg/mL, 10mL vial has been granted FDA approval.

The approved product is therapeutically equivalent to Bloxiverz sold in the United States by Avadel, which is used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.

According to IMS Health data, the U.S. brand and generic sales of Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10mL, and 0.5mg/mL, 10 mL were about $185 million for the 12 months ended June 30, 2017.

Amphastar anticipates launching its product in the fourth quarter of 2017.

LOSERS

1. Axovant Sciences Ltd. (AXON)

Lost 73.90% to close Tuesday's trading at $6.33.

News: The Company's phase III trial of its investigational drug Intepirdine in patients with mild to moderate Alzheimer's disease who were receiving background donepezil therapy, dubbed MINDSET, did not meet its co-primary efficacy endpoints.

Near-term catalyst:

-- A phase 2b study of Intepirdine in patients with dementia with Lewy bodies, dubbed HEADWAY, is ongoing, with top-line results expected at the end of 2017.

2. ProQR Therapeutics N.V. (PRQR)

Lost 19.38% to close Tuesday's trading at $5.20.

News: No news

Recent event:

-- On September 25, 2017, the Company reported positive preliminary top-line results from a Phase 1b safety and tolerability clinical trial of QR-010 in cystic fibrosis patients with F508del mutation.

The study primarily assessed safety, tolerability and pharmacokinetics of QR-010, and a number of exploratory efficacy endpoints including sweat chloride, weight gain, change in CFQ-R Respiratory Symptom Score and FEV1. The study was not powered for statistical significance on the exploratory efficacy endpoints.

Near-term catalysts:

-- First patient is expected to be dosed in clinical trial of QR-110 for Leber's Congenital Amaurosis Type 10 in Sep/Oct; Interim data to be reported in 2018; Full data in 2019. -- First clinical trial of QR-421 for Usher syndrome to start around year-end 2018; Clinical data to be delivered in first half of 2019. -- IND-enabling studies for QR-411 for Usher syndrome to be completed before year-end 2018. -- Clinical trial of QR-313 Dystrophic Epidermolysis Bullosa to start in 2018.

Financial strength:

The Company had cash of 42.3 million euros at the end of Q2, 2017.

3. Repligen Corp. (RGEN)

Lost 14.44% to close Tuesday's trading at $36.98.

News: No news

Recent event:

On August 3, 2017, the Company reported results for its second quarter ended June 30, 2017.

Adjusted net income (non-GAAP) for the second quarter of 2017 was $6.8 million or $0.20 per share on revenue of $32.5 million. This compared with a non-GAAP net income of $6.0 million or $0.18 per share and revenue of $29.2 million in the year-ago quarter.

For full year 2017, the Company foresees adjusted net income range of $22.5 million to $24.5 million or adjusted EPS of $0.57 to $0.62, and revenue in the range of $138 million to $144 million.

4. PTC Therapeutics Inc. (PTCT)

Lost 13.84% to close Tuesday's trading at $16.81.

News: The briefing documents posted by the FDA staff ahead of the panel meeting don't look good.

The briefing documents are used as the basis for discussion by the FDA panel members. The FDA panel meeting to review the Company's Translarna for the treatment for nonsense mutation Duchenne muscular dystrophy is slated for September 28, 2017.

The briefing documents on Translarna NDA read as "Ultimately, no positive results from any prospectively planned analyses that are persuasive have been provided with this application. The applicant has presented only the results from numerous post hoc and exploratory analyses that are intended to mitigate two negative clinical trials".