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VNDA - Lag Or Rise? ANAB - Gallop Or Flounder? And More...

august aug19 lt

We are halfway through the third quarter. In the healthcare sector, Axsome Therapeutics Inc. (AXSM), with a gain of over 770 percent, tops the list of best-performing stocks year-to-date, thanks to promising trial results of its lead drug candidate AXS-05 in a couple of indications.

On the flip side, Intec Pharma Ltd. (NTEC) is one of the biggest year-to-date percentage decliners. The stock has lost 94 percent of its value on the failure of its phase III trial of Accordion Pill, a drug meant to treat symptoms of advanced Parkinson's disease.

Like clinical trial results, regulatory events can also send a stock soaring or plummeting depending upon the outcome.

Shares of Acer Therapeutics Inc. (ACER) are down nearly 90 percent year-to-date, and the FDA rejection of the lead drug candidate Edsivo for the treatment of vascular Ehlers-Danlos syndrome in June of this year is to be blamed for the setback.

Some of the healthcare stocks with pending regulatory or clinical trial catalysts that bear watching this month are:

1. Vanda Pharmaceuticals Inc. (VNDA)

The FDA decision on the expanded indication for Vanda Pharma's Hetlioz for the treatment of jet lag disorder due on August 16, 2019, is awaited.

Jet lag is a temporary sleep disorder that results from a mismatch between a person's circadian (24-hour) rhythms and the time of day in the new time zone.

Hetlioz is already approved for the treatment of Non-24-Hour Sleep-Wake Disorder for the totally blind. Non-24-Hour Sleep-Wake Disorder is a serious, chronic disorder that disrupts a person's circadian rhythms.

The drug brought home annual sales of $115.8 million for Vanda in 2018 compared to $89.97 million in 2017. In the first half of 2019, Hetlioz net product sales were $66.79 million.

Vanda expects to file an sNDA for Hetlioz for the treatment of Smith-Magenis Syndrome in the third quarter of 2019. A phase II clinical study of Hetlioz in delayed sleep phase disorder (DSPD) in patients who have a mutation in the CRY1 gene, which is believed to be causative in a subset of patients with DSPD, is also expected to be initiated this quarter.

VNDA closed Friday's (Aug.16, 2019) trading at $15.19, up 1.88%.

2. AnaptysBio Inc. (ANAB)

AnaptysBio's interim top-line data from its phase II trial of ANB019 in up to 10 patients with generalized pustular psoriasis, or GPP, also known as the GALLOP trial, due in mid-2019, are awaited.

Generalized pustular psoriasis is a severe and rarest form of psoriasis.

ANB019 is also under a phase II trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with top-line data anticipated in the first half of 2020.

Some of the other clinical events lined up for this year include:

-- Initiation of a phase II trial of Etokimab in 300-400 eosinophilic asthma patients in the fourth quarter of 2019.
-- Reporting of top-line data from a phase IIb study of Etokimab in approximately 300 adult patients with moderate-to-severe atopic dermatitis, dubbed ATLAS, in the fourth quarter of 2019.
-- Reporting of interim top-line data from a phase II trial of Etokimab in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial, in the fourth quarter of 2019.

ANAB closed Friday's trading at $49.20, down 1.58%.

3. Nabriva Therapeutics plc (NBRV)

Nabriva Therapeutics' New Drug Applications for intravenous (IV) and oral formulations of antibiotic Lefamulin are under priority review, with a decision expected on August 19, 2019.

The Company is seeking approval of Lefamulin for the treatment of community-acquired bacterial pneumonia.

Lefamulin works by inhibiting the synthesis of bacterial protein, which is required for bacteria to grow.

According to Nabriva, Lefamulin has the potential to provide a much-needed monotherapy treatment option for adults with community-acquired bacterial pneumonia.

Analysts expect the drug to achieve peak sales of over $600 million.

Another regulatory event to watch out for in the coming months is the resubmission of CONTEPO New Drug Application early in the fourth quarter of 2019. The Company is seeking approval of CONTEPO for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. CONTEPO was turned down by the FDA in April 2019 due to issues related to facility inspections and manufacturing deficiencies at one of Nabriva's contract manufacturers.

NBRV closed Friday's trading at $2.28, up 5.56%.

4. Sarepta Therapeutics Inc. (SRPT)

The FDA is expected to announce its decision on Sarepta Therapeutics' New Drug Application seeking accelerated approval for VYONDYS 53 (Golodirsen) on August 19, 2019.

VYONDYS 53 is a phosphordiamidate morpholino oligomer developed for the treatment of patients with Duchenne muscular dystrophy who have genetic mutations subject to skipping exon 53 of the dystrophin gene. Patients with a 53 mutation represent 8 percent of those with Duchenne.

The Company already has one approved drug for Duchenne muscular dystrophy, by the name Exondys 51, but it is used to treat those with DMD caused by a mutation amenable to skipping exon 51, which affects about 13 percent of the population with DMD.

The net product sales of Exondys 51 were $181.7 million in the first half of 2019 compared to $138 million in the year-ago period.

SRPT closed Friday's trading at $124.95, up 2.44%.

5. TrovaGene Inc. (TROV)

TrovaGene, a clinical-stage, oncology therapeutics company, is scheduled to present new clinical data from its phase II trial of lead drug candidate Onvansertib in metastatic Castration-Resistant Prostate Cancer (mCRPC) on August 24, 2019.

The study, dubbed TROV-053, is evaluating Onvansertib in combination with Zytiga. Initiated in June 2018, TROV-053 is designed to enroll 64 patients with metastatic Castration-Resistant Prostate Cancer.

The primary efficacy endpoint is the proportion of patients achieving disease control after 12 weeks of study treatment, as defined by lack of prostate-specific antigen (PSA) progression in patients who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving abiraterone acetate and prednisone.

The study is expected to be completed in 2021.

TROV closed Friday's trading at $2.09, up 28.22%.

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