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Healthcare Stocks That Hit New Highs (XENE, AQST, DRNA...)

pharma 052617 03dec19 lt

The following are some of the healthcare stocks that hit a new high yesterday.

1. Cassava Sciences, Inc. (SAVA) hit a new high of $1.76 in intraday trading on Monday, before closing at $1.71. The stock jumped 100% year-to-date.

Cassava Sciences is a clinical-stage biopharmaceutical company focused on developing novel solutions for Alzheimer's disease.

Lead product candidate, PTI-125 for the treatment of Alzheimer's disease is in phase 2b study with results expected in the fourth quarter of 2020.

The company is developing PTI-125Dx, a blood-based diagnostic to detect Alzheimer's disease, funded by the National Institutes of Health (NIH).

As of September30, 2019, cash & cash equivalents were $17.8 million.

2. Oramed Pharmaceuticals Inc. (ORMP) recorded a new high of $5.80 in intraday trading on Monday, before closing at $5.72. The stock is up 90% year-to-date.

Oramed Pharmaceuticals is a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems. The company's proprietary technology protein oral delivery (POD) is used for the development of orally ingestible drugs presently administered by way of injection.

Lead drug candidate, oral insulin ORMD-0801 is being investigated in Type 1 and Type 2 diabetes. Positive results from the initial cohort of phase IIb study of ORMD-0801 for the treatment of Type 2 diabetes were reported last month.

The read-out of data from a second cohort of the phase IIb trial of ORMD-0801 is expected in the first quarter of 2020 and further discussions with the U.S. FDA about phase III trials.

Cash and Cash equivalents as on September 30, 2019, were $28.58 million.

3. Xenon Pharmaceuticals Inc. (XENE) jumped to a new high of $13.75 in intraday trading on Monday, before closing at $12.31. The stock is up nearly 100% year-to-date.

Xenon Pharmaceuticals is a clinical-stage biopharmaceutical company, focused on developing drugs for the treatment of neurological disorders.

The lead drug candidate is XEN496 for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). Xenon expects to file an Investigational New Drug application in the first quarter of 2020 in order to initiate a Phase 3 clinical trial in KCNQ2-DEE.

Another drug candidate, XEN1101 is being investigated in phase IIb study as adjunctive treatment in adults with focal epilepsy. Top-line results are anticipated in the second half of 2020.

Up next in the pipeline is XEN901, proposed for the treatment of Epilepsy. A Phase 1 clinical trial was completed using a powder-in-capsule formulation of XEN901 in healthy adult subjects.

Yesterday, the company inked license agreement with Neurocrine Biosciences, Inc. (NBIX) to develop first-in-class treatments for epilepsy. As per the agreement, Neurocrine Biosciences gains an exclusive license to XEN901 and other pre-clinical compounds for development, along with a multi-year research collaboration to discover, identify and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors.

As per the deal, Xenon will receive $30 million upfront and $20 million equity investment by Neurocrine Biosciences at $14.196 per share. Xenon pharma is also eligible for other milestone payments.

Neurocrine Biosciences anticipates filing an IND application with the FDA in the middle of 2020 to start clinical trials of XEN901 in CN8A developmental and epileptic encephalopathy (SCN8A-DEE) patients.

4. Aquestive Therapeutics, Inc. (AQST) hit a new high of $10.00 in intraday trading on Monday, before closing at $8.74. The stock has gained nearly 40% year-to-date.

Aquestive Therapeutics is a revenue-generating specialty pharmaceutical company.

The company's lead drug in the pipeline is Libervant (diazepam) buccal film, proposed for the management of seizure clusters in patients with refractory epilepsy. Yesterday, the company announced the completion of the rolling submission of NDA for Libervant to the FDA.

Late last month, the Company received FDA approval for its drug Exservan for the treatment of neurological disorder amyotrophic lateral sclerosis (ALS).

Total revenues were $12.4 million in the third quarter ended September 30, 2019, compared to $13.3 million in the same quarter last year. Aquestive expects full-year revenue to be in the range of $45 million to $47 million while analysts foresee $46.36 million.

5. Krystal Biotech, Inc. (KRYS) recorded a new high of $63.51 in intraday trading on Monday, before closing at $61.54. The stock is up nearly 200% year-to-date.

Krystal Biotech is a clinical-stage gene therapy company developing treatments for skin diseases using its proprietary Skin TARgeted Delivery (STAR-D) platform.

Lead drug candidate, KB103 is in phase I/II study, dubbed GEM in Dystrophic epidermolysis bullosa, or DEB, an incurable, often fatal skin blistering condition caused by a lack of collagen protein in the skin. Positive results were reported in October this year. The company expects to start phase 3 pivotal trial before the year-end 2019.

Another drug candidate of the company KB105 is in phase I/II study, dubbed GEM-3, in transglutaminase-1 (TGM1) deficient autosomal recessive congenital ichthyosis (ARCI). Interim results from this trial are expected in 1H 2020. ARCI is a genetic skin disease with life-long pronounced scaling of the skin with increased transepidermal water loss.

The Company is planning on filing an IND on KB104 for the treatment of Netherton Syndrome and an IND for KB301 (an undisclosed aesthetic condition) in 1H 2020.

6. Dicerna Pharmaceuticals, Inc. (DRNA) jumped to a new high of $26.69 in intraday trading on Monday, before closing at $26.48. The stock has gained nearly 150% year-to-date.

Dicerna Pharmaceuticals focuses on the discovery and development of ribonucleic acid interference (RNAi)-based pharmaceuticals.

Yesterday, the company announced that its Board of Directors approved employees stock options for eight new employees to purchase 178,500 shares at $26.48 per share, within a 10-year term form the grant date of December 2, 2019.

Lead drug candidate, DCR-PHXC is being investigated for the treatment of all three genetic forms of primary hyperoxaluria (PH).

A pivotal phase II study of DCR-PHXC for the treatment of primary hyperoxaluria type1 and 2 in children and adults, dubbed PHYOX2, is ongoing. Completion of enrollment of the PHYOX2 pivotal clinical trial is expected by the end of the first half of 2020.

Last month, the company announced that it signed an agreement with Novo Nordisk to discover and develop therapies for liver-related cardio-metabolic diseases using Dicerna's proprietary GalXC RNAi platform technology.

In October, Dicerna signed a collaboration agreement with Roche to develop and commercialize Dicerna's DCR-HBVS for the treatment of chronic hepatitis B virus (HBV) infection. Proof-of-concept data from all planned cohorts of the DCR-HBVS Phase 1 clinical trial is expected in mid-2020.

7. Cue Biopharma, Inc. (CUE) recorded a new high of $12.52 in intraday trading on Monday, before closing at $12.30.The stock is up more than 150% year-to-date.

Cue Biopharma is a clinical-stage biopharmaceutical company, developing treatments for cancer and autoimmune diseases. The company is developing drugs using its proprietary Immuno-STAT (Selective Targeting and Alternation of T cells) platform.

The lead candidate Cue-101 is in phase I study for the treatment of HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

As of September 30, 2019, the Company had approximately $31.3 million in cash and cash equivalents.

8. Evofem Biosciences, Inc. (EVFM) hit a new high of $7.50 in intraday trading on Monday, before closing at $6.86. The stock jumped 60% year-to-date.

Evofem Biosciences is a clinical-stage biopharmaceutical company that develops and commercializes women's sexual and reproductive health products.

Lead product candidate, Amphora is being investigated for the prevention of Chlamydia and Gonorrhea as well as for the prevention of pregnancy.

Positive top-line results were reported yesterday from the phase II b study of Amphora for the prevention of chlamydia and gonorrhea in women, dubbed AMPREVENCE.

Last month, Evofem resubmitted the NDA for the FDA approval of Amphora, based on the positive results of a pivotal Phase III trial, dubbed AMPOWER for prevention of pregnancy. FDA decision is expected in May 2020 based on a six-month review.

Cash and cash equivalents as of September 30, 2019, were $32.12 million.

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