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Week Ahead In Pharmaceuticals: 13 Stocks To Watch (EIDX, NOVN, ZYME...)


The week that went by saw pot stocks gain big, following the U.S. midterm election results, and resignation of Attorney General Jeff Sessions, a vocal opponent of marijuana legalization.

The healthcare payers such as Molina Healthcare and Centene Corp. were also driven by the election results, which gave Democrats control over the House of Representatives.

NantKwest Inc. (NK), which reported promising first in human clinical trial results of its NANT Cancer Vaccine, and Clearside Biomedical Inc. (CLSD), which failed to meet the primary endpoint in its phase III Retinal Vein Occlusion study, were some of the other healthcare stocks that grabbed headlines in the week.

Clinical trial data is an important catalyst, and any update on the clinical studies can send the biotech stocks soaring or stumbling depending upon the news.

Now, here are some of the pharma/biotech stocks to watch out for in the week starting November 12.

1. Eidos Therapeutics Inc. (EIDX)

Eidos is a clinical stage biopharmaceutical company focused on developing drugs for diseases caused by transthyretin (TTR) amyloidosis (ATTR).

The Company's lead drug candidate is AG10, under phase II clinical trial in patients with ATTR cardiomyopathy.

Watch out for...

Eidos will present the phase II data for AG10 in with ATTR cardiomyopathy at the Annual Scientific Sessions of the American Heart Association (AHA) in a late-breaking Featured Science oral presentation on November 10.

The Company will also host a conference call and webcast on November 12, 2018, to highlight details of the phase II data.

EIDX closed Friday's trading at $12.71, up 2.50%.

2. Mirati Therapeutics Inc. (MRTX)

Mirati is a clinical-stage oncology company.

The Company's lead product candidate is Sitravatinib, which is being evaluated as a single agent and in combination with Opdivo in non-small cell lung cancer. Also in the pipeline are MRTX849 and Mocetinostat, both of which are also being developed for non-small cell lung cancer.

Watch out for...

Preliminary biomarker data from the ongoing phase II clinical trial of Sitravatinib in combination with OPDIVO in non-small cell cancer lung patients are expected to be presented on November 10.

Data update in the ongoing phase II clinical trial of Mocetinostat in combination with IMFINZI in NSCLC patients is expected to be presented on November 11.

MRTX closed Friday's trading at $39.56, down 5.65%.

3. CymaBay Therapeutics Inc. (CBAY)

CymaBay is a clinical-stage biopharmaceutical company developing therapies for liver and other chronic diseases.


The Company's lead drug candidate is Seladelpar, in two indications -- primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).

A global phase III registration study of Seladelpar for patients with PBC, dubbed ENHANCE, was initiated last month.

A phase IIb proof-of-concept study of Seladelpar for the treatment of patients with NASH is also underway. Enrollment in this study is expected to be completed in the first quarter of 2019.

Last October, the Company reported twelve-week interim analysis results from the ongoing phase II study of Seladelpar in patients with primary biliary cholangitis. In April of this year, positive new 12-week and 26-week results from the ongoing phase II PBC trial were reported.

Watch out for...

52- and 26-week results from the ongoing phase II study of Seladelpar in patients with primary biliary cholangitis (PBC) will be featured on November 12, 2018 during The Liver Meeting hosted by the American Association for the Study of Liver Diseases (AASLD) in San Francisco.

The 52-week composite responder rates in the ongoing phase II study for the 5 mg/5 mg to 10 mg titration and 10 mg Seladelpar groups were 59% and 71%, respectively.
Results suggest that Seladelpar is not associated with drug-induced pruritus and may support the hypothesis that Seladelpar decreases pruritus in PBC patients, according to the Company.

CBAY closed Friday's trading at $11.56, down 1.53%.

4. Theravance Biopharma Inc. (TBPH)

On November 13, 2018, the FDA will decide whether or not to approve Yupelri, an investigational, once-daily nebulized long-acting muscarinic antagonist (LAMA) for the treatment of moderate to very severe chronic obstructive pulmonary disease.

If approved, Yupelri (revefenacin) would be the first once-daily, long-acting single-agent product for COPD patients who require, or prefer, nebulized therapy.

Developed by Theravance Biopharma and Mylan N.V. (MYL), Yupelri is designed to be compatible with any standard jet nebulizer.

Theravance Biopharma is eligible to receive up to $220 million in development and sales milestone payments, as well as a profit-sharing arrangement with Mylan on US sales and double-digit royalties on ex-US sales of Yupelri.

TBPH closed Friday's trading at $25.81, up 5.13%.

Updated: The FDA has approved Yupelri for the treatment of moderate to very severe chronic obstructive pulmonary disease. The announcement was made after-hours on Friday.

5. Novan Inc. (NOVN)

Novan is a clinical-stage biotechnology company focused on treating dermatological and oncovirus-mediated diseases.


-- SB204, under late-stage development for acne.
-- SB414, which recently completed complementary phase Ib clinical trials in patients with psoriasis and atopic dermatitisis.
-- SB206, under phase II study, for the treatment of molluscum contagiosum.

Watch out for...

The top line results from trial Cohorts 1 to 3 of the phase II study of SB206 in molluscum contagiosum are anticipated by mid-November 2018.

NOVN closed Friday's trading at $2.58, down 3.37%.

6. Zymeworks Inc. (ZYME)

Zymeworks is a clinical-stage biopharmaceutical company developing biotherapeutics, with a focus on immuno-oncology and other therapeutic areas.

The lead product candidates are ZW25 and ZW49, which are wholly-owned by the Company.

ZW25 is currently being evaluated in a phase I clinical trial in patients with locally advanced (unresectable) and/or metastatic HER2-expressing cancers. HER2 is over-expressed in subsets of breast, ovarian, gastric, colorectal, pancreatic and endometrial cancers. (Source: NCBI).

The phase I study of ZW25, being conducted in the U.S., consists of two parts - dose escalation, and dose expansion - and is designed to enroll 99 patients with advanced HER2-expressing cancers.

The Company presented the completed dose escalation portion of its ongoing phase I study of ZW25 last December. The second part of the phase I study, i.e. dose expansion, is enrolling patients, and enrollment is expected to be completed this year.

Watch out for...

New data from the phase I trial of ZW25 is expected to be presented at the 30th EORTC-NCI-AACR symposium in a plenary session on November 14.

ZYME closed Friday's trading at $13.81, down 2.54%.

7. Mallinckrodt Public Limited Co. (MNK)

An FDA panel is scheduled to review Mallinckrodt's MNK-812, an abuse-deterrent, immediate-release reformulation of Roxicodone, on November 14.

The Company is seeking approval of MNK-812 for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The New Drug Application for MNK-812 was submitted under 505(b)(2) regulatory pathway as MNK-812 is a reformulation of the oxycodone hydrochloride tablets USP (Roxicodone).

The FDA usually follows the recommendations of its advisory panels, although it is not required to do so. The regulatory agency's final decision is slated for November 16.

MNK closed Friday's at $30.89, down 0.90%.

8. TRACON Pharmaceuticals (TCON)

TRACON is a clinical stage biopharmaceutical company developing novel targeted therapeutics for cancer and wet age-related macular degeneration.

The Company's lead drug candidate is TRC105 for the treatment of angiosarcoma, under a phase III trial called TAPPAS. TRC105 is also under phase IIb clinical trial in combination with Inlyta in patients with advanced or metastatic renal cell carcinoma, dubbed TRAXAR.

Also in the pipeline are:

-- TRC253, under phase I/II trial, in patients with metastatic prostate cancer.
-- TRC102, under phase II study, in combination with Temodar, in patients with glioblastoma, phase II study in combination with Alimta for Mesothelioma, and phase I study in lung and solid tumors.
-- DE-122, partnered with Santen Pharmaceutical Co., under phase II study for wet AMD.
-- TRC253, under phase I study, for prostate cancer.
-- TRC694, under preclinical testing, for myeloma.

Watch out for...

Announcement of safety and efficacy data from the phase II trial of TRC102 in combination with Temodar in patients with glioblastoma at the Society for Neuro-Oncology annual meeting, which is to be held November 15-18.

TCON closed Friday's trading at $1.43, down 4.67%.

9. Blueprint Medicines Corp. (BPMC)

Blueprint Medicines is developing a new generation of targeted and potent kinase medicines to improve the lives of patients with genomically defined subsets of patients with cancer and other debilitating diseases driven by the abnormal activation of kinases.

Avapritinib (BLU-285), BLU-554 and BLU-667 are the Company's clinical drug candidates.

Watch out for...

Updated results from NAVIGATOR, a phase I trial of Avapritinib in advanced gastrointestinal stromal tumors, will be presented on November 15.

BPMC closed Friday's trading at $60.22, down 4.85%.

10. Syros Pharmaceuticals (SYRS)

Syros is pioneering a new area of drug discovery and development focused on controlling the expression of genes.


The lead drug candidate is SY-1425, currently under phase II clinical trial to assess its efficacy and safety in combination with standard-of-care and targeted therapies in genomically defined subsets of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients.

Another drug candidate is SY-1365, under phase I clinical trial as a single agent and in combination with standard-of-care therapies in multiple patient populations with ovarian and breast cancers.

Watch out for...

Clinical data from the dose escalation portion of the phase I trial of SY-1365 in patients with advanced solid tumors are scheduled to be presented at the 30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium on November 15.

SYRS closed Friday's trading at $7.36, down 4.91%.

11. ArQule Inc. (ARQL)

ArQule is a biopharmaceutical company developing targeted therapeutics to treat cancers and rare diseases.


ARQ 531, under phase I trial for patients with B-cell malignancies refractory to other therapeutic options; Miransertib in a Phase 1/2 company-sponsored study for Overgrowth Diseases, in a Phase 1 study for ultra-rare Proteus syndrome, and in Phase 1b in combination with the hormonal therapy, anastrozole, in patients with advanced endometrial cancer; ARQ 751, in phase I trial for patients with AKT1 and PI3K mutations; Derazantinib, in a registrational trial for intrahepatic Cholangiocarcinoma (iCCA) and ARQ 761, in Phase 1/2 in multiple oncology indications in partnership with the University of Texas Southwestern Medical Center.

Watch out for...

Clinical data from a phase I trial evaluating the combination of ARQ 751 with immune checkpoint inhibitor and other therapeutic agents are expected to be presented on November 16.

ARQL closed Friday's trading at $3.99, down 1.72%.

12. VBI Vaccines Inc. (VBIV)

VBI Vaccines is a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines.

The Company's marketed product is Sci-B-Vac, a hepatitis B vaccine that is approved for use in Israel and 10 other countries.


-- A pivotal phase III clinical program for Sci-B-Vac, the Company's Hepatitis B vaccine, consisting of two studies, dubbed PROTECT and CONSTANT, is underway in the U.S.
-- VBI-1501, a prophylactic cytomegalovirus (CMV) vaccine candidate, for which positive topline phase I data was announced in May 2018
-- VBI-1901, a therapeutic glioblastoma vaccine candidate, currently in phase I/IIa study.

Watch out for...

Initial clinical data from the phase I/IIa study of VBI-1901 in recurrent Glioblastoma (GBM) patients will be presented on November 16.

VBIV closed Friday's trading at $2.05, down 5.53%.

13. Aquestive Therapeutics Inc. (AQST)

Aquestive Therapeutics' AQST-119, a vasodilator for the treatment of erectile dysfunction, is under FDA review, with a decision anticipated on November 18.

AQST-119 is an oral soluble film formulation of Tadalafil, a vasodilator that is used to treat erectile dysfunction, or ED.

There are a number of treatments for treating ED. They include oral medications like Sildenafil (Viagra); Tadalafil (Adcirca, Cialis); Vardenafil (Levitra, Staxyn) and Avanafil (Stendra); other medications like Alprostadil self-injection and Alprostadil urethral suppository, implants and surgery. (Source: Mayo Clinic).

AQST-119 is designed to provide patients a discreet product with increased ease of use, according to the Company.

AQST closed Friday's trading at $17.00, down 5.56%.

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