Next week we have the GI ASCO symposium where some data releases are coming. Overall though, biotech stocks remain a very risky gambit in the current market environment.

9 Top Biotech Stocks To Watch

Below are the top biotechnology stocks to watch as data release catalysts could explode these stocks higher, or send them to the dog house.

IMMU Stock

SACTUZUMAB GOVITECAN (IMMU-132) for metastatic triple-negative breast cancer. PDUFA date, under priority, review is set for January 18, 2019. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of mTNBC.

“We are delighted that the FDA has accepted the sacituzumab govitecan BLA for Priority Review,” commented Michael Pehl, President and Chief Executive Officer. “We will continue to work closely with the regulatory agency as we strive to bring this potential new treatment to mTNBC patients expeditiously.”

The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.

Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC). It is currently under review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer.

IMMU stock chart

IMMU stock does not present a good setup but prices have been consolidating lately and the volatility has been reduced. This is a hard read though because sacituzumab govitecan could become the first and only ADC approved for the treatment of metastatic triple-negative breast cancer.

Another problem is that the FDA issued citations against Immunomedics for multiple violations at its Morris Plains, New Jersey facility. The FDA citations included the manipulation of bioburden samples, backdating of records, and misrepresentation of integrity test procedures. Based on these facts, the Company’s public statements were false and materially misleading throughout the class period. On December 17, 2018, published an article entitled “FDA Hits Immunomedics for Data Integrity Breach.” Upon this news, Immunomedics’ stock price fell sharply, damaging investors.

EXEL Stock

Cabozantinib (CELESTIAL) for advanced hepatocellular cancer (HCC). PDUFA date coming Monday, January 14, 2019.

“Patients with this aggressive form of advanced liver cancer urgently need new treatment options after they progress on first-line therapy,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “The acceptance of our sNDA filing for CABOMETYX is a critical step forward as we work to help address this unmet need, and we intend to work closely with the FDA as they review the application.”

CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who received prior sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function. Enrollment of the trial was completed in September 2017. Patients were randomized 2:1 to receive 60 mg of cabozantinib once daily or placebo and were stratified based on etiology of the disease (hepatitis C, hepatitis B or other), geographic region (Asia versus other regions) and presence of extrahepatic spread and/or macrovascular invasion (yes or no). No cross-over was allowed between the study arms during the blinded treatment phase of the trial. The primary endpoint for the trial is overall survival, and secondary endpoints include objective response rate and progression-free survival. Exploratory endpoints include patient-reported outcomes, biomarkers and safety.

In October 2017, Exelixis announced that the independent data monitoring committee for the CELESTIAL study recommended that the trial be stopped for efficacy following review at the second planned interim analysis, with cabozantinib providing a statistically significant and clinically meaningful improvement in overall survival compared with placebo in patients with previously treated advanced HCC. In March 2017, the FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC.

Liver cancer is the second-leading cause of cancer death worldwide, accounting for more than 700,000 deaths and nearly 800,000 new cases each year. In the U.S., the incidence of liver cancer has more than tripled since 1980. HCC is the most common form of liver cancer, making up about three-fourths of the estimated nearly 42,000 new cases in the U.S. in 2018. HCC is the fastest-rising cause of cancer-related death in U.S. Without treatment, patients with advanced HCC usually survive less than 6 months.

EXEL chart

EXEL stock has already had a big upward move and the MACD suggests upward momentum is slowing. EXEL is not a good entry right now. It is probably a good idea to wait for a consolidation before taking an entry.

AMGN Stock

EVENITY (Romosozumab) for osteoporosis. A CRL was issued July 16, 2017. BLA filing resubmission announced July 13, 2018. An Advisory Committee meeting is set for January 16, 2019.

The FDA Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review data supporting the Biologics License Application (BLA) for EVENITYTM (romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk for fracture at a meeting on January 16, 2019.

“After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year, and these fractures can be life-changing. Yet these patients often remain undiagnosed and untreated and could benefit from a potential new bone forming therapy that has been shown to reduce their risk of fracture within the first year,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We look forward to discussing the efficacy and safety data from our EVENITY clinical program with the members of the Committee.”

The EVENITY development program includes three pivotal Phase 3 studies that included more than 11,000 patients: including 7,180 postmenopausal women with osteoporosis; including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and including 245 men with osteoporosis. The BRUDAC will focus its discussion on the FRAME and ARCH studies in its review of the clinical benefit:risk profile of EVENITY, including the cardiovascular safety findings seen in the ARCH study, for the potential to reduce the risk of fractures and increase bone mineral density (BMD) in postmenopausal women with osteoporosis.

“We are currently seeing a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated 77 percent of women aged 67 or older remaining undiagnosed and untreated in the first six months after a fracture. This is a stark reminder of the need to improve post-fracture care and reduce the risk of future fractures,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “We believe EVENITY has the potential to help postmenopausal women with osteoporosis who are at high risk for fracture, and we look forward to the interactions with the members of the Committee.”

EVENITY is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program included two large fracture trials comparing EVENITY to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.

AMGN stock

AMGN presents an ok setup on the chart. We see reduced volatility while prices have been consolidating in the most recent period but the Twiggs Money Flow is negative and large players volume is falling. There is a resistance zone just above the current price starting at $207.87. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $196.40, a stop order could be placed below this zone.

RNN Stock

RX-3117 in combination with Abraxane for first-line pancreatic cancer. A Phase 2 update data release is scheduled at the GI ASCO between January 17-19, 2019.

The company intends to primarily focus its near-term efforts on the ongoing Phase 2 clinical trial of RX-3117 in combination with ABRAXANE® (nab-paclitaxel) in patients newly diagnosed with metastatic pancreatic cancer. Encouraging preliminary safety and efficacy data from this trial was presented in October at the 5th NCI Pancreatic Cancer Symposium. Updated data from this study will be presented at the American Society of Clinical Oncology Annual Gastrointestinal Cancers Symposium (ASCO-GI) being held January 17-19, 2019 in San Francisco, CA.

In the ongoing Phase 2 RX-3117 study in advanced bladder cancer, Rexahn has completed enrollment of 30 evaluable patients and will finalize the data once all patients in the study have completed treatment, which is expected during the first half of 2019. “We are currently evaluating development pathways for RX-3117 in bladder cancer to optimize positioning for future commercialization and potential partnering,” said Lisa Nolan, Ph.D., chief business officer of Rexahn. “We look forward to providing updated data from this study next year.”

RNN stock

RNN stock shows a decent setup pattern. Prices have been consolidating lately and the volatility has been reduced. There is a very little resistance above the current price. I really like the Twiggs Money Flow that has recently gone positive which suggests traders are accumulating the stock; however, large players are not really buying.

LXRX Stock and SNY Stock

Sotagliflozin for type 1 diabetes. The PDUFA date is not until March 22, 2019, but an Advisory Committee meeting is scheduled for January 17, 2019.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) plans to review Lexicon collaborator Sanofi’s New Drug Application (NDA) for sotagliflozin, an investigational oral treatment for adults with type 1 diabetes, on January 17, 2019.

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.

Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and has exercised an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes. In the U.S., Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan). A New Drug Application (NDA) and a Marketing Authorization Application (MAA) for sotagliflozin are currently under review at the U.S. Food and Drug Administration and the European Medicines Agency (EMA), respectively, and the product has not yet been approved for use in the U.S. or in Europe.

LXRX stock

LXRX stock shows a decent setup pattern. Prices have been consolidating lately and the volatility has been reduced. I like the rising large players volume but the negative Twiggs Money Flow suggests weakness and the possibility the stock could continue to chop out sideways. There is a resistance zone just above the current price starting at $7.55. Right above this resistance zone may be a good entry point.

SNY stock chart

SNY stock shows a decent setup pattern and I like it a little better than the LXRX stock chart but again, the negative Twiggs Money Flow is problematic as it suggests the stock could continue to chop out sideways. We see reduced volatility while prices have been consolidating in the most recent period. There is a resistance zone just above the current price starting at $42.48. Right above this resistance zone may be a good entry point. We notice that large players showed an interest for SNY in the last couple of days, which is a good sign.

TCON Stock

TRC105 and Nexavar for hepatocellular carcinoma (HCC) cancer. Phase 2 dosing was initiated May 2016 with poster presented January 19, 2018 at ASCO GI showing 2/8 partial responses. Full data to be presented at GI ASCO January 17-19, 2019.

TCON stock chart

TCON stock does not look like a good entry. It’s been consolidating which is good, but the Twiggs Money Flow and large players volume are so negative that this stock is too risky a gambit IMO.

ASLN Stock

Varlitinib + gemcitabine and cisplatin for biliary tract cancer. Phase 1/2 new data will be presented at the ASCO Gastrointestinal Cancers Symposium on January 18, 2019.

Two abstracts on varlitinib have been accepted for poster presentation at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, January 17-19, 2019.

ASLAN will present safety and efficacy data from an ongoing multicenter phase 1b/2 study of varlitinib plus gemcitabine and cisplatin in first line biliary tract cancer (BTC).

In a second poster, data from a pooled analysis of three phase 1 studies of varlitinib in combination with platinum-based regimens in BTC will be presented.

Abstract Title: A multicenter, phase 1b/2 study of varlitinib plus gemcitabine and cisplatin (gem/cis) for treatment of naïve, advanced, or metastatic biliary tract cancer (BTC).
Abstract Number: 319
Board Number: G17
Session Information: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date/Time: Friday, 18 January, 11:30 AM-1:00 PM; 5:30 PM-6:30 PM (PST)

Abstract Title: Efficacy and safety of varlitinib, a reversible pan-HER tyrosine kinase inhibitor, in combination with platinum-based regimens in biliary tract cancers: A pooled analysis from three phase I studies.
Abstract Number: 331
Board Number: H9
Session Information: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date/Time: Friday, 18 January, 11:30 AM-1:00 PM; 5:30 PM-6:30 PM (PST)

Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. These receptors can be mutated or overexpressed in many tumors, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumor growth. Varlitinib is currently being studied in gastric, biliary tract, breast and colorectal cancers. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.

ASLN stock chart

ASLN stock does not look like a decent setup with that roll-over pattern last week. Large players volume is headed down and the Twiggs Money Flow has just gone negative which suggests somebody knows something and is dumping this stock. This stock is too dangerous IMO.

TYME Stock

SM-88 for pancreatic cancer. Phase 2 interim data to be presented on January 18, 2019 at 11:30 AM at the Gastrointestinal Cancers Symposium.

SM-88 is a combination therapy utilizing our proprietary dysfunctional racemic D/L tyrosine derivative as the backbone. Tyrosine is a non-essential amino acid that is readily consumed by cancer cells but has shown minimal uptake by normal healthy cells. SM-88’s tyrosine derivative is designed to be absorbed by the cancer cell as if it were a functional tyrosine, but after uptake, interrupt the processes of protein synthesis. Disrupting the protein synthesis also impedes key defenses of the cancer cell, making it vulnerable to oxidative stress and apoptosis.

The key target we aim to disrupt within the cancer cell is mucin, specifically mucin 1, produced by the MUC1 oncogene. Mucin is highly overexpressed by most cancer cells and acts as a protective layer on the outside of each cancer cell, offering multiple defenses to the harsh tumor microenvironment and shielding it from the immune system.

The internal environment of cancer cells is also harsh, with elevated levels of free radicals or reactive oxygen species (ROS) created from the altered metabolism that cancers utilize (aerobic glycolysis). MUC1 has also been shown to be important in balancing the elevated ROS by triggering the upregulation of key antioxidant defenses of the cell and preventing cancer from triggering its own death (apoptosis).

Overall, SM-88’s disruption of the cancer cell’s protein synthesis further destabilizes an already vulnerable cell with a goal of triggering cell death and potentially immune recognition of the cancer cell.

There are three additional components to SM-88: sirolimus, phenytoin, and methoxsalen used at sub-therapeutic levels to alter the physiology of the patient or their tumor in order to complement and augment the activity of our novel tyrosine derivative. Each agent is FDA approved, generic, and has years of research behind the physiological mechanism for which it is employed in our therapy.

TYME stock chart

TYME stock is not a good setup right now because price movement has been a little bit too volatile to find a nice entry and exit point. Positive large players volume and Twiggs Money Flow suggests TYME stock could be a good entry as soon as we get more of a consolidation pattern. Don’t try and catch a falling knife, instead, wait for a consolidation pattern.

Disclosure: I do not hold any position in any stock mentioned in this article.