The big problem with biotech stocks right now is IBB. Unless you nail a catalyst perfectly in the week ahead, you will likely lose money in biotech stocks if IBB keeps going down.

IBB stock chart
Big sell off on Friday, March 22, 2019 warrants extra caution going into trading on Monday.

Top 7 Biotech Stocks

Below are the top seven biotech stocks to watch with upcoming catalysts.

FCSC Stock

FCX-007 for recessive dystrophic epidermolysis bullosa. Phase 1/2 updated data due March 27, 2019.

Fibrocell Science announced it will report financial results for the year ended December 31, 2018 and operational highlights on March 27, 2019 before the open of the U.S. financial markets.

John Maslowski, President and Chief Executive Officer of Fibrocell, will host a conference call and webcast at 8:30 a.m. EDT on the same day to discuss the Company’s financial results. In addition, he will discuss the recent Type B end-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding the Phase 3 clinical trial design for FCX-007, Fibrocell’s gene therapy candidate for the treatment of RDEB. Furthermore, Mr. Maslowski will provide additional data and address progress from the ongoing Phase 1/2 clinical trial of FCX-007 for the treatment of RDEB.

Large players showing some interest in FCSC stock over the last couple of sessions.

Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first.

GLPG and GILD Stocks

Filgotinib, FINCH 1, for rheumatoid arthritis (RA). Phase 3 data is due in Q1 2019.

“Gilead is committed to the development of new therapies that offer meaningful benefit for people living with rheumatoid arthritis and other serious inflammatory diseases,” said John McHutchison, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “These initial Phase 3 data support the potential of filgotinib, in combination with select disease modifying drugs, to help patients with active rheumatoid arthritis who do not adequately respond to current biologic disease modifying agents. These data are particularly encouraging as we look ahead to Phase 3 results from the ongoing FINCH 1 and 3 trials, which are exploring filgotinib in other populations of patients with rheumatoid arthritis.”

“We are pleased that filgotinib has demonstrated significantly improved clinical responses in this difficult to treat population,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. “The good tolerability in this study is also very encouraging.”

GLPG stock chart
Symmetrical Triangle breakout to either the downside or the upside coming.

Prices have been consolidating lately. There is a resistance zone just above the current price starting at $104. Right above this resistance zone may be a good entry point. We notice that large players showed an interest for GLPG in the last couple of days, which is a good sign.

GILD stock chart
Testing Symmetrical Triangle support.

Prices have been consolidating lately. There is a resistance zone just above the current price starting at $65. Right above this resistance zone may be a good entry.

PRTO Stock

Vonapanitase (PRT-201), PATENCY-2, for chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF). Phase 3 data is due March 2019.

The company expects to release top-line results this month for PATENCY-2, the second Phase 3 clinical trial of investigational vonapanitase. PATENCY-2 is a multicenter, randomized, double-blind, placebo-controlled trial that treated 603 patients in the United States and Canada with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. The study’s co-primary endpoints are fistula use for hemodialysis and secondary patency (i.e., time to fistula abandonment), each of which demonstrated improvements in PATENCY-1 using the same definitions as in PATENCY-2. As previously disclosed, Proteon has received written confirmation from the U.S. Food and Drug Administration (FDA) that, if PATENCY-2 is successful in showing statistical significance (p≤0.05) on each of the co-primary endpoints, the PATENCY-2 trial together with data from previously completed studies would provide the basis for a Biologics License Application (BLA) submission. If PATENCY-2 is successful in showing statistical significance (p≤0.05) on each of the co-primary endpoints, Proteon expects to submit a BLA to the FDA in the fourth quarter of 2019.

The company received scientific advice and pediatric waiver from the European Medicines Agency (EMA) in 2018. Based on the EMA scientific advice, Proteon expects to submit a Marketing Authorization Application (MAA) to the EMA in the first half of 2020 if PATENCY-2 is successful. In addition, Proteon filed a pediatric investigational plan with EMA in 2018 and received a pediatric waiver from conducting pediatric trials prior to EMA approval.

“We are looking forward to the expected release this month of top-line results from PATENCY-2, our second Phase 3 clinical trial of investigational vonapanitase,” said Timothy Noyes, President and Chief Executive Officer of Proteon. “We are now focused on preparing for a potential BLA filing in the fourth quarter of 2019. It is a very exciting time for all of us at Proteon.”

PRTO stock chart
Large players don’t seem interested in PRTO stock at all.

Prices have been consolidating lately and the volatility has been reduced. A pullback is taking place, which may present a nice opportunity for an entry at some point but it’s troubling that large players are not interested in this stock. There is a very little resistance above the current price.

SGEN Stock

Enfortumab vedotin, EV201, for urothelial cancer. Phase 2 pivotal data is due before the end of Q1 2019.

“During 2018, we received FDA approval for two ADCETRIS frontline indications, a major accomplishment that significantly expands the number of patients eligible to benefit from treatment. These approvals for frontline advanced Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma (PTCL) were based on phase 3 data showing superior efficacy of the ADCETRIS-containing regimens compared to combination chemotherapy agents that have been used for decades,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Additionally, we made progress in 2018 with our late-stage clinical programs, leading to important anticipated milestones this year. Notably, we expect to report top-line data in the first quarter of 2019 from the pivotal trial of enfortumab vedotin in metastatic urothelial cancer and to report top-line data later in the year from the pivotal trial of tucatinib in HER2-positive metastatic breast cancer. Taken together, we are positioned to establish ADCETRIS as the standard of care in the frontline setting in both advanced Hodgkin lymphoma and CD30-expressing PTCL, and realize our vision of becoming a company with multiple oncology products addressing unmet medical needs.”

SGEN stock chart
Continuation pattern and decent large players volume.

Prices have been consolidating lately. A pullback is taking place, which may present a nice opportunity for an entry. There is a very little resistance above the current price. There is a support zone below the current price at 71.90, a stop order could be placed below this zone. Another positive sign is the recent Pocket Pivot signal (blue dot).

NVS Stock

BAF312 for secondary progressive multiple sclerosis. PDUFA date under priority review set for March 2019. Exact date not given.

Back on October 8, 2018, Novartis announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s New Drug Application (NDA) and Marketing Authorization Application (MAA) respectively, for investigational oral, once-daily siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis (SPMS) in adults. This phase of multiple sclerosis (MS) can substantially impact lives, due to physical and cognitive impairments. To bring this treatment to the MS community as quickly as possible, Novartis used a review voucher to expedite the review of siponimod in the US. Regulatory action for siponimod is anticipated in the US in March of 2019 and in Europe in late 2019.

More than 80% of people with relapsing-remitting MS (RRMS) – the most common form of the condition at diagnosis – go on to develop SPMS, with or without relapses. SPMS is a form of MS that leads to progressive, irreversible disability, such as the need for enhanced walking aids and wheelchairs, bladder dysfunction and cognitive decline, largely independent of relapses. Following the initial RRMS course, there is a gradual increase in the number of patients transitioning to SPMS, with around 25% progressing by 10 years post-onset, 50% by 20 years and more than 75% by 30 years.

“We are excited to see a potential new treatment on the horizon,” said Bruce Bebo, Executive Vice President Research, National MS Society, United States. “It is a significant milestone in our unrelenting search for treatments that can benefit adults living with secondary progressive MS who currently have few options.”

“Siponimod is the first investigational medicine to show a significant delay in disability progression in typical SPMS patients,” said Paul Hudson, Chief Executive Officer, Novartis Pharmaceuticals. “With siponimod, we underpin our strong commitment to the MS community by reimagining care for people whose lives have been considerably disrupted by this devastating illness. We are closely working with the FDA and EMA to ensure siponimod is available for patients as soon as possible.”

The regulatory application is based on data from the EXPAND study, a randomized, double-blind, placebo-controlled Phase III study, comparing the efficacy and safety of siponimod versus placebo in people living with typical SPMS. At study initiation, more than 50% of patients in the EXPAND study relied on a walking aid. Results from the pivotal study showed siponimod significantly reduced the risk of three-month confirmed disability progression versus placebo (primary endpoint; 21% versus placebo, p=0.013). Siponimod also meaningfully delayed the risk of six-month confirmed disability progression (26% vs placebo, p=0.0058) and demonstrated favorable outcomes in other relevant measures of MS disease activity and progression. Further, more advanced analyses of the EXPAND study showed that siponimod reduced the risk of disability progression largely disassociated from relapses (three-month disability progression, range 14-20%; six-month disability progression 29-33%).

In addition, Novartis conducted the BOLD study, a randomized, double-blind, placebo-controlled, adaptive dose-ranging, Phase II study in patients with RRMS. The study showed that siponimod significantly reduced the annualized rate of relapses (ARR) over six months compared to placebo (ARR siponimod 2 mg vs. placebo 0.20 vs. 0.58 (p=0,041)).

In Switzerland, Swissmedic granted fast track authorization procedure for siponimod in SPMS. Discussions with additional health authorities regarding siponimod are ongoing.

Siponimod (BAF312) is an investigational, selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor. Siponimod binds to the S1P1 sub-receptor on lymphocytes, which prevents them from entering the central nervous system (CNS) of patients with multiple sclerosis. This leads to the anti-inflammatory effects of siponimod. Siponimod also enters the CNS and binds to the S1P5 sub-receptor on specific cells in the CNS (oligodendrocytes and astrocytes). By binding to these specific receptors, siponimod has the potential to modulate damaging cell activity, and preclinical studies suggest that it may prevent synaptic neurodegeneration and promote remyelination in the CNS.

Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss. In adults, there are three types of MS: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS). Approximately 85% of people with MS have RRMS, where the immune system attacks healthy tissue. In children and adolescents, RRMS accounts for nearly all cases (approximately 98%).

The evolution of MS results in an increasing loss of both physical and cognitive (e.g. memory) function. This has a substantial negative impact on the lives of the approximately 2.3 million people worldwide affected by MS, of which between three and five percent are estimated to be children or adolescents.

NVS stock chart
Rising large players volume looks great as NVS stock is in a continuation pattern. A pullback to uptrend support near $91.50 would be the ideal entry.

Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a pullback or consolidation first.

NLNK Stock

NLG207 (CRLX101) and paclitaxel for platinum-resistant ovarian cancer. Phase 2 data to be presented at AACR April 2, 2019.

NLG207 (formerly CRLX101) is an investigational nanoparticle-drug conjugate (NDC) composed of a cyclodextrin-based polymer backbone conjugated to camptothecin, a topoisomerase-1 inhibitor. NDCs enhance drug delivery to tumors where gradual payload release inside cancer cells augments antitumor activity while reducing toxicity. Topoisomerase 1 inhibitors are a class of drugs that modify DNA damage responses in cancer cells. NewLink Genetics is evaluating NLG207 in a series of clinical trials in advanced refractory ovarian cancer patients.

Abstract 7933 (Poster 17) entitled, A phase II study of NLG207 (formerly CRLX101) in combination with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer, Duska, L., et al, will be presented during the poster session entitled, “Phase II-III Clinical Trials: Part 1,” in Exhibit Hall B, Poster Section 16 on Tuesday, April 2, 2019 from 8:00 a.m. – 12:00 p.m. ET.

NLNK stock chart
NLNK stock looks like a classic turnaround candidate on the chart.

Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first.

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