With IBB pushing up against its 200 day moving average, it’s probably a good idea to wait for resolution off that level before going long most biotech stocks.

IBB stock chart

6 Top Biotech Stocks To Watch

Below are the top biotech stocks to watch next week that could see big moves ahead of upcoming PDUFA and/or clinical trial data releases.

SNY Stock

Fluzone Quadrivalent (Influenza Vaccine) Influenza A for children 6-35 months of age. The PDUFA for the sBLA is set for January 28, 2019.

The U.S. Food and Drug Administration has accepted for review a supplemental Biologics License Application to expand the age indication of the 0.5 mL dose of Sanofi Pasteur’s Fluzone® Quadrivalent (Influenza Vaccine) to include children 6 through 35 months of age. Per the Prescription Drug User Fee Act, the target action date is January 28, 2019. If approved, physicians will be able to reserve the vaccine for young children for the 2019–2020 flu season.

The application is supported by clinical data from a Phase IV safety and immunogenicity study conducted in nearly 2,000 children. Detailed results from the Phase IV, randomized, observer-blinded, controlled, multicenter study will be presented at medical meetings later this year.

“We are dedicated to helping protect patients of all ages against the flu, which can be especially severe and life threatening for more vulnerable groups such as younger children,” said Dr. David P. Greenberg, Associate Vice President and Regional Medical Head of North America, Sanofi Pasteur. “We are one step closer to potentially offering clinicians the option to use 0.5 mL dose of Fluzone Quadrivalent vaccine with all of their eligible pediatric patients 6 months of age and older.”

Fluzone Quadrivalent vaccine is designed to help protect people 6 months of age and older against the four flu viruses that cause the most disease: two influenza A subtypes, A(H1N1) and A(H3N2), and two influenza B lineages, Victoria and Yamagata. A 0.25-mL dose of Fluzone Quadrivalent vaccine is currently approved for use in children 6 through 35 months of age; a 0.5-mL dose is approved for people 36 months of age and older.

Influenza is a leading cause of vaccine-preventable deaths among children in the United States. Children of all ages can get the flu, including those who are otherwise healthy. Each year, young children are admitted to the hospital because of the flu more often than for any other vaccine-preventable disease – including approximately 20,000 children younger than 5 years of age.

SNY stock chart

SNY stock presents an ok setup. Prices have been consolidating lately and the volatility has been reduced. There is a resistance zone just above the current price starting at $41.68. Right above this resistance zone may be a good entry point.

MDWD Stock

NexoBrid for severe burns. Phase 3 data is due before the end of January 2019.

“This has been an active quarter, and we continue to make progress on numerous fronts. We were very pleased to have been awarded an additional BARDA contract for the development of NexoBrid® for Sulfur Mustard injuries,” commented Gal Cohen, MediWound’s President and Chief Executive Officer. “The contract provides approximately $12 million of funding to support research and development activities up to pivotal studies in animals, under the U.S. Food and Drug Administration (FDA) Animal Rule, allowing for marketing approval based on animal studies. It also includes options for additional funding of up to $31 million for additional and subsequent development activities, including animal pivotal studies and FDA Biologics License Application (BLA) submission.”

“Now that the last enrolled patient in our NexoBrid® Phase 3 DETECT study has completed the acute treatment and entered the follow-up period, we look forward to announcing top line results in January 2019,” added Mr. Cohen. “Additionally, we continue to recruit patients in the U.S. and Europe for our expanded NexoBrid® Phase 3 CIDS study in children after receiving both FDA concurrence on the protocol and BARDA funding. As planned, we have submitted our pivotal protocol for clinical development of EscharEx® to the FDA, and we recently met with the Agency. We had a constructive discussion, received concurrence on many aspects, and suggested additional secondary efficacy endpoints on which we were requested to provide additional information. We plan to submit, the information, and subject to FDA concurrence, to initiate EscharEx® clinical development program in the first half of 2019.”

“Finally, we were also happy to receive marketing authorization from the Russian Ministry of Health to sell NexoBrid® to patients with deep partial and full-thickness thermal burns. This authorization augments additional clearances we have secured from the European Medicines Agency (EMA) and from the Israeli, Argentinian and South Korea’s Ministries of Health for the same indication. It also further validates our strategy of using the EMA approved registration file for seeking approval in international markets through collaboration with local companies that possess the expertise in the local regulatory, market access and marketing efforts, and assume the financial commitment and diligence,” concluded Mr. Cohen.

Stephen T. Wills, MediWound’s Chairman, added, “As we have discussed in our prior earnings calls, MediWound was approached earlier this year by a third party to consider a potential strategic transaction. Subsequently, we engaged an investment bank to help us review the proposal and advise in our discussions. We commenced discussions, and thereafter, received approaches and engaged in discussions and diligence with other strategic parties on different strategic transaction scenarios. At this stage, we continue to be in discussions and diligence with a subset of those parties. The Board continues to be advised by Moelis & Company regarding evaluation and assessment of all strategic options and avenues. As we have said, there can be no assurances that a definitive agreement between the parties or any other agreement will be reached.”

MDWD stock

MDWD is an ok setup but I don’t like the falling large players volume. Prices have been consolidating lately and the volatility has been reduced. There is a resistance zone just above the current price starting at $4.38. Right above this resistance zone may be a good entry point.

COCP Stock

CC-31244 for Hepatitis C. Phase 2a initial data due before the end of January 2019.

“Over the course of the quarter, we continued to advance our U.S. Phase 2a study of CC-31244 for the ultra-short treatment of HepC. We are very pleased to be moving forward with our Hong Kong investigator-initiated Phase 2a study for the ultra-short treatment of HepC, which will include for the first time a protease inhibitor with CC-31244,” commented Dr. Gary Wilcox, Vice Chairman and Chief Executive Officer of Cocrystal. “In addition, our R&D team has been focused on advancing our preclinical IND-enabling studies for our influenza program with the goal of starting our human clinical program next year. We are setting the stage for numerous operational, clinical and regulatory milestones in 2019.”

CC-31244, the Company’s lead product in development for HepC, is an investigational, oral, potent, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). It has a high barrier to drug resistance designed and developed using the Company’s proprietary structure-based drug discovery platform. It is active against HCV genotypes 1-6 with low level cytotoxicity in multiple cell types.

CC-31244 is currently being evaluated in an ongoing Phase 2a clinical study for the ultra-short treatment of HCV-infected individuals. The Phase 2a open-label study is designed to evaluate the safety, tolerability and preliminary efficacy of CC-31244 with Epclusa®. Enrolled subjects self-administered orally 400 mg of CC-31244 daily and a fixed dose of Epclusa daily for 14 days. After 14 days the subjects continued daily treatment for another 4 weeks on Epclusa alone. Subjects will be followed up until 24 weeks after the last dose of Epclusa to determine if they have achieved a sustained virologic response (SVR). Primary and secondary efficacy endpoints are SVR at 12 weeks post-treatment (SVR12) and at 24 weeks post-treatment (SVR24), respectively.

COCP stock chart

COCP presents a decent setup pattern but the Twiggs Money Flow is negative which suggests the sideways chop-out could continue. 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. There is a resistance zone just above the current price starting at $4. Right above this resistance zone may be a good entry point.

AUPH Stock

Voclosporin Ophthalmic Solution (VOS) for dry eye syndrome. Phase 2 data is due before the end of January 2019.

“We achieved a significant milestone in September with the completion of enrollment for the AURORA Phase III trial ahead of schedule. Our target enrollment of 324 patients was surpassed due to high patient demand with 358 LN patients randomized in sites across 27 countries.” said Richard M. Glickman, Aurinia’s CEO and Chairman of the Board. “I continue to be impressed by our clinical team which has delivered on our important milestones, and to that end, I am pleased to announce enrollment for the phase II dry eye trial will be completed in the next couple of days, and we expect top-line data in January 2019.”

Voclosporin, an investigational drug, is a novel and potentially best-in-class CNI with clinical data in over 2,400 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension.

AUPH stock

AUPH is a good setup right now. We see reduced volatility while prices have been consolidating in the most recent period. The rising large players volume and positive Twiggs Money Flow looks good.

SNNA Stock

SNA-001 for the reduction of light-pigmented hair. Phase 3 data is due sometime in late January or early February 2019.

SNA-001 is a topical photoparticle therapy designed to enhance the effects of laser treatment for hair reduction of unwanted light-pigmented hair. Light-pigmented hair reduction is a $3+ billion market in the U.S.

Laser hair removal is the highest volume aesthetic procedure performed globally. Traditional laser hair removal methods are largely ineffective for patients with light-pigmented hair (i.e. white, gray, blond, light brown and light red). As a result, patients are often turned away by healthcare practitioners if their hair color is too lightly pigmented.

SNA-001 is the first effective hair removal solution for light-pigmented hair.

SNA-001 uses precisely engineered silver particles to facilitate local tissue injury (hair follicle) through a process called selective photothermolysis. The particles are designed to work with current installed base of lasers in practices. Multiple additional indications possible.

SNNA stock chart

SNNA does present a good setup opportunity. Prices have been consolidating lately and the volatility has been reduced. There is very little resistance above the current price. Large players are also showing an increasing interest in SNNA stock which is bullish.

EOLS Stock

DWP-450 for glabellar lines. CRL was announced on May 16, 2018. A new PDUFA date was set for February 2, 2018.

The glabella is the skin between the eyebrows and above the nose. It also refers to the underlying bone which is slightly depressed, and joins the two brow ridges.

David Moatazedi, President and Chief Executive Officer of Evolus, stated, “We have worked diligently to advance our regulatory submission for DWP-450. With this notice from the FDA we remain on track to launch commercially in the U.S. in Spring 2019. We look forward to providing an update on the status of our application per our PDUFA date of February 2, 2019 and to continuing the development of our sales and marketing strategy for DWP-450.”

Evolus is a company dedicated to aesthetic medicine focused on providing physicians and their patients with expanded choices in aesthetic treatments and procedures. Evolus’ lead candidate DWP-450, also known by the chemical name prabotulinumtoxinA, is a 900 kDa purified botulinum toxin type A complex that was approved by Health Canada for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients under 65 years of age and is being evaluated for marketing approval in the United States and other areas.

EOLS stock chart

EOLS stock presents a good setup opportunity. We see reduced volatility while prices have been consolidating in the most recent period. A pullback is taking place, which may present a nice opportunity for an entry. There is a clearly defined resistance zone just above the current price starting at $16. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $15.97, a stop order could be placed below this zone. The Twiggs Money Flow is rising which is bullish.

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