It continues to be a very dangerous market for biotech stocks so personally I am not trying to swing trade any of them right now. Nevertheless, if you have some gambling money to put to work, below are some biotech stocks with up-coming catalysts in the weeks ahead.
9 Top Biotech Stocks To Watch
Ignoring these promising biotech stocks could be a mistake but chasing any of these stocks would be an even bigger mistake. Make sure you follow the rules of trading biotech stocks here.
“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 does show a decent setup pattern. There is reduced volatility while prices have been consolidating in the most recent period. There is a resistance zone just above the current price starting at $16.46. Right above this resistance zone may be a good entry point.
LXRX Stock and SNY Stock
Both Lexicon Pharmaceuticals (LXRX) and Sanofi (SNY) are pushing sotagliflozin for Type 1 diabetes. The PDUFA is not until March 22, 2019 but an Advisory Committee meeting is coming January 17, 2019.
The FDA accepted the NDA for sotagliflozin on May 22, 2018. The NDA included data from the inTandem clinical trial program, which includes three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled type 1 diabetes.
The target date for an FDA action regarding sotagliflozin under the Prescription Drug User Fee Act (PDUFA) is anticipated to be March 22, 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 presents an OK setup on the chart. Prices have been consolidating and there is a very little resistance above the current price. Large players are showing some interest in LXRX stock over the last couple of days which is a bullish sign.
SNY stock also presents an OK setup on the chart. There is reduced volatility while prices have been consolidating. There is a resistance zone just above the current price starting at $42.98. A break above this resistance zone may be a good entry point. There is a support zone below the current price at $42.66, a stop loss order could be placed below this zone.
Varlitinib for gastric cancer. Phase 2 data is due to be released sometime in January 2019.
Varlitinib, and oral reversible pan-HER inhibitor has shown activity in a range of tumour types with differentiated tolerability profile.
“In August 2017, we initiated a phase 2/3 trial of varlitinib in first line gastric cancer. We completed recruitment of 52 patients for the phase 2 part of the study in August 2018 and expect to report topline phase 2 data in January 2019.”
Varlitinib in pivotal studies for BTC and GC with first pivotal read-out in 2019:
- Pan-HER inhibitor Highly potent, oral, reversible, small molecule with balanced inhibition across all HER family receptors.
- Robust activity Demonstrated activity in biliary tract, gastric, breast, colorectal
cancer. Two phase 2 trials completed, over 500 patients dosed.
- Competitive efficacy 60% response rate in randomised 2nd line HER2+ breast cancer.
- Superior to standard of care.
- Differentiated safety Differentiated tolerability for pan-HER class.
- 5% grade 3/4 diarrhea across all studies.
- Focus on subsets of BTC and GC
- Only pan-HER being developed in BTC and HER1/HER2 GC.
- US orphan drug designation obtained from the FDA.
ASLN stock presents an OK setup opportunity. Prices have been consolidating lately and the volatility has been reduced. Large players have shown an interest in ASLN over the last couple of days, which is a bullish sign.
Voclosporin Ophthalmic Solution (VOS) for dry eye syndrome. Phase 2 data is due sometime in 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.”
We initiated a Phase II head-to-head tolerability study of voclosporin ophthalmic solution (“VOS”) versus Restasis® (cyclosporine ophthalmic emulsion) 0.05% for the treatment of Dry Eye Syndrome (“DES”) in July 2018, and full enrollment is anticipated imminently. This four-week study of approximately 90 patients is expected to complete by the end of 2018 with data available in January 2019. We believe calcineurin inhibitors (“CNIs”) are a mainstay of treatment for DES, and the goal of this program is to develop a best-in-class treatment option.
AUPH stock does not look like a good setup right now. There is reduced volatility while prices have been consolidating in the most recent period, but it has already had a move up and its currently pulling back. We want a bit more of a consolidation and reduced volatility before taking a long entry.
AXS-05 ASCEND for Major Depressive Disorder (MDD). Phase 2 data is due early January 2019.
Axsome is evaluating AXS-05 (dextromethorphan/bupropion) in the following indications: treatment resistant depression, major depressive disorder, Alzheimer’s disease agitation, and smoking cessation.
To date, just under 90% of the target number of subjects have been randomized in the Phase 3 STRIDE-1 trial in treatment resistant depression (TRD), with topline results anticipated in the first quarter of 2019. STRIDE-1 is a multicenter, randomized, double-blind, controlled trial in which subjects with TRD are randomized to treatment with AXS-05 or bupropion. A positive interim futility analysis was previously announced for the STRIDE-1 trial. The interim analysis was conducted by an independent data monitoring committee (IDMC) which recommended continuation of the study. Axsome has received U.S. Food and Drug Administration (FDA) Fast Track designation for AXS-05 for the treatment of TRD.
Axsome has completed enrollment in the Phase 2 ASCEND study in major depressive disorder (MDD), and is on track to announce topline results in early January 2019, as previously disclosed. ASCEND is a multicenter, randomized, double-blind, controlled trial in which subjects with MDD are randomized to treatment with AXS-05 or bupropion.
AXSM does present an OK setup opportunity. There is reduced volatility while prices have been consolidating. There is a resistance zone just above the current price starting at $2.64. Right above this resistance zone may be a good entry point.
NexoBrid for severe burns. Phase 3 data is due sometime in 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 presents a good setup opportunity. Prices have been consolidating lately. There is a very little resistance above the current price. Large players have showed an interest for MDWD over the last week or so which is a bullish sign.
SAGE-217 for postpartum depression (PPD). Phase 3 data due sometime in January 2019.
“At Sage, our approach to scientific discovery and development is focused on transforming the lives of people with life-altering CNS disorders. Our first program, in PPD, exemplifies this philosophy. Members of the PPD patient advocacy community and healthcare providers across the country have shared their sense of urgency with us – they are seeking a new way of thinking about PPD and an opportunity to rapidly alleviate suffering from this condition. If approved, ZULRESSO has the potential to meet these needs and to be an important new tool that healthcare providers can use to ease the burden of PPD for patients and their families,” said Jeff Jonas, M.D., chief executive officer of Sage. “Sage is committed to helping women diagnosed with PPD access ZULRESSO, if it is approved. We are currently assessing potential patient support options to help lessen financial barriers to access for women with PPD in need of treatment, where appropriate and permitted. We aspire to define a new normal for brain health and we’re just getting started.”
- SAGE-217 in Major Depressive Disorder (MDD) and PPD
- PPD Phase 3 trial enrollment completed: Enrollment was recently completed for the Phase 3 placebo-controlled trial evaluating SAGE-217 in patients with PPD, and Sage plans to announce top-line results in January 2019.
- MDD Phase 3 trial initiated: Plans are on-track for enrollment to begin in a Phase 3 placebo-controlled trial of SAGE-217 in MDD in 4Q 2018. The trial will evaluate the potential of episodic treatment through a protocol including two weeks of 20mg or 30mg SAGE-217 treatment compared to placebo in approximately 450 patients with MDD, with four weeks of additional follow-up.
- Long-term retreatment study: Additional data regarding patient safety and potential treatment of recurrent or new major depressive episodes will be acquired through a long-term retreatment study evaluating SAGE-217 treatment and episodic retreatment as needed.
- SAGE-217 in Other Psychiatric Indications
- Bipolar depression: Dosing of patients is underway in Part A of a two-part Phase 2 clinical trial evaluating open-label SAGE-217 treatment in up to 30 patients with bipolar I/II disorder with a current major depressive episode. If Part A is successful, the Company plans to progress to a randomized, placebo-controlled Part B study. The Part A trial is intended to evaluate the safety and tolerability of SAGE-217 and secondary endpoints, including efficacy in improving depressive symptoms and sleep. The top-line results from Part A are planned to be announced in 1H 2019.
- Sleep disorders: Additional data from a placebo-controlled trial in a model of insomnia demonstrating an encouraging impact of SAGE-217 on sleep architecture was recently presented at the 31st European College of Neuropsychopharmacology Congress. Sage plans to initiate a Phase 3 placebo-controlled polysomnography trial of SAGE-217 in MDD patients with co-morbid insomnia in 4Q 2018, and also plans to seek feedback in 2019 from the FDA on potential development plans for SAGE-217 for the treatment of sleep disorders and other indications.
SAGE does present a good setup opportunity. Prices have been consolidating lately. There is a support zone below the current price at $97.50, a stop order could be placed below this zone. Large players have showed great interest in SAGE stock over the last month, which is a bullish sign.
MitoGel – UGN-101 for urothelial carcinoma. Phase 3 data is due sometime in January 2019. Initiation of rolling NDA announced December 17, 2018.
UroGen Pharma announced that it has initiated the rolling submission with the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) for UGN-101 (mitomycin gel) for instillation as a treatment for patients with low-grade upper tract urothelial cancer (LG UTUC). The company expects to complete its NDA submission by mid-2019, with potential approval in 2019.
“This is an important milestone in our mission to bring innovative, non-surgical treatment options to patients with urothelial cancers and potentially eliminate the need for repetitive surgical intervention and kidney removal,” said Ron Bentsur, Chief Executive Officer of UroGen. “UGN-101 has the potential to be the first non-surgical therapy for LG UTUC, and the first drug ever approved in this indication. We are grateful to our UroGen team and clinical investigators who have worked diligently to advance this potentially paradigm-shifting program.”
The NDA submission is supported by clinical data from the Phase 3 OLYMPUS clinical trial of UGN-101 for the non-surgical treatment of LG UTUC. Results from an interim analysis were presented at the American Urologic Association Annual Meeting in May 2018. UroGen plans to present topline data from the OLYMPUS study in January 2019.
The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.
UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade upper tract urothelial cancer (LG UTUC). Utilizing the RTGel™ technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of mitomycin to urinary tract tissue, thereby enabling the treatment of tumors by non-surgical means. UGN-101 is delivered to patients using standard ureteral catheters.
URGN stock is not a good setup right now. The stock has already ran up ahead of the Phase 3 data release coming sometime in January. It is better to wait for a pullback or consolidation before taking a long entry.
Disclosure: I do not hold a position in any stock mentioned in this article.