The Biotech ETF IBB broke above its 200 day moving average last week after the President’s State of the Union speech showed strong support from the Trump Administration for moving drugs through clinical trials as fast as possible, giving critically ill people the right to try drugs that are not yet approved of by the FDA, and a plan for $500,000,000 to go to childhood cancer research over the next 10 years.
We are looking for a retracement of IBB and then for the 200 day moving average resistance to become support.
Below are the top biotech stocks to watch next week.
12 Top Biotech Stocks To Watch
BCX7353 – ZENITH-1 for angioedema attacks in patients with hereditary angioedema (HAE). Phase 2 data will be presented on February 23, 2019 at the AAAAI meeting.
BioCryst will present an abstract including results from the ZENITH-1 study at the upcoming annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) February 22-25 in San Francisco.
Oral Plasma Kallikrein Inhibitor BCX7353 is Safe and Effective as an On-Demand Treatment of Angioedema Attacks in Hereditary Angioedema (HAE) Patients: Results of the ZENITH-1 Trial; Session 2209, Urticaria and Angioedema, Poster 110, Moscone Center South, Exhibition Level, Hall B, Saturday, February 23, 9:45 a.m. PT
BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union.
BCRX stock is not a good setup pattern. The large players volume is falling which is usually a bad time to take a new long entry. 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 at some point in the future when large players volume is no longer falling.
Actinium Pharmaceuticals announced that a presentation of data from the pivotal Phase 3 SIERRA trial of Iomab-B has been selected as one of four late breaking oral presentations at the 2019 TCT or Transplantation & Cellular Therapy Meetings™ of ASBMT and CIBMTR, which is being held February 20 – 24 in Houston, Texas. In addition, three abstracts related to Actinium’s targeted conditioning pipeline have been accepted for poster presentations.
Highlights of Actinium’s key meeting activities are:
Late Breaking Oral Presentation
Novel Re-Induction and Anti-CD45 Targeted Conditioning with Iodine (131I) Apamistamab [Iomab-B] Yields Encouraging Results in Older Patients with Active, Relapsed or Refractory AML: Safety & Feasibility Data from the Prospective Randomized Phase III SIERRA Trial
Sergio Giralt, MD, Chief Attending Physician, Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center
Sunday, February 24th, 12:30-12:45 PM CT
Hilton Americas – Grand Ballroom A
Lymphodepletion with CD45 Radioimmunotherapy as a Targeted Conditioning Regimen Prior to Adoptive Cell Therapy or CAR-T
Dale Ludwig, PhD, Chief Scientific Officer, Actinium Pharmaceuticals, Inc.
Wednesday, February 20th, 6:45 – 7:45 PM CT
George R. Brown Convention Center – GRB Exhibit Hall B3
Survival of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Patients Receiving Stem Cell Transplantation (SCT)
Rajneesh Nath, MD, Director Bone Marrow Transplant & Acute Leukemia Program, Banner MD Anderson Cancer Center
Wednesday, February 20th, 6:45 – 7:45 PM CT
George R. Brown Convention Center – GRB Exhibit Hall B3
Burden of Hospitalization in Allogeneic Stem-Cell Transplantation for Acute Myeloid Leukemia
Vijay Reddy, MD, PhD, Vice President, Clinical Development and Head of Bone Marrow Transplant, Actinium Pharmaceuticals, Inc.
Wednesday, February 20th, 6:45 – 7:45 PM CT
George R. Brown Convention Center – GRB Exhibit Hall B3
TCT 2019 Satellite Symposium
Satellite symposia are attended by nearly 2,000 physicians, scientists and allied health professionals working in blood and marrow transplantation in BMT programs throughout the United States, Canada and over 30 other countries.
Integrating Innovative Therapeutics with Allogeneic HSCT in AML: Insights and Evidence from Induction to Maintenance
James Foran, MD, Associate Professor of Medicine, Mayo Clinic and Alexander Perl, MD, Associate Professor of Medicine, University of Pennsylvania
Saturday, February 23rd, 12:30 – 1:30 PM
George R. Brown Convention Center, Grand Ballroom ABC
Dr. Mark Berger, Chief Medical Officer of Actinium commented, “TCT brings together the close-knit community of BMT and CAR-T physicians and health professionals resulting in an incredibly productive and valuable meeting. We are honored to have the opportunity to share so much of our research and clinical programs with the meeting attendees this year. Given the recent promising data presented at ASH for Iomab-B, our late breaking oral presentation for Iomab-B and the recent launch of our Iomab-ACT program for CAR-T, I expect this year to be our most productive and rewarding conference yet.”
ATNM stock does show an ok setup pattern but large players volume suggests that large buyers are not interested in this stock right now. Prices have been consolidating lately and the volatility has been reduced. There is a support zone below the current price at $0.52, a stop order could be placed below this zone.
Loteprednol Gel 0.38% for ocular inflammation. The PDUFA date is set for February 25, 2019.
Bausch + Lomb announced back in July 2018 that the FDA has accepted the New Drug Application (NDA) for its sub-micron loteprednol etabonate ophthalmic gel, 0.38% with a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2019. If approved, the product would be the lowest concentrated loteprednol ophthalmic corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
“The sub-micron loteprednol etabonate ophthalmic gel, 0.38% will offer eye care professionals and their patients a lower concentration formulation with less frequent dosing compared to currently available formulations of loteprednol,” said Tracy Valorie, senior vice president, U.S. Pharmaceuticals and Surgical, Bausch + Lomb. “We are committed to developing innovative ophthalmic treatment options to help serve the needs of patients and look forward to bringing this new product to market.”
This investigative product utilizes a novel submicron particle to help increase ocular penetration and residence time in anterior segment tissues.
BHC stock presents a decent setup pattern. Prices have been consolidating lately and the volatility has been reduced. There is a resistance zone just above the current price starting at $25.49. Right above this resistance zone may be a good entry point. Large players volume looks great and the Twiggs Money Flow shows that BHC stock is being accumulated.
Selinexor for quadruple refractory multiple myeloma. An Advisory Committee meeting will be held on February 26, 2019. Briefing notes will likely be released to the public on February 22, 2019. The PDUFA date under priority review is set for April 6, 2019.
The Oncologic Drugs Advisory Committee (ODAC) of the FDA is scheduled to review data supporting the Company’s New Drug Application (NDA) requesting accelerated approval for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, at a meeting on February 26, 2019 at 12:30 p.m. ET. The proposed indication to be discussed at this upcoming ODAC meeting is for selinexor in combination with dexamethasone for the treatment of patients with refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen.
The ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
Karyopharm’s NDA seeking accelerated approval for oral selinexor in combination with dexamethasone as a treatment for patients with triple class refractory multiple myeloma who have received at least three prior therapies is under Priority Review by FDA with an action date of April 6, 2019, under the Prescription Drug User-Fee Act (PDUFA).
The Company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for selinexor requesting conditional approval for the treatment of patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy and whose disease is refractory to at least one PI, one IMiD, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen. The selinexor MAA has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use.
Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. In 2018, Karyopharm reported positive data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm’s New Drug Application (NDA) has been accepted for filing and granted Priority Review by the FDA, and oral selinexor is currently under review by the FDA as a possible new treatment for patients with penta-refractory multiple myeloma. The Company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval and was granted accelerated assessment. Selinexor is also being studied in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In 2018, Karyopharm reported positive top-line results from the Phase 2b SADAL study evaluating selinexor in patients with relapsed or refractory DLBCL after at least two prior multi-agent therapies and who are ineligible for transplantation, including high dose chemotherapy with stem cell rescue. Selinexor has received Fast Track designation from the FDA for the patient population evaluated in the SADAL study. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade® (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor.
KPTI stock shows an ok setup pattern. The problem with the chart is that large players volume keeps going lower. Prices have been consolidating lately. There is a resistance zone just above the current price starting at $9.22. Right above this resistance zone may be a good entry point.
N8-GP for hemophilia A. BLA filing announced February 27, 2018. The estimated PDUFA date from the BLA filing is February 26, 2019.
The BLA submission is based on results from the pathfinder clinical trial programme. The pathfinder programme included more than 250 people with haemophilia A and investigated efficacy and safety of N8-GP in adults and children as well as people undergoing surgery. In the trial, adults treated prophylactically with N8-GP every fourth day experienced a median annualised bleeding rate of 1.3 episodes compared to 30.9 episodes for people treated on-demand. Paediatric participants experienced a median annualised bleeding rate of 1.95 episodes when administered twice weekly. In the surgery trial, all surgeries were effectively performed with N8-GP, and clinical efficacy evaluated by haemostatic response was reported as ‘excellent’ or ‘good’ in 43 out of the 45 performed surgeries.
Across the pathfinder clinical trial programme, N8-GP demonstrated a safe and welltolerated profile. “We are excited to file the regulatory application for long-acting N8-GP in the US and EU,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Based on the results from the global pathfinder clinical trial programme, we believe N8-GP can reduce the burden of treatment by decreasing the number of intravenous infusions while achieving the benefits in terms of efficacy and safety for people with haemophilia A.”
N8-GP (turoctocog alfa pegol) is a glycopegylated form of turoctocog alfa designed for prolonged half-life. The site specific glycopegylation is within the truncated B-domain. N8-GP is a B-domain modified form of turoctocog alfa and hence the active factor VIII generated by thrombin activation is identical to both activated endogenous FVIII and turoctocog alfa.
NVO stock has ran too far to the upside over the last couple of weeks to be a good entry at the moment. For a nice entry it is better to wait for a consolidation.
HS-110 and nivolumab (Opdivo) for Non-small cell lung cancer (NSCLC). Phase 2 interim data to be presented at 2019 ASCO-SITC February 28, 2019.
On January 14, 2019, Heat Biologics announced the dosing of its first patient in its Phase 2 clinical trial investigating HS-110 in combination with Merck’s anti-PD1 checkpoint inhibitor, KEYTRUDA® (pembrolizumab), in patients with advanced non-small cell lung cancer (NSCLC). This expansion of the Company’s Phase 2 trial into first-line maintenance treatment with Keytruda follows positive interim results reported last year on previously treated patients receiving HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo® (nivolumab). Heat will continue to dose patients with HS-110 in combination with Opdivo® as well.
The Company amended its Phase 2 master protocol to include additional patient cohorts in the front-line maintenance setting for advanced NSCLC. Patients in these cohorts will have received a minimum of 9 weeks of pembrolizumab, with or without chemotherapy, and will begin maintenance treatment receiving HS-110 with pembrolizumab ± pemetrexed. Patients will be evaluated for objective response rate as well as progression-free and overall survival.
Jeff Wolf, Heat’s CEO, further noted, “The expansion of this trial to include a combination of HS-110 with KEYTRUDA® is in line with our strategy to combine our T-cell activation platform with multiple checkpoint inhibitors. We are very excited to begin dosing patients in this cohort.”
New interim data on those patients in this ongoing Phase 2 trial that have been treated with the HS-110 plus nivolumab combination have been selected for oral presentation at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium on February 28.
HTBX stock looks like a good setup but that’s contingent on the large players volume continuing to rise. Prices have been consolidating lately. There is a very little resistance above the current price. There is a support zone below the current price at $1.41, a stop order could be placed below this zone. Another bullish sign is the recent Pocket Pivot signal (blue dot).
VP-102 for Molluscum contagiosum. Phase 3 trials met primary endpoints on January 9, 2019. Data to be presented at AAD meeting on March 2, 2019.
Results from two pivotal Phase 3 clinical trials of its lead product candidate, VP-102, will be presented in a late-breaking oral presentation during the annual meeting of the American Academy of Dermatology (AAD) being held March 1-5, 2019 in Washington, DC.
VP-102 is a proprietary topical drug-device combination therapy in development for the treatment of molluscum contagiosum, a highly contagious, primarily pediatric, viral skin infection that affects an estimated six million people in the United States, and for which there is currently no FDA-approved treatment.
The presentation, “CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Studies Investigating VP-102, a Drug-Device Combination Containing a Novel Topical Formulation of Cantharidin, for the Treatment of Molluscum Contagiosum,” will take place during the Late-Breaking Research: Clinical Studies/Pediatric Session on Saturday, March 2 from 3:30-5:30 p.m. in Room 154A. The results will be presented by lead investigator, Dr. Lawrence F. Eichenfield, Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego.
The CAMP-1 and CAMP-2 studies enrolled 528 patients in total and were conducted at 31 centers in the United States. The trials evaluated the safety and efficacy of VP-102 compared to placebo in patients two years of age and older with molluscum contagiosum. Complete clearance of molluscum lesions was evaluated by assessment of the number of lesions at study visits over 12 weeks.
Verrica will also present an abstract from its Phase 2 Innovate study in an online e-poster titled “Innovate: A Phase 2 Study Investigating VP-102, a Drug-Device Combination Containing a Novel Topical Formulation of Cantharidin, for the Treatment of Molluscum Contagiosum.”
Verrica is currently advancing its lead product VP-102, a proprietary topical drug-device combination therapy containing a topical solution of 0.7% cantharidin in a novel, single-use applicator, for the treatment of molluscum contagiosum, verruca vulgaris (common warts), and external genital warts.
Molluscum contagiosum, or molluscum, is a highly contagious, primarily pediatric, viral skin infection affecting an estimated six million people in the United States. It is caused by a pox virus that produces multiple raised flesh-colored papules, or skin lesions. Molluscum typically presents with 10 to 30 lesions, and in some cases over 100 lesions. If left untreated, molluscum lesions persist for an average of 13 months with some cases remaining unresolved for more than two years. There are currently no FDA-approved drugs for molluscum.
VRCA stock is an ok setup. Large players volume is falling which is bearish but the Twiggs Money Flow is rising which is bullish. Still, I wouldn’t feel comfortable going long a stock when the large players volume is falling. Prices have been consolidating lately. There is a resistance zone just above the current price starting at $13.90. Right above this resistance zone may be a good entry point.
CTP-543 for alopecia areata. Phase 2 8mg data released November 12, 2018 and the primary endpoint was met. An oral presentation of the data will be made at the AAD meeting on March 2, 2019.
Interim clinical data from its CTP-543 Phase 2 trial in alopecia areata has been selected for an oral presentation at the Late-Breaking Research Program during the American Academy of Dermatology (AAD) Annual Meeting being held March 1 – 5, 2019 in Washington, D.C.
The details of the presentation are as follows:
Title: JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata
Date and Time:Saturday, March 2, 2019, 1:00 – 4:00 p.m.
Session: S034: Late-Breaking Research: Clinical Trials
Room: Ballroom A
Abstract Number: 11291
CTP-543 was discovered by applying Concert’s deuterium chemistry technology to modify ruxolitinib, a drug which inhibits Janus kinases 1 and 2 (JAK1 and JAK2) and is commercially available under the name Jakafi® in the United States for the treatment of certain blood disorders. Deuterium modification of ruxolitinib was found to alter its human pharmacokinetics in ways which may enhance its use as a treatment for alopecia areata. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543.
Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body that may affect up to 650,000 Americans at any given time. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life with the majority of patients initially having symptoms by age 40. It is believed to equally affect both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently no drugs approved by the FDA for the treatment of alopecia areata.
CNCE stock does present a nice setup opportunity. Prices have been consolidating lately. There is a resistance zone just above the current price starting at $15.02. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $14.24, a stop order could be placed below this zone. We notice that large players showed an interest for CNCE in the last couple of days, which is a good sign.
Serlopitant for pruritus associated with psoriasis. Phase 2 data was released on December 10, 2018 and the primary endpoint was met. Presentation of the data will occur on March 2, 2019, at the American Academy of Dermatology Annual Meeting. A Phase 3 study is planned for 2019.
An abstract has been accepted for oral presentation at the Late-Breaking Research Program during the 2019 Annual Meeting in Washington, D.C.
The abstract, “Serlopitant Reduced Pruritus Associated with Psoriasis in Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial” will be presented as part of Late Breaking Research: Clinical Trials on Saturday, March 2, 2019, between 1:00 p.m. and 4:00 p.m. in Ballroom A.
In addition, a second abstract, “Improvement of Itch and Pain in Patients with Prurigo Nodularis Treated with Serlopitant: Secondary analysis of Phase 2 Clinical Trial” was accepted as an oral presentation and online e-poster. Presentations will be held on Friday, March 1 and Saturday, March 2.
Serlopitant is a once-daily oral NK1 receptor antagonist being developed for the treatment of pruritus, or itch, associated with various conditions such as prurigo nodularis, psoriasis and chronic pruritus of unknown origin. Menlo has completed three positive Phase 2 clinical trials with serlopitant showing a statistically significant reduction in pruritus compared to placebo. Serlopitant has been evaluated in over 1,600 patients and has been shown to be well-tolerated, including in patients who have received treatment for up to one year. Serlopitant is an investigational drug that is not currently approved for use in any indication in any country.
Menlo Therapeutics Inc. is a late-stage biopharmaceutical company focused on the development of serlopitant, a once-daily oral NK1 receptor antagonist, for the treatment of pruritus. The Company’s clinical development program for serlopitant includes two ongoing Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis, a planned Phase 3 program for the treatment of pruritus associated with psoriasis, and a Phase 2 clinical trial for the treatment of chronic pruritus of unknown origin.
MNLO stock is not a good setup at the moment. Prices have been extended to far to the upside lately for a good entry. For a nice entry it is better to wait for a consolidation.
KX-01 (KX2-391) ointment for actinic keratosis. Phase 3 data was released on July 26, 2018. The primary endpoint was met. A presentation of the data will occur at the American Academy of Dermatology Annual Meeting on March 2, 2019.
An abstract reporting the results from two Phase III studies of KX2-391 Ointment in the treatment of actinic keratosis has been accepted for presentation at the Late-Breaking Research Program at the 2019 American Academy of Dermatology Annual Meeting, to take place March 1–5, 2019 in Washington, DC.
The presentation (Abstract 11216), with the title “KX2-391 Ointment 1%, a Novel Dual Src/Tubulin Inhibitor, is Efficacious and Safe in the Treatment of Adults with Actinic Keratosis in Two Phase III Studies”, will be delivered in Session S034 (Late-breaking Research: Clinical Trials) on Saturday, March 2, 2019, between 1:00pm and 4:00pm Eastern Time in Ballroom A at the Walter E. Washington Convention Center.
The two Phase III studies (KX01-AK-003 and KX01-AK-004) are double-blind, vehicle-controlled, randomized, parallel group, multicenter, efficacy and safety studies of KX2-391 Ointment 1% in adults with actinic keratosis on the face or scalp. Each study enrolled 351 subjects in 31 US sites, totaling 702 subjects in 62 US sites. The results of the previous Phase II study of KX2-391 Ointment 1% were reported in the 2018 American Academy of Dermatology Annual Meeting in San Diego in February 2018.
ATNX stock presents an ok setup. Price movement has been a little volatile, making it difficult to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first but with the strong large players volume and Twiggs Money Flow, waiting for a consolidation pattern first could be challenging as well.
Esketamine for treatment resistant depression. An estimate of the PDUFA date is March 3, 2019 assuming priority review. The FDA Advisory Committee Meeting on February 12, 2019, voted 14-2 that benefits outweigh risks.
JNJ stock has beautiful looking large players volume and Twiggs Money Flow. The problem is that the stock has already been moving higher so it does not present a good entry at the moment. For a nice entry it is better to wait for a consolidation.
Disclosure: I do not any position in any stock mentioned in this article.