(RTTNews.com) - Clinical trial data is an important catalyst, and any update on the clinical studies can send the biotech/pharma stocks soaring or stumbling depending upon the news.
The week that just rolled by saw such extreme stock moves.
On September 18, shares of Viking Therapeutics Inc. (VKTX) rose as much as 130% to $24, following positive top-line results from its 12-week phase II study of VK2809 in patients with non-alcoholic fatty liver disease and elevated low-density lipoprotein cholesterol.
On September 21, GTx Inc. (GTXI) cratered 93% to a low of $1.66 as its phase II trial of orally-administered Enobosarm in post-menopausal women with stress urinary incontinence did not achieve its primary endpoint.
Now, here are some of the pharma/biotech stocks to watch out for in the week starting September 24.
1. Checkpoint Therapeutics Inc. (CKPT)
Checkpoint is a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers.
The Company has two clinical drug candidates namely, CK-101 and CK-301.
CK-101, a third-generation EGFR inhibitor, for the treatment of non-small cell lung cancer (NSCLC) patients carrying the susceptible EGFR mutations, is under phase I/II study. CK-301, a fully human anti-PD-L1 antibody, for lung cancer and other solid tumors, is under phase I study.
Watch out for...
The preliminary safety and efficacy data from the Phase 1/2 clinical trial of CK-101 in advanced non-small cell lung cancer is expected to be presented at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer on September 24.
CKPT closed Friday's trading at $4.72, up 7.52%.
2. Syndax Pharmaceuticals Inc. (SNDX)
Syndax is a clinical stage biopharmaceutical company developing an innovative pipeline of combination therapies in multiple cancer indications.
The Company's lead product candidate is Entinostat, and the most advanced clinical program is a phase III trial of endocrine therapy plus Entinostat or placebo in patients with hormone receptor-positive advanced breast cancer, dubbed Study E2112.
The other ongoing trials with Entinostat include:
-- A phase Ib/II study of Entinostat in combination with Keytruda in patients with Non-small Cell Lung Cancer, with expansion cohorts in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch Repair-Proficient Colorectal Cancer, dubbed ENCORE 601/KEYNOTE 142.
-- A phase Ib/II clinical trial evaluating the combination of Entinostat plus Genentech's TECENTRIQ in patients with triple negative breast cancer, dubbed ENCORE 602.
-- A phase Ib/II clinical trial evaluating Entinostat in combination with Pfizer/Merck KGaA's BAVENCIO in patients with ovarian cancer, dubbed ENCORE 603.
Also in the pipeline is SNDX-6352, which is under a phase I multiple ascending dose (MAD) clinical trial.
Watch out for...
The progression free survival results from E2112, the ongoing phase III trial of Entinostat plus endocrine therapy in HR+, HER2- breast cancer due this month are awaited.
Data from the PD-(L)1 refractory non-small cell lung cancer cohort of the ENCORE 601 study will be reported at the International Association for the Study of Lung Cancer on September 24.
SNDX closed Friday's trading at $6.77, up 5.31%.
3. Spectrum Pharmaceuticals Inc. (SPPI)
Spectrum Pharma is a commercial-stage biotechnology company focused on oncology/hematology products.
The Company has three drugs in advanced development namely, Eflapegrastim that is being investigated in a phase III trial for the treatment of chemotherapy-induced neutropenia in patients with breast cancer; Apaziquone, also under phase III study, in the treatment of non-muscle invasive bladder cancer, and Poziotinib, under phase II studies, for non small cell lung cancer and breast cancer.
Interim results from the phase II study of Poziotinib in non-small cell lung cancer, which included data from the EGFR cohort and, the HER2 cohort, were presented on September 5. According to the interim results, the EGFR cohort had an objective response rate of 58% and a disease control rate of 90% while the HER2 cohort had an objective response rate of 50% and a disease control rate of 83%.
Watch out for...
Updated data from the phase II study of Poziotinib in non-small cell lung cancer will be presented at the IASLC World Conference on Lung Cancer on September 24.
SPPI closed Friday's trading at $21.36, down 0.74%.
4. Loxo Oncology Inc. (LOXO)
Loxo Oncology is a biopharmaceutical company focused on developing highly selective medicines for patients with genomically defined cancers.
The Company's lead product candidate is Larotrectinib, under Priority Review by the FDA for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion, with a decision expected on November 26, 2018.
The other clinical programs in the pipeline are LOXO-292, which is under a phase I/II trial in patients with advanced solid tumors, dubbed LIBRETTO-001 study, and LOXO-195, which is under a phase 1/2 trial in patients with TRK fusion cancers who have progressed while receiving another TRK inhibitor or are intolerant to another TRK inhibitor.
The Company presented positive interim clinical data from the LOXO-292 global phase I LIBRETTO-001 study in June of this year. The data demonstrated a 77% Overall Response Rate in RET Fusion Cancers and 45% Overall Response Rate in RET Mutated Medullary Thyroid Cancer.
Watch out for...
An updated analysis of patients with RET fusion non-small cell lung cancer (NSCLC) enrolled in the dose escalation cohorts of the ongoing LIBRETTO-001 phase I/II clinical trial will be presented on September 25.
LOXO closed Friday's trading at $159.27, up 0.01%.
5. NovoCure Limited (NVCR)
Novocure is an oncology company developing a proprietary platform technology called Tumor Treating Fields.
Tumor Treating Fields in combination with standard of care chemotherapy is an investigational treatment for malignant pleural mesothelioma.
According to the final results from phase II registration trial in mesothelioma, dubbed STELLAR, reported early this month, mesothelioma patients who received Tumor Treating Fields with pemetrexed and cisplatin or carboplatin experienced median overall survival of 18.2 months compared to 12.1 months in historical control with no increase in systemic toxicity.
Watch out for...
The final STELLAR results will be presented at the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (IASLC) on September 25, in Toronto.
Novocure will host an analyst and investor briefing on September 25 to review data presented at the IASLC and to provide a general update on research and development activities.
NVCR closed Friday's trading at $48.65, down 1.12%.
6. Adamis Pharmaceuticals Corp. ( ADMP )
Adamis Pharma's low dose Symjepi product candidate of dose 0.15mg for the emergency treatment of anaphylaxis is under FDA review, with a decision expected on September 27.
Anaphylaxis is a potentially life-threatening allergic reaction. Certain medications, especially penicillin, anesthesia and aspirin, insect stings, certain foods and latex can trigger anaphylaxis.
Symjepi is a pre-filled epinephrine syringe. Considered as a low-cost alternative to Mylan Pharmaceuticals' (MYL) EpiPen, Adamis' Symjepi Injection received regulatory approval in the U.S. last June for a 0.3mg dose. But it is yet to be launched.
In July of this year, Adamis inked a distribution and commercialization agreement with Sandoz Inc., a division of the Novartis Group, to commercialize Symjepi. The timing of launch of Symjepi in the U.S. will be at Sandoz's sole discretion.
ADMP closed Friday's trading at $3.10, up 1.64%.
7. Insmed Inc. (INSM)
Insmed's investigational drug ALIS, which won support from an advisory committee to FDA on August 7, awaits the final decision on September 28.
ALIS or Amikacin liposome inhalation suspension is an investigational drug comprising the antibiotic Amikacin in Insmed's proprietary liposomal technology formulation.
The Company is seeking approval of ALIS for adult patients with Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium avium complex.
Nontuberculous Mycobacterial (NTM) lung disease is a rare and serious disorder, with patients experiencing a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum, and fatigue.
If approved, ALIS will be the first approved inhaled therapy for the treatment of this serious and debilitating lung infection in the United States.
INSM closed Friday's trading at $21.31, down 1.93%.
8. Ra Pharmaceuticals Inc. (RARX)
Ra Pharma is a clinical-stage biopharmaceutical company focused on developing drugs for the treatment of serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system.
The Company's lead drug candidate is RA101495 that is being developed for convenient self-administered subcutaneous injection for the treatment of paroxysmal nocturnal hemoglobinuria, Myasthenia Gravis, and renal indications such as atypical hemolytic uremic disorder (aHUS) and lupus nephritis.
Watch out for...
Top-line data from a phase Ib study designed to evaluate the pharmacokinetic (PK) profile of RA101495 SC in patients with renal impairment due this month are awaited.
RARX closed Friday's trading at $16.36, up 5.01%.
9. Amarin Corp. plc (AMRN)
Amarin's landmark cardiovascular outcomes study, dubbed REDUCE-IT, is the next large cardiovascular outcomes study to report results.
REDUCE-IT is evaluating the effect of FDA-approved Vascepa, administered at 4 grams per day, as an add-on to statin therapy, on major adverse cardiovascular events as compared to statin treated patients plus placebo. REDUCE-IT is the first cardiovascular outcomes study to be conducted in patients who despite low density lipoprotein cholesterol (LDL-C) control have risk factors for cardiovascular disease, including elevated triglyceride levels.
Vascepa is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia.
Watch out for...
Top-line results from the REDUCE-IT study are expected to be reported before the end of September 2018.
AMRN closed Friday's trading at $2.99, up 2.05%.
10. Cytokinetics Inc. (CYTK)
Cytokinetics is a late-stage biopharmaceutical company focused on developing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining.
The Company's lead product candidate is Omecamtiv mecarbil, under a phase III clinical trial in patients with heart failure, being developed in collaboration with Amgen. Next up in the pipeline is Reldesemtiv, under phase II trials in patients with spinal muscular atrophy, in patients with COPD, in patients with ALS, and a phase Ib trial in elderly adults with limited mobility, being developed in collaboration with Astellas.
Watch out for...
Results from the phase II clinical trial of Reldesemtiv in patients with chronic obstructive pulmonary disease which is designed to assess its effect on physical function, due this quarter are awaited.
An interim analysis of data from the phase Ib clinical trial of Reldesemtiv in elderly subjects with limited mobility which is designed to assess its effect on measures of physical function, due this quarter are awaited.
CYTK closed Friday's trading at $8.50, up 4.29%.
10 Pharma Stocks To Watch This Month
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