The week that went past witnessed some stocks making big moves on the back of clinical trial results and regulatory outcome.
The mixed data from ARCA biopharma Inc.'s (ABIO) phase IIb trial of Gencaro, a potential treatment for atrial fibrillation, dubbed GENETIC-AF, on Feb.26, 2018, sent the stock reeling to a 52-week low.
Novavax Inc. (NVAX) soared to a new 52-week high on Mar. 1, 2018, following positive top-line results from its phase I/II clinical trial of its NanoFlu recombinant influenza vaccine in older adults.
Another stock that touched a 52-week high on Mar. 1, 2018, is Sorrento Therapeutics Inc. (SRNE), thanks to FDA approval of the Company's ZTlido, a next-generation non-opioid, lidocaine patch for the relief of pain associated with post-herpetic neuralgia.
Let's take a look at the pharma stocks and upcoming events to keep an ear out for in the coming week.
1. Clearside BioMedical Inc. (CLSD)
Clearside Biomedical is focused on developing potential therapies for eye diseases.
The Company's proprietary suspension formulation of the corticosteroid triamcinolone acetonide for suprachoroidal administration (suprachoroidal CLS-TA) is being studied for potential administration both alone and together with an intravitreal anti-VEGF agent.
A pivotal phase III trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis, dubbed PEACHTREE, is underway. The top line results from this trial are expected to be reported before the market opens on Monday, March 5, 2018.
CLSD closed Friday's (Mar.2) trading at $7.82, up 11.24%.
2. Bristol-Myers Squibb Co. (BMY)
Bristol-Myers' supplemental Biologics License Applications seeking to update Opdivo dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications await the FDA ruling on March 5, 2018.
As a monotherapy, Opdivo is approved for the below-mentioned indications under the following dosing regimen:
-- Advanced melanoma 240 mg IV infused over 1 hour every 2 weeks
-- Advanced non-small cell lung cancer (NSCLC) 240 mg IV infused over 1 hour every 2 weeks
-- Advanced renal cell carcinoma (RCC) 240 mg IV infused over 1 hour every 2 weeks
-- Metastatic Urothelial carcinoma 240 mg IV infused over 1 hour every 2 weeks
-- Hodgkin lymphoma 3 mg/kg IV infused over 1 hour every 2 weeks
-- Advanced head & neck squamous cell carcinoma 3 mg/kg IV infused over 1 hour every 2 weeks.
Opdivo generated global sales of $4.95 billion in 2017, up from $3.77 billion in 2016.
BMY closed Friday's trading at $66.17, up 0.73%.
3. Amgen Inc. (AMGN)
Amgen's supplemental Biologics License Application seeking to expand Blincyto's use for the treatment of patients suffering or inflicted with minimal residual disease- positive B-cell precursor acute lymphoblastic leukemia is slated to be reviewed by an FDA panel on March 7, 2018.
Minimal residual disease, or MRD, refers to the presence of a small amount of detectible cancer cells that remain in the patient after treatment.
Currently there are no approved therapies for patients with MRD-positive acute lymphoblastic leukemia.
Blincyto is already approved for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The drug raked in annual sales of $175 million in 2017 compared to $115 million in 2016.
AMGN closed Friday's trading at $185.08, up 0.98%.
4. Pfizer Inc. (PFE)
A panel of outside experts convened by the FDA is scheduled to review Pfizer's supplemental New Drug Application seeking to expand the approved use of Xeljanz to include the treatment of ulcerative colitis on March 8, 2018.
Xeljanz, an oral Janus kinase (JAK) inhibitor, is already indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis and adult patients with active psoriatic arthritis.
The global annual sales of Xeljanz totaled $1.35 billion in 2017, up from $927 million in 2016.
The final decision of the FDA on Xeljanz in the proposed new indication of ulcerative colitis is expected in June of this year.
PFE closed Friday's trading at $35.95, up 0.90%.
5. Regeneron Pharmaceuticals Inc. (REGN)
Regeneron Pharma is a commercial-stage biopharmaceutical company. It also has fifteen product candidates in clinical development.
On March 10, 2018, at the meeting of American College of Cardiology, the Company will be presenting data from the 18,000-patient ODYSSEY OUTCOMES study.
The ODYSSEY OUTCOMES study is designed to determine whether the addition of cholesterol-lowering drug Praluent to intensive statin therapy reduces major adverse cardiac events among patients who had previously experienced an acute coronary syndrome, such as a heart attack or unstable angina.
Praluent, developed by Sanofi (SNY) and Regeneron Pharma, was approved by the FDA on July 24, 2015. The global net sales of Praluent were $195 million in 2017 compared to $116 million in 2016.
REGN closed Friday's trading at $330.47, up 2.70%.
6. Savara Inc. (SVRA)
Savara is a clinical-stage company developing drugs for the treatment of rare respiratory diseases.
The Company has 2 drug candidates in late-stage development and 1 under phase II development.
Molgradex for Pulmonary Alveolar Proteinosis (PAP), and AeroVanc for MRSA in Cystic Fibrosis (CF) are the Company's late stage assets. Aironite for Diastolic Heart Failure (HFpEF) is a phase II drug candidate.
The top line results from the phase II study of Aironite in Diastolic Heart Failure, dubbed INDIE, are expected to be presented at the American College of Cardiology 67th Annual Scientific Sessions & Expo on March 11th, 2018.
SVRA closed Friday's trading at $11.28, up 2.08%.
7. Synlogic (SYBX)
Synlogic is a clinical-stage company applying synthetic biology to probiotics to develop novel living medicines.
The Company's lead drug candidate is SYNB1020, a Synthetic Biotic medicine designed to remove excess ammonia from the blood in patients with genetic urea cycle disorders (UCD) or chronic liver disease. SYNB1020 is under phase I testing.
Last November, the Company announced positive top-line clinical data from its phase I placebo-controlled single (SAD) and multiple ascending dose (MAD) clinical trial of SYNB1020 in healthy volunteers.
Full data from the phase I study of SYNB1020 are expected to be presented at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting - March 11-14, 2018.
SYBX closed Friday's trading at $10.74, up 3.37%.
by RTTNews Staff Writer
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