(RTTNews.com) - The week that just went by delivered a couple of surprises and a bit of bad news to biotech investors.
One such surprise was the FDA approval of Pacira Pharmaceuticals Inc.'s (PCRX) supplemental New Drug Application for Exparel as a nerve block for regional analgesia on April 7, 2018, despite an FDA panel voting it down in February. Though the FDA is not bound to follow the panel's recommendations, it generally does. So the FDA taking a different stance in the case of Pacira was a sweet surprise for the biotech investors.
SELLAS Life Sciences Group Inc. (SLS) was the top performer of the week, gaining nearly 99%, thanks to positive interim data from its mid-stage trial of NeuVax in breast cancer patients.
NewLink Genetics Corp. (NLNK) was one of the top losers of the week, tumbling over 42%, following the Company's decision to review its clinical programs on the heels of an unsuccessful trial of melanoma combo therapy of Merck/Incyte.
Let's take a look at the pharma stocks and upcoming events to keep an ear out for in the coming week.
1. Selecta Biosciences Inc. (SELB)
Selecta is a clinical-stage biopharmaceutical company, and its lead product candidate is SEL-212.
A phase II trial of SEL-212 for the treatment of chronic severe gout is underway. Initial data from this study, reported on June 15, 2017, sent the stock up 9% that day. Updated results from this study were reported on November 7, 2017, following which the shares tumbled 54%.
The Company expects to present additional data from this ongoing phase II trial of SEL-212 for the treatment of chronic severe gout at the Pan American League of Associations for Rheumatology (PANLAR) Congress on April 10, 2018.
SELB closed Friday's trading at $10.20, down 3.04%.
2. Eiger BioPharmaceuticals Inc. (EIGR)
Eiger is a clinical-stage biopharmaceutical company developing novel products for the treatment of rare diseases.
Watch out forâ€¦
An update on the planned registration program for chronic HDV on April 11, 2018.
Lonafarnib is the lead program in Hepatitis Delta Virus (HDV) infection, and is expected to advance into phase III trial by the end of the year.
Another HDV drug candidate is Lambda, under a phase II trial called LIMT HDV study. Positive interim data from this study were reported at American Association for the Study of Liver Diseases (AASLD 2017) meeting.
EIGR closed Friday's trading at $9.10, down 11.65%.
3. Aeglea BioTherapeutics Inc. ( AGLE )
Aeglea is a clinical-stage biotechnology company developing innovative human enzyme therapeutics for patients with rare genetic diseases and cancer.
The Company's lead drug candidate is Pegzilarginase (AEB1102) under phase I/II trial in adult and pediatric patients with Arginase 1 Deficiency. The study, designed to enroll 10 patients (adult and pediatric) consists of two parts - single ascending dose part and repeat dose part.
Arginase 1 deficiency, a rare inherited disorder, is characterized by gradual accumulation of ammonia in the blood.
On March 12, 2018, the Company reported encouraging repeat dose data from its phase I/II clinical trial of Pegzilarginase for two adult patients, and single ascending dose data for one pediatric patient with Arginase 1 Deficiency.
Watch out forâ€¦
New data from the phase I/II trial of Pegzilarginase in adult and pediatric patients with Arginase 1 Deficiency is expected to be presented at the Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics (ACMG) on April 12, 2018.
AGLE closed Friday's trading at $8.92, down 8.89%.
4. MediciNova Inc. (MNOV)
MediciNova is a biopharmaceutical company developing novel therapeutics for neurology, respiratory, and liver diseases with unmet medical needs.
One of the core clinical programs of the Company is MN-001 for fibrotic diseases like nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF).
On April 1, 2018, the Company announced that it is terminating its phase II clinical trial of MN-001 in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with hypertriglyceridemia early based on the significant positive results from an interim analysis.
The interim analysis of the phase II study demonstrated that that MN-001 significantly reduced mean serum triglycerides, a primary endpoint, from 260.1 mg/dL before treatment to 185.2 mg/dL after eight weeks of treatment. There were no clinically significant safety or tolerability issues during the study.
Watch out forâ€¦
Details of the interim analysis will be presented at the International Liver Congress 2018, the 53rd annual meeting of the European Association for the Study of the Liver (EASL), during the NAFLD: Therapy poster session on Friday, April 13, 2018 in Paris, France.
MNOV closed Friday's trading at $12.24, down 4.00%.
5. Galectin Therapeutics Inc. (GALT)
Galectin is developing novel therapies for the treatment of patients with chronic liver and skin diseases and cancer.
The Company's lead drug candidate is GR-MD-02 for the treatment of non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH related fibrosis.
GR-MD-02 has been successfully studied in a phase IIb clinical trial in NASH cirrhosis patients, dubbed NASH-CX trial.
On December 5, 2017, the Company announced that its NASH-CX trial of GR-MD-02 showed statistically significant and clinically meaningful results in reducing the primary endpoint measurement of HVPG (hepatic venous pressure gradient) in comparison to placebo in NASH cirrhosis patients without esophageal varices, which represented 50 percent of the patients enrolled in the clinical trial.
Watch out for...
The Company is slated to make a late-breaker oral presentation, focusing on the phase IIb NASH-CX trial results and the innovative work it is doing for patients with non-alcoholic steatohepatitis (NASH) cirrhosis and portal hypertension on April 14, 2018, in the Main Plenary at The International Liver Congress 2018, European Association for the Study of the Liver (EASL) in Paris, France.
GALT closed Friday's trading at $4.68, up 2.41%.
6. Alnylam Pharmaceuticals Inc. (ALNY)
Alnylam Pharma is a pioneer in the emerging field of RNA interference (RNAi) technology.
The lead RNAi therapeutic drug candidate of the Company is Patisiran, proposed for the treatment of hereditary ATTR (hATTR) amyloidosis. Patisiran is under FDA review, with a decision expected on August 11, 2018.
Another investigational RNAi therapeutic is Givosiran for the treatment of acute hepatic porphyrias (AHPs).
Ongoing trials in hepatic porphyria patients are:
-- A phase I/II study to evaluate the long-term safety and clinical activity of subcutaneously administered Givosiran in patients with acute intermittent porphyria who have completed a previous clinical study with Givosiran.
-- A phase III study evaluating the efficacy and safety of Givosiran in patients with acute hepatic porphyrias, dubbed ENVISION.
-- A multinational, prospective, observational study aimed at characterizing the natural history and clinical management of patients with acute hepatic porphyrias who experience recurrent attacks or receive prophylactic treatment to prevent attacks, dubbed EXPLORE.
Watch out forâ€¦
New results from phase I/II study of Givosiran, and data from the ongoing EXPLORE study are expected to be presented at the European Association for the Study of the Liver (EASL) 53rd Annual International Liver Congress on April 14, 2018.
ALNY closed Friday's trading at $95.08, down 1.41%.
7. Blueprint Medicines Corp. (BPMC)
Blueprint Medicines is developing a new generation of targeted and potent kinase medicines to improve the lives of patients with genomically defined diseases.
Avapritinib (BLU-285), BLU-554 and BLU-667 are the Company's clinical drug candidates, all of which are under phase I testing.
BLU-285 is being explored in the indications of advanced gastrointestinal stromal tumors and advanced systemic mastocytosis. BLU-554 for the treatment of advanced hepatocellular carcinoma, and BLU-667, a potent and selective inhibitor of RET mutations, fusions, and predicted resistant mutants, is being explored in RET-altered cancers.
Watch out forâ€¦
The preliminary data from phase I trial of BLU-667 for the treatment of RET-altered non-small cell lung cancer, medullary thyroid cancer, and other advanced solid tumors will be presented in an oral presentation in a Clinical Trials Plenary Session at the American Association for Cancer Research (AACR) Annual Meeting on April 15, 2018.
BPMC closed Friday's trading at $89.64, down 2.57%.
8. ArQule Inc. (ARQL)
ArQule is a biopharmaceutical company developing targeted therapeutics to treat cancers and rare diseases.
The Company's clinical drug candidates are:
-- ARQ 087 (Derazantinib), under phase III trial in Intrahepatic Cholangiocarcinoma (iCCA).
-- ARQ 531, proposed for heme malignancies, is under phase 1a/b testing.
-- Miransertib (ARQ 092) under phase I/II trial for Proteus syndrome, and phase Ib trial in combination with Carboplatin plus Paclitaxel, in combination with Paclitaxel, or in combination with Anastrozole in subjects with selected solid tumors.
-- ARQ 751, under phase I dose escalation study in subjects with advanced solid tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other known actionable PTEN mutations.
Watch out forâ€¦
Data from the phase Ib trial for Miransertib in combination with Anastrozole in PIK3CA or AKT1-mutant endometrial and ovarian cancers will be presented on April 15, 2018.
Results of phase I dose escalation study of ARQ 751 will also be presented on April 15, 2018.
ARQL closed Friday's trading at $2.85, down 3.39%.
9. Bristol-Myers Squibb Co. (BMY)
Bristol-Myers' (BMY) supplemental Biologics License Application for Opdivo plus Yervoy to treat intermediate-and poor-risk patients with advanced renal cell carcinoma is under priority review - with a decision expected on April 16, 2018.
Opdivo and Yervoy are blockbuster drugs of Bristol-Myers. In 2017, the global sales of Opdivo were $4.95 billion, up 31% over 2016, and that of Yervoy totaled $1.24 billion, up 18% over 2016.
BMY closed Friday's trading at $60.88, down 2.29%.
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