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fdanotapproved-feb15.jpg Shares of Motif Bio plc (MTFB) plunged as much as nearly 75% today to touch a new low of $2.61, following disappointing regulatory news.
British drug maker AstraZeneca Plc (AZN.L, AZN) announced Wednesday that the US Food and Drug Administration or FDA has granted Orphan Drug Designation or ODD to Fasenra (benralizumab) for the treatment of hypereosinophilic syndrome or HES. The company noted that HES is a group of rare, potentially...
British drug maker AstraZeneca Plc (AZN.L, AZN) and its biologics research and development arm, MedImmune, announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation for MEDI8897, a next-generation preventive medicine for respiratory syncytial virus or RSV. Separately,...
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bank-feb04.jpg Historically, biotech stocks have performed reasonably well in the month of January, and this year too, it has been no different. The iShares Nasdaq Biotechnology ETF (IBB) a bellwether of investor sentiment, has so far gained nearly 16%. Listed below are some of the biotech stocks that made triple-digit gains in January, and their near-term catalysts to watch out for.
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The U.S. Department of Agriculture's Food Safety and Inspection Service announced that City of Industry, Calif. firm Richwell Group, Inc., doing business as Maxfield Seafood, is recalling approximately 55,300 pounds of Siluriformes fish products that were not presented for import re-inspection into the...

The U.S. Department of Agriculture's Food Safety and Inspection Service announced that Lakewood, Calif. firm Q's American Best Trading Inc. is recalling approximately 1,008 pounds of imported Siluriformes fish products that were not presented for import re-inspection into the U.S. This problem was...

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Tyson Foods, Inc. is recalling approximately 36,420 pounds of chicken nugget products due to contamination with extraneous materials, specifically rubber. Meanwhile, there have been no confirmed reports of adverse reactions due to consumption of these products.

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Perdue Foods, LLC is recalling approximately 16,011 pounds of ready-to-eat chicken nugget products due to presence of milk, a known allergen, which is not declared on the product label. This problem was discovered when a retail store notified the company of an incorrect label. Meanwhile, there have been no confirmed reports of adverse reactions due to consumption of these products.

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Date Company Name Ticker Drug Event Outcome Details
06/10/2019 Merck & Co Inc. MRK KEYTRUDA (sBLA) FDA decision on KEYTRUDA as Monotherapy or in combination with Chemotherapy
05/28/2019 Nektar Therapeutics NKTR NKTR-181 (NDA) FDA decision on NKTR-181 for chronic low back pain in adult patients new to opioid therapy
04/28/2019 Sanofi SNYNF, SNY Praluent (sBLA) FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/28/2019 Regeneron Pharmaceuticals REGN Praluent (sBLA) FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/02/2019 ADMA BIOLOGICS, INC. ADMA RI-002 (BLA resubmission) FDA decision on RI-002 to treat primary immune deficiency disease
04/01/2019 Evoke Pharma, Inc. EVOK Gimoti (NDA) FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis
03/24/2019 Recro Pharma Inc. REPH Resubmitted IV Meloxicam (NDA) FDA decision on resubmitted IV Meloxicam for management of moderate to severe pain
03/22/2019 Lexicon Pharmaceuticals Inc. LXRX Sotagliflozin (NDA) FDA decision on Sotagliflozin for type 1 diabetes
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Results Date Company Name Ticker Event Indication Outcome
Mid 2019 Sesen Bio Inc SESN 12-month data from phase III trial of Vicinium (VISTA) High grade non-muscle invasive bladder cancer (NMIBC) Positive results announced on Jan 3
Mid 2019 VBI Vaccines Inc. VBIV Pivotal Phase 3 clinical program for Sci-B-Vac to evaluate the safety and immunogenicity (PROTECT) Hepatitis B
Mid 2019 VBI Vaccines Inc. VBIV Pivotal Phase 3 clinical program for Sci-B-Vac to demonstrate lot-to-lot consistency for immune response (CONSTANT) Hepatitis B
Mid 2019 Nightstar Therapeutics plc NITE Preliminary Data from expansion study of phase I/II clinical trial of NSR-RPGR (XIRIUS) X-Linked Retinitis Pigmentosa (XLRP)
Mid 2019 Caladrius Biosciences, Inc. CLBS Final results from phase II clinical trial of CLBS12 Critical limb ischemia
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Shares of Bausch Health Companies Inc. (BHC), formerly known as Valeant Pharmaceuticals International Inc., are up 35% since the start of this year.
Anchiano Therapeutics, formerly known as Biocancell, is a clinical-stage biotechnology company developing a targeted gene therapy to improve the standard treatment for early-stage bladder cancer.
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Non-alcoholic steatohepatitis, or NASH, which refers to liver inflammation due to fat buildup in the liver, is said to affect an estimated 16 million Americans. NASH is a more severe form of nonalcoholic fatty liver disease, or NAFLD. The incidence of NASH is on the rise, and even worrying is the fact that there are no approved treatments for the disease, yet.
2018 was a banner year not just for novel drug approvals but for novel device approvals as well. Last year, 59 novel drugs and 106 novel devices were greenlighted by the regulatory agency compared to 46 novel drugs and 99 novel devices approved in 2017. Now, let's take a look at the biotech stocks that await a ruling from the FDA in February 2019.
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Shares of Motus GI Holdings Inc. (MOTS) are down nearly 60% from their 52-week high of $10.66 recorded on July 9, 2018.
Shares of Menlo Therapeutics Inc. (MNLO) are down 86% from their 52-week high of $39.86 recorded on February 6, 2018.
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