Weekly Movers: Lion Biotech, Adamis, Sarepta…
pharmafile | June 13, 2016 | Feature | Manufacturing and Production, Research and Development, Sales and Marketing | Alexion, Biogen, Shares, Stock Markets, Stock Movement, drug trial, sarepta
Drug trial results remained the important theme over the past week with several companies announcing key study results. The trial results also guided stock price movements for a host of companies over the past days.
Here’s a quick look at some of the biggest movers of the week:
Shares in Lion Biotechnologies (Nasdaq: LBIO) jumped to gain over 43% after the company named Maria Fardis its chief executive officer, effective June 1.
Fardis succeeds Elma Hawkins.
Shares in Adamis Pharmaceuticals (Nasdaq: ADMP) declined over 50% after the company said the US Food and Drug Administration (FDA) has issued a complete response letter regarding a filing for its epinephrine injection for emergency treatment of acute anaphylaxis.
The regulator asked Adamis to expand its patient usability and reliability study of the pre-filled single dose syringe product. The company said it expects to be able to complete the additional testing in a relatively short period of time at an immaterial cost.
Chief Executive Dennis Carlo said: “Our goal is to submit the protocols for these studies to the FDA within a matter of weeks and begin the testing as soon as we receive their feedback.”
Continuing the roller coaster ride Sarepta Therapeutics (Nasdaq: SRPT) soared 25% after the US Food and Drug Administration requested additional data from an ongoing study for its muscle-wasting treatment as the regulator considers whether or not to approve the drug.
Shares soared as the announcement fuelled hopes of a possible approval.
Last month, the FDA deferred a highly anticipated decision on whether to approve Sarepta’s drug, eteplirsen, following an advisory committee recommendation the treatment was not effective.
The agency requested that Sarepta provide dystrophin data from biopsies already obtained from the ongoing confirmatory study of eteplirsen.
Sarepta’s drug has been in the focus for the past few months.
Duchenne muscular dystrophy is a rare genetic disorder characterized by progressive muscular weakness and is caused by a lack of dystrophin, a protein needed to keep muscles healthy. Eteplirsen is designed to increase the production of dystrophin.
Biogen (Nasdaq: BIIB) shares dropped after the company said mid-stage trials for its drug candidate to treat relapsing forms of multiple sclerosis failed to meet primary endpoints.
The company said the trial drug Opicinumab also did not meet the secondary efficacy endpoint, which evaluated the slowing of disability progression. Safety and pharmacokinetics were also assessed as secondary endpoints.
Shares in Alexion Pharmaceuticals (Nasdaq: ALXN) dropped over 10% after the company said its trial drug for refractory generalized myasthenia gravis failed in late stage trials.
The company was studying Solaris for a neuromuscular disease, which causes patients to suffer muscle weakness that makes it difficult or impossible to perform simple daily tasks like walking, talking, swallowing and breathing normally.
Alexion said the study did not show a statistical significance from the baseline after week 26 of the trial.
Anjali Shukla
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