Biotek-snakken — Juni 2020
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Piper Sandler analyst Edward Tenthoff raised the firm's price target on Chiasma to $22 from $13 and reiterates an Overweight rating on the shares after the FDA approved Mycapssa, the first and only oral therapy for the treatment of acromegaly. The analyst sees "significant" demand for an oral therapy from acromegaly patients who he notes currently receive "painful" monthly injections and often experience break-through symptoms and insufficient coverage.
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Cantor Fitzgerald analyst Brandon Folkes maintained an Overweight rating and $18 price target on Chiasma. The analyst said that the FDA approval for Mycapssa for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide is a "giant leap" for Chiasma. He sees Mycapssa, as the only approved oral octreotide, gaining meaningful share in the market once launch in Q4.
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HRTX fik et CRL fra FDA - aktien falder 28% øv. https://finance.yahoo.com/news/heron-therapeutics-receives-complete-response-124500540.html
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The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or CMC issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing
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release specification of the allowable level of an impurity based on animal toxicology coverage. We do not believe that any of the issues are significant barriers to ultimate approval, as all of the excipients have extensive histories of use in pharmaceuticals and the specification can be revised. The Company will request a Type A meeting to obtain agreement with the Agency on our responses and resubmit the application as quickly as possible.
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