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FOLD

Amicus

$13.28

-0.39 (-2.85%)

06:05
09/13/17
09/13
06:05
09/13/17
06:05

Amicus: Phase 3 SD-101 study did not meet primary, secondary endpoints

Amicus Therapeutics reported that top-line data from the randomized, double-blind, placebo-controlled Phase 3 clinical study to assess the efficacy and safety of the novel topical wound-healing agent SD-101 did not meet the primary endpoints or secondary endpoints in participants with epidermolysis bullosa. The Phase 3 ESSENCE study randomized 169 participants with a documented diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz epidermolysis bullosa to SD-101 (n=82) or placebo (n=87) during a three-month primary treatment period. SD-101 did not show a statistically significant difference from placebo in the intent to treat population (n=169). The first primary endpoint, the time to target wound closure within 3 months, was not different between groups (Hazard ratio=1.004, p=0.985).1 The second primary endpoint, the percentage of patients achieving target wound closure by month 3, was also not different between groups (49% SD-101; 54% placebo; p=0.390).2 Similarly, the secondary endpoints did not reach statistical significance versus placebo. Encouraging trends in wound closure were observed in certain sub-populations. Treatment-emergent adverse events were similar across both the SD-101 and placebo groups. The most common TEAEs were nasopharyngitis, pruritis, and pyrexia. Amicus plans to further analyze and share the Phase 3 ESSENCE results with key stakeholders in the epidermolysis bullosa community including physicians, patient organizations and regulators. In the interim, in consultation with their physicians, participants in the ongoing extension studies (SD-004 and -006) will have the opportunity to continue being treated with SD-101. Based on these top-line data Amicus has no current plans to invest in any additional clinical studies or commercial preparation activities for SD-101.

FOLD Amicus
$13.28

-0.39 (-2.85%)

08/17/17
JPMS
08/17/17
NO CHANGE
JPMS
JPMorgan lists top SMID Biotechnology picks following Q2 results
Analysts at JPMorgan continue think selectively remains important in the small-to-mid cap Biotechnology space. The analysts listed their favorite ideas in "five key buckets." Amicus (FOLD) is the top long-term pick, Ironwood (IRWD) is the top pick among relative underperformers, Otonomy (OTIC) is the top play for a clinical/binary event, Sarepta (SRPT) is the name to take advantage of the recent share weakness, and Ignyta (RXDX) is the "underfollowed/undervalued" favorite, according to JPMorgan's Biotech team.
07/11/17
COWN
07/11/17
NO CHANGE
Target $16
COWN
Outperform
Amicus price target raised to $16 from $10 at Cowen
07/11/17
JPMS
07/11/17
NO CHANGE
JPMS
Overweight
Amicus could be up 15%-20% on today's news, says JPMorgan
JPMorgan analyst Anupam Rama believes shares of Amicus Therapeutics could be up 15%-20% today on news of the FDA confirming that the regulatory filing for migalastat for the treatment of Fabry can now be submitted. The stock in premarket trading is up 31% to $13.45. The analyst estimates that a U.S. launch of migalastat is now moved up by two years. Rama has an Overweight rating on Amicus.
06/05/17
JPMS
06/05/17
NO CHANGE
Target $13
JPMS
Overweight
Amicus shares can double on positive zorblisa data, says JPMorgan
JPMorgan analyst Anupam Rama believes investor sentiment remains very low on Amicus Therapeutics' Phase 3 readout of zorblisa. The Phase 3 Essence data for the treatment of epidermolysis bullosa are expected in Q3. The trial is "high-risk/high-reward," Rama tells investors in a research note. The analyst says he's taking a "very conservative" approach for zorblisa with $300M in peak sales and a 40% probability of success. Rama believes the stock at current levels reflects no value for zorblisa. On positive data, Amicus shares have the potential to double, Rama writes. On negative data, he sees only "sentiment based" downside of 5%-15%. The analyst keeps an Overweight rating on Amicus with a $13 price target.

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AAN

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