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APLS

Apellis

$23.45

-0.38 (-1.59%)

07:43
06/27/19
06/27
07:43
06/27/19
07:43

Apellis complete enrollment of Phase 3 APL-2 head-to-head study

Apellis Pharmaceuticals announced the completion of enrollment for its PEGASUS Phase 3 trial assessing the safety and efficacy of APL-2 in patients with paroxysmal nocturnal hemoglobinuria compared to eculizumab. The study enrolled 80 patients, approximately half of whom were transfusion dependent. Apellis expects to release top-line data in December 2019. PEGASUS is a randomized, active-controlled study comparing APL-2 monotherapy to eculizumab monotherapy in patients currently on treatment with eculizumab who have a hemoglobin level less than10.5 g/dL, regardless of eculizumab dose or transfusion history. In the trial, patients are co-treated for 4 weeks with APL-2 and eculizumab, and then randomized to either APL-2 monotherapy or eculizumab monotherapy for a 16-week randomized controlled period. The primary endpoint is change from baseline to week 16 in hemoglobin level. Key secondary endpoints include transfusion avoidance during the 16-week randomized controlled period, as well as week 16 changes from baseline in reticulocyte count, lactate dehydrogenase levels and FACIT-Fatigue scale score. The 16-week randomized controlled period is followed by a 32-week open-label treatment period in which all subjects will receive treatment with APL-2 monotherapy. APL-2 is being developed for patients with PNH, autoimmune hemolytic anemia, complement-associated kidney diseases, and geographic atrophy. Cumulative systemic exposure is over 50 patient years of treatment on APL-2. There have been no serious adverse drug reactions in the systemic development programs for hematology indications to date.

  • 09

    Sep

APLS Apellis
$23.45

-0.38 (-1.59%)

01/23/19
JPMS
01/23/19
DOWNGRADE
Target $34
JPMS
Neutral
JPMorgan downgrades Apellis to Neutral with no data until Q4
JPMorgan analyst Anupam Rama downgraded Apellis Pharmaceuticals to Neutral from Overweight with an unchanged price target of $34. The analyst continues to like the shares long term and view APL-2 as an underappreciated asset in the complement space. However, with data not out until Q4, the analyst expects Apellis shares to perform in line with the market in the first half of 2019.
03/28/19
BARD
03/28/19
INITIATION
Target $45
BARD
Outperform
Apellis initiated with an Outperform at Baird
Baird started Apellis Pharmaceuticals with an Outperform rating and $45 price target.
03/28/19
BARD
03/28/19
INITIATION
Target $45
BARD
Outperform
Apellis initiated with an Outperform at Baird
Baird analyst Madhu Kumar initiated Apellis with an Outperform rating and a price target of $45. The analyst says the company's lead asset, complement C3 inhibitor APL-2, has the "potential to disrupt multiple diseases, including the ophthalmologic market of geographic atrophy and orphan disease market of paroxysmal nocturnal hemoglobinuria". Kumar sees Apellis' top-line data from the Phase 3 PEGASUS trial in paroxysmal nocturnal hemoglobinuria as a "key near-term catalyst" for its shares.
03/29/19
03/29/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Etsy (ETSY) initiated with a Perform at Oppenheimer. 2. Apellis (APLS) and uniQure (QURE) initiated with an Outperform at Baird. 3. BRT Apartments (BRT) initiated with a Buy at DA Davidson. 4. Lilis Energy (LLEX) initiated with an Equal Weight at Stephens. 5. Outfront Media (OUT) initiated with an Outperform at Oppenheimer. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

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CGIX

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NUVSF

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SVRGF

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