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MRK

Merck

$82.92

-0.95 (-1.13%)

16:43
09/29/19
09/29
16:43
09/29/19
16:43

Merck presents data from pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial

Merck announced results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial in patients with early-stage triple-negative breast cancer. The trial investigated a regimen of neoadjuvant KEYTRUDA, Merck's anti-PD-1 therapy, plus chemotherapy, followed by adjuvant KEYTRUDA as monotherapy compared with a regimen of neoadjuvant chemotherapy followed by adjuvant placebo. In the neoadjuvant phase, KEYTRUDA plus chemotherapy resulted in a statistically significant increase in pathological complete response versus chemotherapy, from 51.2% with neoadjuvant chemotherapy to 64.8% for neoadjuvant KEYTRUDA plus chemotherapy, in patients with early-stage TNBC. Pathological complete response, one of the dual primary endpoints was defined as ypT0/Tis ypN0. The improvement seen when adding KEYTRUDA to neoadjuvant chemotherapy was observed regardless of PD-L1 expression. In the other dual primary endpoint of event-free-survival, with a median follow-up of 15.5 months, the KEYTRUDA regimen reduced the risk of progression in the neoadjuvant phase and recurrence in the adjuvant phase by 37% - a favorable trend for EFS - compared with the chemotherapy-placebo regimen. The safety profiles of KEYTRUDA and chemotherapy in KEYNOTE-522 were consistent with previous studies. As previously announced, KEYTRUDA plus chemotherapy was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration for the neoadjuvant treatment of patients with high-risk, early-stage TNBC. The BTD was granted based on data from Phase 1b KEYNOTE-173 and Phase 2 I-SPY2 trial, which demonstrated encouraging anti-tumor activity with neoadjuvant KEYTRUDA plus chemotherapy in these patients. As previously announced, Merck plans to share early interim analysis data from KEYNOTE-522 with regulatory authorities. The company continues to progress a robust clinical development program for KEYTRUDA in breast cancer, which encompasses several internal studies and external collaborative trials, including KEYNOTE-355 and KEYNOTE-242.

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MRK Merck
$82.92

-0.95 (-1.13%)

08/07/19
ARGS
08/07/19
NO CHANGE
Target $105
ARGS
Buy
Merck price target raised to $105 from $95 at Argus
Argus analyst David Toung raised his price target on Merck to $105 and kept his Buy rating after its "strong" Keytruda-driven Q2 earnings beat, also boosting his FY19 and FY20 EPS view by 16c and 10c to $4.89 and $5.35 respectively. The analyst sees Merck's "blockbuster" Keytruda drug on track for additional indications in the U.S., Japan, China and Europe, with additional growth drivers coming from its Gardasil, Bridion, Lynparza, and Lenvima programs.
08/15/19
LEER
08/15/19
INITIATION
Target $103
LEER
Outperform
Merck initiated with an Outperform at SVB Leerink
SVB Leerink analyst Daina Graybosch initiated Merck with an Outperform rating and $103 price target.
08/16/19
08/16/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Merck (MRK) initiated with an Outperform at SVB Leerink. 2. DocuSign (DOCU) initiated with a Buy at DA Davidson. 3. iQIYI (IQ) initiated with an Underweight at JPMorgan. 4. Goodyear Tire (GT) initiated with an Outperform at Exane BNP Paribas. 5. BlackBerry (BB) initiated with a Neutral at Macquarie. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
09/18/19
RHCO
09/18/19
NO CHANGE
Target $14
RHCO
Hold
Lannett price target raised to $14 from $10 at SunTrust
SunTrust analyst Gregg Gilbert raised his price target on Lannett (LCI) to $14, adjusting his model to reflect its potentially significant opportunity with the recent launch of posaconazole - a generic version of Merck's (MRK) Noxafil. The analyst notes that he now models sales and EBITDA at the higher end of the company's FY20 targets while also raising his FY20 EPS view by 19c to $1.33. Gilbert still keeps his Hold rating on the stock, citing the uncertainty around Lannett's capital structure and limited pipeline visibility as well as the challenging environment for generics.

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OHI

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RETA

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Options
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AKRX

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EHTH

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