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ESPR

Esperion

$23.67

-5.98 (-20.17%)

, AMGN

Amgen

$168.61

-11.5 (-6.39%)

13:58
03/20/17
03/20
13:58
03/20/17
13:58

Esperion jumps as FDA clears approval path for cholesterol drug

Shares of Esperion Therapeutics (ESPR) are on the rise after the small biotech company announced that the Food and Drug Administration gave feedback on its cholesterol-lowering drug, saying the bempedoic acid Phase 3 program is adequate to support approval of an LDL-C lowering indication prior to outcomes data. The news sparked positive commentary from Wall Street analysts. PATH TO APPROVAL: Esperion announced that the FDA recently confirmed that its LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid. Esperion plans to submit a new drug application, or NDA, by the first half of 2019 for an LDL-C lowering indication based on the successful completion of the global pivotal Phase 3 program. The proposed product label would include specific language for use of bempedoic acid as an adjunct to maximally tolerated statin therapy in patients with hypercholesterolemia. CLEAR POSITIVE: Following Esperion's regulatory announcement, JPMorgan analyst Jessica Fye told investors that the news is a "clear positive" for the company as it lifts one of the largest overhangs on the stock over the past 18 months. Some expectation for this type of update "started to come into the stock" on the back of Amgen's (AMGN) FOURIER top-line results from the trial of its own cholesterol-lowering drug, Repatha, the analyst noted. Fye pointed out that she now sees the potential for approval of bempedoic acid in 2020, adding that she continues to see a "good likelihood" of clinical success when the Phase 3 trials read out in mid-2018. The analyst reiterated a Neutral rating on Esperion's shares. Meanwhile, her peer at Needham raised the price target on Esperion's shares to $58 from $25. Analyst Chad Messer told investors in a research note of his own that the announcement resolves a long standing issue for Esperion regarding the ability to get its drug approved without a completed cardiovascular outcome trial. The analyst pointed out that the regulatory confirmation comes on the heels of the positive FOURIER outcomes data for Repatha and the genetic validation of the target for bempedoic acid that was presented at the American College for Cardiology. He reiterated a Buy rating on Esperion's shares. This morning, Credit Suisse also upgraded Esperion to Neutral from Underperform. FOURIER TRIAl: Late last week, Amgen released data for its 27,564-patient Repatha cardiovascular outcomes study, which showed that it reduced the risk of heart attacks, strokes and other heart-related problems by 15% compared to a placebo, though investors seemed to be expecting a cardiovascular risk reduction of 20%-22%. Shares of Amgen and some others working on cholesterol lowering drugs, such as The Medicines Co. (MDCO) and Esperion, moved lower on Friday. CASH RAISE SEEN AS LIKELY: Citi analyst Joel Beatty told investors that Esperion's stock was oversold on the Repatha news and reiterated his Buy rating and $39 price target on the shares, saying that he believed there is a potential that bempedoic acid could be approved by the FDA based on LDL lowering as a surrogate endpoint. Additionally, Beatty argued that Esperion will likely need to raise cash before a potential approval by the FDA. WHAT'S NOTABLE: Commenting on the share's rise today, TheStreet's Adam Feuerstein tweeted, "$ESPR reaction to widely expected regulatory news this morning is puzzling." PRICE ACTION: In afternoon trading, shares of Esperion have jumped about 62% to $38.24. Meanwhile, Medicines Co. shares are up nearly 3% to $49.74.

ESPR

Esperion

$23.67

-5.98 (-20.17%)

AMGN

Amgen

$168.61

-11.5 (-6.39%)

MDCO

The Medicines Co.

$48.38

-4.2 (-7.99%)

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ESPR Esperion
$23.67

-5.98 (-20.17%)

03/20/17
JPMS
03/20/17
NO CHANGE
JPMS
Neutral
Esperion LDL-C lowering endpoint news a clear positive, says JPMorgan
After Esperion (ESPR) announced that the FDA confirmed that the bempedoic acid phase 3 program is adequate to support approval of an LDL-C lowering indication prior to outcomes data, JPMorgan analyst Jessica Fye said some expectation for this type of update "started to come into the stock" after Amgen's (AMGN) release of the FOURIER trial top-line results on last Friday. Still, the news is a clear positive for Esperion as it lifts one of the largest overhangs on the stock over the past 18 months. Fye, who now sees the potential for approval of bempedoic acid in 2020, keeps a Neutral rating on Esperion shares.
03/20/17
SBSH
03/20/17
NO CHANGE
Target $39
SBSH
Buy
Esperion likely needs to raise cash before FDA approval, says Citi
Following the company's conference call last night, Citi analyst Joel Beatty continues to believe Esperion Therapeutics' bempedoic acid could be approved by FDA based on LDL lowering as a surrogate endpoint. The company will likely need to raise capital before a potential FDA approval, however, Beatty tells investors in a research note. Further, the FDA is unlikely to provide clarity on LDL as a surrogate ahead of a filing in early 2019, the analyst adds. He keeps a Buy rating on Esperion with a $39 price target. The stock in early trading is up 55%, or $13.03, to $36.70.
03/20/17
FBCO
03/20/17
UPGRADE
FBCO
Neutral
Esperion upgraded to Neutral from Underperform at Credit Suisse
03/17/17
NEED
03/17/17
NO CHANGE
Target $25
NEED
Strong Buy
Needham calls Esperion selloff on Amgen data 'counter-intuitive'
Needham analyst Chad Messer believes the selloff in shares of Esperion Therapeutics (ESPR) based on Amgen's (AMGN) Repatha's data is "counter-intuitive." The fact that there was a statistically significant benefit confirms that LDL reductions prevent heart attacks and strokes, Messer tells investors in a research note. Bempedoic acid will likely be priced more in line with other oral cholesterol therapies, which makes the value debate for PCSK9 drugs a positive for Esperion, not a negative, the analyst contends. The analyst keeps a Buy rating on Esperion with a $25 price target.
AMGN Amgen
$168.61

-11.5 (-6.39%)

03/17/17
PIPR
03/17/17
NO CHANGE
PIPR
Overweight
Amgen weakness a buying opportunity, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer recommends using today's weakness in shares of Amgen as a buying opportunity. The analyst believes Amgen can still turn Repatha into a $5B-plus product and he reiterates an Overweight rating on the shares.
03/17/17
JPMS
03/17/17
NO CHANGE
JPMS
Overweight
Amgen data do not justify Medicines selloff, says JPMorgan
JPMorgan analyst Jessica Fye believes today's cholesterol data from Amgen (AMGN) do not justify the downward move in shares of The Medicines Co. (MDCO). The analyst sees a "clear clinical benefit" from Amgen's Repatha, which she thinks support the likelihood of clinical success and value for Medicines' inclisiran. The analyst remains comfortable with her 70% probability of success and $1.6B peak sales forecast for inclisiran. Fye keeps an Overweight rating on Medicines and believes the 18% selloff today is overdone.
MDCO The Medicines Co.
$48.38

-4.2 (-7.99%)

03/17/17
JPMS
03/17/17
NO CHANGE
JPMS
The Medicines Co. selloff on Amgen data overdone, says JPMorgan
03/17/17
LEER
03/17/17
NO CHANGE
LEER
Outperform
Leerink reiterates Outperform on Medicines after Amgen data
Leerink analyst Joseph Schwartz says Amgen's (AMGN) cholesterol lowering data this morning is less positive than expectations, in part due to management's bullishness ahead of the news. The analyst sees a "less than perfect read-through" to The Medicines Co. (MDCO), however, since the company is likely to study inclisiran in patients with more elevated cholesterol going forward. He reiterates an Outperform rating on Medicines shares. The stock is morning trading is down 21% to $41.38.
01/06/17
JEFF
01/06/17
NO CHANGE
Target $49
JEFF
Buy
Amgen ruling could mean 'blue skies' for Medicines Co., says Jefferies
Jefferies analyst Biren Amin raised his price target for The Medicines Co. (MDCO) to $49 from $43 after the District Court of Delaware ruled in favor of Amgen (AMGN) on the permanent injunction against Sanofi (SNY) and Regeneron's (RENG) Praluent. The ruling should have a favorable read-through to Medicines' inclisiran since the drug is "completely unique to the monoclonal antibody approach" and therefore would not infringe on Amgen's patents, Amin tells investors in a research note titled "Injunction on Sanofi/REGN's Praluent Could Mean Blue Skies for Inclisiran." The analyst raised his inclisiran peak sales estimates to $2.4B in 2027 and keeps a Buy rating on Medicines shares. The stock is up $2.98, or 8%, to $38.50 in pre-market trading.

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