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LLY

Eli Lilly

$111.85

-0.77 (-0.68%)

06:51
11/14/18
11/14
06:51
11/14/18
06:51

Eli Lilly submits NDA for lasmiditan, gets breakthrough designation for Emgality

Eli Lilly has announced the submission of a new drug application, or NDA, to the FDA for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity. It is the first and only molecule in the "-ditan" class under evaluation for the acute treatment of migraine in adults. Lilly also plans to submit an sBLA to the FDA for Emgality for the preventive treatment of episodic cluster headache in adults by the end of the year. The FDA has granted breakthrough therapy designation to Emgality for episodic cluster headache. Currently, there are no approved preventive treatments for episodic cluster headache in the U.S. The NDA for lasmiditan includes data from two Phase 3 single-attack studies, which evaluated the safety and efficacy of lasmiditan for the acute treatment of migraine. In both studies, at two hours following the first dose of lasmiditan, the percentage of patients who were migraine pain-free was significantly greater compared to placebo. These results were significant across all studied doses. Lasmiditan also met the key secondary endpoint, with a significantly greater percentage of patients free of their most bothersome symptom, or MBS, compared with placebo at two hours following the first dose. In these studies, patients chose their MBS from sensitivity to light, sensitivity to sound or nausea. The most commonly reported adverse events after lasmiditan dosing were dizziness, paresthesia, somnolence, fatigue, nausea, muscle weakness and numbness.

  • 03

    Dec

LLY Eli Lilly
$111.85

-0.77 (-0.68%)

10/31/18
10/31/18
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. General Electric (GE) upgraded to Buy from Neutral at UBS with analyst Steven Winoker saying he has conviction that new CEO Larry Culp can lead a turnaround of the business and his upside/downside analysis for shares now stands at a favorable 3:1 skew following the recent selloff. 2. Eli Lilly (LLY) upgraded to Neutral from Underperform at Credit Suisse. 3. Comerica (CMA) upgraded to Strong Buy from Outperform at Raymond James with analyst David Long saying the pullback in the sector provides more attractive risk/reward in Comerica shares and said its deposit base is relatively attractive given its high 52% composition of noninterest-bearing deposits, 87.5% loan/deposit ratio, and low 21% cumulative deposit beta. 4. Denny's (DENN) upgraded to Overweight from Equal Weight at Stephens with analyst Will Slabaugh saying the company's transition to a 95%-plus franchised model, and the improving return on invested capital that accompanies the transition, should "command a higher valuation." 5. ASML (ASML) upgraded to Buy from Hold at Santander. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/31/18
HCWC
10/31/18
NO CHANGE
Target $24
HCWC
Buy
Dicerna price target raised to $24 after Lilly, Alexion pacts at H.C. Wainwright
H.C. Wainwright analyst Ed Arce raised his price target on Dicerna (DRNA) shares to $24 from $20 after the company announced collaborations with Eli Lilly (LLY) and Alexion Pharmaceuticals (ALXN). Arce views these partnerships as further strong validation of Dicerna's GalXC RNAi platform and keeps a Buy rating on the shares.
10/31/18
FBCO
10/31/18
UPGRADE
FBCO
Neutral
Eli Lilly upgraded to Neutral from Underperform at Credit Suisse
10/29/18
SBSH
10/29/18
NO CHANGE
Target $30
SBSH
Buy
Dicerna price target raised to $30 from $27 at Citi
Citi analyst Robyn Karnauskas said Dicerna's (DRNA) licensing and research collaboration with Eli Lilly (LLY) validates the former's RNAi platform and provides it with a meaningful cash infusion. The $200M upfront payment adds $3 to her discounted cash flow-derived price target, moving the target up to $30. Karnauskas keeps a Buy rating on Dicerna shares.

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