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MYL

Mylan

$19.26

-0.38 (-1.93%)

, TBPH

Theravance Biopharma

$20.19

-0.44 (-2.13%)

10:19
05/20/19
05/20
10:19
05/20/19
10:19

Theravance, Mylan study highlights possible role of Yupelri in COPD treatment

Theravance Biopharma (TBPH) and Mylan N.V. (MYL) announced the presentation of data from its pivotal Phase 3 efficacy studies and a 52-week safety study at the 2019 American Thoracic Society International Conference in Dallas, Texas. YUPELRI inhalation solution, a long-acting muscarinic antagonist is the first and only once-daily, nebulized bronchodilator approved for the maintenance treatment of chronic obstructive pulmonary disease in the U.S., the companies said in a statement. Researchers presented a subgroup analysis of data from the revefenacin Phase 3 program of patients treated concurrently with long-acting beta agonists either with or without inhaled corticosteroids. A prespecified subgroup analysis was conducted on pooled data from two 12-week replicate placebo-controlled trials. Separately, exploratory endpoint data from a 52-week randomized, tiotropium-controlled safety trial were analyzed. Overall, an average of 43% of patients across the three studies were using concurrent LABA or LABA/ICS combination therapy. This subgroup had more severe disease at baseline. The results suggest the use of YUPELRI with LABA or ICS/LABA may provide additional COPD symptom control particularly in patients with more severe disease, though additional studies are needed to confirm any such benefit. In the analysis of the pooled data, the once daily nebulized treatment with revefenacin produced greater improvements from baseline compared with placebo in day 85 trough FEV1 among the non-LABA and LABA subgroups. Additionally, a clinically significant improvement of an approximately 100-mL increase in trough FEV1 was sustained for 12 weeks for those treated with revefenacin in both the LABA and non-LABA subgroups.

MYL

Mylan

$19.26

-0.38 (-1.93%)

TBPH

Theravance Biopharma

$20.19

-0.44 (-2.13%)

  • 31

    May

MYL Mylan
$19.26

-0.38 (-1.93%)

05/08/19
RBCM
05/08/19
NO CHANGE
Target $26
RBCM
Outperform
Mylan price target lowered to $26 from $45 at RBC Capital
RBC Capital analyst Randall Stanicky lowered his price target on Mylan to $26, saying yesterday's 24% stock price plunge and investor frustration are "justified", even though the magnitude of the sell-off may be "overly punitive." The analyst cites the management's forecasting challenges, "delays in responding to industry change", and governance issues as factors in the stock price decline. Stanicky also keeps his Outperform rating and expects the pressure on the company's board to facilitate change to increase.
05/08/19
05/08/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Mylan (MYL) downgraded to Market Perform from Outperform at Wells Fargo with analyst David Maris saying Mylan reported "disappointing" results which missed consensus on several key metrics including revenue and revenue by segment. 2. Inogen (INGN) downgraded to Neutral from Overweight at JPMorgan with analyst Robert Marcus saying the company's in-line Q1 results were overshadowed by a $25M reduction to guidance. 3. Fortive (FTV) downgraded to Equal Weight from Overweight at Morgan Stanley with analyst Joshua Pokrzywinski citing the stock's valuation after a 29% year-to-date advance as well as the sector valuation of "high quality industrials". 4. Farmer Bros. (FARM) downgraded to Neutral from Buy at Roth Capital with analyst Gerry Sweeney saying the company's results were hurt by significant operating issues and Mike Keown stepped down as CEO. 5. 2U (TWOU) downgraded to Neutral from Outperform at Credit Suisse with analyst Brad Zelnick noting the company reported Q1 and lowered its fiscal year revenue guidance, primarily accounting for schools tightening their admissions. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
05/13/19
WELS
05/13/19
NO CHANGE
WELS
Lawsuit against Teva, others to hit generic drug stocks, says Wells Fargo
Wells Fargo analyst David Maris believes the lawsuit by 44 states against 20 generic drugmakers will weigh on generic drug stocks this week and remain an "overhang issue for some time." Actual penalties and damages are impossible to calculate, but could be material, Maris tells investors in a research note. The analyst spoke to the Connecticut attorney general's office this morning and learned they are preparing for trial in these cases. Language the attorney general has used, such as "unprecedented" and his desire to clawback all gains from collusion, should be indicative of the states' intent, Maris writes. He believes that for a sector that is generally highly levered, and with some companies named already facing an overhang from opioid litigation like Teva (TEVA), this is "especially unwelcome news."
05/15/19
WELS
05/15/19
NO CHANGE
WELS
Lawsuit creates overhang for Teva, Mylan, says Wells Fargo
Wells Fargo analyst David Maris continues to be cautious on Teva (TEVA) and Mylan (MYL) following the price fixing lawsuit against generic companies, and said that the lack of criminal charges "does not take away the financial overhang of the suit." The analyst added that this suit may stop "opportunistic price increases in generics." He remains on the sidelines on both Teva and Mylan, both of which he has Market Perform ratings on.
TBPH Theravance Biopharma
$20.19

-0.44 (-2.13%)

09/27/18
PIPR
09/27/18
NO CHANGE
Target $55
PIPR
Overweight
Theravance financial flexibility, assets underappreciated, says Piper Jaffray
Piper Jaffray analyst Tyler Van Buren says recent meetings with Theravance Biopharma management support his Overweight rating on the shares. The Trelegy royalty stream could potentially be monetized in the near-term as a source of non-dilutive financing, which would alleviate concerns regarding the need for cash, a significant portion of the current bear thesis, Van Buren tells investors in a research note. Further, he notes that management remains confident in a Yupelri approval on November 13. The analyst continues to recommend that investors own Theravance shares as he believes both its financial flexibility and current assets are underappreciated.
10/23/18
PIPR
10/23/18
NO CHANGE
PIPR
Overweight
Piper says Theravance data shows 'disruptive potential' of oral JAK inhibitor
After Theravance Biopharma (TBPH) presented four-week data from the Phase Ib ulcerative colitis study of TD-1473, a gut-selective pan-JAK inhibitor for the treatment of inflammatory bowel disease, at the United European Gastroenterology Week, Piper Jaffray analyst Tyler Van Buren said the data provides substantial proof of concept and shows the "disruptive potential" that could lead to "multi-billion" global sales for Theravance and partner Janssen (JNJ). He maintains an Overweight rating on Theravance shares.
12/13/18
PIPR
12/13/18
NO CHANGE
Target $55
PIPR
Overweight
Piper Jaffray impressed by Theravance scientific approaches, data presentations
Piper Jaffray analyst Tyler Van Buren attended Theravance's R&D Day where management provided brief overviews of its late-stage programs 1473 and ampreloxetine, as well as the product Yupelri. The analyst thinks the company did a great job of laying the foundation for 5 earlier-stage organ-selective programs that are set to enter the clinic over the next couple of years, and was "impressed" by the scientific approaches and data presentations. Van Buren reiterates an Overweight rating and $55 price target on the shares.
04/08/19
CANT
04/08/19
NO CHANGE
Target $55
CANT
Overweight
Good time to take another look at Theravance, says Cantor Fitzgerald
Cantor Fitzgerald analyst Louise Chen believes it is a good time to take another look at Theravance Biopharma given its "inexpensive valuation" and "important catalysts" this year. The company's cash and equivalents totaled $517.1M at the end of 2018 and it appears well positioned to receive over $1B in milestones and payments, Chen tells investors in a research note. However, its market capitalization is only $1.3B, says the analyst. She thinks the peak sales potential of Theravance's organ-selective JAKs, Ampreloxetine, Yupelri and Trelegy, are all underappreciated and keeps an Overweight rating on the shares with a $55 price target.

TODAY'S FREE FLY STORIES

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AUPH

Aurinia Pharmaceuticals

$6.37

0.03 (0.47%)

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NSANY

Nissan

$0.00

(0.00%)

, RNSDF

Renault

$0.00

(0.00%)

06:39
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Nissan

$0.00

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$0.00

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FISV

Fiserv

$89.05

0.08 (0.09%)

, FDC

First Data

$26.50

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ARMP

Armata Pharmaceuticals

$2.81

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NCMI

National CineMedia

$6.44

-0.03 (-0.46%)

06:35
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Ares Management

$27.30

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TSN

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MRK

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BA

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SIX

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GNLN

Greenlane

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EADSY

Airbus

$0.00

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