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TEVA

Teva

$42.96

-1.32 (-2.98%)

, REGN

Regeneron

$371.68

-4.11 (-1.09%)

07:01
10/17/16
10/17
07:01
10/17/16
07:01

Regeneron, Teva say FDA places clinical hold on Phase 2b fasinumab study

Regeneron Pharmaceuticals (REGN) and Teva Pharmaceutical (TEVA) provided an update on fasinumab, triggered by a recent development in a Phase 2b fasinumab study in patients with chronic low back pain. Fasinumab is an investigational Nerve Growth Factor antibody in clinical development for osteoarthritis pain and chronic low back pain. The U.S. FDA has placed the Phase 2b study in chronic low back pain on clinical hold and requested an amendment of the study protocol after observing a case of adjudicated arthropathy in a patient receiving high dose fasinumab who had advanced osteoarthritis at study entry. As a result of the FDA decision, Regeneron completed an unplanned interim review of results and has stopped dosing in the study. The unplanned analysis showed clear evidence of efficacy with improvement in pain scores in all fasinumab groups compared to placebo at the 8- and 12-week time points. Preliminary safety results are generally consistent with what has been previously reported with the class. The Phase 2b chronic low back pain study enrolled approximately 70 percent of the targeted 800 patients in four dose groups: placebo, 6mg subcutaneously monthly, 9mg subcutaneously monthly and 9mg intravenously every two months. Regeneron has notified health authorities and study investigators about the decision. Patients will continue to be followed for up to 36 weeks. Based on these results, Regeneron and Teva plan to design a pivotal Phase 3 study in chronic low back pain that excludes patients with advanced osteoarthritis. The companies plan to submit a pivotal program plan for review with the FDA and other health authorities.

TEVA

Teva

$42.96

-1.32 (-2.98%)

REGN

Regeneron

$371.68

-4.11 (-1.09%)

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TEVA Teva
$42.96

-1.32 (-2.98%)

10/06/16
WELS
10/06/16
NO CHANGE
WELS
Wells calls Teva partnership with Celltrion 'good news'
Wells Fargo analyst David Maris views Teva Pharmaceutical's partnership to commercialize two of Celltrion's monoclonal antibody biosimilar candidates as "good news." Teva is now a "little more firmly in the biosimilar game," Maris tells investors in a research note. He likes that the initial cash outflow is small and the partner. Maris has an Outperform rating on Teva.
10/07/16
LEER
10/07/16
NO CHANGE
Target $57
LEER
Outperform
Teva price target lowered to $57 from $61 at Leerink
Leerink analyst Jason Gerberry lowered his price target for Teva to $57 from $61 and trimmed his estimates to reflect near-term headwinds and a more conservative Copaxone outlook. The analyst continues to view a generic Copaxone launch in late the second half of 2017 as a risk. Nonetheless, Gerberry reiterates an Outperform rating on the stock as he views shares as attractively valued despite near-term EPS concerns and believes investor attention will eventually pivot to Teva's attractive late stage pipeline.
10/11/16
LEHM
10/11/16
UPGRADE
Target $19
LEHM
Overweight
Momenta upgraded to Overweight from Equal Weight at Barclays
Barclays analyst Douglas Tsao upgraded Momenta Pharmaceuticals to Overweight after attending the consolidated Copaxone 40mg trial. The analyst sees low risk of Momenta being blocked from the 40mg opportunity past 2018 and views the stock's risk/reward as "compelling" at current levels. Tsao believes there is a "good likelihood" that Sandoz, Momenta's partner, launches Copaxone 40mg at-risk as soon as February 2017 upon FDA approval when the 30-month stay expires. The analyst raised his price target for Momenta shares to $19 from $13.
10/12/16
LEER
10/12/16
NO CHANGE
Target $70
LEER
Outperform
Neurocrine recent selloff a buying opportunity, says Leerink
Leerink analyst Paul Matteis views the 18% pullback in shares of Neurocrine Biosciences (NBIX) over the past few weeks as a buying opportunity. The analyst finds the catalyst for the selloff "difficult to pinpoint," but notes he's been receiving questions from investors on the size of the market opportunity for vesicular monoamine transporters in Tardive Dyskinesia. A doctor survey suggests a target market of 300,000 TD patients for Neurocrine's and Teva's VMAT2 inhibitors, which is enough to offer a "significant revenue opportunity" for both drugs, Matteis tells investors in a research note. Further, the analyst believes the upcoming Phase II data in Tourette's Syndrome, which he sees as having a high probability of success, offers a "nice catalyst for investors" into Q1 of next year. Matteis reiterates an Outperform rating on Neurocrine with a $70 price target.
REGN Regeneron
$371.68

-4.11 (-1.09%)

09/21/16
ROTH
09/21/16
NO CHANGE
Target $520
ROTH
Buy
Teva deal important for Regeneron, says at Roth Capital
Roth Capital analyst Joseph Pantginis points out that Regeneron (REGN) has signed a global partnership for fasinumab with Teva (TEVA), which he sees as an important new partnership for the former both on the product development front as well as a significant next step for fasinumab and the anti-NGF class of drugs. The analyst believes Regeneron has solid growth prospects and upside potential, and reiterates a Buy rating and $520 price target on the shares.
10/03/16
ROTH
10/03/16
NO CHANGE
Target $520
ROTH
Buy
Regeneron has 'solid' growth prospects, upside potential, says Roth Capital
After Regeneron (REGN) and Sanofi (SNY) released positive results from their Dupixent Phase 3 trials, SOLO 1 and SOLO in patients with atopic dermatitis, Roth Capital analyst Joseph Pantginis notes that clinical studies of Dupixent for additional atopic and allergic diseases are progressing and says he believes Regeneron's shares are poised for upside on upcoming catalysts. Moreover, the analyst says Regeneron has "solid" growth prospects based on approved and late stage products, deep pipeline, expansion of indications for current products, strong partners, and strong cash management. He reiterates a Buy rating and $520 price target on Regeneron's shares.
10/04/16
JPMS
10/04/16
NO CHANGE
Target $110
JPMS
Overweight
Ophthotech price target raised to $110 from $95 at JPMorgan
JPMorgan analyst Anupam Rama raised his price target for Ophthotech to $110 from $95 citing the elimination of Regeneron (REGN) from the Wet age-related macular degeneration space following its trial failure. Ophthotech closed yesterday down $2.56 to $43.57. The stock is down 20% since last Friday amid mechanism concerns following Regeneron's phase 2 data, Rama tells investors in a research note. The analyst views the weakness in Ophthotech as a buying opportunity. There are important mechanistic differences between the company's Fovista and Regeneron's REGN2176-3, and early phase 1 data for Fovista "are comparatively more compelling," the analyst contends. He points out that the Phase 3 results with Fovista + Lucentis combination therapy are expected this quarter. The analyst keeps an Overweight rating on Ophthotech.
10/13/16
BTIG
10/13/16
NO CHANGE
Target $18
BTIG
Buy
Ocular deal with Regeneron has favorable terms, says BTIG
BTIG analyst Ling Wang believes Ocular Therapeutix's (OCUL) strategic collaboration with Regeneron (REGN) comes with favorable deal terms. The back-end loaded structure brings the potential for large upside, Wang tells investors in a research note. In addition, the partnership provides external validation for Ocular's platform technology, Wang adds. The analyst reiterates a Buy rating on the shares with an $18 price target

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