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SRPT

Sarepta

$49.88

0.94 (1.92%)

, PTCT

PTC Therapeutics

$7.55

-0.42 (-5.27%)

12:53
10/19/16
10/19
12:53
10/19/16
12:53

FDA official says Sarepta 'NOT a good model for other development programs'

In an October 18 slide presentation prepared for the NORD Summit Meeting, John Jenkins, director of the FDA's Office of New Drugs states: "A poorly planned and executed development program for a rare disease misuses valuable patient resources and serves to delay obtaining the knowledge required to understand the benefits and risks of a drug to support regulatory review and approval... Path taken by Sarepta NOT a good model for other development programs." Sarepta (SRPT) recently received approval for Exondys 51, its Duchenne muscular dystrophy treatment, despite criticism that it had not proven a true clinical benefit. In the wake of the medicine's controversial approval, market observers and analysts have debated whether drug candidates from PTC Therapeutics (PTCT) and BioMarin (BMRN) could benefit from the FDA's seemingly loosened approval standards and apparent desire to see Duchenne treatments on the market. Reference Link

SRPT

Sarepta

$49.88

0.94 (1.92%)

PTCT

PTC Therapeutics

$7.55

-0.42 (-5.27%)

BMRN

BioMarin

$85.40

-0.05 (-0.06%)

  • 19

    Oct

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    Nov

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    Dec

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    Apr

SRPT Sarepta
$49.88

0.94 (1.92%)

10/18/16
FBCO
10/18/16
INITIATION
Target $68
FBCO
Outperform
Sarepta initiated with an Outperform at Credit Suisse
Credit Suisse analyst Alethia Young initiated Sarepta with an Outperform and a $68 price target. The analyst has positive expectations on the US EXONDYS 51 launch, confidence of approval and IP settlement in Europe, and success with the Exon 53 program in mid-2017.
10/17/16
JANY
10/17/16
NO CHANGE
JANY
PTC's denial has negative read-through for BioMarin, says Janney Capital
Janney Capital noted that PTC Therapeutics' (PTCT) Translarna and Sarepta's (SRPT) Exondys 51 address non-overlapping DMD populations and there was an expectation of flexibility from the FDA following the conditional approval of Exondys 51. However, the FDA has denied the first appeal of the refuse to file letter regarding PTC's NDA for Translarna for the treatment of nonsense mutation DMD, which the firm said has potential negative read-through for BioMarin's (BMRN) attempt to rekindle Kyndrisa, which is a direct competitor to Sarepta's Exondys 51. The firm added that the news might positively impact reimbursement decisions for Exondys 51.
10/07/16
BARD
10/07/16
NO CHANGE
Target $102
BARD
Outperform
Anthem policy does not mean insurer not covering Sarepta drug, says Baird
Baird analyst Brian Skorney noted Anthem (ANTM) has categorized Sarepta (SRPT) Duchenne muscular dystrophy drug Exondys 51 as "not medically necessary" in a new coverage policy, but he cautions this "does not mean that Anthem is not covering the drug." The analyst explains that the policy means prior authorization requirements may be stricter, but he "highly doubts" that eligible patients will be denied coverage. Skorney, who adds that other large insurers appear to have favorable coverage for the drug, keeps an Outperform rating and $102 price target on Sarepta shares.
10/05/16
ADAM
10/05/16
NO CHANGE
Target $28
ADAM
Buy
Summit Therapeutics price target raised to $28 from $14 at Canaccord
Canaccord analyst Arinda Lee raised her price target on Summit Therapeutics (SMMT) to $28 from $14 following the announcement of its collaboration and licensing agreement with Sarepta Therapeutics (SRPT). The deal calls for Sarepta to gain EU commercialization rights to Summit's pipeline of oral utrophin modulators for all patients with Duchenne muscular dystrophy. Lee reiterated her Buy rating Summit Therapeutics shares.
PTCT PTC Therapeutics
$7.55

-0.42 (-5.27%)

09/20/16
JEFF
09/20/16
NO CHANGE
Target $7
JEFF
Hold
Jefferies thinks eteplirsen approval will have limited impact on PTC
Jefferies analyst Gena Wang believes yesterday's FDA approval of Sarepta Therapeutics' (SRPT) eteplirsen will have a limited impact on PTC Therapeutics (PTCT). While PTC's potential treatment for Duchenne muscular dystrophy ataluren is considered safe, the FDA approval of eteplirsen is mainly based on the marginal increase of dystrophin level and PTC does not have any dystrophin data from Phase 3, Wang tells investors in a research note. Eteplirsen's approval could pressure the FDA to reconsider the review progress of ataluren, but the final outcome would likely remain the same, the analyst contends. She keeps a Hold rating on PTC with a $7 price target. The stock closed yesterday up 21%, or $1.88, to $10.99.
10/03/16
BOFA
10/03/16
NO CHANGE
Target $15
BOFA
Buy
PTC Therapeutics price target raised to $15 from $9 at BofA/Merrill
BofA/Merrill analyst Tazeen Ahmad raised PTC Therapeutics' price target to $15 from $9 following partner Roche's recruitment for a trial it is conducting to investigate a potential treatment for Spinal Muscular Atrophy, or SMA, patients. Given this advancement, the analyst is raising his probability of approval to 30% from 20% in SMA and maintains his Neutral rating.
10/17/16
SBSH
10/17/16
NO CHANGE
Target $9
SBSH
Neutral
Citi says time running out for PTC Therapeutics in Europe
Citi analyst Joel Beatty says that while the FDA's denial of PTC Therapeutics' first appeal was widely expected, the major objection relating to the efficacy of Translarna by Europe's Committee for Medicinal Products for Human Use is more concerning. The move highlights that the CHMP is still not comfortable with the overall risk-benefit profile of Translarna ahead of an expected decision by year-end, Beatty tells investors in a research note. He sees heightened risk of Translarna's marketing authorization not being renewed in Europe and feels PTC's time is running out to alleviate CHMP's concerns. The analyst has a Neutral rating on the shares with a $9 price target. PTC is trading down 30%, or $3.94, to $9.34 in morning trading.
BMRN BioMarin
$85.40

-0.05 (-0.06%)

10/14/16
BARD
10/14/16
NO CHANGE
Target $115
BARD
Outperform
BioMarin hemophilia drug update encouraging, says Baird
Baird analyst Michale Ulz said he is encouraged by BioMarin's update on its Phase 1/2 study of its Hemophilia A drug, BMN-270. The analyst noted U.K. regulators approved continued enrollment in the gene-therapy study and the study was amended to allow dose optimization ahead of the Phase 2b study expected in 2017. Ulz reiterated his Outperform rating and $115 price target on BioMarin shares.
10/07/16
GSCO
10/07/16
NO CHANGE
GSCO
Smid-cap Biotech sector upgraded to Attractive from Neutral at Goldman
Goldman analyst Salveen Richter upgraded the Smid-cap biotechnology to Attractive and said he favors and companies with near-term pipeline data or regulatory events where he has conviction.Names he recommends are Buy rated BioMarin (BMRN), bluebird bio (BLUE), GW Pharma (GWPH), Incyte (INCY), Kite (KITE), and Sage (SAGE).
09/21/16
LEER
09/21/16
NO CHANGE
LEER
Market Perform
Previous PTAB ruling remains overhang on Sarepta eteplirsen, says Leerink
Leerink analyst Joseph Schwartz notes that Sarepta (SRPT) has announced favorable Patent Trial and Appeal Board of the U.S. Patent and Trademark Office decisions in favor of its exon 51 and 53 composition of matter patent interference cases against BioMarin (BMRN). However, he points out that these rulings are subject to appeal and a previous ruling from the U.S. Patent Trial and Appeal Board, or PTAB, in favor of BioMarin's method of use patent remains an overhang on the commercialization of Sarepta's eteplirsen. The analyst reiterates a Market Perform rating on Sarepta's shares.

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Sarepta

$34.72

-0.14 (-0.40%)

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SRPT

Sarepta

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-0.14 (-0.40%)

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SRPT

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