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ALNY

Alnylam

$70.30

1.73 (2.52%)

, MDCO

The Medicines Co.

$38.51

0.32 (0.84%)

16:34
10/05/16
10/05
16:34
10/05/16
16:34

Alnylam ends revusiran development after nerve damage risk

Alnylam Pharmaceuticals (ALNY) announced that, upon the recommendation of the ENDEAVOUR Phase 3 study data monitoring committee to suspend dosing, the company has decided to discontinue development of revusiran, an investigational RNA interference therapeutic that was being developed for the treatment of hereditary ATTR amyloidosis with cardiomyopathy. "This decision was made yesterday evening and has been communicated to investigators, study sites, and regulatory authorities. Following recent reports in the Phase 2 OLE study of new onset or worsening peripheral neuropathy, the ENDEAVOUR DMC assembled yesterday at the company's request to review these reports and ENDEAVOUR data on an unblinded basis. The DMC did not find conclusive evidence for a drug-related neuropathy signal in the ENDEAVOUR trial, but informed the company that the benefit-risk profile for revusiran no longer supported continued dosing. The company subsequently reviewed unblinded ENDEAVOUR data which revealed an imbalance of mortality in the revusiran arm as compared to placebo... We remain committed to serving the needs of the ATTR amyloidosis community," the company explained. The company noted it will "continue to evaluate ENDEAVOUR data to understand the potential cause of these findings." The decision to discontinue development of revusiran does not affect patisiran, which is currently in Phase 3 development for the treatment of hATTR amyloidosis with polyneuropathy, or any other Alnylam investigational RNAi therapeutic program in development. Based on a current assessment of the safety data across the company's other programs, which include the ALN-PCSsc program partnered with The Medicines Company (MDCO), there is no evidence of a drug-related neuropathy signal in over 800 treated subjects and patients with exposure of up to 34 months. The company reaffirms its "Alnylam 2020" guidance and remains committed to the advancement of these investigational RNAi therapeutics.

ALNY

Alnylam

$70.30

1.73 (2.52%)

MDCO

The Medicines Co.

$38.51

0.32 (0.84%)

  • 14

    Oct

  • 06

    Nov

ALNY Alnylam
$70.30

1.73 (2.52%)

08/22/16
WEDB
08/22/16
NO CHANGE
WEDB
Intellia Therapeutics data positive, says Wedbush
Wedbush analyst David Nierengarten says that additional data on Intella's (NTLA) TTR program in mice was "meaningful" and indicates that the program compares favorably with competing products. The analyst says that competing programs, including those of Alnylam (ALNY) and Ionis (IONS) have shown "only a transient benefit." He reiterates a $38 price target and Outperform rating on Intella.
09/09/16
LEER
09/09/16
NO CHANGE
LEER
Leerink updates therapeutics best ideas for 2016
In a note to investors this morning, Leerink has updated its best ideas for 2016 from the firm's five therapeutics analysts. The list includes Alexion (ALXN), Dermira (DERM), Intra-Cellular (ITCI), Sanofi (SNY), Allergan (AGN), Alnylam (ALNY), Innate Pharma (IPHYF), The Medicines Co. (MDCO), and Ophthotech (OPHT).
09/15/16
FBRC
09/15/16
INITIATION
Target $82
FBRC
Underperform
FBR calls Alexion overvalued, starts shares at Underperform
FBR Capital analyst Christopher James initiated coverage of Alexion Pharmaceuticals (ALXN) with an Underperform rating and $82 price target. The biotech focused on patients with ultra-rare disorders closed yesterday up $2.63 to $129.42. Alexion shares are overpriced as the company is facing a competitive near-term landscape, particularly from Alnylam's (ALNY) ALN-CC5, James tells investors in a research note. Further, near-term expansion into additional indications will be challenging given the recent failed study with eculizumab in refractory generalized myasthenia gravis, the analyst contends. He also sees possible pricing pressures from biosimilars, including an Amgen (AMGN) biosimilar product in development. James this morning also initiated Achillion Pharmaceuticals (ACHN) and Arena Pharmaceuticals (ARNA) with Outperform ratings.
09/28/16
JANY
09/28/16
INITIATION
Target $74
JANY
Neutral
Alnylam initiated with a Neutral at Janney Capital
Janney Capital analyst Roy Buchanan initiated Alnylam with a Neutral and a $74 fair value estimate. The analyst is not confident about the outcome for the pivotal study for patisiran in transthyretin familial amyloid neuropathy, expected in about 12 months, and give patisiran a 50% chance of success.
MDCO The Medicines Co.
$38.51

0.32 (0.84%)

05/13/16
JEFF
05/13/16
NO CHANGE
Target $43
JEFF
Buy
The Medicines Co. could rally $4/share on positive data, says Jefferies
Jefferies analyst Biren Amin says The Medicines Co. has a "catalyst-rich" second half of 2016, including the Phase III trials of Carbavance in complicated urinary tract infections and carbapenem resistant enterobacteriaceae infections. The analyst expects both of the trials will be successful and show non-inferiority leading to potential FDA approval. Amin thinks shares could move $3 to $4 per share on positive data readout. He keeps a Buy rating on The Medicines Co. with a $43 price target.
07/11/16
JEFF
07/11/16
NO CHANGE
Target $43
JEFF
Buy
Jefferies views The Medicines Co. ruling as positive surprise
Jefferies analyst Biren Amin views today's Court of Appeals ruling as a "positive surprise" for The Medicines Company. The ruling "breathes potential life" into the company's Angiomax patents, Amin tells investors in a research note. He expects Hospira to file an appeal within 90 days. The analyst has a Buy rating on The Medicines Co. with a $43 price target.
08/02/16
EVER
08/02/16
NO CHANGE
EVER
Buy
Pfizer shelves oral PCSK9, a Medicines Co. competitor, says Evercore ISI
Evercore ISI analyst Umer Raffat said Pfizer (PFE) management does not thin the profile for oral PCSK9 will be competitive with the strong efficacy of antibodies and have moved other interesting products forward. Raffat said some Medicines Co. (MDCO) investors had worried that a potential oral PCSk9 from Pfizer could greatly reduce enthusiasm for an every-6-month PCSk9 from MDCO. The analyst said the next catalyst for The Medicines Co. is A1 Milano readout this month. Raffat rates The Medicines Co. a Buy with a $52 price target.

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