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LOXO

Loxo Oncology

$160.01

-7.58 (-4.52%)

, BAYRY

Bayer

$0.00

(0.00%)

13:58
10/21/18
10/21
13:58
10/21/18
13:58

Loxo's larotrectinib delivers 81% ORR in expanded dataset of 109 TRK fusion cancer

Bayer (BAYRY) and Loxo Oncology (LOXO) announced updated clinical data for larotrectinib in adult and pediatric patients with TRK fusion cancer across 24 unique tumor types. The update included approximately one year of additional follow-up for a primary dataset of 55 patients as well as results from a supplementary dataset of 67 patients.1 The overall response rates in these groups were 80% and 81%, respectively, while the median duration of response had not yet been reached in either group. Complete responses in the primary dataset continued to mature, increasing to 18%, while the additional patients in the supplementary dataset experienced a CR rate of 17%. This is the only analysis to examine the efficacy and safety of a single-purpose drug for the treatment of TRK fusion cancer. The 122-patient integrated dataset included both adult and pediatric patients with TRK fusion cancer across 24 unique tumor types, ranging in age from approximately one month to 80 years. Tumor types included 10 distinct soft tissue sarcomas, salivary gland, infantile fibrosarcoma, thyroid, lung, melanoma, colon, gastrointestinal stromal tumor, breast, bone sarcoma, cholangiocarcinoma, carcinoma of unknown primary, congenital mesoblastic nephroma, appendiceal, and pancreas cancers. Safety results were generally consistent with previous presentations, with the majority of adverse events grade 1 or 2. No treatment-related grade 3 or 4 AEs occurred in more than 5 percent of patients. The U.S. Food and Drug Administration granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase gene fusion. The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act. Bayer has submitted a Marketing Authorization Application in the EU and additional filings in other markets are underway.

LOXO

Loxo Oncology

$160.01

-7.58 (-4.52%)

BAYRY

Bayer

$0.00

(0.00%)

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LOXO Loxo Oncology
$160.01

-7.58 (-4.52%)

09/26/18
STFL
09/26/18
NO CHANGE
Target $217
STFL
Buy
Loxo data not 'transformational,' but keeps inspiring confidence, says Stifel
Stifel analyst Stephen Willey said the incremental follow-up data from Loxo Oncology's (LOXO) LIBRETTO-001 trial isn't "transformational," but it does confirm his confidence in the establishment of a high competitive hurdle for LOXO-292, which he sees being a "best-in-class" and first-to-market asset in a $1B+ market. He remains confident LOXO-292 is the superior asset, but acknowledges the anticipation of Blueprint Medicines' (BPMC) updated BLU-667 data at some point in late-FY18 to early-FY19 could serve as a bit of headwind on Loxo shares nearer to that data release. Willey keeps a Buy rating and $217 price target on Loxo shares.
10/07/18
PIPR
10/07/18
NO CHANGE
Target $200
PIPR
Overweight
Loxo Oncology's 292 remains on top after RET data updates, says Piper Jaffray
Piper Jaffray analyst Tyler Van Buren reiterates an Overweight rating and $200 price target for Loxo Oncology (LOXO) after the company provided an update of the thyroid patients in the Phase I/II study of LOXO-292. The analyst highlights that in the largest patient population the response rate increased from 45% to 59% with three additional patients responding between 9 and 12 months. Blueprint Medicines' (BPMC) competing BLU-667 reported a 49% ORR in a similar patient population and recall that adverse events of hypertension are still a concern, he notes. Van Buren believes that the 667's safety profile could continue to look worse as it continues to administer the drug to patients at higher doses and that treatment discontinuations could increase. Overall, the analyst believes Loxo's 292 appears to be the superior RET inhibitor in development, both in terms of efficacy and safety and could easily become a $1B+ drug.
10/08/18
IFSG
10/08/18
UPGRADE
IFSG
Outperform
Loxo Oncology upgraded to Outperform from Market Perform at IFS Securities
10/08/18
10/08/18
UPGRADE
Target $190

Outperform
Loxo Oncology upgraded to Outperform on LOXO-292 update at IFS Securities
As previously reported, IFS Securities analyst David Bouchey upgraded Loxo Oncology to Outperform from Market Perform, with $190 price target, after the company reported updated results from its Phase I/II trial for LOXO-292. The analyst believes the response rates for LOXO-292 continue to look "very strong," the safety data is "excellent" and early results show that these responses appear durable. So far, the drug has outperformed expectations, he adds.
BAYRY Bayer
$0.00

(0.00%)

08/27/18
08/27/18
UPGRADE
Target $34

Neutral
Portola Pharmaceuticals upgraded to Neutral as MARINER sinks at Credit Suisse
As previously reported, Credit Suisse analyst Vamil Divan upgraded Portola Pharmaceuticals (PTLA) to Neutral from Underperform after Johnson & Johnson (JNJ)/Bayer (BAYRY) presented disappointing data for Xarelto in the acute medically ill population at ESC. The analyst notes that the data avoids a worst case scenario for Portola's Bevyxxa by essentially removing a potentially strong competitor, but does put the pressure on Portola to successfully change medical practice on its own, without help from a larger player such as Johnson & Johnson. Divan also raised his price target on Portola's shares to $34 from $28.
09/11/18
EXAN
09/11/18
DOWNGRADE
EXAN
Neutral
Bayer downgraded to Neutral from Outperform at Exane BNP Paribas
09/18/18
09/18/18
UPGRADE

Bayer upgraded to Buy from Hold at M.M. Warburg
M.M. Warburg analyst Ulrich Huwald upgraded Bayer to Buy and raised his price target for the shares to EUR 88.50 from EUR 85.
09/20/18
SBSH
09/20/18
UPGRADE
SBSH
Buy
Bayer upgraded to Buy from Neutral at Citi
Citi analyst Peter Verdult upgraded Bayer to Buy saying the current risk/reward is "difficult to ignore" with investor sentiment at "rock bottom." The analyst believes the negative earnings revisions have likely bottomed out.

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