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LOXO

Loxo Oncology

$159.49

-3.01 (-1.85%)

13:20
10/07/18
10/07
13:20
10/07/18
13:20

Loxo Oncology announces LOXO-292 durability update in RET-Mutant MTC

Loxo Oncology announced updated interim clinical data for LOXO-292 from the global Phase 1/2 LIBRETTO-001 trial in patients with RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer who were initially included in the LOXO-292 presentation at the 2018 ASCO Annual Meeting. In these 38 patients, approximately 3.5 months of additional patient follow-up were available, as were first follow-up scans for the nine patients most recently enrolled. Sixteen of 17 responding RET-mutant MTC patients remained on therapy, with median follow-up of 8.4 months. Seven of seven responding RET fusion-positive thyroid cancer patients remained on therapy, with median follow-up of 8.5 months. Inclusion of new restaging data for the most recently enrolled patients resulted in a 59% overall response rate in the presented subset of RET-mutant MTC patients, and a 78% confirmed overall response rate in the presented subset of RET fusion-positive thyroid cancer patients. These data were presented at the 88th Annual Meeting of the American Thyroid Association. The data presented were based on a July 19, 2018 data cut-off date and included the 29 patients with RET-mutant MTC and the nine patients with RET fusion-positive thyroid cancer who were initially included in the LOXO-292 presentation at the 2018 ASCO Annual Meeting. Patients were heavily pretreated, having received a median of three prior systemic treatment regimens. Of the patients with RET-mutant MTC, 79% had previously received cabozantinib or vandetanib and 45% had received prior treatment with both agents. Of the patients with RET fusion-positive thyroid cancer, 78% had previously received radioactive iodine and 78% had previously received sorafenib or lenvatinib. Anti-tumor activity was observed regardless of RET mutation, RET fusion partner, and prior multikinase inhibitor treatment. One patient, with RET fusion-positive thyroid cancer, had RECIST target lesions in the central nervous system and exhibited an intracranial partial response by RECIST 1.1, pending confirmation. Of the 82 patients in the safety analysis, most treatment-emergent adverse events were Grade 1 in severity and judged by the investigator as not related to LOXO-292.

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LOXO Loxo Oncology
$159.49

-3.01 (-1.85%)

09/17/18
GUGG
09/17/18
INITIATION
Target $184
GUGG
Neutral
Loxo Oncology initiated with a Neutral at Guggenheim
Target $184.
09/24/18
LEER
09/24/18
INITIATION
Target $205
LEER
Outperform
Loxo Oncology initiated with an Outperform at Leerink
Leerink analyst Andrew Berens started Loxo Oncology with an Outperform rating and $205 price target.
09/26/18
PIPR
09/26/18
NO CHANGE
Target $200
PIPR
Overweight
Loxo RET inhibitor still looks superior to Blueprint's, says Piper Jaffray
Loxo Oncology (LOXO) provided an update of the Phase I/II Libretto study of LOXO-292, the company's RET inhibitor and the vast majority of the current valuation, Piper Jaffray analyst Tyler Van Buren tells investors in a research note. While the overall response rate dropped slightly from 77% to 68% in more patients, it still appears superior to Blueprint Medicines' (BPMC) competing BLU-667, which has thus far demonstrated a 47% response rate in a similar patient population, the analyst contends. Van Buren adds that he's unconcerned by the two new grade three adverse events reported. He believes there "may very well" be upside to his current $1.5B peak sales estimate by the mid-2020s. The analyst reiterates an Overweight rating on Loxo Oncology with a $200 price target.
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.

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