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Showing posts with label BMRN. Show all posts
Showing posts with label BMRN. Show all posts

Friday, April 6, 2018

=Incyte (INCY) and Merck (MRK) : failed key Phase 3 melanoma study


  • Biotech stocks (XBI) lower after important immune-oncology combo data (Incyte's IDO inhibitor plus Merck's Keytruda) fails in key Phase 3 melanoma study:  NLNK (IDO inhibitor peer) -37.57%,  INCY -18.23%,  NKTR -9.84%,  JNCE -10.20%,  LABU -5.14%,  FPRX -3.84%,  ONCS -3.72%,  SAGE -2.21%,  SGEN -1.81%,  BLUE -4.85%,  PBYI-1.85%,  SPPI -2.46%,  CRVS -9.17%,  TSRO +0.37%,  BMRN -2.01%, GLYC-2.03%, MRK-1.19% 
  • IBB -1.99%,  XBI -1.78%




Incyte announces that the External Data Monitoring Committee determined that the Phase 3 ECHO-301/KEYNOTE-252 study did not meet the primary endpoint 
The co and Merck (MRK) announced that an external Data Monitoring Committee review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte's epacadostat in combination with Merck's KEYTRUDA in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy.
  • The study's second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA.
Incyte and Merck will inform investigators of the results and work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

Wednesday, July 19, 2017

=Sarepta Therapeutics (SRPT) reported earnings on Wed 19 July 2017 (a/h)



Sarepta Therapeutics (SRPT) stock bolted late Wednesday after the biotech smashed Wall Street views for second-quarter sales and reported narrowing losses just a day after it settled a patent dispute with BioMarin Pharmaceuticals (BMRN).

For the second quarter ended June 30, Sarepta reported adjusted losses of 46 cents a share on revenue of $35 million, compared with losses of $1.19 per share and no revenue in the year-ago quarter. Both metrics topped the consensus for a 92-cent loss and $22 million in sales.

The biotech also boosted its 2017 guidance to $125 million to $130 million after, earlier in the day, announcing a program to expand access to its only approved drug, Exondys 51, a treatment for patients with Duchenne muscular dystrophy.

Patients in North America, South America and Europe will benefit from the program which, Leerink analyst Joseph Schwartz said earlier Wednesday, could add meaningful revenue to Sarepta's top line in 2017. Schwartz has an outperform rating on Sarepta stock.