Sarepta drops after U.K. trial halt

Sarepta drops after U.K. trial halt, but analysts unconcerned

Sarepta drops after U.K. trial halt,
Sarepta drops after U.K. trial halt,

Shares of Sarepta Therapeutics (SRPT) dropped in morning trading following a report that said that the company had halted treatment at sites in the United Kingdom testing its Duchenne muscular dystrophy drug golodirsen due to “one serious adverse event” that could be related to the drug.

TRIAL HALT

According to news analysis service EP Vantage, Sarepta has temporarily halted treatment at U.K. sites in a clinical trial of golodirsen, an investigational therapy for Duchenne muscular dystrophy in boys with the gene that is amenable for skipping Exon 53, following “one serious adverse event that could possibly be related to the investigational drug product.”

EP Vantage said it learned of the halt after seeing posts on Facebook from a parent of a child enrolled in the trial.

According to the parent, the trial was halted due to an occurrence of rhabdomyolysis, a condition in which damaged skeletal muscle tissue breaks down rapidly.

Sarepta confirmed that the Medicines and Healthcare products Regulatory Agency, or MHRA, ordered dosing to be halted at its four centers in the U.K. because of “U.K.-specific stopping rules,” and added that safety data from all patients in the ESSENCE study have been reviewed by an independent monitoring committee, which deemed that dosing could continue for all subjects.

PATIENT RESTARTED WITH NO FURTHER ISSUES

STAT’s Adam Feuerstein tweeted this morning that “Only thing I’d add, based on my calls, is that the patient re-started golodirsen in the study w/ no further problems.”

He added that “Folks calling out $SRPT CEO Doug Ingram for lack of transparency after he ripped $SLDB for same. Valid criticism.”

According to reports, Solid Biosciences (SLDB) failed to disclose some negative issues related to its work on its own DMD treatment.

In its IPO filing, Solid said testing of SGT-001 had been partially suspended since November. While the partial clinical hold has kept Solid from administering a high dose of the gene therapy, it is permitted to continue testing a lower dose.

WHAT’S NOTABLE

In September, Sarepta said that in a Phase 1/2 trial in Europe that enrolled 25 boys with DMD, there was a 100% response rate with golodirsen “demonstrating proof of mechanism.”

ANALYSTS DOWNPLAY ISSUE

JPMorgan analyst Anupam Rama kept an Overweight rating on Sarepta and said downside in shares this morning is overdone as he does not view the update on the company’s ESSENCE trial as a major setback, noting the safety board has suggested the study can continue recruitment.

Piper Jaffray analyst Edward Tenthoff reiterated an Overweight rating and $60 price target on Sarepta, and said he is awaiting further clarity on the trial halt before making adjustments.

He sees Exondys51 sales of $152M in 2017, at the high end of the $150M-$155M guidance.

PRICE ACTION

In Friday’s trading, shares of Sarepta Therapeutics are down over 8% to $52.50.


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Pieris Pharmaceuticals higher on collaboration with Seattle Genetics

Pieris Pharmaceuticals, Seattle Genetics enter collaboration, license agreement

Pieris Pharmaceuticals higher on collaboration with Seattle Genetics
Pieris Pharmaceuticals higher on collaboration with Seattle Genetics

Pieris Pharmaceuticals (PIRS) and Seattle Genetics (SGEN) announced they have entered into a collaboration and license agreement with the goal of developing multiple targeted bispecific immuno-oncology treatments for solid tumors and blood cancers.

The collaboration leverages the expertise and core technologies of both companies to develop novel Antibody-Anticalin fusion proteins.

Under the terms of the agreement, Seattle Genetics will pay Pieris a $30M upfront fee, tiered royalties on net sales up to low double-digits, and up to $1.2B in total success-based payments across three product candidates.

The companies will pursue multiple Antibody-Anticalin fusion proteins during the research phase, and Seattle Genetics has the option to select up to three therapeutic programs for further development.

Prior to the initiation of a pivotal trial, Pieris may opt into global co-development and US commercialization of the second program and share in global costs and profits on a 50/50 basis.

Seattle Genetics will solely develop, fund and commercialize the other two programs.

PIRS closed at $7.14. It last traded at $8.32.


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Amazon.com enters delivery business

Amazon.com to directly compete with United Parcel Service and FedEx

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Amazon.com to directly compete with United Parcel Service and FedEx

Amazon.com Inc. (AMZN) is preparing to launch a delivery service for businesses, positioning it to directly compete with United Parcel Service Inc. and FedEx Corp.

Amazon is planning to launch a delivery services for businesses called “Shipping with Amazon” that would compete with FedEx (FDX) and UPS (UPS), The Wall Street Journal reports.

The service would involve Amazon picking up packages from businesses and shipping them to consumers, people familiar with the matter say.

The tech giant expects to roll out the SWA service in Los Angeles “in the coming weeks” with third-party merchants that sell products through its website, the people say, and could expand the service to more cities as soon as this year.

Amazon’s business delivery is expected to roll out in Los Angeles in the coming weeks with third-party merchants that sell goods via its website. More cities are to follow.

UPS said it is still a partner of Amazon.

“UPS continues to support Amazon and many other customers and we don’t make comments about their business strategies or decisions regarding their utilization of UPS services,” a spokesperson for the company said.

In pre-market trading, FedEx is down about 2% and UPS dropped 3.5%.


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