Kura Oncology (NASDAQ:KURA) +7.9% pre-market after announcing data from a phase 2 clinical trial of its tipifarnib drug candidate in patients with relapsed or refractory peripheral T-cell lymphoma.
Kura says the results of the trial showed “ongoing anti-tumor activity and a manageable safety profile” in advanced patients with angioimmunoblastic T-cell lymphoma, as well as non-AITL relapsed or refractory peripheral T-cell lymphoma.
The company believes the data support the potential to register tipifarnib in both the AITL and PTCL-NOS patient populations, and plans to seek regulatory feedback on next steps for the program.
AstraZeneca’s (NYSE:AZN) Lokelma Phase IIIb DIALIZE trial showed statistically significant and clinically meaningful improvement in treating high blood potassium levels in patients with end-stage renal disease on hemodialysis.
41.2% of patients with hyperkalemia on stable hemodialysis receiving Lokelma (sodium zirconium cyclosilicate) maintained pre-dialysis normal potassium levels on at least three out of four dialysis treatments after the long interdialytic interval and didn’t require urgent rescue therapy vs. 1.0% of patients receiving placebo.
Safety profile observed in the study was consistent with previous trials.
Data from the DIALIZE trial will support label updates in the U.S. as the dosing regimen used in the trial is not currently approved.
Enata Pharmaceuticals (NASDAQ:ENTA) is up 6.8% premarket after the company notes EDP-938 cut the amount of virus detected in the body in a study of healthy adults infected with respiratory syncytial virus.
It also resolved symptoms better than placebo.
The drug achieved its primary and secondary endpoints in the phase 2a human challenge study.
“Based on today’s positive data for EDP-938, the only N-inhibitor in clinical development, our goal is to initiate our first Phase 2b study by the end of calendar 2019 in adult outpatients with confirmed RSV infections,” says CEO Jay Luly.
Karyopharm Therapeutics (NASDAQ:KPTI) gains 4.0% in premarket trading after presenting new and updated data from its Phase 1b/2 STOMP study evaluating selinexor and dexamethasone in combination with standard approved multiple myeloma therapies in patients with previously treated multiple myeloma.
Once weekly oral selinxor in combination with Kyprolis and low-dose dexamethasone demonstrates 78% overall response rate in patients with heavily pretreated Kyprolis-naive multiple myeloma.
Two patients in Kyrprolis arm achieved a complete response.
Once weekly oral selinexor in combination with Darzalex and low-dose dexamethasone demonstrates 73% ORR in patients with heavily pretreated Darzalex-naive multiple myeloma.
Once weekly oral selinexor in combination with oral Pomalyst and low-dose dexamethasone demonstrates 57% ORR in Polmalyst-naive and Revlimid-relapsed or -refractory multiple myeloma with 12.2 month progression-free survival.
Darzalex and Pomalyst arms showed encouraging rates of very good partial responses, “which indicate a 90% or greater reduction in a patient’s disease burden,” said Karyopharm President Sharon Shacham.
Restaurant chains Red Robin Gourmet Burgers (NASDAQ:RRGB) and White Castle are seeing broad shortages of meat-free patties from Impossible Foods (IMPSBL), according to Bloomberg.
The ongoing shortages are said to show the pressure that Impossible Foods is facing to manufacture for the mass market and get a head start on wide distribution before larger companies jump in.
Impossible Foods estimates that its already on the menu at 9K restaurants and is expected to roll out nationally at Burger King locations this year.
Within the alternative protein sector, shares of Beyond Meat (NASDAQ:BYND) are down 0.26% in premarket trading to $141.02 as Tyson’s announcement yesterday of a meatless brand not doing too much to rattle investors.
Dr. Reddy’s Laboratories Limited (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announces that it has entered into a definitive asset purchase agreement with Upsher-Smith Laboratories, LLC (Upsher-Smith), pursuant to which Dr. Reddy’s would sell its US and select territory rights for ZEMBRACE® SYMTOUCH® (sumatriptan injection) 3 mg and TOSYMRA™ (sumatriptan nasal spray) 10 mg (formerly referred to as “DFN-02”), which are commercialized through its wholly owned subsidiary, Promius Pharma, LLC.
Under the agreement, Dr. Reddy’s will receive U.S.$70 million as upfront consideration, U.S.$40.5 million in near term milestones and additional financial considerations including existing contractual obligation and inventory. Subsequently, Dr. Reddy’s will receive sales based royalties on a quarterly basis.
The closing of the transaction is subject to various customary closing conditions including antitrust review under Hart-Scott-Rodino Act.
“This is a testament to our strong R&D capabilities, and delivering solutions to unmet needs of patients. In a short time, we created a well-recognized migraine specialty business in the US and we look forward to our partnership with Upsher-Smith,” said G.V. Prasad, Co-Chairman and CEO, Dr. Reddy’s Laboratories Limited.
“Tosymra and Zembrace were designed and developed with the goal of addressing unmet needs of large but discrete segments of patients suffering from episodic migraine who need options other than their current therapies. We are excited to partner with Upsher-Smith, which has established a strong presence in neurology,” said Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products and Head, Promius Pharma.
Officials want to know who supplied the alcoholic beverages the victims drank in the minutes and hours before their deaths over the past year — and if the drinks had any dangerous chemicals in them, law enforcement sources said.
The FBI is assisting and will take blood samples from the dead back to its research center in Quantico, Va., a source said.
The Dominican government insists the fatalities are isolated incidents, while reps for both of the resorts where victims have died — the Hard Rock Hotel & Casino and Bahia Principe — described the deaths as simple accidents.
But most of the deaths bear similarities, as they involve apparently healthy adults — at least some of whom drank from their hotel room minibar before suddenly becoming gravely sick.
Five American tourists have died in mysterious circumstances on the island this year, while the family of two others who died in 2018 say they now suspect their loved ones met foul play.
Others have reported falling ill, but surviving, after drinking from their minibars.
A Post reporter at one of the resorts noted the vodka in the room had a strange, potent smell resembling pure alcohol.
Lawrence Kobilinsky, a forensic science professor at John Jay College of Criminal Justice in Manhattan, said the symptoms among some of the dead — including nausea, vomiting, diarrhea — were consistent with poisoning from methanol or pesticides.
Methanol is a type of alcohol not safe for humans. It is regularly used as antifreeze.
“Adulterated alcohol is usually methanol added to alcohol or just plain methanol, which is very, very toxic,” Kobilinsky said.
“It looks to me, from what I’ve heard and read, is that something was added to the drinks or bottles in those little refrigerators.”
Health inspectors from multiple agencies conducted extensive tests on the pool, air conditioning units, food areas and alcohol at two Bahia Principe resorts where three visitors died, said the Dominican Ministry of Public Health. They are waiting for the results.
“There should be no methanol at all” in the liquor, Kobilinsky said. “If it’s there, it means it’s been adulterated or put there deliberately.”
In 2017, Dominican National Police dismantled five labs used for the manufacture of alcohol not safe for human consumption.
But Hard Rock bartender Angel Santana, 43, said contamination claims were “not possible.”
“I have been working here for nine years, and everything here has always been very safe,” he said.
In a statement, the Hard Rock said clinical tests from Hospiten Bavaro, a hospital in Punta Cana, showed both deaths at its resort were caused by heart attacks.
The hotel also said it buys only “unopened products from licensed and reputable vendors.”
The first suspicious death at the Hard Rock came in July 2018, when American tourist David Harrison, 45, fell ill in his room and died. On April 14, Robert Bell Wallace, 67, also died there.
On May 25, Miranda Schaupp-Werner, 41, of Pennsylvania, died after drinking from the minibar of her room at the Luxury Bahia Principe Bouganville resort.
Five days later, Maryland couple Nathaniel Edward Holmes, 63, and Cynthia Day, 49 were found dead in their room at the neighboring Grand Bahia Principe.
Yvette Monique Short, of Philadelphia, died in June 2018 after drinking from her minibar at the resort.
The family of a seventh person, Leyla Cox of Staten Island, said on Thursday that she died mysteriously in her room during a trip last week. It was not clear where she was staying.
