Guggenheim upgraded shares of Incyte (NASDAQ:INCY) from a neutral rating to a buy rating in a research note published on Thursday.
https://www.fairfieldcurrent.com/news/2019/01/04/incyte-incy-upgraded-by-guggenheim-to-buy.html
Friday, January 4, 2019
Galapagos, Fibrocor sign partnership in fibrosis
Fibrocor Therapeutics L.P. and Galapagos NV announced a global partnership focused on a novel target for idiopathic pulmonary fibrosis and other indications. Fibrocor specializes in the development of tissue-specific therapeutics to treat the underlying cause of fibrotic diseases of the kidney and other organs. The collaboration announced today concerns a small molecule inhibitor program, currently in the lead optimization stage of development for the treatment of fibrotic diseases of the lung and other organs, the target of which is undisclosed. In exchange for global commercialization rights to Galapagos, Fibrocor will receive an upfront payment, and potentially is eligible for further milestone and royalty payments. Galapagos will be responsible for all further development of the program. “This collaboration validates the fibrosis drug development expertise of Fibrocor,” says Mark A. Steedman, President and CEO of Fibrocor. “I take my hat off to Dr. Richard Gilbert and the scientific team, including Evotec GmbH, our CRO partner, for establishing a compelling data package that ultimately attracted Galapagos, a world-renowned biotech company with a key franchise in fibrosis. We feel this is the beginning of a great relationship and look forward to working with Galapagos to the benefit of fibrosis sufferers everywhere.”
https://thefly.com/landingPageNews.php?id=2844049
Regulus gains after hours on positive preclinical kidney disease data
Nano cap Regulus Therapeutics (NASDAQ:RGLS) is up 8% after hours in response to its announcement of positive results from a new mouse toxicity study of RGLS4326, a candidate for autosomal dominant polycystic kidney disease (ADPKD).
After 13 weeks of dosing, no adverse events or other significant findings were observed across all doses tested. The company plans to restart a Phase 1 trial.
Last summer, it suspended the Phase 1 after seeing “unexpected observations” in the first mouse study that was being conducted in parallel. The company believes the unexpected results were due to technical issues at the contract research organization running the study.
RGLS4326 is a novel oligonucleotide that the company says preferentially targets the kidney by inhibiting an RNA gene called miR-17.
Insmed gains after saying expects drug Arikayce to bring in $9.8 million in Q4
Shares of Insmed Incorporated INSM, +6.76% shot up 18% in after-hours trading Friday after the company announced it expected sales of its antibacterial Arikayce to be $9.8 million for the fourth quarter, with $9.2 million in U.S. sales and $600,000 in sales outside the U.S. The drug is used to treat patients with a lung disease caused by a group of bacteria called Mycobacterium avium complex (MAC) and who do not respond to traditional treatment. Arikayce was granted accelerated approval by the FDA in September. Insmed said more than 500 U.S. patients had started treatment with the drug and approximately 600 physicians had written at least one prescription for the therapy as of Dec. 31
https://www.marketwatch.com/story/shares-of-insmed-shoot-up-18-in-after-hours-after-company-says-it-expects-drug-arikayce-to-bring-in-98-million-in-fourth-quarter-2019-01-04
https://www.marketwatch.com/story/shares-of-insmed-shoot-up-18-in-after-hours-after-company-says-it-expects-drug-arikayce-to-bring-in-98-million-in-fourth-quarter-2019-01-04
Amarin off after hours on soft 2019 outlook for Vascepa
Amarin (NASDAQ:AMRN) is down 7% after hours on the heels of its announcement of preliminary 2018 results and 2019 forecast, information that will be presented next week at JPM19.
Vascepa (icosapent ethyl) sales in Q4 2018 were $72M – 76M, above consensus of $69.4M. 2018 sales were $224M – 228M, above consensus of $221.4M.
Its outlook for 2019 is ~$350M, below consensus of $417.5M. It does not expect managed care coverage to change much from last year.
The company plans to file a supplemental marketing application in the U.S. seeking approval for a cardioprotective claim for Vascepa this quarter. It does not expect the new indication, if approved, to impact its 2019 forecast.
It plans to spend an additional $50M – 75M this year to purchase additional inventory of product to support a revenue rate of ~$700M this year.
Salesforce now numbers 400, up from 150 last year.
#JPM19
RegeneRx Update on Dry Eye and EB Clinical Trials
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug development company focused on tissue protection, repair and regeneration, is updating the status of the U.S. phase 3 dry eye clinical trial (ARISE-3) and the U.S. trial in patients with epidermolysis bullosa (EB) based on a letter to stockholders issued today by its partner, GtreeBNT. GtreeBNT is the sponsor of the EB trial while a U.S. joint venture between GtreeBNT and RegeneRx, ReGenTree, LLC, is the sponsor of the dry eye trial.
ARISE-3 DRY EYE TRIAL
GtreeBNT stated that it is planning to sign the contract for management of the clinical trial in February and that the trial will start thereafter. The company went on to say that manufacturing of the investigational drug has been completed and confirmed that the FDA had previously agreed on the protocol. The company also clarified that while the FDA requires multiple pivotal studies and reproducibility for NDA approval, due to the multi-factorial nature of dry eye syndrome and heterogeneity of the patient population, Gtree is not designing ARISE-3 to do more than the FDA requires for products currently on the market. The company also stated that it intends to keep its stockholders informed on the progress with ARISE-3 after the contract is signed.
EPIDERMOLYSIS BULLOSA TRIAL
GtreeBNT stated that it has selected the clinical trial sites that specialize in EB and one of the sites has begun patient recruitment. Since most of the clinical trial sites selected are university hospitals, the approval procedures from the institutional review boards (IRB) is required and will take several months to complete in some cases, most of which are expected to come in February. Therefore, it is expected that several hospitals will begin enrolling and administering the investigational drug simultaneously and that GtreeBNT expects fairly rapid progress.
“We are pleased our partner, GtreeBNT, is now moving forward with these two important clinical trials after some delay and that they will be keeping us informed of the progress on a regular basis, which we will relay to our stockholders. We look forward to success with both of our product candidates over the next twelve months and hope that 2019-2020 will be the most productive period in the history of RegeneRx,” stated J.J. Finkelstein, RegeneRx president and CEO.
NICE broadens approval for AstraZeneca’s severe asthma drug
AstraZeneca’s Fasenra (benralizumab) has seen its fortunes reverse after NICE approved the drug for severe eosinophilic asthma – broadening its recommendations for the drug’s use and giving patients a potentially more convenient treatment option in comparison to rival therapies.
Guidance published by the Institute today says that benralizumab is cost-effective for use on the NHS in England and Wales by some adults who have the disease and have struggled to control it with inhalers.
It is the third biological treatment for severe eosinophilic asthma approved for NHS use by NICE, following GSK’s Nucala (mepolizumab) in December 2016 and Teva’s Cinqaero (reslizumab) in October 2017. This uncommon and relatively uninvestigated form of asthma is believed to affect around 100,000 people in the UK. Fasenra targets and depletes the immune cells (eosinophils) in the blood which cause the condition.
The drug suffered a blow in NICE’s initial draft guidance last year, which said that it was not cost effective and therefore could only be funded for patients meeting a strict set of criteria – including ineligibility for Nucala.
But after negotiations with AstraZeneca the final guidance gives Fasenra broader approval – and NICE even noted that, because it is given as an injection every four weeks for the first three doses, and every eight weeks thereafter, it is potentially more convenient than Nucala and Cinqaero, both of which are given every four weeks throughout treatment.
Meindert Boysen, director of NICE’s Centre for Health Technology Evaluation, said: “People with severe eosinophilic asthma that is inadequately controlled often have a severely impaired quality of life – it can hold them back from doing many basic daily tasks, lead to psychological problems including anxiety and depression, and leave them in constant fear of a potentially lethal asthma attack. By keeping their asthma under better control, biological treatments have transformed the lives of some of these sufferers.”
Subscribe to:
Posts (Atom)