Bayer CEO says has not had contact with activist investor Elliott

Bayer Chief Executive Werner Baumann said on Monday he has not had any contact with Elliott Management, following a Reuters report which said the U.S.-based activist investor had taken a position in the German pharmaceuticals giant.

“Nobody has called me,” Baumann said in response to a question about contact with activists at an event in Duesseldorf.

Reuters reported on Friday that Elliott has invested in Bayer, citing three people familiar with the matter.

https://www.marketscreener.com/BAYER-436063/news/Bayer-CEO-says-has-not-had-contact-with-activist-investor-Elliott-27733184/

Novartis: Sandoz, Pear Therapeutics get FDA clearance for reSET-O

Sandoz, a division of Novartis, and Pear Therapeutics announced that the U.S. Food and Drug Administration has granted clearance for reSET-O as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician in outpatient treatment for Opioid Use Disorder. Under the terms of a commercial deal announced in April 2018, Sandoz will lead marketing and commercialization of reSET-O and reSET, Pear’s PDT for the treatment of Substance Use Disorder. Sandoz launched reSET in November 2018 and plans to launch reSET-O in the coming days in the U.S.
https://thefly.com/landingPageNews.php?id=2834841

Jazz Pharmaceuticals announces $400M increase to share repurchase program

Jazz Pharmaceuticals announced that its Board of Directors has authorized a $400M increase in the company’s share repurchase program, which the company intends to use over time based on market conditions and other factors. Prior to this increased authorization, the Board of Directors had authorized $620M under the company’s share repurchase program, of which $194M had been utilized through September 30, 2018. Since that date, the company has utilized the remainder of that prior authorization.
https://thefly.com/landingPageNews.php?id=2834859

Gene Therapy Firms Including Homology Medicines Gain

Thinly traded gene therapy developer Homology Medicines (FIXX +3.6%) is up on below-average volume. Shares have rallied over 42% since touching $18.20 on November 21.

The stock debuted at $16 in late March. Lead candidate is Phase 1/2-stage HMI-102 for phenylketonuria.

Other gene therapy players in the green: (MGTX +1.9%)(GNPX +3.3%)(ABEO +4.1%)(CRSP +1.6%)(EDIT +0.4%)(NTLA +2.3%)(SRPT +2%)(ZIOP +0.3%)(RGNX +1.3%)(BMRN +0.2%)(RARE +1.1%)(VYGR +0.8%)(SGMO +1.9%)(ONCE +4.2%)(ADVM +0.8%)

https://seekingalpha.com/news/3415731-homology-medicines-4-percent

PhRMA Highlights Impact of Cell and Gene Therapies in New Report

Over the past few years, cell and gene therapies have become significant components in the R&D spending of numerous drug companies. And more funding is likely to be devoted to that segment as more and more therapies are approved by global regulatory agencies.

This morning the Pharmaceutical Research and Manufacturers of America (PhRMA) released a report that shows there are nearly 300 novel cell and gene therapies currently in development throughout the industry. The therapies are being studied as treatments for a variety of diseases and conditions. The range of diseases these therapies can address is broad and covers blood and eye disorders, cancer and infectious disease to name a few, according to the report.

Cancer is by far the leading recipient of cellular and gene therapy research. According to the report, of the 289 therapies currently in development, there are 111 different types aimed at cancer. The report does not break down the types of cancer that are the subject of these therapies. Perhaps the most widely known therapy of this type for cancer is CAR-T. So far the U.S. Food and Drug Administration has approved two CAR-T treatments for blood cancers. Multiple companies are working on similar treatments for other cancers, as well as SPEAR-T treatments for solid tumors. The first CAR-T cancer therapies were approved by the FDA last year.

In the PhRMA report, the story of Justin is shared. At the age of 7, Justin was diagnosed with acute lymphoblastic leukemia, a blood cancer. Justin was treated with a CAR-T treatment and his cancer is now in remission.

“Justin remains resilient and hopeful for his own future, as the treatment has given him new hope, even with the setbacks he’s faced. Now, other patients and families can have hope for their path to longer, healthier lives as well,” the PhRMA report said.

The next leading therapeutic target for these therapies are in the eye. There are 28 different cell and gene therapies in pipelines right now for eye disorders. Almost one year ago, the FDA approved Spark Therapeutics’ Luxturna, a gene therapy for a rare, genetic form of blindness. Luxturna was the first FDA-approved gene therapy that targets a disease caused by mutations in a specific gene.

Blood disorders, cardiovascular disease and neurologic disorders are also a common focus of cell and gene therapies. The report highlights several treatments that are in development, including Novartis’ gene therapy treatment for spinal muscular atrophy, which was granted priority review by the FD last week.

The therapies target DNA or RNA. As the PhRMA report notes, both approaches “seek to modify genetic material to improve functioning or fight disease.” Gene therapies use genetic materials to manipulate the cells of a patient. There are multiple types of gene therapies in development. These therapies seek to replace a mutated gene that is the cause of a genetic disease.

Cell therapy is slightly different. That procedure involves the infusion or transplanting of whole new cells, such as stem cells or dendritic cells, into a patient who is battling a disease. Those new cells are used to help replace or repair damaged cells in order to help the body fight a disease.

In the report, PhRMA noted that the field of gene and cell therapy is making an impact in regenerative medicine. John F. DiPersio, president of the American Society for Blood and Marrow Transplantation, said regenerative medicine is “enhancing science, education and clinical care” in order to “provide patients with expanded and genetically modified stem and immune effector cells for the treatment of inherited diseases, solid tumors and hematologic malignancies to live longer lives.”

https://www.biospace.com/article/phrma-highlights-impact-of-cell-and-gene-therapies-in-new-report/

JMP boosts Marinus target to $29, sees ‘clear’ competitor to Sage Therapeutics

JMP Securities analyst Jason Butler raised his price target for Marinus Pharmaceuticals (MRNS) to $29 from $22 after the company announced positive results for both IV and oral formulations of ganaxolone in postpartum depression. The stock in midday trading is up 1c to $5.18. The results make comparisons to Sage Therapeutics’ (SAGE) brexanolone and SAGE-217 relevant, Butler tells investors in a research note. Further, the analyst sees “potentially differentiating attributes” for ganaxolone. Specifically, at 60 hours, the optimal dose cohort for the IV formulation showed a 16.9 point reduction from baseline in HAM-D, and by comparison, in its Phase 3 trial, brexanolone showed a 17.7 point to 19.9 point reduction, explains the analyst. Butler increased his probability of approval for ganaxolone in PPD to 70% from 55%. He believes this morning’s results show that Marinus represents a “clear and relevant competitor” to Sage. The analyst reiterates an Outperform rating on Marinus Pharmaceuticals.
https://thefly.com/landingPageNews.php?id=2834731

Produce for Food Deserts: Dollar General Plans Nearly 1,000 New Stores Next Year

Dollar General is planning to open 975 new stores during its next fiscal year, which begins early in February, and will remodel 1,000 more.

Part of the company’s expansion strategy is to offer more food and expand into areas, especially rural areas, that lack grocery options.

Dollar General CEO Todd Vasos specifically mentioned the concept of food deserts in the company’s fiscal Q3 earnings call on Tuesday.

“So having those opportunities to put stores … with a produce selection in the areas that are more food deserts in the United States, both in the rural communities and, by the way, in more metro settings, we find that we can drive a tremendous amount of traffic that way,” Vasos said.

According to the U.S. Department of Agriculture, 23.5 million Americans live in food deserts. A food desert is an area where residents within a 1-mile radius lack access to a full-service supermarket.

New produce sections will be going in about 200 of the Dollar Generals to be remodeled next year. Right now, about 425 of the company’s stores carry produce, which is a relatively small number considering its total of more than 15,200 locations nationwide.

“Our remodel store delivers a 4% to 5% comp lift on average and a [Dollar General Traditional Plus] remodel delivers on average a 10% to 15% comp lift, and when produce is included in a DGTP, it delivers a comp lift on average at the high end of that range,” Vasos said.

Dollar General Traditional Plus is a variation on the company’s standard store that includes more grocery offerings and coolers for perishable items.

Vasos also stressed that not all Dollar Generals are going to resemble each other, because markets vary. For instance, about 10 of the new stores will be in the company’s DGX format, which is half the size of standard stores.

“We intentionally develop these additional formats to be able to move into certain demographics across the U.S. where a one-size-fits-all mentality is really not the way to be productive and to make the most of your real estate portfolio,” Vasos said.

Goodlettsville, Tennessee-based Dollar General had a strong third quarter, with net sales up 8.7% year over year and same-store sales growing 2.8% since last year, beating analysts’ expectations. The company continues to do well because its products cater to a demographic in need of low-cost items, with the average Dollar General shopper part of a household that earns $40K or less per year.

The chain’s locations are also strategic. Stores tend to be located at a far enough distance from Walmart stores to avoid competition from the retail giant.

https://www.bisnow.com/national/news/retail/dollar-general-plans-nearly-1000-new-stores-next-fy-including-more-food-offerings-95724