Oncology, neurology, and fatty liver disease are among the areas where one can expect to see significant activity this year, according to forecasts from investment bank analysts.

Anticipated highlights for 2020 include potentially the first regulatory approval of a drug to treat the liver disease nonalcoholic steatohepatitis, or NASH; the launches of two new drugs for sickle cell disease; and late-stage data for a drug to treat amyotrophic lateral sclerosis, among others. Several company executives also shared their insights in a story published over the weekend.

In Canaccord Genuitys forecast, analyst Edward Nash highlighted the big expectations in the disease NASH, which is the most severe form of nonalcoholic fatty liver disease. New York-based Intercept Pharmaceuticals obeticholic acid will go before an FDA advisory committee in on April 22, 2020, on the back of successful Phase II and Phase III data, thus potentially becoming the first drug approved for the disease in the middle of the year. Galectin Therapeutics, Galmed Pharmaceuticals, Genfit and Madrigal Pharmaceuticals are also expected to have Phase III data.

Allogeneic off-the-shelf cell therapies are also expected to be in the news, according to Canaccord Genuity analyst John Newman. Allogene is expected to have Phase I data in its product candidates in non-Hodgkins lymphoma and multiple myeloma in the first half of this year and by the years end, respectively. Meanwhile, Precision BioSciences is expected to have data in lymphoma and acute lymphoblastic leukemia in the first quarter. Allogeneic CAR-Ts are made with donor T-cells rather than the patients own T cells, as is the case with autologous CAR-Ts like the FDA-approved ones made by Novartis and Gilead Sciences.

In benign hematology, Newman highlighted the expected launches of recently approved sickle cell disease therapies, namely Novartis Adakveo (crizanlizumab) and Global Blood Therapeutics Oxbryta (voxelotor).

Another Canaccord Genuity analyst, Arlinda Lee, highlighted bispecific antibodies that may produce data this year, including those from Xencor, Y-mAbs Therapeutics and Zymeworks. However, BTIG analyst Thomas Shrader and colleagues pointed to both cell therapies and complex antibodies which would include bispecifics as areas of intense competition, with the large number of product candidates going after diseases like diffuse large B-cell lymphoma and acute lymphoblastic leukemia looking a little overwhelming.

Neurology and Cambridge, Massachusetts-based Biogen, the biggest company in that space also figured prominently in the forecasts. Its plan is to file for Food and Drug Administration approval of its controversial back-from-the-dead Alzheimers disease therapy, aducanumab, based on reevaluated data from the Phase III trials of the drug indicating that the amyloid beta-targeting therapy might have some efficacy after all. Declaring The 800lb gorilla returns, BTIG gave the drug about a 50% chance of winning approval when the FDA takes a closer look at the data. Anticipated topline data from the Phase III trial of BIIB067 in ALS, expected in the middle of this year, also garnered close attention.

Canaccord Genuitys report highlighted several other upcoming neurology catalysts ranging from FDA submissions to Phase III data readouts are expected for small- and mid-cap neurology-focused companies, like Acadia Pharmaceuticals, BioXcel Therapeutics, Intra-Cellular Therapies and others.

Aside from events in specific disease states and therapeutic areas, BTIGs Shrader wrote that 2020 looks like a ripe year for mergers and acquisitions, with the high-profile deals of 2019 being a good sign for the biopharma sector. Stoke Therapeutics, Alector, Gritstone Oncology and Sutro Biopharma were named as potential acquisition targets.

Photo: AndreyPopov, Getty Images

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Analysts weigh in on what to expect in biopharma this year - MedCity News