JPM23, Day 1: Lilly's busy schedule, Mirati's new pipeline, Galapagos' clear-out

The J.P. Morgan Healthcare Conference has long been the most anticipated event in the biotech and pharma calendars. But this year there’s special attention being paid to the meet-up—and not just because this morning will see the return of in-person attendance, bringing with it all kinds of opportunities for networking and impromptu catchups that have traditionally been the lifeblood of the industry.

This year’s conference comes off the back of a tough time for the sector. You only have to look at Fierce Biotech’s Layoff Tracker to see that players of every size had their backs against the wall in 2022, often resorting to workforce layoffs or pipeline restructuring to keep the show on the road. Then there's the shadow of a potential global recession, which could further dampen an already faltering IPO scene.

In our lookahead for this year, Leslie Loveless, CEO of life sciences executive search firm Slone Partners, told Fierce that JPM 2023 will set the tone for the coming months, with industry watchers wanting to see how bullish investors still are about the opportunities in biotech.

So will we see green shoots or more pink slips for the industry? The warm-up to the conference itself suggests the appetite for M&A hasn’t deserted Big Pharma, with the likes of AstraZeneca and Ipsen first to make headlines with their own acquisitions. Then there was the FDA greenlight for Biogen and Eisai’s Alzheimer’s treatment Leqembi late on Friday, which should re-energize a tricky research area rocked by failure.

For all of these and much more, the Fierce team will be on the conference floor hunting down the biggest announcements and interviews, so stay tuned.

Check out our Day 2 coverage here


11:40 a.m. ET Jan. 10: Roivant is not watering down expectations as it braces for a torrential downpour of data in 2023, with CEO Matt Gline calling this ‘the single most exciting year’ with respect to new readouts. Much of Gline’s excitement is sourced to RVT-3101, the company’s ulcerative colitis med acquired from Pfizer that just passed a phase 2 checkpoint. But he hopes that’s just the tip of the iceberg. Story


8:47 a.m. ET Jan. 10: Galapagos had a busy year cleaning out its portfolio as part of a broader pivot to CAR-T, but CEO Paul Stoffels believes that 2023 will be all about picking the right pipeline replacements.

The only loose thread is GLPG2737, a kidney disease drug that, if successful in an ongoing phase 2 trial, will be licensed away. Beyond that, “I think at the moment we have done everything we needed to do on the clearing out,” Stoffels told a JPM session on Monday afternoon.

“Now for us it’s the hard work to see if we can add one or two additional business deals in the course of the year with products in clinical stage and add that to the portfolio,” the CEO said.

The Belgian biotech has been keen to highlight its CAR-T plans in the wake of acquiring CellPoint last June, and Stoffels explained that his vision is to have a cell therapy in commercialization alongside the company’s approved rheumatoid arthritis drug Jyseleca by 2028.

But this doesn’t mean both of the hoped-for acquisitions will definitely lean towards cancer. Instead, Stoffels would prefer a “balance” between oncology and immunology. “We have a very strong immunology team and capability in small molecules, which we don’t want to leave behind,” he explained.


4:47 p.m. ET: Beam Therapeutics is keeping an eye on the competition in sickle cell, with peer companies bringing up a number of different approaches to tackle the long-ignored disease. Executives also commented on the base editing biotech's Pfizer collaboration, which was signed at last year's conference, and future deal making. Story   


2:36 p.m. ET: Eli Lilly is prepping for five launches, leaving the company's schedule jam packed. 

“It's daunting—we need to leave J.P. Morgan and get back to work,” Dan Skovronski, M.D., Ph.D, Lilly’s chief scientific officer and chief medical officer, told Fierce Biotech on the conference sidelines. Story


1:37 p.m. ET: Mirati Therapeutics became a commercial organization last year with the approval of adagrasib, now known as Krazati, and the company is churning out its next candidates. 

While that means a loaded pipeline, CEO David Meek, in a nod to the tough market conditions facing biotechs at the moment, said at the conference Monday that the company won't be afraid to cut and run if any of the assets don't prove their worth. Story


12:45 p.m. ET: Cytokinetics' full-attention is turning towards runner-up asset aficamten, less than a month after FDA advisers poured cold water on the company's lead heart failure med, omecamtiv mecarbil. It's an unsurprising reprioritization after the adcomm meeting, with CEO Robert Blum telling the JPM crowd that 60% of the company's R&D spend in 2023 will be geared toward aficamten. 

Cytokinetics also announced the completion of enrollment for a fourth cohort for the phase 2 REDWOOD study assessing aficamten in patients with symptomatic hypertrophic cardiomyopathy at the end of 2022, with results slated to readout in the first half of 2023. The company plans to have an end of phase 2 meeting and launch on a phase 3 trial by the end of the year, with application plans for 2024. 

Cytokinetics is still prepping for an unlikely omecamtiv mecarbil approval should the agency go against its advisers. The company has hired 75 people to its commercial team, 10 of whom are dedicated specifically to omecamtiv mecarbil. The majority of the team will be hired if the drug nabs approval.


12:28 p.m. ET: A few hours after presenting data marred by placebo overperformance, Arrowhead Pharma’s CEO Christopher Anzalone, Ph.D, faced investors at JPM. He defended the readout and path forward for the Takeda-partnered drug, now called fazirsiran. The therapy is to be advanced into a phase 3 trial for the rare genetic disorder alpha-1 antitrypsin deficiency (AATD-LD).

“My take home message is that the drug is doing what it's intended to do, and it's doing it in all patients and many of those patients are then improving in fibrosis,” Anzalone said during the Monday presentation. He was speaking to evidence from the phase 2 study that showed the therapy reduced a marker of the disorder but didn’t do much better than placebo at fixing liver scarring.

Responding to a question about possible competition in the indication, Anzalone spoke to the history of AATD-LD, which was previously thought to be a lung disease. But now, as smoking has reduced in the population, the liver impacts of the disorder are becoming more prominent. So, the CEO said the therapy’s ability to lower markers of liver damage is key.

“This drug is designed to do one thing and one thing only, and it is to silence the protein that causes that fibrosis in these patients,” Anzalone said. “So at least for the time being, we don't see any near term competitive pressure.”

Arrowhead is also gearing up to enter the market with ARO-APOC3 in several indications, which is in late-stage studies at the moment. Anzalone said “the way we get into that market is through a staged approach.” Up first is familial chylomicronemia syndrome (FCS), then severe hypertriglyceridemia and finally the broader mixed dyslipidemia population, which Anzalone said represents about more than 12 million possible patients. The phase 3 severe hypertriglyceridemia trial, which is ongoing now, will take a bit longer to pursue than the FCS studies.


12:12 p.m. ET: What keeps Keith Gottesdiener, M.D., up at night? Not a lot, the Prime Medicine CEO told attendees at a JPM23 session. The “regulatory bumps” from the FDA that Prime’s gene editing peers have experienced are “growing pains” that are likely to be solved over the next couple of years, Gottesdiener suggested. Meanwhile, the biotech has a “strong cash runway” and isn’t worried about funding for the time being, he added.

In fact, if there’s one problem Prime has, it may be deciding where to focus their tech and cash. “We literally have the potential to work in hundreds of indications,” the CEO said. “With 18 programs, we really don’t need new indications at all.” No wonder Gottesdiener made no secret of the fact the company is open to partnerships.


11:31 a.m. ET: The first day of JPM started off with a flurry of licensing deals, similar to last year. For more on these stories, see below. 

Lilly rides TRex into regulatory T-cell space, paying $55M upfront for 3 immune-mediated disease drugs

Boehringer offers 3T Biosciences $268M to plug its data into biotech's TCR cancer platform

Neurocrine blows fresh wind in Voyager's sails with $175M upfront for CNS capsid collab

Stalicla pledges $270M to take forward Novartis' failed former fragile X candidate

Other announcements included the departure of Novavax's CEO Stanley Erck and a restructuring at Editas