Plonmarlimab

The J.P. Morgan Healthcare Conference rolled on Tuesday with corporate updates from Eli Lilly and other companies. As the J.P. Morgan Healthcare Conference rolls on in San Francisco, BioNTech, Alnylam, and many other companies updated investors on their businesses heading into 2024.  We'll update this page throughout the day; be sure to check back regularly. Tuesday, Jan. 9 at 8:30 p.m. ET AstraZeneca laid out its lofty goals for the end of the decade, which include not only delivering “industry-leading growth” by 2030, but placing in at least “the top-three position” in its five focus areas, chief financial officer Aradhana Sarin said during the company’s presentation. That means AZ is looking to be a top player in oncology, rare diseases, vaccines/immunotherapies, respiratory diseases/immunology plus the field of cardiovascular, renal and metabolism. With a wide geographic footprint and a vast pipeline contributing to “strong growth potential,” the company calls its growth profile “relatively de-risked” compared to peers. As for a more short-term goal, the drugmaker is targeting double-digit growth from 2021 to 2025, a rate that it is “very much on track” to achieve, Sarin said. Even more important than the numbers is the “confidence we have in delivering that growth ambition,” the CFO said. That confidence is backed by the company’s existing products and new indications, plus the previously divulged plan of launching 15 meds by 2030. Release Tuesday, Jan. 9 at 8:09 p.m. ET Novavax is in discussions with Walgreens to add the company's COVID-19 vaccine to the pharmacy's stores for the 2024-25 season, company executives told Fierce Pharma on the sidelines of this year's J.P. Morgan Healthcare Conference. The chain pharmacy elected not to carry the vaccine this season, sticking only with the mRNA options.  Meanwhile, Novavax is in the latter half of its first full COVID vaccination season in the U.S., joining Moderna and Pfizer, though its shot remains under emergency use authorization. The Maryland vaccine maker expects that to change, however, with FDA approval tentatively planned for the end of August or early September, according to Chief Operating Officer John Trizzino  New CEO John Jacobs is finally coming up for air after a year marked by significant cuts to administrative, manufacturing and R&D costs. The company disclosed that a second round of "focused headcount reductions" would be included in the most recent $300 million cost-cutting plan, announced in November. But he's bullish now, saying the company has $2 billion in cash that's "virtually guaranteed" when considering cash on hand, government contracts and existing receivables. Novavax reported having $666 million in cash as of the end of September 2023.  Jacobs says that's enough for the company to solo develop its COVID-flu combination vaccine, slated for a phase 3 trial in humans this year.  UPDATED: Tuesday, Jan. 9 at 6:19 p.m. ET Eli Lilly CEO David Ricks threw credit to Novo Nordisk for pursuing GLP-1s for obesity during his Tuesday presentation: “We have tremendous respect for Novo Nordisk and have competed with them for like 100 years and know each other pretty well. “I think here's a case where probably competition spurs us both on to go faster and build out more indications and really take the insight—which, credit to Novo, was to exploit high dose GLPs to pursue weight loss, noticing the separation between A1C and weight loss at the higher doses and we're following them and driving that and I think the world would benefit from that.” The obesity market lends itself to more involvement given the massive demand. Ricks said the two companies are not fighting over a “fixed pie,” but instead using their combined powers to advance the GLP-1 field into addressing other health challenges such as cardiovascular risks, sleep apnea and so on.  Ricks said that Novo is the first competitor Lilly thinks about, but another potential threat is the number of larger companies buying into obesity using M&A. “If you're sitting in a boardroom of a large drug company, you're probably asking the CEO, like where's our obesity program? So they're getting one,” Ricks said with a laugh. “Some of them will succeed. Some won't.” First-mover advantage is often crucial in the pharma industry and obesity is no different, especially given the manufacturing scale needed to make a difference in the space, according to Ricks. New entrants will need to push hard on the additional health benefits of their medicines beyond obesity, he added. “We should take them all seriously, and I think sometimes competition discovers new things that we didn't think of, and that's good,” Ricks said. “There is a huge addressable market here. So I'm not saying it'll be two companies that find it all. But probably the benefit of time and experience with this platform really lends to us and a Danish company.” UPDATED: Tuesday, Jan. 9 at 5:40 p.m. ET After more than 25 years in the field, Novo Nordisk has largely proved its obesity thesis, CEO Lars Fruergaard Jørgensen said Tuesday at the J.P. Morgan Healthcare Conference. But even as the potentially multi-billion-dollar market opens up, “we are just getting going,” the CEO said. Not long after Wegovy’s obesity launch, demand outstripped supply, with that inventory uncertainty persisting through 2023. As for the coming year, “I’m very comfortable looking into 2024—and specifically for Wegovy in the U.S.—that we can add significant additional volumes,” Jørgensen explained. That additional capacity for 2024 didn’t come all at once, either, the CEO pointed out. “This is a continued journey of building capacity for the years to come,” Jørgensen said.  UPDATED: Tuesday, Jan. 9 at 5:30 p.m. ET GSK expects that Nucala could see around £500 million to £1 billion in additional peak sales in chronic obstructive pulmonary disease (COPD) if a phase 3 readout expected in the second half of 2024 turns out positive, CEO Emma Walmsley said Tuesday. Previously, Nucala’s direct rival, AstraZeneca’s Fasenra, failed two COPD trials. Meanwhile, GSK’s Nucala follow-on candidate, the long-acting IL-5 antibody depemokimab, should deliver phase 3 data in the first half of this year. Walmsley put that drug’s peak sales potential at more than £3 billion. That’s much more than the £1 billion to £2 billion range that the company put out during an investor update in mid-2021. Compared with the 2021 update, the anti-GM-CSF antibody otilimab has lost its place in GSK’s immunology portfolio after disappointing phase 3 results led to its discontinuation in 2022. Taking its place is camlipixant, a chonic cough program that GSK got last year from its $2 billion acquisition of Bellus Health. After the FDA's recent complete response letter for Merck’s rival med gefapixant, GSK believes camlipixant could generate more than £2.5 billion in peak sales. The drug’s phase 3 program is on track to report results in the second half of 2025. UPDATED: Tuesday, Jan. 9 at 4:55 p.m. ET Four years after the arrival of the company’s CEO Paul Hudson, the “new” Sanofi has finally started to take shape. With the goal to become a tech-powered, immunology powerhouse, Sanofi is now in the midst of a “real moment,” Hudson said Tuesday at the J.P. Morgan Healthcare Conference in San Francisco. “It’s been a long time in the making, and we really feel like we’re demonstrating that we’re the new Sanofi,” he said. Much of the company’s momentum will continue to hinge on its Regeneron-partnered megablockbuster Dupixent, which Hudson expects to reel in roughly 13 billion euros in sales in 2024. But while Dupixent will continue to grow “until its end,” Hudson knows the medicine’s patent cliff is looming sometime during the next decade. In turn, Sanofi is going all-in on R&D, with the goal to generate more than 10 billion euros in sales from new medicines by 2030. “This is a very important moment for the company to have multiple shots on goal in massive diseases,” Hudson said. “This is a deck stacked for success.” After declines for its hematology franchise earlier in the decade, Roche is riding the rebound. The company's hemophilia A blockbuster Hemlibra is providing much of the sales firepower, but newer T-cell engagers Lunsumio and Columvi are giving Roche more reasons for optimism. Those two meds are off to strong starts, and Roche is running studies to potentially move them into earlier treatment lines. Also in Roche's hematology portfolio is the lucrative antibody-drug conjugate Polivy. In all, Roche sees its blood-cancer franchise delivering 14% average annual growth through 2026, following sizable sales declines in 2020 and 2021. Story UPDATED: Tuesday, Jan. 9 at 3:37 p.m. ET While 2024 will be “monumental” for Sarepta Therapeutics, the company’s ambitions extend to 2030, when it’s poised to “become a big biotech,” CEO Doug Ingram said at the conference. Last year, the biotech scored an accelerated approval for its Duchenne muscular dystrophy (DMD) gene therapy Elevidys under a restricted label. Now, Sarepta hopes to expand the approved usage to cover all DMD patients. Despite missing the primary endpoint in a key trial, the company maintains its belief that the data “exceeded the threshold for substantial evidence of effectiveness,” Ingram said. Meanwhile, the FDA is “committed to evaluating a labeling expansion to the fullest extent possible,” according to the CEO’s presentation. The treatment brought in an estimated $200 million in 2023 after its June approval. Mizuho analysts called the sales estimate “better than expected” and believe the “odds are high” for the potential label expansion. Sarepta projected its total 2023 revenue to come in at $945 million, exceeding its previous guidance. Release UPDATED: Tuesday, Jan. 9 at 10:45 a.m. ET After its overwhelming success during the pandemic, Pfizer was knocked down a peg in 2023. Its launches came up short and the company was blindsided by a sudden drop in demand for its pandemic products. After some retooling, the company is set for a “year of execution,” Pfizer CEO Albert Bourla said. “We used to be the stars of the industry for a few years, so the drop really hurts.” The silver lining for the company in 2023 was a record nine FDA approvals for novel products, including two for Abrysvo, though the company has some regrets about the early performance of its RSV vaccine launch. Story The new year brings Merck closer to 2028 when the company will lose patent protection for mega-blockbuster Keytruda. At the J.P. Morgan Healthcare Conference, CEO Rob Davis tried to de-emphasize the impact of the Keytruda cliff by focusing on the company’s pipeline assets, including three antibody-drug conjugates that Merck has in-licensed from Daiichi Sankyo and a Moderna-partnered cancer vaccine. Last January, Merck said its pipeline of oncology prospects could eventually produce $10 billion annually. A year later, Merck has jacked up its oncology portfolio estimate to $20 billion-plus by the middle of the next decade. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. It’s just another year.” Story UPDATED: Tuesday, Jan. 9 at 10:36 a.m. ET As COVID vaccine revenues sink across the board, mRNA specialist BioNTech is turning its attention to its oncology pipeline. This year pledges to be one of “significant execution,” CEO and co-founder Ugur Sahin, M.D., said in a strategic update. The company projects revenues of approximately €3 billion ($3.28 billion) for 2024, mainly driven by its Pfizer-partnered COVID vaccine Comirnaty, which is expected to “remain profitable.” That would be a drop from last year, given that BioNTech has guided for 2023 COVID-19 vaccine sales of €4 billion. Also last year, BioNTech added six new prospects to its oncology pipeline, which now includes a mix of phase 2 and phase 3 assets. Outside of cancer therapies, the company is working on an mRNA-based combination COVID and influenza vaccine alongside Pfizer. BioNTech’s full corporate update will take place later today at 12 p.m. ET. Release Alnylam collected revenues of $1.24 billion in 2023 thanks to its polyneuropathy of hATTR amyloidosis meds Onpattro and Amvuttra, plus its hepatic porphyria therapy Givlaari and primary hyperoxaluria type 1 treatment Oxlumo. The company’s ATTR franchise garnered $913 million, while the two ultra-rare drugs pulled a total of $329 million. Total revenues from Alnylam’s portfolio were up 39% from 2022. The company believes it is on the way toward positioning itself as a “top-tier, global, multi-product commercial company with a broad pipeline and organic platform poised to deliver sustainable innovation well into the future, a profile rarely seen in our industry,” CEO Yvonne Greenstreet said in a statement. The RNAi drugmaker will report results from its phase 3 study of its vutrisiran in cardiomyopathy of ATTR amyloidosis early this year. Alnylam will further discuss its financial results and commercial updates at the J.P. Morgan Healthcare Conference today during its presentation at 12:45 p.m. ET. Release  

Nasdaq plans to delist the stock from its Capital Market and suspend trading from Wednesday. Humanigen is running out of options. Talks over a reverse merger have collapsed and, with efforts to find another deal or raise funding failing, the biotech is considering filing for bankruptcy in the third quarter.  The New Jersey-based biotech has been on the ropes since its anti-human GM-CSF monoclonal antibody failed to improve outcomes in hospitalized COVID-19 patients last year. Humanigen was already reeling from the FDA’s rejection of its request for emergency use authorization and the stock has stayed firmly rooted in penny stock territory ever since the late-phase flop. By the end of March, Humanigen was down to its last $3.1 million but a non-binding letter of intent with a private biopharma company presented an exit strategy. Humanigen was in exclusive negotiations over a stock-for-stock deal and seeking external financing in connection with the reverse merger. That exit strategy now lies in tatters. Talks with the biopharma company have ended “without execution of a definitive agreement.” Humanigen has looked for another strategic or equity financing transaction without success, leaving it without a way out of its predicament. Holding dwindling cash and lacking avenues for securing more, Humanigen is “exploring all restructuring options, which may include commencing a bankruptcy or other insolvency proceeding sometime in the third quarter of 2023.” The biotech is “evaluating term sheets” relating to the potential sales of assets in a bankruptcy proceeding that could “result in a complete or substantial loss of value” for shareholders.  Humanigen shared the update alongside news that three of its board members resigned with immediate effect last week. The resignations, which Humanigen said “were not the result of disagreements,” render the biotech noncompliant with Nasdaq listing requirements. Humanigen is also noncompliant with other requirements and, after seeing merger talks collapse, told Nasdaq it doesn’t expect to regain compliance. Nasdaq plans to delist the stock from its Capital Market and suspend trading from Wednesday. Trading will switch to the OTC Pink Market, with Humanigen telling investors the delisting will harm its ability to raise money. Investors responded by sending shares in Humanigen down 72% to just five cents in pre-market trading.