Companies and investors, well aware of the natural up and down fluctuations of the market, keep expecting the current downturn to end. They’ve been expecting it to begin an upturn for the past two years. During a Feb. 26 session on venture capital trends at the BIO CEO & Investor Conference in New York, investors said the tough times might well extend further into 2024 than they would like.
Helping executive and investors prepare for better economic times is a strong theme in the upcoming BIO CEO 2024 conference, which runs Feb. 26 and 27 in New York. The annual conference, sponsored by the Biotechnology Innovation Organization, is designed to present a broad, unbiased view of investment opportunities. Panels of experts are set to discuss hot therapeutic areas and the key business issues facing companies and the industry.
The biological processes giving rise to the central nervous system symptoms of long COVID remain a mystery. But multiple studies suggest they do not appear to be a result of a direct viral infection of brain tissue. The latest such research, which appeared online in Nature Neuroscience on Feb. 16, 2024, demonstrated that local immune response in brain tissues persisted long after SARS-CoV-2 virus had disappeared.
4DMT Molecular Therapeutics Inc. is looking ahead to phase III as positive data continue to roll out for gene therapy candidate 4D-150 in wet age-related macular degeneration (AMD), with the results from the phase II portion of the phase I/II Prism trial showing the single-shot treatment significantly reduced the need for chronic anti-VEGF injections. Presented over the weekend at the Angiogenesis, Exudation, and Degeneration 2024 Conference, results from the 24-week dose-expansion cohort, which comprised wet AMD patients with severe disease and high treatment burdens, showed patients receiving the high dose (3E10 vg/eye) had a 90% reduction in annualized anti-VEGF injection rates.
Shares of Corbus Pharmaceuticals Inc. (NASDAQ:CRBP) doubled on opening Jan. 26 and ended the day up a whopping 249% as investors got a look at data from a first-in-human study testing next-generation Nectin-4-targeted antibody-drug conjugate (ADC) CRB-701. Licensed from CSPC Pharmaceutical Group for $7.5 million up front in February 2023, CRB-701 has IND clearance from the U.S. FDA, and Corbus plans to start its own clinical testing in the first quarter of 2024.
Analysts from the hosting firm talked up their takeaways on biopharma from the J.P. Morgan (JPM) Healthcare Conference and looked ahead to 2024, anticipating a generally better year than those in the recent past.
Setting the tone for the biopharma industry as it enters a new year, the J.P. Morgan Healthcare Conference (JPM) held each January has once again led to reflections, projections and earnest hopes for improving financial and M&A markets. Despite concerns over valuations, raising money and pricing issues, industry leaders are generally upbeat as the industry moves into 2024. JPM’s Sophie Jones, managing director of health care investment banking, noted in a Jan. 18 webinar sponsored by the Biotechnology Innovation Organization that the conference included more than 700 companies. “It’s morphing now into really the kickoff into everybody’s year.”
Merck & Co. Inc. CEO Robert Davis said the pneumococcal vaccines (PCVs) space is “an area where there is still a high unmet need, and what we have is a new vaccine specifically targeted to the adult population that addresses 83% of the residual disease. That's about 30% higher than anyone else that's out there.” Speaking Jan. 9 at the J.P. Morgan Healthcare Conference (JPM), Davis predicted that his firm “will take a majority share” of the market if approved. The Merck candidate, V-116, bears a PDUFA date with the U.S. FDA of June 17.
“This is a tough business. It’s never a straight line from start to success.” Those words, from Exelixis Inc. CEO Michael Morrissey, during a presentation at the J.P. Morgan Healthcare Conference (JPM), could easily sum up any aspect of the biopharma industry. But with more biopharma firms than ever having reached commercial status, along with the introduction of new therapeutic modalities into the health care market, many are finding the toughest part comes after regulatory approval, whether it’s navigating a competitive landscape, getting payers and physicians on board, or satisfying regulators’ stringent postmarketing requirements. As industry players and observers head home after a busy week in San Francisco, BioWorld offers a brief glimpse at a few firms taking on those post-approval challenges in 2024.
The U.S. FDA is promising to make 2024 a “breakout” 12 months for gene therapies, with a number of initiatives to promote clinical development, approvals and uptake. “This is a great year to focus on gene therapy,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA. “I just want to focus on moving ahead gene therapy,” he told attendees of the J. P. Morgan Healthcare Conference on Jan. 8.
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