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Home » Newsletters » BioWorld

BioWorld

Jan. 22, 2024

View Archived Issues
Liver illustration

Sagimet soars with phase IIb NASH data

Sagimet Biosciences Inc. stock (NASDAQ:SGMT) more than doubled Jan. 22 as shares closed 170% higher at $18.42 each as a phase IIb study of lead candidate denifanstat performed well against nonalcoholic steatohepatitis (NASH) compared to placebo. Top-line data from the 52-week, randomized, double-blind Fascinate-2 trial showed the oral fatty acid synthase inhibitor resulted in statistically significant improvements in biopsy-confirmed NASH patients with stage 2 or stage 3 fibrosis, which is moderate to severe disease, at week 52. Read More
Gainers-and-losers

2023 gainers and losers: Positive trial outcomes and M&As propel biopharma stocks to strong finish

Biopharma stocks saw a resurgence in 2023, with the BioWorld Stock Index finishing the year with a gain of 33.59%, in contrast to the 32.75% decline in 2022. An analysis of 516 stocks from the index showed that 193 companies (37%) concluded the year on a positive note, while shares of 322 companies (62%) experienced a downturn. Anebulo Pharmaceuticals Inc. (NASDAQ:ANEB), a biopharma focused on substance use disorders, saw its stock end 2023 at the same price as its 2022 closing. Meanwhile, the BioWorld Biopharmaceutical Index ended November up 4.37%. Read More
Judge's gavel with US flag

US FDA’s trade secret disclosure still a live legal question

Is it an unconstitutional taking when U.S. FDA reviewers disclose a brand company’s claimed trade secrets or confidential commercial information to would-be competitors? That’s a question the U.S. Court of Federal Claims has yet to answer. While the court dismissed some of Vanda Pharmaceuticals Inc.’s claims against the FDA, its Jan. 18 opinion left open the debate of whether such disclosures, intentional or inadvertent, are a per se or regulatory taking. Read More

Gilead disappoints with top-line phase III data in metastatic NSCLC

What had been viewed as a major catalyst for Gilead Sciences Inc. going into 2024 turned into a disappointment on the stock market, as antibody-drug conjugate Trodelvy (sacituzumab govitecan) failed to meet the overall survival primary endpoint in the phase III Evoke-01 study in previously treated metastatic non-small-cell lung cancer (NSCLC). Read More
Doctor with stethoscope listening to heart of girl

FDA offers life support to Mesoblast’s Revascor via rare pediatric disease designation

The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition. Read More
US-capital-washington-congress-government.png

Latest US continuing budget resolution leaves docs dyspeptic

The U.S. Congress has passed a continuing resolution (CR) for the fiscal 2024 budget, an exercise that has become all too common as a substitute for a full suite of spending bills in an era of growing deficits. Read More

Biden administration concedes to court on copay accumulators

With little fanfare, the Biden administration dropped its appeal Jan. 16 of a recent court decision that vacated a 2021 U.S. Health and Human Services rule permitting health insurance issuers and group health plans to use so-called copay accumulator adjustment programs that prevent drug manufacturers’ copay assistance from counting toward a patient’s deductible or out-of-pocket maximum. Read More

ICYMI: Week in review, Jan. 15-19

A quick look back at top stories. Read More

Biggest gainers and losers for Jan. 15-19, 2024

The top 10 biopharma stock gainers and losers for the week. Read More

Appointments and advancements for Jan. 22, 2024

New hires and promotions in the biopharma industry, including: Apnimed, Bayer, Elevation Oncology, Neumora, NMD, Respirerx, Siga, Transgene, Tris. Read More

Financings for Jan. 22, 2024

Biopharmas raising money in public or private financings, including: Aarvik, Arrivent, Calcimedica, Mitosense, Oric. Read More

In the clinic for Jan. 22, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeon, Coherus, Deciphera, Optinose, Prilenia. Read More

Other news to note for Jan. 22, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abpro, AC Immune, AFT, Atlantic Coastal, Basilea, Cara, Coherus, Fauna, Genentech, Hyloris, Ikena, Knight, PMV, Promis, Propagenix, Reithera, Roche, Sandoz, Stemcell, Vaxart. Read More

Regulatory actions for Jan. 22, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anges, Astrazeneca, Eiger, Mesoblast, Processa, Sensorion, Verastem. Read More

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