Here are the latest stories being discussed in biopharma today:
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Aerovate’s Stock Plummets After PAH Drug Fails Phase 2 Study
Aerovate Therapeutics faced a significant setback as its Phase 2b study for pulmonary arterial hypertension (PAH) failed to show meaningful improvement in patients’ blood pressure compared to a placebo. This disappointing result sent the company’s shares tumbling more than 90%, from $24.62 to $2.26. Though the inhaled version of the cancer treatment imatinib, branded as AV-101, was well tolerated, it did not significantly improve pulmonary vascular resistance across three dose ranges, which was the trial’s primary endpoint. The drug also failed to show substantial improvements in several secondary endpoints, casting doubt on its competitive standing against Merck’s newly introduced Winrevair.
Life Sciences Investor Decheng Capital Targets $700M for Fifth Fund
Joining the ranks of major life sciences investment initiatives, Decheng Capital has announced plans for a $700 million global life sciences fund. This will be the firm’s fifth such fund and follows significant fund closures from Foresite Capital and JP Morgan within the past week. Decheng Capital operates out of offices in Silicon Valley, Shanghai, and New York. The new funding comes at a crucial time as many biotech startups struggle to secure additional investment amid a challenging financing environment.
Janssen Ordered to Pay $150M Over False Claims Around HIV Drugs
In a recent New Jersey federal court ruling, Janssen, a branch of Johnson & Johnson, has been ordered to pay $150 million for violating the False Claims Act with its HIV medications, Prezista and Intelence. The company was found responsible for 159,574 false claims filed with federal and state governments. The case was initiated in 2012 by whistleblowers and former Janssen employees, who alleged the company’s promotion of these drugs resulted in false claims. However, the jury did not find Janssen in violation of the Anti-Kickback Statute.
J&J Commits to €580M in Italian Investments Over Five Years
Johnson & Johnson Innovative Medicine, formerly Janssen, plans to invest €580 million ($622 million) in Italy, including €125 million ($134 million) allocated to upgrade its tableting manufacturing site in Latina. Aim is to enhance manufacturing efficiency and meet growing demand. The Latina facility, already producing 4 billion tablets per year, will receive new technologies to expedite production.
GSK Readies Blenrep’s Commercial Re-Launch in the US
GSK is preparing for a commercial re-launch of Blenrep, its multiple myeloma drug, which previously faced market withdrawal after a trial failure. Retaining the original salesforce, the company believes in Blenrep’s potential comeback, bolstered by recent positive outcomes in two late-stage trials. GSK aims to submit approval applications to global regulators in the latter half of 2024, signaling a promising future for the drug.
FDA Approves Endometrial Cancer Indications for Keytruda, Imfinzi
The FDA has granted new indications for Merck’s Keytruda and AstraZeneca’s Imfinzi in the treatment of endometrial cancer. Keytruda has been approved in combination with chemotherapy for advanced or recurrent endometrial cancer, marking its 40th indication. Significantly, it is now the first frontline immunotherapy for advanced endometrial cancer patients regardless of mismatch repair status. In trials, dMMR patients on the Keytruda regimen did not reach median progression-free survival, while those with proficient mismatch repair (pMMR) showed median progression-free survival of 11.1 months versus 8.5 months in the placebo group.
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