A Biotech's Binary Bet Ends Badly: The Need-to-Know This Morning
Zentalis Pharmaceuticals Faces Setback
Zentalis Pharmaceuticals announced that the FDA has put a partial hold on clinical trials for its experimental cancer drug azenosertib. This came after two patients passed away, suspected to be due to "presumed sepsis."
Intra-Cellular Therapies Reports Positive Results
Intra-Cellular Therapies shared promising outcomes from a second Phase 3 clinical trial of its antipsychotic medication, Caplyta, aimed at treating patients with major depressive disorder. Earlier positive results from the first Phase 3 study were reported back in April.
Taysha Gene Therapies' New Findings
Taysha Gene Therapies released preliminary results from a study on their gene therapy for children and adults with Rett syndrome.
Ethan Weiss Makes Money Moves
Ethan Weiss, a former UCSF cardiologist and a frequenter on Twitter/X, recently co-founded a biotech startup named Marea. This 10-member team has raised $190 million to develop a drug aimed at lowering “remnant cholesterol”, which could be a new way to tackle cardiovascular disease. Weiss is also the company's chief scientific officer.
The journey of Marea’s new drug, which targets the protein ANGPTL4, highlights why developing medications is challenging and emphasizes the continued fight against heart disease, the leading killer in the U.S., claiming 700,000 lives annually. Marea’s drug, initially developed by Novartis, is now about to begin Phase 2 trials.
Aerovate Therapeutics Sees Major Setback
Shares of Aerovate Therapeutics plummeted 93% due to the failure of its only drug candidate AV-101 in a mid-stage clinical trial. The drug, intended to treat pulmonary arterial hypertension, did not manage to reduce blood pressure in the lungs effectively compared to a placebo. As a result, Aerovate has halted ongoing studies and enrollments, given these unfavorable results.
Merck Wins Approval for Pneumonia Vaccine
The FDA has approved Merck’s new vaccine, Capvaxive, for people aged 18 and older. This vaccine fights against pneumococcal pneumonia, which hospitalizes around 150,000 adults in the U.S. every year. Capvaxive covers 21 different serotypes of Streptococcus pneumoniae, including eight that no other vaccines currently target. Previously, Pfizer's Prevnar 20 covered the most serotypes.
Gilead Sciences and Obesity Stock Speculation
A research abstract about monkey weight changes has sparked speculation, with some analysts like Michael Yee from Jefferies hinting at Gilead Sciences having “exposure to obesity.” The biotech giant has a preclinical metabolic drug, GS-4571, that’s being shown at an upcoming American Diabetes Association meeting. Gilead's stock saw a slight uptick as a result. However, Gilead management clarified that no decision has been made yet to advance GS-4571 into Phase 1 studies.
More Reads
- New data highlight the potential and challenges of CAR-T cell therapy in treating autoimmune diseases.
- The FDA places a partial hold on a BioNTech-MediLink ADC after multiple deaths occurred.
- An East Bay firm turned a brain cancer drug into an $8 million payday.
- Drugmaker Apotex has accused Amarin of dominating the market for its drug Vascepa in a new U.S. lawsuit.
Stay informed with the latest biotech news for more updates and insights.
