Drug developer stocks rebounded over July and August, with 23 companies on the BioWorld Drug Developers Index posting gains and only seven declining. The two-month upswing marks a reversal from the February-through-June period, when the index remained in the negative.
Drug developer stocks rebounded over July and August, with 23 companies on the BioWorld Drug Developers Index posting gains and only seven declining. The two-month upswing marks a reversal from the February-through-June period, when the index remained in the negative.
The BioWorld Drug Developers Index (BDDI) declined in August, ending the month down 1.11% for the year and diverging from its previous trend of mirroring the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA). By the close of August, the BDDI had slipped, while the NBI gained 11.7% year-to-date and the DJIA rose 7.05%.
The disappointments continue for Fibrogen Inc., which is terminating work on its once-promising anti-CTGF monoclonal antibody, pamrevlumab, after reporting missed endpoints in two late-stage pancreatic cancer studies, and cutting its workforce by about 75%.
Fibrogen Inc. has received IND clearance from the FDA allowing the company to initiate a phase I trial of FG-3165, a galectin-9 (Gal9)-targeted monoclonal antibody under development for treatment of solid tumors characterized by high levels of Gal9 expression.
After a complete response letter (CRL) from the U.S. FDA in 2022 and approvals in Europe, Japan and Australia, Akebia Therapeutics Inc.’s Vafseo (vadadustat) has finally been approved by the FDA. But the uphill climb still isn’t over for Akebia, as it has more hurdles to clear for the drug.
Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party.
Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party.
A tough spring has settled into a cruel summer for Fibrogen Inc. as the company has stumbled for the third time in two months. The newest problem is top-line results showing the phase III Zephyrus-1 study of pamrevlumab, a monoclonal antibody, missed its primary endpoint for treating idiopathic pulmonary fibrosis.
It has been a tough spring for Fibrogen Inc., which reported another phase III miss on June 7, this time for rare disease drug pamrevlumab to treat non-ambulatory patients with Duchenne muscular dystrophy (DMD).
