After July’s first-ever release of more than 200 complete response letters (CRLs) by the U.S. FDA, the agency now says it will release letters shortly after sponsors receive them. In addition, the FDA released a new batch of 89 CRLs from 2024 to now that are tied to pending or withdrawn applications.
Shares of CG Oncology Inc. gained 25% April 28 on the back of phase III data presented at the American Urological Association meeting over the weekend showing its cretostimogene grenadenorepvec yielded durable response rates, as well as an enviable safety profile, in patients with high-risk non-muscle invasive bladder cancer unresponsive to Bacillus Calmette Guerin treatment with carcinoma in situ with or without Ta or T1 disease.
Among the drug developers with clinical results featured at the annual meeting of the Society for Urologic Oncology (SUO) in Dallas were Protara Therapeutics Inc. with phase II numbers and CG Oncology Inc. with a phase III update. Protara’s shares (NASDAQ:TARA) closed Dec. 5 at $6.02, up $2.48, or 70%, having traded as high as $10.48 during the day. Less reactive was stock in CG (NASDAQ:CGON), which ended at $33.56, down $2.35.
Engene Holdings Inc.’s recent disclosure of pivotal phase II data with nonviral gene therapy detalimogene voraplasmid (also known as detalimogene, and previously as EG-70) – along with a planned protocol refinement – added intrigue to the non-muscle invasive bladder cancer space, which continues to percolate.
Biopharma IPOs have faced tough conditions in recent years, but 2024 is showing signs of improvement in terms of value, while stumbling on overall performance. IPO values remain significantly lower than the peak years of 2020-2021 and are still below collective values seen in 2014-2019, however, this year's value marks a recovery compared to the challenging environment of 2023.
Biopharma IPOs have faced tough conditions in recent years, but 2024 is showing signs of improvement in terms of value, while stumbling on overall performance. IPO values remain significantly lower than the peak years of 2020-2021 and are still below collective values seen in 2014-2019, however, this year's value marks a recovery compared to the challenging environment of 2023.
The first – and handsomely upsized – IPO of this year by CG Oncology Inc., along with the sizeable financing Feb. 14 by Engene Holdings Inc., proved Wall Street’s interest in non-muscle invasive bladder cancer, where a number of other players also are busy.
The week closed out with two IPOs on their way in. Alto Neuroscience Inc. (NASDAQ:ANRO) and Fractyl Health Inc. (NASDAQ:GUTS) both debuted on Wall Street with offerings looking to raise combined $238.6 million.
The first IPO of 2024 is a greatly upsized one from CG Oncology Inc., which is selling 20 million shares (NASDAQ:CGON) of its common stock at $19 each. Shares closed Jan. 25 95.6% higher at $37.17 each. The company initially had looked to raise about $200.6 million by selling its shares somewhere from $16 to $18 each but adjusted its thinking before the Jan. 25 debut, now anticipating gross proceeds of $389 million.
Therapy delivery and the physicians who administer them are keys in CG Oncology Inc.’s drive to develop bladder cancer treatments. The company, which just closed an oversubscribed $120 million series E financing to continue on the development path, has its lead oncolytic immunotherapy, CG-0070, intravesically delivered via a catheter, in the clinic.
