TRVN To Report Data In Mid-year, TSHA Trims Workforce, FDA Decision On SPRO's NDA To Be Delayed?

(RTTNews) - The following are some of the biotech companies that provided an update on their pipeline progress on Thursday.

1. Galectin Therapeutics Inc. (GALT) now expects to complete enrollment in its NAVIGATE trial by June 30, 2022.

NAVIGATE is an adaptive, two-stage, Phase 2b/3 study assessing the efficacy, safety, and tolerability of Galectin's lead drug candidate Belapectin compared with placebo for the prevention of esophageal varices in with nonalcoholic steatohepatitis (NASH) cirrhosis.

The company's cash on hand totaled $39.6 million as of Dec.31, 2021.

GALT closed Thursday's trading at $1.61, down 5.85%.

2. Soleno Therapeutics Inc. (SLNO), a clinical-stage biopharmaceutical company, is working towards advancing its lead candidate DCCR, a once-daily oral tablet for the treatment of Prader-Willi Syndrome, to an NDA submission.

In June 2020, the company had reported top-line results from its phase III trial of once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome, dubbed DESTINY PWS. The study did not meet its primary endpoint of change from baseline in hyperphagia, the hallmark symptom of PWS, but showed significant improvements in prespecified subgroup with severe hyperphagia.

Last March, the FDA informed Soleno that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR in Prader-Willi Syndrome. Soleno recently submitted a study proposal to the FDA and intends to start the study after an agreement with the FDA is reached.

The company's cash and cash equivalents totaled about $21.3 million as of Dec.31, 2021.

SLNO closed Thursday's trading at $0.22, up 2.43%.

3. Spero Therapeutics Inc. (SPRO), whose New Drug Application for Tebipenem HBr is under regulatory review in the U.S., has been notified by the FDA of certain deficiencies in the application.

The company aims to engage with the FDA to resolve the deficiencies as quickly as possible.

Tebipenem HBr, proposed for the treatment of complicated urinary tract infections, including acute pyelonephritis, caused by susceptible microorganisms, in adults, was initially assigned a decision date of June 27, 2022.

SPRO closed Thursday's trading at $8.70, up 1.05%.

4. Taysha Gene Therapies Inc. (TSHA) expects to receive a feedback from the FDA related to registration pathway for its lead drug candidate TSHA-120 for giant axonal neuropathy by mid-2022.

In January of this year, the company reported positive clinical efficacy and safety data for the high dose cohort as well as long-term durability data across all therapeutic doses of TSHA-120 in giant axonal neuropathy, a progressive neurodegenerative disease.

A phase I/II trial of TSHA-102 in Rett syndrome is underway, with preliminary data anticipated by year-end 2022.

In a bid to increase operational focus and efficiency, the company has decided to minimize activities for some ongoing clinical programs and pause all additional research and development. The company also reveled that it has reduced its workforce by 35%.

TSHA closed Thursday's trading at $6.52, up 6.02%.

5. Trevena Inc. (TRVN) expects to report topline data from a study assessing the potential reduced effect of Olinvyk on cognitive function compared to IV morphine by mid-2022.

Olinvyk, an opioid agonist, was approved by the FDA for the management of moderate to severe acute pain in adults in September 2020.

The company is also conducting post-approval studies to further evaluate the potential impact of on respiratory, gastrointestinal and cognitive function outcomes in the postoperative setting and topline data is expected in the second half of this year.

Jiangsu Nhwa, Trevena's commercial partner in China, has sought regulatory approval for Olinvyk in China, and an application was filed in January 2022.

The company had $66.9 million in cash and cash equivalents as of December 31, 2021.

TRVN closed Thursday's trading at $0.54, up 24.64%.