Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

INmune Bio Planned Midstage Alzheimer's Trial Put On FDA Hold

The FDA has requested additional information on the Chemistry Manufacturing and Controls of the newly manufactured INmune Bio Inc's (NASDAQ:INMB) XPro1595. 

As part of the communication, the FDA placed the company's Investigational New Drug application for the Phase 2 trial of XPro in Alzheimer's Disease on clinical hold. 

INmune plans to provide additional updates pending discussion with the FDA. The Phase 2 trial of XPro remains open in Australia and continues to enroll patients.

Shares are down 27.2% at $5.29 during the premarket session.

Caladrius Biosciences Stops Enrollment In Midstage Heart Disease Study

The FREEDOM trial enrolled approximately one-third of the targeted 105 patients, and at this rate, more than four years would likely be required to reach the primary endpoint follow-up at six months post-treatment for all subjects. 

The interim analysis is expected to be completed in August 2022.

Ensysce Biosciences Initiates First Human Abuse Potential Study

This trial is designed to test and confirm that manipulating and snorting PF614 will not allow the drug abuser to achieve that desired state of euphoria.

Data is expected in September.

BiomX Slashes Workforce By 50%

BiomX said it will reduce its operating costs, including a 50% reduction in personnel, while prioritizing the ongoing cystic fibrosis program.

While the restructuring will cause a delay in BiomX's atopic dermatitis program, it plans to support a range of activities that will continue to move this program forward and expects to provide a more detailed program update later in the year.

FDA Approves First Dry Powder Inhaler For Pulmonary Hypertension

Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.

FDA Approves First Topical Novel Chemical Entity For Psoriasis In 25 Years

Dermavant Sciences is Roivant Sciences Ltd's (NASDAQ:ROIV) subsidiary.

Vtama is an aryl hydrocarbon receptor agonist.

Europe Approves Merck's Keytruda In High-Risk Breast Cancer Setting

The approval comes for Keytruda/chemo combo as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery for adults.

SpringWorks Cancer Candidate Cuts Risk of Disease Progression By 71%

In addition, the trial met all key secondary endpoints, with nirogacestat demonstrating statistically significant improvements as compared to placebo in objective response rate and patient-reported outcomes. 

Shares are up 27.9% at $48.61 during the premarket session.

Clinical Readouts/Presentations

AbbVie Inc (NYSE:ABBV): Data from a Phase 3 trial of cariprazine for the adjunctive treatment of the major depressive disorder at the American Psychiatric Association Annual Meeting.

First Wave BioPharma Inc (NASDAQ:FWBI): James Sapirstein, chairman and chief executive officer, will participate in a "fireside chat" during the H.C. Wainwright Global Investment Conference.

Protagonist Therapeutics Inc (NASDAQ:PTGX): Topline results from the Phase 2 IDEAL study of PN-943 in moderate-to-severe ulcerative colitis at Digestive Disease Week.

On The Radar

PDUFA Dates

Verrica Pharmaceuticals Inc (NASDAQ:VRCA): VP-102 for molluscum contagiosum, a viral skin infection that results in round, firm, painless bumps.