Humanigen, Inc. Stock Price, News & Analysis

Humanigen plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lenzilumab, aimed at treating COVID-19 pneumonia patients. This application will seek Conditional Marketing Authorization across the EU, with a request for accelerated assessment to potentially shorten the review process by 60 days. In light of ongoing COVID-19 challenges, the company is committed to expediting the availability of lenzilumab, driven by recent hospitalization statistics indicating a sustained need for effective treatments.

Humanigen, Inc. (Nasdaq: HGEN) announced participation in multiple virtual investor conferences in September 2021. CEO Cameron Durrant will present a corporate update at the Baird Global Healthcare Conference on September 14, and participate in a panel at the H.C. Wainwright Global Investment Conference on September 15. The company will also present at the Oppenheimer Summit on September 22 and the Cantor Global Healthcare Conference on September 27. Humanigen is focused on treating cytokine storms and has submitted its treatment candidate, lenzilumab, for regulatory review in the UK.

The FDA has declined Humanigen's request for emergency use authorization (EUA) of lenzilumab for newly hospitalized COVID-19 patients, citing concerns over risks versus benefits. Despite this setback, Humanigen is committed to advancing its regulatory processes and intends to submit additional data as it becomes available. Ongoing data from the NIH’s ACTIV-5/BET-B study could support a future EUA request. The company continues its efforts for Marketing Authorization in the UK and other regions for lenzilumab.

Humanigen (Nasdaq: HGEN) provides a corporate and regulatory update along with financial results for Q2 2021. The company submitted an EUA application for its drug lenzilumab for COVID-19 treatment but lacks a timeline from the FDA on the decision. Financially, Humanigen reported a net loss of $70.8 million for Q2, up from $24.0 million in 2020, driven by increased R&D expenses totaling $63.0 million. Cash and equivalents stood at $120.5 million, supporting continued development efforts.

Humanigen (Nasdaq: HGEN) announced findings from its Phase 3 LIVE-AIR study of lenzilumab in hospitalized COVID-19 patients, indicating that Black and African-American patients with CRP<150 mg/L may respond better to treatment. The study found a nearly 9-fold increase in survival without ventilation (SWOV) for this group (p-value=0.0412), while all patients in the CRP<150 mg/L category saw a 2.5-fold increase in SWOV (p-value=0.0009). Humanigen aims to submit these results for peer review and share data with regulatory agencies to enhance treatment options for vulnerable populations.

Humanigen, Inc. (Nasdaq: HGEN) announced that the NIH has advanced the ACTIV-5/BET-B study to Phase 2/3, modifying the primary endpoint to survival without ventilation (SWOV). This study includes 400 patients across up to sixty US sites, with Humanigen providing its treatment, lenzilumab, alongside NIH funding. The design aligns with the Phase 3 LIVE-AIR study, which previously showed a significant efficacy of lenzilumab in improving survival rates among COVID-19 patients. The current study aims to validate lenzilumab's potential for COVID-19 treatment and may support a future BLA submission to the FDA.

Humanigen, Inc. (Nasdaq: HGEN) announced that its partners in South Korea and the Philippines, Telcon RF Pharmaceutical and KPM Tech, have received approval from the MFDS to conduct a Phase 1 study for lenzilumab, aimed at treating hospitalized COVID-19 patients. This randomized, placebo-controlled study will evaluate the safety and pharmacokinetics of lenzilumab in 20 healthy adults. If successful, it may lead to conditional approval for lenzilumab's use in Korea, based on existing data from Humanigen’s Phase 3 LIVE-AIR study.

Humanigen, Inc. (Nasdaq: HGEN) has submitted a request for Marketing Authorization of lenzilumab for COVID-19, which has been accepted by the UK’s MHRA for expedited rolling review. This review process is expected to be faster than standard timelines. Meetings with UK health authorities supported this submission. Despite high vaccination rates, COVID-19 hospitalizations and deaths in the UK have increased significantly. Humanigen plans to prepare for lenzilumab's distribution pending approval in the US and UK.

Humanigen (Nasdaq: HGEN) has initiated a rolling review submission for Marketing Authorization (MA) of its lead drug candidate, lenzilumab, with the MHRA in the UK, following its EUA submission to the FDA. CEO Cameron Durrant expressed optimism about lenzilumab's potential in treating COVID-19, citing positive results from the LIVE-AIR clinical trial, which showed a 54% improvement in survival without ventilation. The drug demonstrated a strong safety profile, indicating no serious adverse events compared to placebo. This marks a significant step for Humanigen as it seeks to enter the market.