$BIVI

Werewolf Therapeutics (HOWL) rose 90% in after-hours trading, with key clinical trials ongoing. GeoVax (GOVX) gained 12.66%, preparing for a pivotal Phase 3 study. Greenwich LifeSciences (GLSI) increased 6.27%, extending share lock-up. Modular Medical (MODD) up 7.87%, planning Pivot pump rollout. Ovid Therapeutics (OVID) rose 6.93%, with multiple clinical milestones. BioVie (BIVI) up 4.84%, awaiting long COVID data.

Tenon Medical (TNON) shares rose 80% after-hours with no specific news, reporting Q2 revenue of $1.3M (up 127% YoY) and a net loss of $4.1M. BioVie (BIVI) gained 55% after positive Phase 2 trial results for its Parkinson's drug. Edesa Biotech (EDSA) advanced 7% after announcing Phase 2 trial preparations for vitiligo treatment. TransCode (RNAZ) and HCW Biologics (HCWB) also saw after-hours gains on trial updates.

Jefferies says Parkinson’s drug development is shifting toward neuroinflammation, while still pursuing alpha-synuclein. It estimates the addressable early US and EU population could exceed 2 million by 2035, implying a ~$8 billion disease-modifying therapy market. It cites Roche’s prasinezumab missed endpoints twice but moved to Phase III, and Denali’s BIIB122 failed broadly. Companies mentioned include Ventyx (VTYX), BioVie (BIVI), and Tiziana (TLSA).

BioVie (NASDAQ: BIVI) shares fell after Phase IIb Parkinson’s trial data. On Aug. 6 the stock opened 33.3% lower at $1.36, briefly down nearly 60% to $0.82, then closed at $1.35, down 33.8% from Aug. 5. The data were released alongside a filing for a stock offering at $1.33 per share.

BioVie (BIVI) reported topline Phase 2 SUNRISE-PD results for Bezisterim in early-stage Parkinson’s. The drug met its primary endpoint with statistically significant improvements on motor and non-motor measures versus placebo, while adverse reactions were more frequent in the placebo arm (39.3% vs 51.7%). BioVie plans to advance to Phase 3.

BioVie Inc (NASDAQ:BIVI) reported positive Phase 2 SUNRISE-PD results for its Parkinson's candidate bezisterim. The drug met prespecified endpoints in early-stage, untreated patients, improving blood inflammatory markers and EPNIC-15 versus placebo. Benefits were strongest in patients with higher baseline platelet counts. Safety was similar to placebo, with 39.3% adverse events vs 51.7%.

BioVie Inc (NASDAQ:BIVI) said its Phase 2 long COVID trial of bezisterim is fully enrolled, with more than 200 patients randomized to placebo or bezisterim. CEO Cuong Do said the study includes sites such as Yale, Mount Sinai, Mayo Clinic and Stanford, targeting symptoms like brain fog, malaise and fatigue. Top-line results are expected by late October or as early as September; the company plans FDA discussions on accelerated approval or EUA if data support benefit-risk.

RedChip Companies said Foremost Clean Energy (Nasdaq:FMST, CSE:FAT) and BioVie (Nasdaq:BIVI) will be featured on its “RedChip Small Stocks, Big Money” show on Bloomberg TV on May 30 at 7 p.m. ET. Foremost’s CEO discussed its Hatchet Lake uranium discovery and Denison partnership; BioVie’s CEO discussed bezisterim clinical readouts expected by end of summer/early fall.

Faruqi & Faruqi, LLP, a national securities law firm, is investigating potential claims against BioVie Inc. (NASDAQ: BIVI) and reminds investors of the March 19, 2024 deadline to seek the role of lead plaintiff in a federal securities class action. The investigation follows a significant drop in BioVie's stock price after the company disclosed issues with its Phase 3 clinical trial for Alzheimer's disease, including significant protocol deviations and Good Clinical Practice violations leading to patient exclusions. Investors who suffered losses exceeding $25,000 between August 5, 2021, and November 29, 2023, are encouraged to contact the firm.

New to The Street will broadcast Show #716 tonight at 6:30 PM ET on Bloomberg Television, featuring companies Stardust Power (NASDAQ:SDST), BioVie (NASDAQ:BIVI), and Roadzen (NASDAQ:RDZN). The episode will also include special segments with Kelsey Grammer discussing his book "KAREN" and Andrew Shaw from 250DAYS.ORG. This broadcast is sponsored programming supported by national commercials from several companies, highlighting New to The Street's "Predictable Media" model.