The Daily Biotech Pulse: Gemini Sinks On Data, Amgen's Migraine Drug Approved In Japan, Liver Congress Gets Underway

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 22)

• AngioDynamics, Inc. ANGO
• Atossa Therapeutics, Inc. ATOS
• Axonics, Inc. AXNX
• Century Therapeutics, Inc IPSC
• Citius Pharmaceuticals, Inc. CTXR
• Edwards Lifesciences Corporation EW
• Intra-Cellular Therapies, Inc. ITCI
• Intuitive Surgical, Inc. ISRG
• PAVmed Inc. PAVM
• Verve Therapeutics, Inc. VERV (IPOed June 17)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 22)

• 4D Molecular Therapeutics, Inc. FDMT
• Adaptimmune Therapeutics plc ADAP
• Adicet Bio, Inc. ACET
• Aeglea BioTherapeutics, Inc. AGLE
• Alzamend Neuro, Inc. ALZN (IPOed June 14)
• Aptose Biosciences Inc. APTO
• Black Diamond Therapeutics, Inc. BDTX
• Bolt Biotherapeutics, Inc. BOLT
• Chembio Diagnostics, Inc. CEMI
• Cullinan Oncology, Inc. CGEM
• ERYTECH Pharma S.A. ERYP
• Impel NeuroPharma, Inc. IMPL
• Innate Pharma S.A. IPHA ( reacted to a mid-stage readout of lacutamab in mycosis fungoides)
• LogicBio Therapeutics, Inc. LOGC
• NexImmune, Inc. NEXI
• Opthea Limited OPT
• ORIC Pharmaceuticals, Inc. ORIC
• Osmotica Pharmaceuticals plc OSMT
• Pharming Group N.V. PHAR
• Pharvaris N.V. PHVS
• Sigilon Therapeutics, Inc. SGTX
• Vertex Pharmaceuticals Incorporated VRTX
• Virpax Pharmaceuticals, Inc. VRPX
• Vivos Therapeutics, Inc. VVOS
• Yumanity Therapeutics, Inc. YMTX

Stocks In Focus

Gemini Reports Positive Phase 2a Data For Advanced Retinal Disease Drug

Gemini Therapeutics, Inc. GMTX announced initial data from its Phase 2a ReGAtta study of GEM103 in patients with secondary to dry age-related macular degeneration.

ReGAtta is a dose escalation trial of GEM103, which is intravitreally administered recombinant human complement factor H, or CFH, in dry AMD patients.

Both 250µg and 500µg doses of GEM103 resulted in sustained, elevated CFH levels from the first evaluated time point of one month that continued to increase dose dependently. The changes in biomarkers of complement activation indicated that GEM103 has the ability to regulate the complement system and overall disease-related inflammation.

The company also noted that GEM103 was well-tolerated with no serious adverse events related to study drug and no serious ocular adverse events as of May. There were no early discontinuations due to the study drug.

The stock slumped 35.01% to $6.35 in after-hours trading.

Enanta Announces Positive Data For Hepatitis B Virus Treatment Candidates EDP-721 and EDP-514

Enanta Pharmaceuticals, Inc. ENTA presented at the EASL International Liver Congress new preclinical data for EDP-721, an oral hepatitis B virus RNA destabilizer being developed for use in an all-oral combination regimen for HBV, showing potent, selective and pangenotypic inhibition of HBV surface antigen, with up to a 3-log drop in the AAV-HBV mouse model.

Separately, the company announced positive data from the first two dose cohorts of its Phase 1b study of EDP-514 in viremic chronic HBV patients who were not being treated with a nucleoside reverse transcriptase inhibitor. The data demonstrated that EDP-514 was safe and well-tolerated through 28 days of treatment, displayed pharmacokinetics supportive of once-daily dosing, and resulted in mean HBV DNA reductions of 2.9 and 3.3 logs at 28 days for the 200 mg and 400 mg cohorts, respectively.

Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates

Tiziana Inks Deal For Initiating Phase 2 Study of Foralumab In Hospitalized Patients With Severe COVID-19 Disease

Tiziana Life Sciences plc TLSA announced that it has signed an agreement with FHI Clinical, a global clinical contract research organization, to conduct a Phase 2 proof-of-concept study in Brazil to evaluate the safety, tolerability and efficacy of intranasal Foralumab in hospitalized patients with severe coronavirus disease 2019 and pulmonary inflammation.

This study is designed to expand on the preliminary findings of safety, tolerability and efficacy of intranasal administration of Foralumab observed in mild to moderate non-hospitalized COVID-19 patients

The stock was up 17.39% at $2.70 in premarket trading Wednesday.

Galapagos' Long-time Chief Scientific Office to Depart

Galapagos NV GLPG said its long-time chief scientific officer Dr. Piet Wigerinck will leave the company later this year. Effective immediately, all early-stage development activities will be added to late-stage clinical development under the responsibility of chief medical officer Dr. Walid Abi-Saab, it added.

The stock was down 1.27% at $70.82 in premarket trading Wednesday.

Lyra Gains On Insider Buying

Lyra Therapeutics, Inc. LYRA disclosed in a filing Ann Merrifield, a director of its board, bought 3,500 shares of the company at $8.9699.

The stock gained 4.58% to $8.45 in after-hours trading.

Amgen's Migraine Preventative Treatment Approved In Japan

Amgen, Inc. AMGN announced that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Aimovig for the suppression of onset of migraine attacks in adults. Aimovig is the first and only approved treatment in Japan to block the calcitonin gene-related peptide receptor, which is believed to play a critical role in migraine.

Offerings

BioXcel Therapeutics, Inc. BTAI announced that it has commenced an underwritten public offering of $100 million of shares of its common stock.

The stock slipped 8.06% to $33.88 in after-hours trading.

On The Radar

Clinical Readouts

Alnylam Pharmaceuticals, Inc. ALNY & Vir Biotechnology, Inc. VIR will present at the International Liver Congress 2021, preliminary on-treatment data from a phase 2 study evaluating VIR-2218 in combination with pegylated interferon alfa-2a in participants with chronic hepatitis B infection.

Capricor Therapeutics, Inc. CAPR is due to present at the Parent Project Muscular Dystrophy annual conference, Phase 2 HOPE-2 open label study of CAP-1002 in Duchenne Muscular Dystrophy.

Radius Health, Inc. RDUS will present at the Prader-Willi Syndrome Association, USA, national convention data from Phase 2 study of RAD011 in Prader-Willi Syndrome.