California-Based Biopharma Advances Lead Asset in COVID-19, Other Indications
Source: Streetwise Reports��(12/8/21)
Humanigen has applications for lenzilumab in the works with U.S., United Kingdom and European drug regulatory agencies, noted a ROTH Capital Partners report. More >

CRO's Shares Rise 18% on Preliminary Q4/FY Financial Results
Source: Streetwise Reports��(12/8/21)
Shares of contract research organization Inotiv Inc. traded higher after the company reported select preliminary unaudited financial results for Q4/21 and FY/21 which included a 90.7% YoY increase in revenue and a 123.0% increase in gross profit.
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Biopharma Seeks to Add Idiopathic Hypersomnia to Narcolepsy Drug's Label
Source: Streetwise Reports��(12/7/21)
Harmony Biosciences Holdings intends to conduct a Phase Three trial next year to evaluate Wakix as a treatment for idiopathic hypersomnia, according to an Oppenheimer report. More >

Partnership With Chewy.com Sends Pet Health Insurer's Shares to the Top of the Pack
Source: Streetwise Reports��(12/7/21)
Shares of pet healthcare insurer Trupanion Inc. reached a new 52-week high after the company reported it is teaming up with Chewy Inc. to offer an exclusive line of pet wellness and health insurance products to Chewy's 20,000,000 customers. More >

Medical Device Firm Engages Distributor for Its TransDermal Infusion System
Source: Streetwise Reports��(12/6/21)
Sensus Healthcare's "needle-free treatment presents a clear competitive advantage in the aesthetic dermatology space," an H.C. Wainwright & Co. report noted. More >

Phase Two Studies Start for Therapy for Chemo-Treated Breast Cancer Patients
Source: Streetwise Reports��(12/6/21)
New clinical trials for G1 Therapeutics’ Cosela are “central to our investment thesis,” H.C. Wainright & Co. noted in a new research report. More >

Biopharma Launches Clinical Trial of Primary Asset in Endometrial Cancer
Source: Streetwise Reports��(12/6/21)
"Solid tumors offers a substantial opportunity for Karyopharm Therapeutics' Xpovio (selinexor) that perhaps investors have not yet realized," noted an H.C. Wainwright & Co. report. More >

Biotech Firm’s T-Cell Therapy Gets Positive Results in B-Cell Non-Hodgkin’s Lymphoma Study
Source: Streetwise Reports��(12/6/21)
Adicet Bio Inc. shares traded 37% higher after the company reported positive interim data from its Phase 1 GLEAN Study of ADI-001, which the firm noted is the first-ever allogeneic, off-the-shelf, gamma delta CAR T investigational cell therapy. More >

Antibody-Drug Conjugate Developer Achieves High Objective Response Rates in Ovarian Cancer Study
Source: Streetwise Reports��(11/30/21)
ImmunoGen Inc. shares traded 30% higher after the company announced positive topline data from its pivotal Phase 3 SORAYA Trial of mirvetuximab soravtansine in platinum-resistant ovarian cancer. More >

Biopharma Launches COVID Vaccine Program in South Africa & Mexico
Source: Streetwise Reports��(11/30/21)
Oramed Pharmaceuticals' oral vaccine offers "convenience and safety advantages as well as coverage of emergent variant strains," noted a Nov. 29, 2021 H.C. Wainwright & Co. report. More >

Emerging SARS-COv-2 Variant Is Revenue Growth Opportunity for Vaccine Developer
Source: Streetwise Reports��(11/30/21)
Just a few days after the WHO deemed the COVID-19 Omicron variant a serious global health concern, leading mRNA-based vaccine developers BioNTech and Pfizer, along with rival Moderna, advised that if needed, the companies would be capable of developing a vaccine for the new mutating strains within roughly 100 days. H.C. Wainwright & Co. commented in a research note that it reiterates its "Buy" rating for BioNTech SE. More >

NRx Pharma's COVID-19 Vaccine Displays Effectiveness Against Delta Variant in Phase 2 Clinical Trial
Source: Streetwise Reports��(11/29/21)
Shares of NRx Pharmaceuticals Inc. traded 50% higher after the company commented on new data released by the Israel Institute for Biological Research regarding the effectiveness of its BriLife® COVID-19 Vaccine against the SARS-CoV-2 "Delta" variant. More >

Gene Therapy Firm's Shares Rise 120% on Topline Data From Pivotal Dystrophic EB Study
Source: Streetwise Reports��(11/29/21)
Shares of Krystal Biotech Inc. reached a new 52-week high after the company reported it met both primary and secondary endpoints in its pivotal GEM-3 trial of VYJUVEK™ in patients diagnosed with Dystrophic Epidermolysis Bullosa, a rare and severe skin disease. More >

Cellular Therapy Co. Earns Rare Pediatric Disease Designation for Infant Congenital Heart Treatment
Source: Streetwise Reports��(11/20/21)
Shares of Longeveron Inc. traded 50% higher after the company reported that the U.S. FDA approved its Lomecel-B for Rare Pediatric Disease Designation to treat a rare and life-threatening defect in infants called Hypoplastic Left Heart Syndrome. More >

RNA Silencing Platform Firm Receives US$3.3 Billion Buyout Offer From Novo Nordisk
Source: Streetwise Reports��(11/18/21)
Shares of Dicerna Pharmaceuticals Inc. traded 78% higher after the company reported it entered into a definitive agreement to be acquired by Novo Nordisk A/S of Denmark for $38.25 per share in cash. More >

Novavax Submits Request to EMA for Conditional Marketing Authorization for COVID-19 Vaccine
Source: Streetwise Reports��(11/17/21)
Shares of Novavax Inc. traded 10% higher after the firm confirmed that the European Medicines Agency is now reviewing its COVID-19 vaccine filing for conditional marketing authorization. The firm advised that an opinion from the agency is expected within a few weeks. More >

Biotech Co.'s Shares Gain 32% After Posting Meaningful Renal Response Rates in Ph. 2 Lupus Study
Source: Streetwise Reports��(11/16/21)
Shares of Kezar Life Sciences Inc. rose to a new 52-week high after the company reported promising interim results from its Phase 2 trial of KZR-616 in patients with lupus nephritis. More >

EyePoint Pharma Reduces Wet AMD Treatment Burden by 79% after 6 Mo.'s in Phase 1 Trial
Source: Streetwise Reports��(11/15/21)
Shares of EyePoint Pharmaceuticals Inc. reached a new 52-week intraday high after the company reported positive data from its Phase 1 DAVIO study of EYP-1901 in Wet AMD and announced plans to move forward to additional Phase 2 clinical trials in 2022. More >

Trial of Psilocybin Therapeutic in Treatment Resistant Depression Yields Positive Topline Results
Source: Streetwise Reports��(11/14/21)
"We believe this data begins to form the basis of an approvable program for Compass Pathways' COMP360" in this indication, noted a BTIG report. More >

Contakt World Technologies Partnership Will Help Satisfy Demand for Vaccine Passport Technology
Source: Streetwise Reports��(11/12/21)
Contakt World plans to build a diversified health technology SaaS platform and address inequity of health access through technology. More >

Advanced Medical Genetics Co. Notches 66% YoY Increase in Q3 Revenue
Source: Streetwise Reports��(11/12/21)
Invitae Corp. reported Q3/21 financial results that highlighted an 89% YoY increase in billable volume to 296,000 tests. Ladenburg Thalmann & Co. Inc. stated in a research note that it has a "Buy" rating for the company with a $55.00/share price target. More >

Robotic Surgical Systems Co.'s Shares Gain 21% on Q3 Earnings and Forward Revenue Outlook
Source: Streetwise Reports��(11/11/21)
Stereotaxis Inc. shares traded higher after the company reported Q3/21 financial results and confirmed its FY/21 revenue guidance. The company added that it is sufficiently funded and is on pace towards doubling its system revenue in FY/22. More >

Microbiome Therapeutics Co.'s Shares Rise on Q3 Earnings & Partnership With Swiss Manufacturing Firm
Source: Streetwise Reports��(11/10/21)
Shares of Seres Therapeutics Inc. traded 20% higher after the company reported Q3/21 financial results and announced it is partnering with Bacthera in Switzerland to manufacture medicine for use in c.Diff treatment. More >

US DEA OKs Use of Psychedelics by This Mental Health Network
Source: Streetwise Reports��(11/9/21)
Clinics that deliver novel psychiatric treatment and host clinical trials of psychedelic medicine have positioned Novamind for breakthroughs in mental health treatment. More >

Key Data Readouts Expected in 2022 for Developer of Cancer Immunotherapies
Source: Streetwise Reports��(11/8/21)
Results expected are for trials of Jounce Therapeutics' two lead product candidates, vopratelimab and pimivalimab, both monoclonal antibodies, noted a ROTH Capital Partners report. More >