Co. Launches Pivotal Phase in Alzheimer's Agitation Drug's Trial
��(12/17/21)
BioXcel Therapeutics' lead drug candidate for agitation in Alzheimer's disease patients could serve a substantial market, noted an H.C. Wainwright & Co. report. More >

Analyst Says Regeneron Could Be 'Biotech Champion'
��(12/17/21)
Regeneron Pharmaceuticals Inc.'s stock was up 36% in 2021 while the NASDAQ Biotechnology Index remained flat, Oppenheimer analyst Hartaj Singh reported in a Dec. 16 research note. More >

Co.'s Shares Gain 27% After FDA Nears Drug Approval
Source: Streetwise Reports��(12/16/21)
Shares of Calliditas Therapeutics AB traded higher after the company reported the U.S. FDA granted accelerated approval for its TARPEYO™ (budesonide) to reduce proteinuria in IgA nephropathy. More >

Target Price Raised on Biotech Based on Management Update
��(12/13/21)
During its recent R&D Day, Prometheus Biosciences announced new strong trial data, another new indication for its lead therapeutic candidate and progress in developing a subcutaneous formulation of it, according to an Oppenheimer report. More >

Arena Pharma Takes Center Stage With Pfizer's $6.7B Cash Buyout
Source: Streetwise Reports��(12/13/21)
Arena Pharmaceuticals shares traded 80% higher after the company reported it agreed to be acquired by Pfizer Inc. for $100.00 per share in cash in a deal valued at $6.7 billion. More >

Biopharma Explains How Its Technology Evolved, Describes Current Programs
��(12/11/21)
F-star Therapeutics "has methodically delivered scientific/preclinical/early clinical data validating its platform bispecific technology," noted an Oppenheimer report. More >

Biopharma's Anti-PD-L1 Antibody Advances in Two Oncologic Indications
Source: Streetwise Reports��(12/10/21)
Checkpoint Therapeutics' "cosibelimab represents a competitive asset on both efficacy and safety with an expected added advantage of lower net price," an H.C. Wainwright & Co. report noted. More >

Biopharma Partners to Commercialize Enzyme Used for Kidney Transplant Patients
��(12/10/21)
The partnership allows Hansa Biopharma to "enter new markets without the cost and risk of building out country-specific commercial organizations for a single product," an H.C. Wainwright & Co. report indicated. More >

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.
More >

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 >

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 >