Streetwise Reports' Article Archives — November 2021 back to current month (25)

Antibody-Drug Conjugate Developer Achieves High Objective Response Rates in Ovarian Cancer Study (11/30/2021)

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.

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Biopharma Launches COVID Vaccine Program in South Africa & Mexico (11/30/2021)

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.

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Emerging SARS-COv-2 Variant Is Revenue Growth Opportunity for Vaccine Developer (11/30/2021)

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.

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NRx Pharma's COVID-19 Vaccine Displays Effectiveness Against Delta Variant in Phase 2 Clinical Trial (11/29/2021)

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.

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Gene Therapy Firm's Shares Rise 120% on Topline Data From Pivotal Dystrophic EB Study (11/29/2021)

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.

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Cellular Therapy Co. Earns Rare Pediatric Disease Designation for Infant Congenital Heart Treatment (11/20/2021)

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.

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RNA Silencing Platform Firm Receives US$3.3 Billion Buyout Offer From Novo Nordisk (11/18/2021)

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.

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Novavax Submits Request to EMA for Conditional Marketing Authorization for COVID-19 Vaccine (11/17/2021)

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.

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Biotech Co.'s Shares Gain 32% After Posting Meaningful Renal Response Rates in Ph. 2 Lupus Study (11/16/2021)

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.

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EyePoint Pharma Reduces Wet AMD Treatment Burden by 79% after 6 Mo.'s in Phase 1 Trial (11/15/2021)

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.

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Trial of Psilocybin Therapeutic in Treatment Resistant Depression Yields Positive Topline Results (11/14/2021)

"We believe this data begins to form the basis of an approvable program for Compass Pathways' COMP360" in this indication, noted a BTIG report.

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Contakt World Technologies Partnership Will Help Satisfy Demand for Vaccine Passport Technology (11/12/2021)

Contakt World plans to build a diversified health technology SaaS platform and address inequity of health access through technology.

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Advanced Medical Genetics Co. Notches 66% YoY Increase in Q3 Revenue (11/12/2021)

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.

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Robotic Surgical Systems Co.'s Shares Gain 21% on Q3 Earnings and Forward Revenue Outlook (11/11/2021)

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.

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Microbiome Therapeutics Co.'s Shares Rise on Q3 Earnings & Partnership With Swiss Manufacturing Firm (11/10/2021)

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.

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US DEA OKs Use of Psychedelics by This Mental Health Network (11/09/2021)

Clinics that deliver novel psychiatric treatment and host clinical trials of psychedelic medicine have positioned Novamind for breakthroughs in mental health treatment.

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Key Data Readouts Expected in 2022 for Developer of Cancer Immunotherapies (11/08/2021)

Results expected are for trials of Jounce Therapeutics' two lead product candidates, vopratelimab and pimivalimab, both monoclonal antibodies, noted a ROTH Capital Partners report.

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Programmed T Cell Therapies Co. Receives $250M Investment From Blackstone to Advance Adult Leukemia Treatment (11/08/2021)

Autolus Therapeutics Plc. shares traded 28% higher after the company reported that Blackstone Life Sciences is investing up to $250 million in the firm to develop obe-cel in treatment of adult Acute Lymphoblastic Leukemia and advance its broader targeted T- Cell technology platform.

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Specialty Pharma Co. Increases Revenues by 22% in Q3; Raises FY Sales and Earnings Forecast (11/05/2021)

Shares of brand, generic and injectable drug maker Endo International traded 25% higher after the company reported Q3/21 financial results and raised its FY/21 revenue and EPS guidance.

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Robotic Surgical Device Maker's Shares Maneuver Higher on Q3 Earnings (11/04/2021)

Shares of robotic performance-guided surgery device maker Asensus Surgical Inc. traded 21% higher after the company reported Q3/21 financial results that included a 215% increase in YoY revenue.

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Surgery Center Operator Posts 23% Increase YTD Revenue and Raises FY21 Adjusted EBITDA Estimates (11/03/2021)

Surgery Partners shares traded 18% higher after the company reported Q3/21 financial results that included a 12.7% increase in YoY revenue and a 6.2% increase in the number of same-facility procedures performed.

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Precision Medicine Co.'s ASM Treatment Drug Gaining Rapid Market Adoption (11/03/2021)

Wedbush Securities Inc. advised that global precision therapy company Blueprint Medicines Corp.'s therapeutic AYVAKIT is gaining traction in patients diagnosed with advanced systemic mastocytosis and gastrointestinal stromal tumors. Wedbush reiterated its Outperform rating for the company and raised its 12-month price target by $4.00 to $136.00 per share.

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Psychedelic Drug Trials Accelerate as Decriminalization Spreads, Investment Expands (11/03/2021)

McAlinden Research Partners estimates it may be only a matter of time before psychedelics become part of a biotech boom.

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SLT Company's 'Cell Replacement in a Bottle' a Powerful Option in Treating Genetic Diseases (11/02/2021)

BTIG commented in a research report that Sigilon Therapeutics is developing a powerful and widely applicable "cell replacement in a bottle" as a potential functional cure for genetic diseases. BTIG advised it is initiating coverage on the company with a "Buy" rating and $14/share price target.

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Diversified Bio-Pharma Firm Gains FDA Approval for Adrenocorticotropic Hormone Gel for Multiple Indications (11/01/2021)

Shares of ANI Pharmaceuticals Inc. traded 50% higher after the company reported the U.S. FDA approved its Purified Cortrophin Gel for use in treating multiple sclerosis, rheumatoid arthritis and nephrotic syndrome.

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