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BioCardia Anticipates DSMB Feedback on Interim Data1. BioCardia Anticipates DSMB Feedback on Interim Data From Pivotal Phase 3 CardiAMP Heart Failure Trial BCDA today announces that it anticipates data safety monitoring board (DSMB) verbal feedback by the end of December 15, 2020 on interim data from the Company’s pivotal Phase 3 CardiAMP Heart Failure Trial that is currently enrolling nationwide for infusion of BioCardia’s CardiAMP™ autologous cell therapy to the myocardium. The DSMB is then anticipated to provide its written feedback approximately 24 hours later. BioCardia plans to provide an announcement pre-market on December 17 , 2020 summnarizing the feedback and outlining the next resulting steps. The CardiAMP Heart Failure study has been approved by the FDA to enroll up to 260 patients at up to 40 centers. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy in the treatment of patients with ischemic heart failure . The FDA has said that the trial qualifies as a pivotal trial to produce the primary data to support market registration for the CardiAMP cell therapy for this significant unmet clinical need. www.globenewswire.com 2. BioCardia, Inc. Announces $8.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules today announced it has entered into definitive agreements with investors for the purchase and sale of 1,789,474 shares of its common stock at a purchase price of $4.75 per share in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about December 16, 2020, subject to the satisfaction of customary closing conditions. finance.yahoo.com
NASDAQ:BCDA
by AlenCiken
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Arvinas Nearly Doubles on Promising Cancer Drug ResultsArvinas Nearly Doubles on Promising Cancer Drug Results The test results show the Arvinas drugs' potential for treating breast and prostate cancer, Cantor said. Arvinas (ARVN) - Get Report shares blasted off Monday as Cantor Fitzgerald offered bullish comments on the biopharmaceutical company after it reported positive news on its breast and prostate cancer treatments. “For ARV-471, interim Phase 1 data show potential for best-in-class safety and tolerability, estrogen receptor (ER) degradation superior to that previously reported for the current standard of care agent (fulvestrant), and robust efficacy signals in heavily pretreated patients with locally advanced or metastatic ER positive / HER2 negative (ER+/HER2-) breast cancer,” the company said in a statement. The test results show ARV-471’s potential as the best-in-class potential estrogen receptor degrader, Cantor analyst Alethia Young wrote in a commentary cited by Bloomberg. The results are “very encouraging and demonstrated ARV-471 was active,” Young wrote. She has an overweight rating and a $66 price target on Arvinas. “The efficacy signals include one Response Evaluation Criteria in Solid Tumors (RECIST) confirmed partial response (PR), two additional patients with unconfirmed PRs, and a clinical benefit rate (CBR) of 42%,” Young said. Separately, Cantor said that “for ARV-110, the ongoing dose escalation portion of the Phase 1/2 trial in men with metastatic castration-resistant prostate cancer (mCRPC) has provided additional evidence of anti-tumor activity and patient benefit, including a prostate specific antigen reduction of more than 50% (PSA50) rate of 40% in a molecularly defined patient population.” Further, “Arvinas has initiated a Phase 2 dose expansion to explore a two-pronged development strategy, including the potential for accelerated approval in molecularly defined, late-line patients, and broader development in less-heavily pretreated mCRPC patients with fewer androgen receptor (AR)-independent mechanisms of tumor resistance,” Young said. Oppenheimer Upgrades Arvinas Inc. (ARVN) to Outperform, Following Clinical Update www.thestreet.com www.streetinsider.com
NASDAQ:ARVN
by AlenCiken
Solid Biosciences Announces $90 Million Private PlacementSolid Biosciences Announces $90 Million Private Placement Solid Biosciences has entered into a securities purchase agreement with a select group of institutional investors and accredited investors for a $90 million private placement, which is expected to close on or about December 15, 2020, subject to the satisfaction of customary closing conditions. The private placement includes new investors Suvretta Capital Management, LLC and Aspire Capital Fund, LLC and existing investors, including RA Capital Management, Perceptive Advisors, LLC, Bain Capital Life Sciences, EcoR1 Capital, LLC, Boxer Capital, and Ikarian Capital, LLC, as well as certain board members and executive officers. In this private placement, the Company is selling 24,324,320 shares of common stock at a price of $3.70 per share. The Company expects to use net proceeds from the private placement to fund research and development expenses, including the advancement of SGT-001, and for working capital and other general corporate purposes. finance.yahoo.com
NASDAQ:SLDB
by AlenCiken
Will LPCN Break back Above Previous Support Or...or will it become resistance? There's been a lot of momentum building up ever since LPCN fell off. We saw some insider buying this month but no new news. Meanwhile other companies are presenting at virtual conferences and all that. It makes you wonder if LPCN has enough steam to reclaim its old levels or if this is just a speculation-driven move in the short term. "In May Lipocine received RDA clearance for an investigational new drug application for a Phase 2 study of LPCN 1148. This is a prodrug of bioidentical testosterone to treat liver cirrhosis. Furthermore, the company reported results of a preclinical study of its LPCN 1144 which demonstrated encouraging results according to the company. H.C. Wainright took notice of these milestones and increased its price target on LPCN stock to $3 while maintaining a Buy rating." Quote Source & Info: Can You Make Money With Penny Stocks? 3 Up Big In June
NASDAQ:LPCN
by PennyStocks101