Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates 2021/04/02 12:00:21 Benzinga
A slew of drugs, including four new molecular entities, were approved in the month of March. NMEs are drugs that contain active moieties that have never been approved by the Food and Drug Administration previously and are indicators of innovation in drug research. Among the notable approvals that came through in the month were Abecma, the first-ever cell therapy for a type of blood cancer; Fotivda, AVEO Pharmaceuticals, Inc.'s (NASDAQ: AVEO ) oral, next-generation therapy for treating advanced renal cell carcinoma; and KemPharm, Inc.'s (NASDAQ: KMPH ) Azstarys, a once-daily product for the treatment of attention deficit hyperactivity disorder in patients age six years and older. PDUFA dates are binary events that invariably serve as make-or-break catalysts for stocks. These dates are deadlines by which the FDA reviews a new drug application before announcing its decision concerning the approvability/non-approvability of the drug. Here are the key FDA approvals scheduled for April. Acadia Hopes Against Hope to Get Label Expansion Psychosis Drug Company: ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD ) Type of Application: supplemental new drug application Candidate: pimavanserin Indication: dementia Date: April 3 Pimavanserin, which is marketed under the trade name Nuplazid, has already been approved by the FDA for the treatment of hallucinations associated with Parkinson's disease psychosis.
AVEO Announces Proposed Public Offering of Common Stock 2021/03/22 20:01:00 Business Wire
BOSTON--(BUSINESS WIRE)--AVEO Oncology (Nasdaq: AVEO) today announced that it has commenced an underwritten public offering of 5,000,000 shares of its common stock. In connection with the offering, AVEO intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock. All of the shares in the offering are to be sold by AVEO. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering
AVEO Pharmaceuticals Confused? Buy or Sell in volatile market - Analyst report Stock market Insights & financial analysis 2021/03/15 19:03:00 Stock Market Daily
AVEO Pharmaceuticals announce their quarterly, annual earnings. See the latest EPS estimates. Listen to the conference call and remind yourself by…
AVEO Pharmaceuticals, CANbridge AV-203 Licensing Deal Axed, AVEO Regains Ex-North American Rights 2021/03/15 10:41:00 Benzinga
AVEO Pharmaceuticals Inc’s (NASDAQ: AVEO) brief positive news of getting FDA approval for Tivozanib in relapsed kidney cancer this …
The Daily Biotech Pulse: Novavax Vaccine Data, ContraFect Secures BARDA Funding, 2 IPOs 2021/03/12 12:36:15 Benzinga
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 March 11) Affimed N.V. (NASDAQ: AFMD ) AngioDynamics, Inc. (NASDAQ: ANGO ) Apyx Medical Corporation (NASDAQ: APYX ) AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO ) Axonics Modulation Technologies, Inc. (NASDAQ: AXNX ) BioAtla, Inc. (NASDAQ: BCAB ) BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX ) Bolt Biotherapeutics, Inc. (NASDAQ: BOLT ) Entera Bio Ltd. (NASDAQ: ENTX ) ( announced positive Phase 2 biomarker data for osteoarthritis drug) Harvard Bioscience, Inc. (NASDAQ: HBIO ) IDEAYA Biosciences, Inc. (NASDAQ: IDYA ) Inari Medical, Inc. (NASDAQ: NARI ) Jounce Therapeutics, Inc. (NASDAQ: JNCE ) Longeveron Inc. (NASDAQ: LGVN ) (announced FDA granting expanded access approval for its investigational cell therapy Lomecel-B to a pediatric patient with hypoplastic left heart syndrome) Magenta Therapeutics, Inc. (NASDAQ: MGTA ) Nuvation Bio Inc. (NASDAQ: NUVB )(announced orphan drug designation for NUV-422 in treating malignant gliomas) Renalytix AI plc (NASDAQ: RNLX ) Sol-Gel Technologies Ltd. (NASDAQ: SLGL ) Surmodics, Inc. (NASDAQ: SRDX ) Verrica Pharmaceuticals Inc. (NASDAQ: VRCA ) Down In The Dumps None of the NYSE- and Nasdaq-listed biotech/diagnostic shares hit 52-week lows Thursday.
Hot Stock Evaluation: Ocugen, Inc. (NASDAQ:OCGN), AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) - Stocks Equity 2021/01/29 21:05:31 Stock Equity
Ocugen, Inc. (NASDAQ:OCGN) with the stream of -1.68% also noticed, India AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) encountered a rapid change of 2.81% in the last hour of Friday’s trading session. Ocugen, …
Ex-CFO of biotech company Aveo loses SEC fraud verdict appeal 2021/01/22 21:22:04 Reuters
A federal appeals court on Friday upheld a jury's verdict finding that Aveo Pharmaceuticals Inc's ex-chief financial officer misled investors about the prospects for regulatory approval of its flagship drug under development.
Global Small Molecule Targeted Cancer Therapy Market 2021:Emerging Opportunities, Revenue Analysis and Growth Projections by Bayer AG; GlaxoSmithKline plc.; AstraZeneca; AVEO Pharmaceuticals, Inc.; Johnson & Johnson Services 2021/01/21 09:15:10 OpenPR
Data Bridge Market research released a new market study on Small Molecule Targeted Cancer Therapy with 100+ market data Tables, Pie Chart, Graphs & Figures spread through Pages and easy to understand detailed analysis In Small Molecule Targeted Cancer
AVEO Oncology Highlights Recent Progress and 2021 Outlook 2021/01/07 12:00:00 Business Wire
BOSTON--(BUSINESS WIRE)--AVEO Oncology (Nasdaq: AVEO) today highlighted its recent progress and outlined its 2021 outlook. “We remain keenly focused on building out our commercial team ahead of the potential U.S. launch of tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC), including the addition of Dr. Corinne Epperly to our Board of Directors,” said Michael Bailey, president and chief executive officer of AVEO. “If approved, we believe tivozanib has the potential t
AVEO Oncology Announces Participation at Two Upcoming Investor Conferences 2021/01/06 12:00:00 Business Wire
BOSTON--(BUSINESS WIRE)--AVEO Oncology (Nasdaq: AVEO) today announced that Michael Bailey, president and chief executive officer of AVEO, will participate in two upcoming virtual investor conferences: H.C. Wainwright Virtual BioConnect Conference Date: Monday, January 11 – Thursday, January 14 B. Riley Virtual Oncology Investor Conference Date: Wednesday, January 20 Time: 1:30 PM Eastern Time A replay of the pre-recorded H.C. Wainwright presentation can be accessed on Monday, January 11, 2021 i