The Week Ahead In Biotech (May 9-15): Heron, Apellis FDA Decisions, Presentations and Earnings
Sunday, 9 May 2021, 16:20:32
Biotech stocks came under pressure in the week ended May 7 as traders digested a slew of earnings news flow and a handful of clinical trial readouts. COVID-19 vaccine stocks came under pressure following the U.S. government's decision to support for taking vaccine technology and intellectual property off patent . ChemoCentryx, Inc. (NASDAQ: CCXI ) shares went from $48.32 to $10.46 over the week, a pullback of over 78% on the back of a negative Adcom verdict. Pfizer, Inc. (NYSE: PFE ) reported strong quarterly results and raised its guidance, standing out from the rest of the big pharma pack. Two biopharma companies debuted on Wall Street this week, raising combined gross proceeds of $171 million. Here are the key catalytic events for the unfolding week: Conferences BofA Securities 2021 Healthcare Conference: May 10-13 American Society of Gene and Cell Therapy, ASGCT, 2021 Virtual Meeting: May 11-14 American Thoracic Society, or ATS, 2021 meeting: May 14-19 American College of Cardiology, or ACC, Annual Scientific Session and Expo: May 15-17 PDUFA Dates The Food and Drug Administration is scheduled to rule on Heron Therapeutics, Inc.'s (NASDAQ: HRTX ) new drug application for HTX001, which is being evaluated for postoperative pain, by the PDUFA date of Wednesday, May 12.
ChemoCentryx Nosedives on Split FDA Panel Decision – TheStreet
Friday, 7 May 2021, 22:09:37
ChemoCentryx falls on the FDA committee's lukewarm support and analysts' downgrades.
— The Street
Analysts React To FDA AdCom Vote On ChemoCentryx's Avacopan, Stock Plunges
Friday, 7 May 2021, 16:17:16
Yesterday, the FDA’s Arthritis Advisory Committee panelists went through cloudy data while complaining about the design of the Phase 3 trial for ChemoCentryx Inc’s (NASDAQ: CCXI ) avacopan. After going over time, they ended up without consensus . This orphan drug has July 7 as its PDUFA date. What do analysts have to say after the AdCom splits slightly in favor of FDA approving this rare disease drug: Raymond James analyst Steven Seedhouse, on a reduced conviction in avacopan approval, downgraded the stock to Outperform from Strong Buy with the price target more than halved to $51 from $120. However, if approved, Seedhouse still thinks avacopan is a blockbuster drug and will … Full story available on Benzinga.com
Adcomm Split On FDA Approval For ChemoCentryx's Vasculitis Candidate
Friday, 7 May 2021, 12:47:28
The FDA’s Arthritis Advisory Committee voted 10 for and 8 against the approval of ChemoCentryx Inc’s (NASDAQ: CCXI ) investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis. The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate to support approval. In the third and final question, the Committee voted 10-8 that the benefit-risk profile is adequate to support approval of … Full story available on Benzinga.com
Why Cocrystal Pharma, Chemocentryx, Neuronetics And BioLineRx Are Moving Today
Tuesday, 4 May 2021, 19:45:43
Cocrystal Pharma, Inc. (NASDAQ: COCP ), ChemoCentryx, Inc. (NASDAQ: CCXI ), Neuronetics, Inc. (NASDAQ: STIM ) and BioLineRx Ltd. (NASDAQ: BLRX ) are among the biggest health care movers Tuesday. Cocrystal Shines On COVID-19 Pipeline: Cocrystal, a clinical-stage biotech engaged in the development of anti-viral therapeutics, announced Monday it is aggressively developing novel coronavirus protease inhibitors for COVID-19 prophylactic and therapeutic use. “These drug candidates bind to a highly conserved region of the active site of SARS-CoV-2 protease that is required for SARS-CoV-2 viral replication,” the company said. Due to their novel mechanism of action, these protease inhibitors are likely to be effective against new variants of SARS-CoV-2, it added. After a muted reaction on Monday, the stock has taken off Tuesday. Reacting … Full story available on Benzinga.com
We recommend that you check out Capital.com as they have a very good selection of stocks available for both going short and long.