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Wednesday, May 5, 2021

Veru Presents Positive Phase 2 Data on Breast Cancer Candidate

 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, today announced that the clinical results from the Phase 2 clinical study of enobosarm, an oral selective androgen receptor targeting agonist, in heavily pretreated women with AR+ER+HER2- advanced breast cancer including further efficacy data and an analysis of patients who have failed both estrogen blocking agents and CDK 4/6 inhibitors, will be presented at the European Society for Medical Oncology (ESMO) Breast Cancer Virtual Congress 2021 to be held May 05-08, 2021.

https://finance.yahoo.com/news/veru-announces-presentation-positive-phase-123000534.html

Athenex Jumps on Plan to Buy Cancer-Therapy Developer Kuur

 Shares of Athenex jumped after the biopharma focused on cancer therapies agreed to buy Kuur, a developer of immunotherapies to treat cancer, for as much as $185 million.

At last check Athenex shares were trading 31% higher at $4.85. Yesterday, the shares touched a 52-week low $3.66.

Kuur Therapeutics is the Houston developer of cell immunotherapies to treat solid and hematological malignancies.

Under the terms, Athenex will pay $70 million -- mainly in stock -- up front and as much as $115 million as the Kuur technology meets development milestones. 

Athenex, Buffalo, N.Y., has the option to make the milestone payments in cash, stock or a combination.


Kuur's technology combined with Athenex's T-cell receptors program "could propel us into a leadership position in cell therapy,” Athenex Chief Executive Johnson Lau said in a statement.

RBC called the deal an “an intriguing pivot” toward the cellular-therapeutics space, Bloomberg reports.

RBC analyst Kennen MacKay says in a note that the “timing is unexpected given potential prospects of climbing research and development expenses if Athenex pursues an additional [Food and Drug Administration]-requested Oraxol trial.”

Athenex shares dropped in March after the company received a complete response letter from the FDA regarding its Oraxol, a metastatic breast cancer drug, signaling that the application was not ready for approval, Bloomberg News said.


The Kuur deal is seen to add a “rather broad” pipeline of three clinical-stage cellular therapeutic agents for multiple indications, MacKay added.

He rates the stock outperform with a $9 target.

https://www.thestreet.com/investing/athenex-jumps-on-plan-to-buy-cancer-immunotherapy-developer-kuur

Chiasma Agrees to Merge with Amryt

 Combination to create a global commercial stage rare and orphan disease leader with a diversified portfolio of therapies and a meaningful late-stage development pipeline

Q1 2021 Net Product Revenues of $1.9M, a 100% increase over Q4 2020

Achieved payor coverage of MYCAPSSA for over 185 million lives

Submitted an Investigational New Drug (IND) application for the study of MYCAPSSA in patients with carcinoid syndrome associated with Neuroendocrine Tumors (NET)

https://finance.yahoo.com/news/chiasma-reports-first-quarter-financial-110500019.html

CytoDyn to Conduct Two COVID-19 Trials in Brazil

 CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the agreement to partner with Academic Research Organization (ARO) - Albert Einstein Israelite Hospital (AEIH) in São Paulo, Brazil for two COVID-19 trials.

The COVID-19 trials in Brazil are intended to provide the Brazilian regulatory authority, ANVISA, with the requisite data to consider advancing the availability of leronlimab to thousands of Brazilians infected with COVID-19. These two Phase 3 trials will be conducted in up to 45 clinical sites.

https://finance.yahoo.com/news/cytodyn-reaches-agreement-albert-einstein-073500605.html

Community Health Systems upped to Buy from Hold by Jefferies

 Target to $18 from $11

https://finviz.com/quote.ashx?t=cyh&ty=c&ta=1&p=d

Esperion cut to Hold from Buy by Stifel

 Target to $20 from $37

https://finviz.com/quote.ashx?t=ESPR

Alcon Reports First Quarter 2021 Results

 

  • First quarter sales of $1.9 billion, up 5% or 2% constant currency

  • Strong commercial execution drives the global launch of new product innovations

  • Substantially completes separation process

  • Full year guidance: sales of $7.8 to $8.0 billion and core diluted EPS of $1.85 to $1.95

  • First quarter sales of $1.9 billion, up 5% or 2% constant currency

  • Strong commercial execution drives the global launch of new product innovations

  • Substantially completes separation process

  • Full year guidance: sales of $7.8 to $8.0 billion and core diluted EPS of $1.85 to $1.95

The Company provided its full year outlook as follows. This assumes markets return to historical levels in the third quarter and grow in the second half of the year.

Net sales

$7.8 to $8.0 billion

Core operating margin(1)

approximately 17%

Core diluted EPS(1)

$1.85 to $1.95

Webcast and Conference Call Instructions

The Company will host a conference call on May 5 at 2:00 p.m. Central European Time / 8:00 a.m. Eastern Time to discuss its first quarter 2021 earnings results. The webcast can be accessed online through Alcon's Investor Relations website, investor.alcon.com. Listeners should log on approximately 10 minutes in advance. A replay will be available online within 24 hours after the event.

The Company's interim financial report and supplemental presentation materials can be found online through Alcon's Investor Relations website at the beginning of the conference, or by clicking on the link:

https://investor.alcon.com/news-and-events/events-and-presentations/event-details/2021/Alcons-First-Quarter-2021-Earnings-Conference-Call/default.aspx

https://finance.yahoo.com/news/alcon-reports-first-quarter-2021-203000026.html