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Thursday, February 2, 2023

Karuna to license mood and anxiety disorder candidate

Karuna to obtain exclusive global license to develop, manufacture, and commercialize multiple TRPC4/5 candidates, including lead clinical-stage candidate GFB-887

Goldfinch Bio assignment estate to receive $15 million upfront payment and up to $520 million in potential milestone payments plus royalties for each TRPC4/5 candidate

Karuna to share details on the planned development of GFB-887 for the treatment of mood and anxiety disorders in the second half of 2023

https://finance.yahoo.com/news/karuna-therapeutics-announces-exclusive-global-113000479.html

Bristol Myers' profit beats on better-than-feared Revlimid sales

 Bristol Myers Squibb Co on Thursday reported quarterly earnings that beat analysts' estimates due to a smaller-than-expected drop in sales of cancer drug Revlimid, which is facing competition from cheaper generic rivals.

Fourth-quarter Revlimid sales of $2.26 billion topped Wall Street estimates of $1.89 billion, according to Refinitiv data.

The company expects Revlimid sales to fall to $6.5 billion in 2023 from $9.98 billion last year.

The forecast suggests Revlimid's "generic erosion will accelerate," William Blair analysts said in a note.

To help offset the decline in Revlimid sales, Bristol Myers has been betting on newer products, such as cancer therapies Opdualag and Abecma.

With the momentum of the new product portfolio, the company expects to roughly double sales of its more recent offerings in 2023 versus last year to about $4 billion, Chief Financial Officer David Elkins said on a call to discuss the company's results.

The New York-based drugmaker reported a nearly 5% decline in sales in the fourth quarter to $11.41 billion, but that was above analysts' expectations of $11.2 billion.

Excluding the effect of foreign exchange, sales grew 3% in 2022, the CFO said.

"This is the first year of generic (competition for Revlimid) and everybody wanted to see if we could grow through the year. We did that," Elkins said.

Bristol Myers shares were up about 1% at $72.06.

The company reported sales of $2.69 billion for the blood thinner Eliquis that it shares with Pfizer Inc in the quarter, and $2.22 billion for cancer immunotherapy Opdivo, up 1% and 11% over a year earlier, respectively.

Bristol Myers said it earned $1.82 per share in the quarter, down from $1.84 a year ago. Analysts, on average, had expected earnings of $1.72 per share.

The company forecast 2023 earnings of $7.95 to $8.25 a share, on revenue it sees increasing by about 2% from 2022 sales of $46.16 billion. 

https://finance.yahoo.com/news/1-bristol-myers-profit-beats-155219174.html

Clearside: Positive 6-Month Results in Wet AMD Study

 Suprachoroidal CLS-AX Resulted in Favorable Safety Data, Durability and Biologic Effect Over 6 Months in Treatment-Experienced Anti-VEGF Sub-Responders -

- 67% of Extension Study Participants Went at Least 6 Months Without Needing Additional Treatment -

- Extension Participants Experienced a 77 - 85% Reduction in Treatment Burden Over 6 Months -

- Webcast and Conference Call Today at 8:30 A.M. ET Hosted by Management and Including Key Opinion Leader, Mark R. Barakat, M.D. -

Clearside will host a webcast and conference call with accompanying slides today at 8:30 a.m. ET, including comments by management and retinal expert, Dr. Mark R. Barakat. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (888) 506-0062 (domestic) or (973) 528-0011 (international) and entering conference code: 676850.

https://finance.yahoo.com/news/clearside-biomedical-announces-positive-6-120500797.html

IRadiMed beats views

 

  • Reports fourth quarter 2022 revenue of $14.9 million, GAAP diluted EPS of $0.29 and non-GAAP diluted EPS of $0.32.

  • Reports full-year 2022 revenue of $53.3 million, GAAP diluted EPS of $1.02 and non-GAAP diluted EPS of $1.10.

  • The Board of Directors approved a special cash dividend of $1.05 per share. This special cash dividend is payable on February 21, 2023, to shareholders of record at the close of business on February 13, 2023.

Pliant: FDA Clears Application for PLN-101095 for the Treatment of Solid Tumors

 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for PLN-101095, an oral, small molecule, dual selective inhibitor of integrins αvβ8 and αvβ1. A Phase 1 first-in-human study evaluating PLN-101095 in patients with solid tumors that are resistant to immune checkpoint inhibitors (ICIs) is expected to initiate in the second quarter of 2023.

https://finance.yahoo.com/news/pliant-therapeutics-announces-fda-clearance-130200435.html

Tonix to Acquire Preclinical Infectious Disease Portfolio from Healion Bio

 The Acquired Portfolio of Infectious Disease Assets Includes a Class of Potential Broad Spectrum Oral Antiviral Agents, TNX-3900 with a Host-Directed Mechanism

Tonix Plans to Develop the TNX-3900 Series of Molecules as Oral Antivirals Either as Monotherapy or in Combination with Other Antivirals

The TNX-3900 Class of Antivirals Has a Novel Mechanism of Action Based on Inhibition of Certain Cathepsin Proteases which are Required for Cell Infection by Many Viruses like SARS-CoV-2

Sina Bavari, Ph.D., Tonix EVP of Infectious Disease R&D and Director of the Frederick, MD Research and Development Center (RDC) was a Scientific Founder of Healion Bio, Inc.

https://finance.yahoo.com/news/tonix-pharmaceuticals-announces-acquisition-preclinical-120000957.html

Amgen, AstraZeneca TEZSPIRE® approved for self-administration

 AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. TEZSPIRE is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.1

The approval by the US Food and Drug Administration (FDA) was based on results from the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trial.2,3 The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer TEZSPIRE both in the clinic and at home throughout the PATH-HOME trial.3 The improvements in asthma control and the safety profile of TEZSPIRE observed in the PATH-HOME trial were consistent with previous clinical trials.

https://finance.yahoo.com/news/tezspire-approved-self-administration-us-140000879.html