Allena ends sales agreement without penalty

Allena Pharmaceuticals previously entered into an At Market Issuance Sales Agreement with B. Riley Securities (the sales agent) on December 23, 2021, pursuant to which the company was able to issue and sell from time to time in an “at-the-market” offering shares of the Company’s common stock, par value $0.001 per share (the common stock). As of June 27, 2022, 6,804,888 shares of Common Stock have been issued and sold under the Sales Agreement.

On June 27, 2022, Allena Pharmaceuticals provided notice to the Sales Agent that it was terminating the Sales Agreement, effective immediately. And the Sales Agreement provided for termination thereof by either party upon ten (10) calendar days’ prior written notice to the other party. Allena Pharmaceuticals will not incur any early termination penalties in connection with the termination of the Sale Agreement.

https://pulse2.com/allena-pharmaceuticals-alna-stock-why-it-surged-over-260/

Regeneron EYLEA Application for Diabetic Retinopathy Accepted for FDA Review

 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the EYLEA® (aflibercept) Injection supplemental Biologics License Application (sBLA) for an every 16-week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy (DR). The target action date for the FDA decision is February 28, 2023.

DR is the leading cause of blindness among working-age American adults, affecting more than 8 million people in the U.S. alone. In 2019, EYLEA was approved for the treatment of all stages of DR with a dosing regimen of every 4 or 8 weeks after five initial monthly doses. If approved, the 16-week dosing regimen could offer certain patients a potentially longer treatment interval and doctors with greater flexibility to individualize treatment.

The sBLA is supported by data from the Phase 3 PANORAMA trial investigating every 8- and 16-week EYLEA dosing regimens, versus sham, in patients with severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). The submission was further supported by data from the NIH-sponsored Protocol W trial investigating an EYLEA every 16-week dosing regimen in patients with moderate to severe NPDR without center-involved DME versus sham.

https://finance.yahoo.com/news/eylea-aflibercept-injection-sbla-every-113000197.html

Why Patterson Companies Shares Are Surging

 

• Patterson Companies Inc 
  PDCO+10.6%+ Free Alerts
   reports Q4 FY22 sales of $1.64 billion, +4.9% Y/Y, beating the consensus of $1.59 billion.
• Dental segment sales reached $636.4 million. Internal sales increased 3.4% Y/Y, including a 0.8% decline in consumables due to the expected moderation of infection control products compared to the pandemic-related performance last year.
• "Patterson delivered an excellent fourth quarter, culminating a year in which we delivered both top and bottom-line growth that exceeded our expectations," said Mark Walchirk, President and CEO.
• Animal Health segment sales reached $1 billion. Internal sales growth of 7.6% was driven by continued strong performance in companion and production animals. 
• The gross margin improved to 21.2% from 19.5% a year earlier.
• Patterson reported an adjusted EPS of $0.71, surpassing the consensus of $0.55, almost double from $0.38 posted a year ago.
• The company returned $136.1 million to shareholders in fiscal 2022 through dividends and share repurchases.
• Guidance: Patterson Companies expects FY23 adjusted EPS of $2.25 - $2.35, versus the consensus of $2.24.

https://www.benzinga.com/news/earnings/22/06/27899901/patterson-companies-stock-jumps-on-better-than-expected-q4-earnings-annual-guidance

Catalyst Biosciences Announces Plan to Distribute Cash to Stockholders

 Catalyst Biosciences, Inc. (NASDAQ: CBIO) (the “Company” or “we”) today announced its intention to distribute cash to the Company’s stockholders through one or more distributions. The intention of the Company’s Board of Directors (the “Board”) is to maximize the size of the total distribution after satisfying or reserving for Company obligations, and to complete the distribution as soon as practicable. The Board currently expects the total amount of cash to be distributed to stockholders to be as much as $65 million, depending upon several factors, including pending stockholder litigation.

“After careful deliberation by the Board and constructive engagement with several of the Company’s largest investors, I am pleased to announce that we are planning to distribute cash to stockholders,” said Nassim Usman, Ph.D., Chief Executive Officer of Catalyst Biosciences. “This follows our recently completed sale of a portion of our product portfolio for up to $60 million in cash, $55 million upfront and $5 million in a 12-month hold-back, after a thorough and competitive process with the assistance of independent financial and legal advisors.”

Dr. Usman continued, “In addition, we have aggressively reduced costs through headcount reductions, ceased all R&D activities, terminated our lab lease and monetized lab and other equipment. We now have six employees – enough to manage the orderly transfer of the technology we sold, continue efforts to monetize the Company’s remaining assets, and satisfy our public company reporting obligations.”

https://finance.yahoo.com/news/catalyst-biosciences-announces-plan-distribute-120000426.html

Agenus: Activity for Combo Med in Colorectal Cancer

 

• Overall response rate of 24%, and disease control rate of 73%, in heavily pre-treated patients with a median of 4 prior lines of therapy

• Responses to botensilimab/balstilimab were durable, with 80% ongoing at data cut-off and median duration of response not reached

• Global, randomized Phase 2 study of botensilimab/balstilimab in MSS CRC to begin this year

• Agenus to host webcast today at 10:00 AM EDT

The Company will host an investor webcast today at 10:00 AM EDT to review these data. Participants may register here, or on the Investors section of the Agenus website at investor.agenusbio.com. The webcast will include presentations by the below speakers and will be followed by a Q&A session:

• Steven O’Day, M.D., Agenus’ Chief Medical Officer

• Dr. Anthony El-Khoueiry, M.D., Associate Director of Clinical Research at the USC Norris Comprehensive Cancer Center, Keck School of Medicine

• Dr. Manuel Hidalgo, Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/NewYork-Presbyterian Hospital, and

• Dr. Heinz-Josef Lenz, M.D., Professor of Medicine and J. Terrence Lanni Chair in Gastrointestinal Cancer Research, Keck School of Medicine

Following the webcast, an archived version will be available on the Agenus website.

https://finance.yahoo.com/news/agenus-shows-unprecedented-activity-botensilimab-110000051.html

ALX Oncology Gets Orphan Drug Designation for Leukemia Treatment

  ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that the U.S. Food and Drug Administration (“FDA”) granted orphan drug designation (“ODD”) to evorpacept, a next-generation CD47 blocker, for the treatment of patients with acute myeloid leukemia (“AML”).

https://finance.yahoo.com/news/alx-oncology-receives-u-fda-110000648.html

Can-Fite: Positive Top-Line Results in Phase 3 Psoriasis Study

 

• Phase III COMFORT™ study met its primary endpoint with statistically significant improvement and Piclidenoson had an excellent safety profile

• Can-Fite has licensing deals for the marketing of Piclidenoson for the treatment of Psoriasis in multiple global regions

https://finance.yahoo.com/news/fite-announces-positive-top-line-110000545.html