ARPO To Report Glaucoma Trial Data In Q4, ARDX To Face FDA In April, PFE's Pipeline Update

biotech sept16

Today's Daily Dose brings you news about Aerpio Pharma's clinical trial catalyst, Adicet Bio's reverse merger with resTORbio, FDA decision date of Ardelyx's Tenapanor, Cel-Sci's phase III study of Multikine for the treatment of newly diagnosed head and neck cancer, and an update on Pfizer's pipeline.

Read on…

. Aerpio Pharma to Report Glaucoma Trial Data in Q4

Aerpio Pharmaceuticals, Inc (ARPO) has completed patient enrollment in its double-blind, placebo-controlled phase II trial of Razuprotafib in patients with elevated intraocular pressure associated with open-angle glaucoma or ocular hypertension.

The trial has enrolled about 195 patients, and topline results are expected next quarter.

The primary endpoint of the study is mean diurnal IOP at 28 days in the Razuprotafib treated groups compared to the latanoprost (Pfizer's Xalatan) monotherapy group.

ARPO closed Tuesday's trading at $1.24, up 5.08%.

2. Adicet Completes Reverse Merger With resTORbio, Listed on Nasdaq

Adicet Bio Inc., a privately-held biopharmaceutical company, has executed a reverse merger with resTORbio Inc. (TORC) to create a combined publicly-traded biotechnology company focused on the development of Adicet's off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications.

The new combined company will operate under the name Adicet Bio, Inc. and will commence trading on the Nasdaq Global Market under the ticker symbol "ACET" on September 16, 2020.

Adicet has a strategic collaboration with Regeneron that was inked in 2016. This collaboration is focused on developing next-generation engineered immune-cell therapeutics using Adicet's gamma delta T cell allogeneic platform technology.

3. Ardelyx to Face FDA in April

Ardelyx Inc.'s (ARDX) New Drug Application of Tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis has been accepted for FDA review, with a decision expected on April 29, 2021.

The New Drug Application was based on three successful phase III trials of Tenapanor involving more than 1,000 patients.

A very common and difficult-to-treat condition in patients with chronic kidney disease (CKD) who require dialysis is hyperphosphatemia, which refers to elevated levels of phosphorus in the blood.

Aside from conventional dialysis and dietary restrictions, oral phosphate binders, which require being taken multiple times or as single large chewable tablets with every meal and snack, are prescribed to manage elevated phosphorus in end-stage renal disease patients.

Tenapanor, which is to be taken only twice per day, if approved, has several advantages over the prescribed oral phosphate binders, according to the company.

ARDX closed Tuesday's trading at $6.09, down 2.48%.

4. Cel-Sci Sees a Delay in Reporting Multikine Trial Results

Cel-Sci Corp. (CVM) has announced that the data lock process for its phase III study evaluating Multikine for the treatment of newly diagnosed head and neck cancer will be delayed due to the COVID-19 pandemic.

The company reached the end of its pivotal phase III study in head and neck cancer in April 2020. In early May 2020, the trial reached the required 298 events (deaths) among the two main comparator groups, signifying the end of the phase III study.

The Clinical Research Organizations (CROs) running the study are now involved in the study phase of performing data lock/analysis. Only upon completion of the analysis according to a pre-specified statistical analysis plan, will CEL-SCI become privy to the study results.

CVM closed Tuesday's trading at $12.80, down 1.46%.

5. Pluristem Awaits Interim analysis Results for Critical Limb Ischemia Trial

Pluristem Therapeutics Inc. (PSTI) has an important milestone to keep an eye on in the coming quarter. The interim analysis results for its global pivotal Phase III study of PLX-PAD in Critical Limb Ischemia are expected next quarter.

The company's two ongoing COVID-19 Phase II clinical trials of its PLX-PAD product candidate for the treatment of severe Acute Respiratory Distress Syndrome in the U.S. and Europe are underway, with enrollment expected to be completed in the first quarter of the calendar year 2021.

PSTI closed Tuesday's trading at $9.66, down 8.09%.

6. Pfizer's Pipeline Well Stocked

Pfizer Inc.'s (PFE) update related to its pipeline, provided as part of a two-day virtual Investor Day, reveals that the company has 89 pipeline projects spread across 6 targeted therapeutic areas with 4 programs in registration and 23 in Phase 3 stage.

A phase III pivotal trial of BNT162b2 vaccine candidate against SARS-CoV-2, the virus that causes COVID-19 disease, is underway, with a conclusive readout on efficacy likely by the end of October.

A phase 1b clinical trial evaluating the safety of a novel investigational therapeutic for COVID-19, PF-07304814, is ongoing.

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, if all goes well as planned.

PFE closed Tuesday's trading at $36.96, down 0.14%.

7. Stocks That Moved On No News

Jounce Therapeutics, Inc. (JNCE) closed Tuesday's trading at $10.95, up 23.73%.

Idera Pharmaceuticals, Inc. (IDRA) closed Tuesday's trading at $2.32, up 15.42%.

Revance Therapeutics Inc. (RVNC) closed Tuesday's trading at $33.46, up 13.96%.

Nano-X Imaging Ltd. (NNOX) closed Tuesday's trading at $38, down 22.78%.

Vaxart Inc. (VXRT) closed Tuesday's trading at $6.50, down 16.45%.

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