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AIMT To Face FDA Panel In Sep., FDA Lifts Hold On ADVM Trial, OTLK Jumps

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Today's Daily Dose brings you news about Aimmune Therapeutics' upcoming regulatory catalyst; FDA lifting the clinical hold on OPTIC trial; Analyst rating on Outlook Therapeutics and Cellectar Biosciences' $10 million financing.

Read on...

Aimmune Therapeutics Inc.'s (AIMT) Biologics License Application for AR101 is slated to be reviewed by an FDA panel on September 13, 2019.

AR101 is an investigational biologic drug for use in oral immunotherapy, as a treatment to reduce the frequency and severity of adverse events, including anaphylaxis, following exposure to peanut.

The FDA's decision on AR101 is expected to be announced by late January 2020. If approved, AR101 will be the first medicine for peanut allergy.

Peanut allergy, a condition in which the immune system mistakenly recognizes a number of proteins from peanuts as potential foreign pathogens, triggering an inflammation, is most common in children.

AIMT closed Thursday's trading at $20.65, down 1.10%.

Shares of Adverum Biotechnologies Inc. (ADVM) rose more than 26% on Thursday, following the lifting of clinical hold on the second cohort of its phase I trial of gene therapy candidate ADVM-022 for wet age-related macular degeneration, dubbed OPTIC.

The Company has completed enrollment and dosing of patients in the first cohort in the OPTIC trial. In April of this year, the FDA sought additional CMC information and requirements on the ADVM-022 manufacturing process and had placed the trial on hold.

Now, that the FDA has lifted the clinical hold on the second cohort, the dosing of patients in this cohort is expected to begin in June 2019. However, the trial remains on partial clinical hold for dosing patients in the third cohort, with the highest dose of 6 x 10^12 vg/eye.

To date, no patient in the first cohort has experienced a serious adverse event, with the first patient completing the 24-week assessment, added the Company.

ADVM closed Thursday's trading at $8.13, up 26.05%.

Shares of Outlook Therapeutics Inc. (OTLK) jumped more than 68 percent on Thursday after Oppenheimer initiated coverage of the Company's stock with a $12 price target.

The Company's lead product candidate is ONS-5010, which is under a phase III clinical trial in Australia) for wet age related macular degeneration, dubbed ONS-5010-001.
Enrollment in this study is nearly complete with 51 of the planned 60 patients enrolled to date.

Another phase III clinical trial of ONS-5010 for wet AMD, initiated in the United States, Australia and New Zealand, is expected to begin dosing patients in June 2019.

The Company, which had cash of $0.2 million at March 31, 2019, raised net proceeds of approximately $26.2 million in April of this year.

OTLK closed Thursday's trading at $1.53, up 68.06%.

Cellectar Biosciences Inc. (CLRB) has entered into definitive agreements with institutional investors to purchase approximately $5.0 million in a registered direct offering of 1.98 million common shares and approximately $5.0 million in a concurrent private placement of 2.01 million common shares.

In conjunction with the offerings, the company issued 4 million unregistered warrants to purchase common stock.

The offerings are expected to result in total gross proceeds of $10.0 million before deducting estimated offering expenses.

The Company's lead product candidate is CLR 131, which is under a phase I trial in Relapsed or Refractory Multiple Myeloma. The initial results from Cohort 6 of this trial demonstrated 50% partial response rate, 50% minimal response rate, and 100% disease control rate. Cohort 7 of this trial has been initiated - with data expected in Q4 2019.

CLRB closed Thursday's trading at $2.18, down 22.70%.

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