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IMDZ Discontinues SYNOVATE, FDA Delays Decision On ADMA's Bivigam, TRVN Snubbed

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Today's Daily Dose brings you news about FDA postponing the decision date on ADMA Biologics' BIVIGAM by 2 months; Immune Design's decision to pull the plug on a phase III study; Corium International getting acquired by a private investment firm; FDA panel voting against approval of Trevena's pain medication Oliceridine, and stock offering of SeaSpine, Iovance and Synthetic Biologics.

Read on...

The FDA decision on ADMA Biologics Inc.'s (ADMA) Prior Approval Supplement filing related to BIVIGAM, which was originally slated for October 25, 2018, has been postponed to December 18, 2018.

BIVIGAM, an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency, received FDA approval on December 19, 2012, when it was under the aegis of Biotest Pharmaceuticals Corp. After selling the drug in the U.S. market for nearly 4 years, Biotest Pharma halted the production of BIVIGAM In December 2016.

ADMA Biologics obtained ownership and all rights, title and interest in BIVIGAM on June 6, 2017 as part of the Biotest Therapy Business Unit asset acquisition.

ADMA closed Thursday's trading at $5.55, down 2.54%.

Shares of Corium International Inc. (CORI) soared more than 50% in extended trading on Thursday, following news of its merger with Gurnet Point Capital (GPC), a private investment firm.

Under the terms of the merger agreement, GPC will pay $12.50 per share in cash upon the closing. The agreement also provides for a Contingent Value Right (CVR) of $0.50 per share that is payable based on the FDA approval of Corium's lead product candidate, Corplex Donepezil, for the treatment of Alzheimer's disease, prior to March 31, 2020.

CORI closed Thursday's trading at $8.31, down 0.24%. In after-hours, the stock was up 50.42% at $12.50.

Shares of Immune Design Corp. (IMDZ) slumped nearly 50% in extended trading on Thursday, following its decision to discontinue the SYNOVATE trial.

SYNOVATE is a phase III clinical trial evaluating CMB305 monotherapy versus placebo in 248 patients 12 years of age and older with NY-ESO-1 positive, unresectable, locally-advanced or metastatic synovial sarcoma.

The decision to pull the plug on the study was based on an early analysis of an ongoing phase II study that showed the combination of CMB305 and Tecentriq (atezolizumab) is not likely to show a survival benefit in relapsed synovial sarcoma patients.

IMDZ closed Thursday's trading at $2.79, down 1.41%. In after-hours, the stock was down 49.82% at $1.40.

Iovance Biotherapeutics Inc. (IOVA) intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering.
The Company said that the sole underwriter, Jefferies LLC, will be granted a 30-day option to purchase up to an additional 15% of the shares of common stock.

Near-term Catalysts:

-- Initiate enrollment into Cohort 4 of its phase II study of LN-144 in metastatic melanoma in early 2019.
-- Submission of Biologics License Application for LN-144 in metastatic melanoma is expected in the second half of 2020.

IOVA closed Thursday's trading at $9.97, down 4.68%.

Shares of Synthetic Biologics Inc. (SYN) plunged 38% on Thursday, following the pricing of an underwritten public offering with expected total gross proceeds of $18 million.

The securities offered by the Company consist of (i) Class A Units consisting of 2.52 million shares of Common Stock and Warrants to purchase 2.52 million shares of Common Stock at a combined price of $1.15, and (ii) Class B Units consisting of 15,102 shares of Series B Convertible Preferred Stock, with a stated value of $1,000 per share, and convertible into an aggregate of 13.13 million shares of Common Stock, and Warrants to purchase 13.13 million shares of Common Stock.

The Warrants will have an exercise price of $1.38, will be exercisable upon issuance and will expire five years from the date of issuance. The underwriters have a 45-day option to purchase additional shares of Common Stock and/or additional Warrants to purchase shares of Common Stock, in amounts up to 15% of the Common Stock, Warrants and/or Common Stock issuable upon conversion of the Series B Convertible Preferred Stock included in the Class B Units sold in the offering, the Company added.

SYN closed Thursday's offering at $0.90, down 38.22%.

SeaSpine Holdings Corp. (SPNE) has offered to sell 3.25 million shares of its common stock to the public at a price of $15.50 each.

The gross proceeds to SeaSpine, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $50.4 million. The offering is expected to close on or about October 15, 2018, subject to customary closing conditions.

The underwriters have a 30-day option to purchase up to an additional 487,500 shares at the public offering price, less underwriting discounts and commissions.

To know more about SPNE, please visit our "In the Spotlight" column.

SPNE closed Thursday's trading at $16.00, down 8.15%.

An FDA panel, which reviewed Trevena Inc.'s (TRVN) New Drug Application for Oliceridine, has voted 8 against, and 7 in favor of its approval.

The Company is seeking approval of Oliceridine for the management of moderate to severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted.

The FDA is not bound by the Advisory Committee's recommendations but takes its advice into consideration when making its decision, which is slated for November 2, 2018.

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