INNL To Be Acquired, ELGX Seeks Funds, Opdivo At FDA Altar Again, NLNK Abuzz

(RTTNews) - Bristol-Myers Squibb Co.'s (BMY) supplemental Biologics License Application seeking to extend the use of Opdivo in previously treated mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer patients has been accepted for priority review by the FDA.

The FDA's decision is slated for August 2, 2017.

Opdivo is already approved for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, and urothelial carcinoma.

Global sales of Opdivo in 2016 were $3.77 billion, up from $942 million in 2015.

BMY closed Tuesday's trading at $54.14, down 0.15%.

Corvus Pharmaceuticals Inc.'s (CRVS) interim safety and efficacy results from its ongoing Phase 1/1b study has demonstrated that treatment with its drug candidate CPI-444 as a single agent and in combination with Genentech's approved cancer immunotherapy Tecentriq was well tolerated and resulted in anti-tumor activity in patients with multiple types of advanced solid tumors, including those resistant or refractory to prior treatment with anti-PD-1 or anti-PD-L1 antibodies.

According to the interim efficacy results, which was based on 96 patients, disease control was observed in 38 percent of those receiving CPI-444 as a single agent and in 39% of those receiving the combination.

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Gainers & Losers Of Apr.4: INNL, BNTC, PRTK, CRVS, STDY...

CRVS closed Tuesday's trading at $10.36, down 49.98%. In after-hours, the stock was up 6.18% to $11.00.

Endologix Inc. (ELGX) has sought from Deerfield Management up to $170 million in funding through a $120 million six-year secured term loan and a $50 million three-year secured asset-based revolving line of credit.

Under the term loan, Deerfield provided Endologix with $120 million of gross proceeds in funding. Endologix estimates that the net proceeds from the term loan will be $113 million, after deducting estimated transaction expense.

At the closing of the term loan, the Company issued Deerfield warrants to purchase up to 6.47 million shares of its common stock at an exercise price of $9.23 per share.

ELGX closed Tuesday's trading at $6.66, down 7.24%.

Gurnet Point L.P., a healthcare investment fund, has entered into an agreement to acquire Innocoll Holdings plc (INNL)

Innocoll is to be acquired for $1.75 per share in cash, and up to $4.90 in cash from a contingent value right, for a total potential per share value of up to $6.65 or up to approximately $209 million in aggregate.

Last month, Innocoll confirmed that it is in discussions which may or may not lead to an offer for the entire issued share capital of the Company.

INNL closed Tuesday's trading at $1.82, up 42.19%. In after-hours, the stock was up 62.09% to $2.95.

Shares of NewLink Genetics Corp. (NLNK) were down more than 9% on Tuesday after reporting interim phase II results of its drug candidate Indoximod in combination with Merck's FDA-approved Keytruda in patients with advanced melanoma.

According to the trial results, patients who received the combination of Indoximod plus Keytruda demonstrated a 52% objective response rate (ORR) and a 73% disease control rate (DRR).

While the Company said that results are robust, investors are of the view that it was not a meaningful benefit compared to Incyte's (INCY) investigational melanoma drug Epacadostat.

In a phase I trial, which evaluated the safety and efficacy of Epacadostat in combination with Keytruda in advanced melanoma patients, the objective response rate was 58% and disease control rate was 74%.

NLNK closed Tuesday's trading at $20.79, down 9.96%.

Shares of OHR Pharmaceutical Inc. (OHRP) were down more than 18% in extended trading on Tuesday after it announced a proposed public offering of common stock and warrants.

OHRP closed Tuesday's trading at $0.77, down 4.94%. In after-hours, the stock was down 18.18% to $0.63.

Spark Therapeutics (ONCE) will present updated interim data from its phase 1/2 clinical trial of SPK-9001 for hemophilia B on Friday, April 7 from 5:15-6:15 p.m. MST.

ONCE closed Tuesday's trading at 51.88 down 0.90%.