CLSD Loses Shine, AVDL’s Q3 Results Disappoint, CWBR Briefly Suspends NASH Trial

CLSD Loses Shine, AVDL’s Q3 Results Disappoint, CWBR Briefly Suspends NASH Trial

The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Clearside Biomedical Inc. (CLSD)

Lost 62.77% to close Monday’s (Nov.5) trading at $2.07.

News: The Company’s phase III study of combination therapy in Retinal Vein Occlusion did not meet its primary endpoint.

The study, dubbed SAPPHIRE, investigated the superiority of XIPERE used together with the intravitreal anti-VEGF agent EYLEA compared to intravitreal Eylea monotherapy for the treatment of retinal vein occlusion (RVO).

In the SAPPHIRE trial, approximately 50% of patients in both arms showed at least a 15 letter improvement in vision. But there was no additional benefit for patients receiving XIPERE together with intravitreal Eylea.

The Company has decided to discontinue clinical development of combination therapy for RVO, which includes SAPPHIRE and its companion phase III clinical trial, TOPAZ.

Near-term Catalyst:

Submit an NDA for XIPERE to treat macular edema associated with non-infectious uveitis to the FDA by the end of 2018.

2. Avadel Pharmaceuticals plc (AVDL)

Lost 23.88% to close Monday’s trading at $3.06.

News: The Company announced its financial results for the third quarter of 2018.

On an adjusted basis, the Company posted a net loss of $23.9 million or $0.65 per share in the recent third quarter compared to a net income of $3.74 million or $0.09 per share in the year-ago quarter.

Revenues for the third quarter 2018 declined to $19.8 million from $39.7 million in the third quarter 2017. The decline on a year-over-year basis was attributed to lower net selling prices across all of its hospital products and lower unit volumes for Akovaz and Bloxiverz as a result of increased market competition.

3. CohBar Inc. (CWBR)

Lost 16.59% to close Monday’s trading at $3.57.

News: The Company has temporarily suspended its phase I clinical study of CB4211, its lead mitochondria based therapeutic candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity, in order to address mild injection site reactions that have been unexpectedly persistent.

4. Health Insurance Innovations Inc. (HIIQ)

Lost 14.37% to close Monday’s trading at $39.62.

News: No news

Recent events:

— On November 2, the Company announced the termination of its relationship with Health Benefits One, LLC.
— On October 29, the Company announced financial results for the third quarter ended September 30, 2018, and raised its annual revenue outlook.

On an adjusted basis, net income for the recent third quarter was $10.05 million or $0.61 per share compared to net income of $7.68 million or $0.46 per share in the year-ago quarter. Revenue for the third quarter of 2018 was $74.0 million, up 16.9%, compared to the third quarter in 2017.

The Company raised its annual guidance of revenue for 2018 to be between $294 million and $304 million, up from its prior outlook range of $293 million to $303 million. The adjusted EPS for the year is expected to be between $2.47 and $2.57.

Revenue in 2017 was $250.5 million and adjusted EPS was $1.65.

5. Marker Therapeutics Inc. (MRKR)

Lost 13.03% to close Monday’s trading at $8.01.

News: No news

Recent event:

— On October 18, 2018, the combined company of TapImmune Inc. (TPIV) and privately-held Marker Therapeutics Inc, took on the name Marker Therapeutics Inc., and began trading on the Nasdaq Capital Market under the new ticker symbol “MRKR”.

Pipeline:

— A phase II clinical trial of novel therapeutic vaccine candidate TPIV200 in the prevention of cancer recurrence in women with triple-negative breast cancer (TNBC) who have completed first-line surgery and radiotherapy/chemotherapy is underway. *The study is expected to be completed in May 2019. (Source: ClinicalTrials.gov)
— A phase II clinical study of TPIV110 that will enroll women diagnosed with ductal carcinoma in situ, an early form of breast cancer is being planned by Mayo Clinic.
— A phase II study of TPIV110, in combination with Herceptin for treating women with HER2/neu-positive breast cancer is also being planned by Mayo Clinic.

6. Fulgent Genetics Inc. (FLGT)

Lost 9.86% to close Monday’s trading at $3.20.

News: No news

Near-term Catalyst:

The Company is slated to release its third quarter 2018 financial results after the market closes on Tuesday November 6, 2018. Wall Street analysts are expecting the Company to report a loss of $0.02 per share and revenue of $5.38 million for the third quarter.

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