Plus   Neg

CMTA Abuzz, EIDX To Report Data In Nov., All Eyes On OPHT


The following are some of today's top gainers in the pharma/biotech sector.

1. Clementia Pharmaceuticals Inc. (CMTA)

Gained 40.23% to close Wednesday's (Oct.24) trading at $14.50.

News: The Company is planning to submit a New Drug Application for Palovarotene to the FDA in the second half of 2019.

Palovarotene is being developed for the prevention of heterotopic ossification (HO) associated with flare up symptoms in patients with fibrodysplasia ossificans progressiva (FOP).

The FDA has agreed that the phase II clinical program of Palovarotene, which showed a statistically significant reduction in mean new heterotopic ossification volume, or bone volume, associated with flare-ups of FOP at 12 weeks compared to placebo or untreated flare-ups, would support filing of an NDA.

2. Lipocine Inc. (LPCN)

Lipocine is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies.

Gained 12.07% to close Wednesday's trading at $1.30.

News: No news


The Company's lead product candidate is for Tlando for treatment of adult males for conditions associated with a hypogonadism. Tlando was issued a Complete Response Letter in May of this year.

The other drug candidates are LPCN 1111, being developed as a next-generation oral testosterone product with potential for once-daily dosing, currently in Phase 2 testing, LPCN 1114, an oral treatment for non-alcoholic steatohepatitis, for which a proof of study is planned, and LPCN 1107, being developed for the prevention of recurrent preterm birth, for which an End of Phase 2 meeting with the FDA has been completed.

Recent Event:

On July 19, the Company completed a Post Action Meeting with the FDA related to Tlando Complete Response Letter. A path forward for NDA resubmission for the potential approval of TLANDO was clarified during the meeting.

Near-term Catalysts:

-- Data from multiple clinical trials of LPCN 1144 in potential non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH) patients are expected to be presented on November 12.
-- An ambulatory blood pressure monitoring study, designed to address one of the concerns raised by the FDA, related to Tlando, is underway, with data expected in the first quarter of 2019.

3. Eidos Therapeutics Inc. (EIDX)

Eidos is a clinical stage biopharmaceutical company focused on developing drugs for diseases caused by transthyretin (TTR) amyloidosis (ATTR).

Gained 11.10% to close Wednesday's trading at $10.71.

News: No news

Clinical Trials & Near-term Catalyst:

-- A phase II clinical trial of AG10 in patients with ATTR cardiomyopathy is underway. The results from this study are expected to be presented on November 10.

Recent event:

The Company's shares began trading on the Nasdaq Global Select Market on June 20, 2018, at an offering price of $17 each.

4. Varian Medical Systems Inc. (VAR)

Varian Medical is a medical device company developing and delivering cancer care solutions.

Gained 7.74% to close Wednesday's trading at $112.40.

News: The Company announced higher earnings and revenue for the fourth quarter and full fiscal year 2018.

Net earnings for the recent fourth quarter were $116.8 million or $1.26 per share on revenue of $801.6 million. This compared with $78.6 million or $0.85 per share and revenue of $721.8 million in the year-ago quarter.

In other news, the Company announced that it has entered into a strategic partnership with GenesisCare, a provider of cancer care treatment, to increase access to advanced cancer care in Australia, the United Kingdom and Spain.

The relationship is intended to cover up to a total of 70 Varian linear accelerators and Varian Eclipse treatment planning software as the preferred GenesisCare solution provider globally. It will also include support of skin cancer clinical trials utilizing Varian RapidArc technology and the development of software for the emerging field of theranostics.

5. Ophthotech Corporation (OPHT)

Ophthotech is focused on developing therapeutics and gene therapy solutions to treat ophthalmic diseases, with a focus on orphan and age-related retinal diseases.

Gained 6.25% to close Wednesday's trading at $2.38.

News: No news

Near-term Catalysts:

-- Report third quarter 2018 financial and operating results on October 31.
-- Top-line data from a phase 2a clinical trial of Zimura in patients with wet age-related macular degeneration is expected to become available before the end of 2018.
-- Initial top line results from a phase 2b trial of Zimura in patients with geographic atrophy are expected in the fourth quarter of 2019.

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