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GEMP Jumps Over 40%, EVFM Awaits Pivotal Contraceptive Gel Data, ARWR Abuzz

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

1. Gemphire Therapeutics Inc. (GEMP)

Gained 42.04% to close Thursday's (Sep.6) trading at $2.23.

News: No news

Near-term Catalysts:

-- The Company is working with the FDA to release the partial hold on its investigational drug Gemcabene with respect to clinical trials of longer than six months in duration.
-- A phase IIa trial of Gemcabene in familial partial lipodystrophy is underway. The initial safety review of the first three patients, on a dose of 300 mg/day has not uncovered any safety or tolerability concerns nor was there a change in biomarkers that would indicate concerns about liver function. The MRI-PDFF scans are to be reviewed at an interim time point in the near future before dosing additional patients.

2. Arrowhead Pharmaceuticals Inc. (ARWR)

Gained 37.52% to close Thursday's trading at $19.39.

News: The Company announced promising data from its phase 1/2 clinical study of AROHBV1001 in patients with chronic hepatitis B virus (HBV) infection who received three monthly doses of ARO-HBV.

According to the study results, the three monthly doses of ARO-HBV led to a maximum reduction in circulating HBV surface antigen (HBsAg) of 4.0 log10, with mean reductions of approximately 2.0 log10 on day 85 in the 100 mg cohort and 1.4 log10 on day 71 in the 200mg cohort (currently the last complete data point available). All eight patients achieved greater than 1.0 log10 reductions in circulating HBsAg.

ARO-HBV was generally well-tolerated with generally mild and self-limiting injection site adverse events being the most common reported event in chronic HBV patients, occurring in around 10% of injections.

3. Sol-Gel Technologies Ltd. (SLGL)

Gained 20.74% to close Thursday's trading at $7.80.

News: No news

Near-term Catalyst:

-- The pivotal phase III clinical trials for the Company's topical drug candidate TWIN in the treatment of acne vulgaris are expected to commence in the fourth quarter of 2018, with top-line data anticipated in 2019.

4. Clementia Pharmaceuticals Inc. (CMTA)

Gained 20.28% to close Thursday's trading at $12.16.

News: No news

Near-term Catalysts:

The Company will present a poster detailing updated data from its Phase 2 clinical trial of Palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP) at the ASBMR 2018 Annual Meeting on Oct. 1, 2018. Positive data from Part B of its ongoing phase II clinical trial evaluating Palovarotene for the treatment of patients with fibrodysplasia ossificans progressive were presented in May of this year.

According to the trial results, treatment with Palovarotene resulted in meaningful reductions in new heterotopic ossification volume (HO, bone growth in abnormal places) as measured by both 12-week flare-up imaging and 12-month whole body CT (WBCT) scan.

A phase III trial of Palovarotene in fibrodysplasia ossificans progressiva, dubbed MOVE Trial, is underway. The MOVE Trial is designed to enroll 80 patients age 4 and older, and enrollment is expected to be completed by the end of 2018, and reach the first interim analysis in mid-2019.

You can find more about CMTA in our "This Day That Year" column.

5. CEL-SCI Corporation (CVM)

Gained 13.22% to close Thursday's trading at $3.34.

News: The National Institutes of Health has selected CEL-SCI and its LEAPS rheumatoid arthritis vaccine candidate as a Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Commercialization Accelerator Program Phase II awardee for 2018-2019.

Near-term Catalyst:

-- The top line results from a phase III trial of its investigational immunotherapy Multikine in the treatment of head and neck cancer may be available as soon as early 2019.

6. Crinetics Pharmaceuticals Inc. (CRNX)

Gained 10.82% to close Thursday's trading at $33.48.

News: No news

Recent events:

-- On August 30, the Company reported financial results for the second quarter ended June 30, 2018.

Net loss for the recent second quarter was $5.6 million or $2.41 per share compared to a net loss of $1.6 million or $1.22 per share for the three months ended June 30, 2017.

On July 18, 2018, Crinetics debuted on the Nasdaq Global Select Market at an offering price of $17.00 per share.

You can find more about CRNX in our report titled "This Week's Biotech IPOs".

7. Evofem Biosciences Inc. (EVFM)

Gained 10.25% to close Thursday's trading at $4.41.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is Amphora, a non-hormonal, surfactant-free bioadhesive vaginal gel.

A phase III clinical trial of Amphora for the prevention of pregnancy and a phase IIb/III clinical trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women are underway.

Data from the phase III clinical trial of Amphora for the prevention of pregnancy are now expected in late 2018, ahead of its earlier guidance of Q1, 2019. If all goes well as planned, resubmit Amphora NDA for contraception in the first half of 2019. A Complete Response Letter was issued by the FDA on April 28, 2016.

8. Invuity Inc. (IVTY)

Gained 9.62% to close Thursday's trading at $5.70.

News: No news

Invuity is a medical technology company focused on minimal access surgery.

Recent event:

-- On August 2, the Company announced financial results for the second quarter ended June 30, 2018.

The net loss for the second quarter of 2018 narrowed to $9 million or $0.37 per share from $10.4 million or $0.61 per share for the second quarter of 2017. Revenue was $10.5 million in the recent second quarter, up 7.5% from $9.8 million in the second quarter of 2017 driven primarily by strong market acceptance of PhotonBlade.

Looking ahead to 2018, Invuity continues to expect revenue to exceed $46 million. Full year 2017 revenue was $39.6 million.

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