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DARE Emboldened, IFRX On Track, APRI Awaits FDA Word, Watch Out For DYNT

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The following are some of the stocks that lost the largest percentage in price today in the pharma/biotech sector.

GAINERS

1. Daré Bioscience Inc. (DARE)

Gained 50% to close Monday's (Feb.12) trading at $2.79.

News: The Company has entered into an agreement to license SST-6007, a potential treatment for Female Sexual Arousal Disorder, from Strategic Science & Technologies LLC.

Daré anticipates commencing a phase 2b clinical trial of SST-6007 in the second half of 2018.

If approved, SST-6007, a 5% Topical Sildenafil Citrate Cream, would be the first FDA approved treatment for Female Sexual Arousal Disorder, or FSAD.

2. Aradigm Corp. (ARDM)

Gained 21.82% to close Monday's trading at $1.34. The stock has lost 80% since the start of this year.

News: No news

Recent event:

On January 29, 2018, the FDA turned down the Company's Linhaliq, proposed for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa.

3. Zosano Pharma Corp. (ZSAN)

Gained 19.40% to close Monday's trading at $4.80.

News: No news

Recent event:

-- A 1-for-20 reverse stock split was implemented on January 26, 2018.

Clinical Trials & Near-term Catalysts:

The lead drug candidate is M207 for the treatment of migraine. A long-term safety study of M207 is underway.

-- The Company expects to enroll 100 patients by the end of Q1, 2018, and 250 patients by Q2, 2018.
-- 6-month safety data from the trial is expected in Q4, 2018.
-- 12-month safety data from the trial is expected in Q1, 2019.
-- NDA filing for M207 for the treatment of migraine is expected by the end of 2019.

4. InflaRx N.V. (IFRX)

Gained 16.32% to close Monday's trading at $27.51.

News: No news

Recent event:

-- The Company went public on the NASDAQ Global Select Market on November 8, 2017, offering its shares at a price of $15.00 each.

Pipeline:

The Company's lead compound is IFX-1, under phase II clinical trial in patients suffering from moderate to severe Hidradenitis Suppurativa (HS), a painful, chronic and debilitating inflammatory skin disease. Positive top line data from an exploratory Phase IIa trial of IFX-1 in Hidradenitis Suppurativa were reported in September of 2017.

Near-term Catalyst:

-- An international, multi-center, randomized, placebo-controlled Phase IIb trial in Hidradenitis Suppurativa is expected to be initiated in Q1, 2018.

5. ImmunoGen Inc. (IMGN)

Gained 18.35% to close Monday's trading at $10.54.

News: The Company reported pipeline progress and 2017 operating results.

The Company's net loss for 2017 was $96.0 million, or $0.98 per share on revenues of $115.4 million. This compared with a net loss of $156.7 million or $1.80 per share, and revenues of $48.63 million in 2016.

Looking ahead to 2018, the Company expects revenues to be between $60 million and $65 million.

Pipeline:

The Company's lead product candidate is Mirvetuximab soravtansine, under a phase III trial as a single agent for the treatment of platinum-resistant ovarian cancer, dubbed FORWARD I, and under a phase 1b/2 study as combination regimens for both platinum-resistant and platinum-sensitive ovarian cancer, known as FORWARD II.

Also in the pipeline are IMGN779 and IMGN632.

IMGN779 is under a phase I trial in adult patients with relapsed/refractory CD33-positive Acute Myeloid Leukemia while IMGN632 recently advanced into phase I testing in patients with CD123-positive hematological malignancies, including acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm.

Near-Term Catalysts:

-- Conduct interim analysis from FORWARD I, for futility only, in 1Q 2018.
-- Report updated dose-escalation findings from the FORWARD II mirvetuximab plus Keytruda combination cohort at the Society of Gynecologic Oncology annual meeting (March 2018).
-- Present highlights from ImmunoGen's technology and innovation in ADCs at the American Association for Cancer Research (AACR) annual meeting (April 2018).
-- Anticipate partner Takeda to begin clinical development of TAK-164 in the first half of 2018.
-- Report updated data from the FORWARD II mirvetuximab plus Avastin combination expansion cohort in over 50 patients in the first half of 2018.
-- Complete patient enrollment in FORWARD I by mid-year.
-- Report findings from the FORWARD II mirvetuximab plus Keytruda combination expansion cohort in over 30 patients the second half of the year.
-- Report additional data from IMGN779 Phase 1 study in 4Q 2018.
-- Report initial data from IMGN632 Phase 1 study in 4Q 2018 and
-- Advance ADAM9 program into IND-enabling activities before year-end 2018.

6. HTG Molecular Diagnostics Inc. (HTGM)

Gained 18.08% to close Monday's trading at $4.05.

News: No news

Recent event:

-- On January 4, 2018, the Company announced preliminary and unaudited financial results for the fourth quarter and full year ended December 31, 2017, and provided initial full year 2018 revenue guidance.

Total revenue for the fourth quarter of 2017 is expected to be between $6.9 million and $7.2 million, compared to $1.5 million in the fourth quarter of 2016.

Total revenue for the full year 2017 is expected to be between $13.8 million and $14.1 million compared to $5.1 million for the full year 2016.

The Company expects full year 2018 revenue to be in the range of $20.0 to $25.0 million.

Near-term Catalyst:

-- The Company expects to announce full 2017 financial results in advance of its quarterly conference call, currently planned for Thursday, March 22, 2018.

7. Apricus Biosciences Inc. (APRI)

Gained 16.88% to close Monday's trading at $2.70.

News: No news

Near-term Catalyst:

The Company's resubmitted New Drug Application for Vitaros awaits the FDA's final word, which is expected on February 17, 2018.

Vitaros is a novel, on-demand topical cream for the treatment of erectile dysfunction, in-licensed from Warner Chilcott Co. Inc., now a subsidiary of Allergan plc. (AGN).

This is Vitaros' second go-around with the FDA. It was turned down by the U.S. regulatory agency in July 2008, with questions being raised about the results of a transgenic mouse carcinogenicity study, which were completed in 2002.

8. uniQure N.V. (QURE)

Gained 16.43% to close Monday's trading at $22.32.

News: No news

Near-Term Catalysts:

-- Initiate a global, pivotal program for AMT-061 in hemophilia B during the third quarter of 2018. Top-line data from the initial patients are expected to be announced before the end of 2018.
-- Complete Good Laboratory Practices (GLP) toxicology study of AMT-130 in mid-2018 and file an IND application with the FDA to advance AMT-130 into Phase I/II study for Huntington's disease in the second half of 2018.
-- The Company and Bristol-Myers Squibb (BMY) expect to initiate a preclinical heart function study of AMT-126 in a diseased minipig model in early 2018.

9. Dynatronics Corp. (DYNT)

Gained 15.66% to close Monday's trading at $3.00.

Near-term Catalyst:

The Company's financial results for the fiscal 2018 second quarter ended December 31, 2017 will be released post market close on Tuesday, February 13, 2018.

10. Odonate Therapeutics Inc. (ODT)

Gained 14.25% to close Monday's trading at $17.64.

News: No news

Recent events:

-- The Company went public on the NASDAQ Global Select Market on December 7, 2017, offering its shares at a price of $24.00 each.
-- On January 2, 2018, Jefferies initiated coverage on Odonate with a Buy rating and a price target of $40.

Clinical Trial:

A phase III study of Tesetaxel in patients with locally advanced or metastatic breast cancer, dubbed CONTESSA, was initiated as recently as December 28, 2018.

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