AXSM Awes Investors, LOXO Snapped Up For $8 Bln, SAGE Excited, TLC On Watch

pharmaup jan07

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

1. Axsome Therapeutics Inc. (AXSM)

Gained 161.22% to close Monday's (Jan.7) trading at $6.87. The stock touched a 52-week high of $8.89 in intra-day trading.

News: The Company reported encouraging results from its phase II study of AXS-05 in major depressive disorder, dubbed ASCEND.

The ASCEND study involved 80 adult patients with confirmed moderate to severe major depressive disorder who were treated either with AXS-05 or the active comparator Bupropion, twice daily for 6 weeks. At Week 6, AXS-05 demonstrated a highly statistically significant reduction of 17.2 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to a 12.1 point reduction for Bupropion, achieving the primary endpoint.

A phase III trial of AXS-05 in patients with treatment-resistant depression, dubbed STRIDE-1, is underway.

2. Loxo Oncology Inc. (LOXO)

Gained 66.33% to close Monday's trading at $232.65.

News: The Company has agreed to be acquired by Eli Lilly and Company (LLY) for $235.00 per share in cash, or approximately $8.0 billion.

The transaction is not subject to any financing condition and is expected to close by the end of the first quarter of 2019, subject to customary closing conditions.

3. Insmed Incorporated (INSM)

Gained 43.23% to close Monday's trading at $21.27.

News: No news

Recent event:

On January 4, the Company reported preliminary unaudited net product sales of ARIKAYCE for the fourth quarter of 2018.

ARIKAYCE was granted accelerated approval by the FDA on September 28, 2018, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options.

The Company expects total net product sales of ARIKAYCE to be approximately $9.8 million for the fourth quarter ended December 31, 2018.

Near-term Catalysts:

-- The audited results for the fourth quarter and for the full year of 2018 are scheduled for release on February 22, 2019.
-- Regulatory filing for ARIKAYCE in Europe is expected to be made in mid-2019 and in Japan in the first half of 2020.
-- Completion of enrolment in six-month phase II trial of INS1007 in patients with non-cystic fibrosis bronchiectasis is expected in mid-2019.

4. Sage Therapeutics Inc. (SAGE)

Gained 42.68% to close Monday's trading at $139.13.

News: The Company's phase III study evaluating SAGE-217 30 mg on depressive symptoms in women with postpartum depression met primary and secondary endpoints.

In the study, dubbed ROBIN, after two weeks of outpatient treatment, statistically significant reduction was observed in women with postpartum depression treated with SAGE-217 compared to placebo. Patients treated with SAGE-217 showed a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression (HAMD-17) score, compared to 13.6 for placebo.

5. Reata Pharmaceuticals Inc. (RETA)

Gained 23.24% to close Monday's trading at $72.75.

News: No news

Near-term Catalyst:

Enrollment in phase III clinical trial of bardoxolone methyl (bardoxolone) in patients with autosomal dominant polycystic kidney disease, dubbed FALCON, is expected to be initiated during mid-2019.

6. Taiwan Liposome Company, Ltd. (TLC)

Gained 22.52% to close Monday's trading at $7.29.

News: No news

Near-term Catalyst:

A phase I/II clinical trial of TLC590 for post-surgical pain in patients following inguinal hernia repair is underway, with top-line data expected in the first quarter of 2019.

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