ALDR Falls On CEO Exit, VERU To File Its 1st NDA, NVLN Awaits CHMP Opinion

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

Alder Biopharmaceuticals Inc. (ALDR)

Lost 15.07% to close Wednesday's (Mar.21) trading at $11.55.

News: The Company's President, CEO and director Dr. Schatzman has stepped down.

Paul Cleveland, a member of the Company's Board of Directors, has been appointed to serve as Interim President and CEO, effective immediately.

Near-term Catalysts:

-- 12 month data from PROMISE 1, a phase III global trial of Eptinezumab for episodic migraine prevention is expected in the first half of 2018.

The primary and secondary endpoint results of PROMISE 1 trial, were reported last June, and they demonstrated statistically significant reductions in monthly migraine days from baseline (average of 8.6 days) over weeks 1 through 12 (i.e. 3 months).

-- 6 month data from PROMISE 2, a phase III global trial of Eptinezumab for chronic migraine prevention is also expected in the first half of 2018.

The primary and secondary endpoint results of PROMISE 2 trial, were reported in January of this year. There was a reduction of 8.2 monthly migraine days from baseline following a single Eptinezumab administration compared to 5.6 days for placebo. -- Results from an open-label safety study of Eptinezumab for migraine prevention are expected in the first half of this year. -- Submit BLA for Eptinezumab for chronic migraine prevention to the FDA in the second half of 2018.

2. Veru Inc. (VERU)

Lost 13.36% to close Wednesday's trading at $1.88.

News: No news

The Company has 2 marketed products and a well stocked pipeline.

FC2 Female Condom and PREBOOST medicated individual wipe, a male genital desensitizing drug product for the prevention of premature ejaculation are the two marketed products.

Pipeline:

TAMSULOSIN DRS and TAMSULOSIN XR capsules for the treatment of benign prostatic hyperplasia, VERU-944 for the treatment of hot flashes caused by prostate cancer hormonal therapies in men with advanced prostate cancer, VERU-111, a novel oral chemotherapy, for metastatic prostate cancer as well as for other forms of metastatic cancers, VERU-722 for the treatment of male infertility, and VERU-112 for the treatment of Gout and Familial Mediterranean Fever, Solifenacin DRG granules for overactive bladder are the Company's investigational drugs.

Near-term Catalysts:

-- File NDA for Tamsulosin DRS and Tamsulosin XR capsules in the U.S. this year. -- Initiate phase II study of VERU-944 for the treatment of hot flashes caused by prostate cancer hormonal therapies in men with advanced prostate cancer, with data expected in 2019. -- Start phase I/II trials of VERU-111 for metastatic castration resistant prostate cancer in 2018.

3. Arbutus Biopharma Corp. (ABUS)

Lost 12% to close Wednesday's trading at $4.40.

News: No news

Near-term Catalysts:

-- Commence a 30-week Phase II triple combination study of ARB-1467, tenofovir, and pegylated interferon for HBV this month. -- Alnylam's Patisiran, proposed for the treatment of hereditary ATTR (hATTR) amyloidosis, is under FDA review, with a decision expected on August 11, 2018. Arbutus will receive royalties on sales of Patisiran. -- Nominate a clinical candidate for IND/CTA-enabling studies of a lead GalNAc conjugate to enable subcutaneous delivery of an RNAi therapeutic that targets HBV in 1H18. -- Submit AB-506 IND/CTA-regulatory filing in mid-2018 to enable Phase I clinical study in HBV patients. -- Submit AB-452 IND/CTA-regulatory filing in mid-2018 to enable start of Phase I clinical study in chronic HBV patients. -- Interim on-treatment results from phase II triple combination study of ARB-1467, tenofovir, and pegylated interferon for HBV in 2H18.

4. Aethlon Medical Inc. (AEMD)

Lost 11.88% to close Wednesday's trading at $1.41.

News: No news

Recent event:

-- On Feb.1, 2018, the Company announced results for its fiscal third quarter ended December 31, 2017.

The net loss was approximately $1.22 million or $0.08 per share for the December 2017 quarter on revenues of $74,813. This compared with a net loss of about $1.21 million or $0.15 per share and nil revenue in the December 2016 quarter.

The Company, which had a cash balance of roughly $5.6 million at year-end 2017, raised approximately $1.4 million over the month of January 2018 through a combination of cash from warrant exercises and sales under the Company's At-The-Market financing agreement.

5. Novelion Therapeutics Inc. (NVLN)

Lost 7.77% to close Wednesday's trading at $3.56.

News: No news

Recent event:

-- On March 15, 2018, the Company announced financial results for the fourth quarter and full year ended December 31, 2017, and provided an overview of recent business activities.

On a pro forma basis, net loss in the fourth quarter of 2017 shrunk to $3.3 million or $0.18 per share from $20.1 million or $1.50 per share for the same period in 2016. GAAP total net revenues from product sales of JUXTAPID and MYALEPT for the fourth quarter of 2017 were $38.9 million, up from $13.6 million in the year-ago quarter.

Near-term Catalysts:

-- The opinion of the European Medicines Agency's Committee for Medicinal Products for Human related to metreleptin (marketed as MYALEPT in the U.S.) is expected next quarter. -- The European Commission's approval decision on metreleptin is scheduled for mid-2018.

The Company is seeking approval of metreleptin as replacement therapy to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in a subset of patients with partial lipodystrophy (PL).

In the U.S., metreleptin, under brand name MYALEPT, is indicated to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. It was approved by the FDA in 2014.