KZIA Up 68% In 5 Days, APLS Bouncing Back, AKAO Clears A Hurdle, MDGL Abuzz

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

1. Kazia Therapeutics Limited (KZIA)

Gained 26.44% to close Tuesday's (Jan.30) trading at $5.69.

News: No news

Clinical Trials & Near-term Catalysts:

The lead program of Kazia, formerly known as Novogen, is GDC-0084, which is being developed to treat glioblastoma multiforme, the most common and most aggressive form of primary brain cancer. Licensed from Genentech in late 2016, GDC-0084 entered a phase II clinical trial December 2017. Initial data is expected in late calendar 2018 and the study is expected to complete in 2021.

Also in the pipeline is TRX-E-002-1 for ovarian cancer, currently undergoing a phase I clinical trial in Australia and the United States. Initial data is expected in the first half of calendar 2018.

2. Immuron Limited (IMRN)

Gained 18.77% to close Tuesday's trading at $8.29.

News: A recent study on the immuno-reactivity of the Company's commercially available and over-the-counter gastrointestinal and digestive health supplement Travelan has demonstrated that the drug is reactive to all 180 strains of bacteria including Camylobacter and Shigella.

To know more about IMRN, please visit our Company Spotlight column.

3. AzurRx BioPharma Inc. (AZRX)

Gained 13.73% to close Tuesday's trading at $3.48.

News: Equities research analysts at SeeThruEquity have initiated coverage on AzurRx BioPharma with a 12-month price target of $10.00.

Pipeline:

The Company's current product pipeline consists of two therapeutic proteins under development - MS1819 for exocrine pancreatic insufficiency associated with chronic pancreatitis, and for exocrine pancreatic insufficiency associated with cystic fibrosis, and AZ1101, for the prevention of hospital-acquired infections and antibiotic-associated diarrhea, under pre-clinical testing. A phase II study of MS1819 for exocrine pancreatic insufficiency associated with chronic pancreatitis is underway in Australia.

Near-term Catalysts:

-- Proof of concept data for AZX1101 is expected in Q1, 2018. -- Enrollment in phase II study of MS1819 for exocrine pancreatic insufficiency associated with chronic pancreatitis is expected to be completed in the first half of 2018. -- Initiation of phase II study of MS1819 for exocrine pancreatic insufficiency associated with cystic fibrosis is planned for mid 2018. -- Submit IND/CTA for MS1819 in the second half of 2018. -- Final results of phase II study of MS1819 for exocrine pancreatic insufficiency associated with chronic pancreatitis expected in the second half of 2018. -- Initial results from phase II study of MS1819 for exocrine pancreatic insufficiency associated with cystic fibrosis are expected in Q4, 2018.

4. Madrigal Pharmaceuticals Inc. (MDGL)

Gained 10.78% to close Tuesday's trading at $139.85.

News: The Company will be presenting 12-week results from an ongoing MGL-3196 Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis (NASH) on April 13, 2018 during a main plenary session at the Annual Meeting of the European Association for the Study of the Liver (EASL).

The 12-week results were reported on December 6, 2017, which sent the stock soaring over 118% that day.

Near-term Catalysts:

-- The 36 weeks results from the phase II NASH trial of MGL-3196 are expected in the second quarter of 2018. -- Top-line results from the phase II study of MGL-3196 in heterozygous familial hypercholesterolemia (HeFH) are expected in early 2018.

5. Apellis Pharmaceuticals Inc. (APLS)

Gained 10.46% to close Tuesday's trading at $18.27.

News: No news

Recent event:

The Company debuted on the NASDAQ Global Select Market on November 9, 2017, offering its shares at a price of $14.00 each.

Clinical Trials & Near-term Catalysts:

-- APL-2 has been successfully studied in a phase II clinical trial (FILLY) in patients with geographic atrophy associated with age-related macular degeneration. -- APL-2 is also under two phase Ib trials in paroxysmal nocturnal hemoglobinuria - one as monotherapy and the other as add-on to Soliris. -- A phase III program of APL-2 for the treatment of patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD) is planned to begin in the second half of 2018.

6. Achaogen Inc. (AKAO)

Gained 10.04% to close Tuesday's trading at $12.17.

News: The FDA has amended the compliance status of Pfizer CentreOne's manufacturing site in McPherson, Kansas, which is involved in manufacturing Achaogen's drug candidate Plazomicin, to "Voluntary Action Indicated" (VAI).

The McPherson site was issued a warning letter last February. The upgraded VAI designation received by Pfizer's McPherson facility is a positive outcome, according to Blake Wise, Achaogen's Chief Executive Officer.

Achaogen's New Drug Application for Plazomicin is currently under FDA review, with a decision expected on June 25, 2018.

7. Novelion Therapeutics Inc. (NVLN)

Gained 8.08% to close Tuesday's trading at $4.95.

News: The Court has sentenced Aegerion Pharmaceuticals, an indirect subsidiary of Novelion, but has decided not to impose a criminal fine.

The sentence is part of a settlement of the ongoing investigations into Aegerion's sales activities and disclosures related to JUXTAPID capsules, an adjunct therapy to treat homozygous familial hypercholesterolemia (HoFH).

A restitution fund in the amount of $7.2 million will be established, which includes administration costs, to be paid to the SEC in installments over three years.

Aegerion's global settlement consists of a series of agreements, including the criminal plea agreement, which, if all of the agreements are finally approved, would result in an approximately $40.1 million aggregate penalty to be paid over three years, including the restitution fund.

8. Atara Biotherapeutics Inc. (ATRA)

Gained 8.05% to close Tuesday's trading at $40.25.

News: No news

Clinical Trials & Near-term Catalysts:

Two phase III trials for Tab-cel intended to support approval in the treatment of rituximab-refractory Epstein-Barr Virus-Associated Post Transplant Lymphoproliferative Disorder (EBV-PTLD) after hematopoietic cell transplant (HCT), dubbed MATCH, or solid organ transplant (SOT), dubbed ALLELE, are underway.

Open first U.S. sites for ongoing phase I allogeneic ATA188 study in patients with progressive multiple sclerosis in the first half of 2018.

Initiate phase 1/2 study of Tab-cel in combination with Merck's KEYTRUDA for treatment of nasopharyngeal carcinoma in the second half of 2018.

9. Geron Corp. (GERN)

Gained 7.66% to close Tuesday's trading at $2.53.

News: No news

Pipeline:

The Company's lead drug candidate is Imetelstat, which is being developed for the potential treatment of hematologic myeloid malignancies.

A phase 2/3 clinical trial of Imetelstat, dubbed IMerge, in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent, is underway.