TLRY On A High, GALT Gallops, MLNT On Watch, ALRN To Report Phase II Data In Q4

pharmaup aug20

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

1. Aileron Therapeutics Inc. (ALRN)

Aileron is a clinical-stage company developing stapled peptide therapeutics for cancers and other diseases.

Gained 30% to close Monday's (Aug.20) trading at $2.60.

News: No news


The Company's lead product candidate is ALRN-6924. Multiple clinical studies of ALRN-6924 are underway, including a Phase 1 All-comers trial in advanced solid tumors or lymphomas, a Phase 2a trial in peripheral T-cell lymphoma (PTCL), a Phase 1 trial in acute myeloid leukemia (AML) and advanced myelodysplastic syndrome (MDS) as a monotherapy, and a Phase 1b trial in AML/MDS in combination with cytosine arabinoside (Ara-C).

Near-term Catalysts:

-- Additional interim data from the Phase 2a trial of ALRN-6924 for the treatment of patients with peripheral T-cell lymphoma are expected to be reported in the fourth quarter of 2018.
-- Interim data from Phase 1 and 1b open-label, multi-center clinical trials of ALRN-6924 as a monotherapy and in combination with cytosine arabinoside (Ara-C) for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are expected in the fourth quarter of this year.
-- John Longenecker was named interim Chief Executive Officer on May 15, 2018. Aileron is actively engaged in a process to appoint a new CEO.

2. Tilray Inc. (TLRY)

Tilray is a company involved in cannabis research, cultivation, processing and distribution.

Gained 16.98% to close Monday's trading at $35.90.

News: Tilray Canada Ltd., a wholly owned subsidiary of Tilray, has signed an agreement with the Ontario Cannabis Retail Corp. to supply the province of Ontario with a variety of adult-use cannabis brands and products.

The brands that will be offered include, Marley Natural, Irisa and CANACA, each of which are expected to be made available in Ontario through online sales starting October 17, 2018, the anticipated date of launch for adult-use cannabis products in Ontario.

3. Chiasma Inc. (CHMA)

Gained 15% to close Monday's trading at $2.30.

Chiasma is a clinical-stage biopharmaceutical company developing drugs for rare and serious chronic diseases.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead drug candidate is MYCAPSSA (octreotide capsules), being developed as a maintenance treatment for adult patients with acromegaly.

A phase III trial of octreotide capsules in adult acromegaly patients (at least 20% of whom must be recruited from the United States) whose disease is biochemically controlled, dubbed CHIASMA OPTIMAL, is ongoing. Chiasma expects the trial to complete randomization by the end of 2018, and anticipates the release of top-line data from this phase III clinical trial in Q4 2019.

Another trial known as MPOWERED, which is an international phase III clinical trial under a protocol accepted by the European Medicines Agency evaluating octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly, is also ongoing. The trial is scheduled to be completed in Q4 2019, with top-line data expected to be released by early 2020.

4. Galectin Therapeutics Inc. (GALT)

Galectin is a development stage biotech company, focused on developing treatments where the galectin-3 protein is implicated in disease.

Gained 14.99% to close Monday's trading at $4.45.

News: No news


The lead drug candidate is GR-MD-02 in NASH cirrhosis.

Clinical Trials & Near-term Catalysts:

The Company is proceeding with plans for a phase III trial GR-MD-02 in NASH Cirrhosis. Details of the Phase 3 clinical trial design, including projected timings and costs, will be announced once the planning phase has been completed and the Company has submitted a final clinical trial protocol with the FDA.

5. Melinta Therapeutics Inc. (MLNT)

Melinta is a commercial-stage pharmaceutical company dealing with various anti-infectives for the treatment of bacterial infectious diseases in North America. The Company began trading on the NASDAQ on November 6, 2017, following its reverse merger with Cempra Inc.

Gained 14.46% to close Monday's trading at $4.75.

News: No news

Near-term Catalysts:

-- Pivotal phase III data for Baxdela in community acquired bacterial pneumonia (CABP) expected this year. Baxdela is already approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
-- Vabomere EMA regulatory approval decision is expected in 2018. The drug was approved by the FDA last August for adults with complicated urinary tract infections (cUTI).
-- Additional ex-U.S. submissions for Baxdela in Central and South America are also planned for this year.

6. Cerecor Inc. (CERC)

Gained 14.32% to close Monday's trading at $4.47.

News: No news

Recent event:

On August 1, the Company enrolled the first patient in a phase I study of its proprietary drug candidate CERC-301 in patients with neurogenic Orthostatic Hypotension (nOH) associated with Parkinson's disease. Data from this trial is expected during the first half of 2019.

7. KalVista Pharmaceuticals Inc. (KALV)

KalVista is a clinical-stage company developing drugs for hereditary angioedema, diabetic macular edema, and other plasma kallikrein-associated diseases.

Gained 13.72% to close Monday's trading at $14.84.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's most advanced program is KVD001, an intravitreally administered plasma kallikrein inhibitor, under phase II trial in patients with diabetic macular edema, with data expected to be reported in the second half of 2019.

A phase II trial of KVD900 as an on-demand treatment for acute Hereditary Angioedema attacks is expected to be initiated in late 2018, with completion anticipated in mid-2019.

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