Premarket Biotech Digest – ANTM May Increase Premium, IPXL Receives FDA Approval, ZTS Receives EC Nod

Top Pick of the Day: MNOV

MediciNova Inc. (MNOV) announced that it has received positive preliminary results from a six-month open-label extension period evaluating MN-166 (ibudilast) in patients with amyotrophic lateral sclerosis. ALS patients who completed both the six-month treatment period in the Phase 2 clinical trial and the six-month open-label extension period (n=31) experienced significantly higher survival rates compared to patients who withdrew from the study before the open-label period (n=16). 26 ALS patients who completed the entire study period and then were evaluated after two weeks with no ibudilast treatment showed significant decreases in muscle strength (hip, leg and neck flexion).

The company stock reacted positively to the news and gained 8 percent in the previous trading session, trimming its 12 months losses to a little over 27 percent.

Focus Ticker: ALNY

Alnylam Pharmaceuticals Inc. (ALNY) reported results from its 24-month Phase 2 open-label extension study ofpatisiran in patients with hATTR amyloidosis. The results showed a treatment benefit. 26 participants who received patisiran experienced a mean decrease in the modified neuropathy impairment score (mNIS+7) at month 24, suggesting that patisiran treatment has the potential to stop or improve the progression of neuropathy in these patients.
Alnylam Pharmaceuticals stock lost nearly a quarter of its value in the past 12 months. However, it showed recovery in the current year as the stock is now trading 44 percent up on Year to Date basis.

Sector News

Anthem (ANTM) said that its premium may increase by 20 percent or more pursuant to the loss of federal subsidies supporting Obamacare plans. The company said that it may also pull back from the business.

AstraZeneca (AZN) announced that the top line results from its Phase 3 clinical trial, ARCTIC, assessing durvalumab (MEDI4736) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) arenow likely to be announced in mid-November. The company earlier expected the results to be out in the second quarter of the year. The delay is due to the number of observed clinical events not yet reaching the protocol target.

Approvals

Impax Laboratories (IPXL) announced receiving the FDA approval for its its generic version of cholesterol drug Vytorin (ezetimibe/simvastatin). Vytorin has been developed by Merck. This is the first generic version to be commercially available in the U.S. Merck sold over $1.1 billion worth of Vytorin in 2016.
Zoetis (ZTS) announced receiving approval of its Cytopoint (lokivetmab) from the European Commission for veterinary use to treat atopic dermatitis in dogs weighing at least three pounds. It is the first monoclonal antibody approved in the EU for this indication.

Deals and Collaborations

United Therapeutics (UTHR) announced its new collaboration with 3D Systems (DDD). The deal involves working on printing the outline of human organs. The companies also plan to progress towards creating parts using a person’s own cells. The collaboration is likely to take place in a new 3D Systems bioprinting lab in San Diego.

Flex Pharma (FLKS) announced that the FDA has approved its nvestigational New Drug application related to FLX-787.The company plans to  submit a protocol for a mid-stage study in Charcot-Marie-Tooth, a group of inherited neuropathies. It also plans to  initiate a U.S. Phase 2 clinical trial in patients with amyotrophic lateral sclerosis (ALS) this summer.

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