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Lilly, Teva, Pfizer & Others Await FDA Decisions in September


Like 2017, 2018 is turning out to be a pretty good one for pharma and biotech stocks as far as FDA decisions are concerned. The regulatory body approved 34 novel drugs till August. Last year, the FDA had given nod to 31 new drugs till August and approved 46 drugs in the full year.

We remind investors that last year the FDA approved the highest number of drugs in over a decade. Looking at the trend this year so far, it appears that the number will increase further. With President Trump saying that the FDA will be streamlined and the drug approval process expedited, innovation has picked up pace in the sector, thus increasing the possibility of approvals.

Landmark decisions this year so far include J&J’s JNJ Erleada (apalutamide) for pre-metastatic prostate cancer; Vertex Pharmaceuticals Incorporated’s VRTX third medicine to treat the underlying cause of cystic fibrosis (CF), Symdeko; Amgen AMGN & Novartis’ NVS calcitonin gene-related peptide (CGRP) migraine treatment, Aimovig; AbbVie’s ABBV Orilissa for pain associated with endometriosis and BioMarin Pharmaceuticals’ Palynziq to treat phenylketonuria (PKU).

The drug development process is lengthy and requires a lot of funds and resources. Consequently, pipeline events including data readouts and regulatory updates are of paramount importance and could act as major catalysts. Let’s take a look at a few important regulatory events scheduled for the month of September.

FDA Decision on Lilly & Teva’s Migraine Treatments: The FDA is expected to give its decision on Eli Lilly LLY and Teva’s TEVA CGRP antibodies for migraine prevention, Emgality (galcanezumab) and fremanezumab, respectively. While a decision on fremanezumab is expected on Sep16, the same on Emgality is expected later this month. Amgen’s CGRP antibody, Aimovig/erenumab was approved and launched in the United States in the second quarter of 2018 and will pose competition for Emgality and Fremanezumab, if approved.

We remind investors that in May, the FDA postponed the action date for fremazumab from June to September. In 2018, Teva’s manufacturing partner for fremanezumab, Celltrion, which makes the active pharmaceutical ingredient (API), received a warning letter from the FDA, which delayed approval of the candidate.

Lilly is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

FDA Decision on Pfizer’s Lung Cancer Drug: Later this month, the FDA is expected to give its decision on Pfizer’s regulatory application for dacomitinib. Pfizer is looking to get dacomitinib approved for the first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR activating mutations. Dacomitinib is one of the four oncology medicines of Pfizer under FDA’s priority review. Decisions on all four expected this month.

New Indication for Glaxo’s Nucala: On Sep 7, the FDA is expected to give its decision on Glaxo’s supplemental biologics license application (sBLA) for label expansion of its asthma drug Nucala for a new indication – eosinophilic chronic obstructive pulmonary disease (COPD). In July, however, an FDA advisory committee voted against recommending approval of Nucala for COPD. The committee recommended that the risk-benefit profile of Nucala, demonstrated in studies, was not adequate to support its approval.

Nucala is already approved for the treatment of severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). It is being evaluated in late-stage studies for nasal polyps.

Antares Pharma’s Xyosted and Insmed’s ALIS Await FDA Nod: The FDA will give its decision on Antares Pharma’s Xyosted injection, which has been developed to treat adult men with testosterone deficiency, on Sep 29. Antares Pharma had received a complete response letter for Xyosted in October last year. The CRL addressed FDA’s concerns that Xyosted could cause a clinically meaningful increase in blood pressure and could also result in depression and suicidality. However, Antares Pharma was not required to conduct any new clinical studies to support the resubmission in April 2018.

On Sep 28, the FDA will give its decision on Insmed Incorporated’s NDA for ALIS (Amikacin Liposome Inhalation Suspension) inhaled therapy developed to treat a serious lung infection – nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).


Some key FDA decisions expected in the remaining three months of the year include Regeneron Pharmaceuticals/Sanofi’s cemiplimab for cutaneous squamous cell carcinoma; Acorda Therapeutics’ Inbrija for treating OFF periods in patients with Parkinson’s disease (PD) and Jazz Pharmaceuticals’ solriamfetol for excessive sleepiness in narcolepsy & obstructive sleep apnea among others. Hence, investors are expected to keep a close watch on the FDA’s actions through the rest of this year

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