Gamida Cell Ltd GMDA will provide updates on its pipeline when it releases second-quarter 2020 results.
The company flaunts a mixed earnings surprise history, surpassing expectations in two of the trailing four quarters, while missing in the other two. The four-quarter earnings surprise was 6.68%, on average. In the last reported quarter, the company delivered an earnings surprise of 27.91%.
Shares of Gamida Cell have gained 4.9% in the year so far compared with the industry’s growth of 9.8%.
Let’s see how things are shaping up for this announcement.
Factors to Consider
Gamida Cell does not have any marketed product and so the focus will be on its pipeline candidates during the second-quarter conference call
The company’s most advanced pipeline candidate is omidubicel, which is an advanced cell therapy candidate currently in phase III studyin patients with high-risk hematological malignancies in need of a bone marrow transplant. The company, in May 2020, announced positive top-line data from the study. The study achieved its primary endpoint with a high degree of statistical significance. The company expects to report full phase III data, including secondary endpoints, in the second half of 2020. Further, the company expects to submit a biologics license application (BLA) for omidubicel on a rolling basis in the fourth quarter of 2020 and launch the candidatein the second half of 2021. We expect the company to provide updates on the filing timeline in the second quarter.
The company also has a second cell therapy candidate, GDA-201, in its pipeline, which is being evaluated to treatpatients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) in a phase I study. The company expects to report additional data from the phase I study of GDA-201in the second half of 2020.
Based on the data from the ongoing phase I study of GDA-201 previously presented in February 2020, Gamida Cell expects to submit an investigational new drug application to the FDA in the fourth quarter of 2020 to enable the initiation of a phase I/II study in patients with NHL in 2021.
In the first-quarter conference call, the company had mentioned that due to the COVID-19 impact, new patient enrollment in the ongoing clinical study of GDA-201 hadslowed.
The company had also said that COVID-19 will have limited overall impact on the timing of the regulatory submission for omidubicel.
An update is expected in the second-quarter conference call.
Pipeline development is likely to have led to increased research and development expenses in the second quarter.
What Our Model Indicates
Our proven model does not conclusively predict an earnings beat for Gamida Cell this season. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. But that is not the case here as you will see below.
Earnings ESP: GamidaCell has an Earnings ESP of 0.0%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: The company carries a Zacks Rank #3.
Stocks to Consider
Here are some biotech stocks with the right mix of elements to beat on earnings this time around:
Alkermes Plc. ALKS has an Earnings ESP of +362.51% and a Zacks Rank #3. The company is scheduled to release second-quarter 2020 results on Jul 29. You can see the complete list of today’s Zacks #1 Rank stocks here
Agenus Inc. AGEN has an Earnings ESP of +15.85% and a Zacks Rank #2.
ACADIA Pharmaceuticals, Inc. ACAD has an Earnings ESP of +8.12% and a Zacks Rank of 3. The company is scheduled to release second quarter 2020 results on Aug 5.
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