Johnson & Johnson JNJ announced that it had submitted a supplemental Biologics License Application (“sBLA”) to the FDA. J&J seeks approval for Rybrevant, combined with chemotherapy (carboplatin-pemetrexed), as initial treatment for patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with EGFR exon 20 insertion mutations.
The sBLA is based on positive top-line data from the phase III PAPILLON study, which evaluated Rybrevant plus chemotherapy in patients with newly diagnosed advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
The PAPILLON study met its primary endpoint of progression-free survival (“PFS”). Data from the study showed that patients who received Rybrevant plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS compared with those who were treated with chemotherapy alone.
Currently, Rybrevant is approved in the United States for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The sBLA is also intended to satisfy regulatory requirements for this accelerated approval.
Shares of J&J have lost 5.9% year to date against the industry’s 7.6% growth.
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The sBLA will be being reviewed by the FDA through the Real-Time Oncology Review (“RTOR”) program. The filings reviewed under the RTOR program are subjected to a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, with the FDA engaging in early iterative communication with the applicant.
Apart from the PAPILLON study, J&J is also evaluating Rybrevant across multiple NSCLC indications in various stages of clinical development. These include two phase III studies on combination therapies with Rybrevant in patients as first-line and second-line treatments for locally advanced or metastatic NSCLC with EGFR exon 19 deletions (ex19del) or L858R substitution mutations.
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Zacks Rank & Other Stocks to Consider
J&J currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include AN2 Therapeutics ANTX, ANI Pharmaceuticals ANIP and Annovis Bio ANVS, each carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for AN2 Therapeutics’ 2023 loss per share have narrowed from $3.56 to $3.36. During the same period, the earnings per share estimates for 2024 have improved from $3.73 to $3.45. Year to date, shares of ANTX have surged 56.6%.
Earnings of AN2 Therapeutics beat estimates in two of the last four quarters while missing the mark on one occasion and meeting the mark on another. On average, the company witnessed a negative earnings surprise of 2.08%. In the last reported quarter, AN2’s earnings beat estimates by 4.71%.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2023 earnings per share have risen from $3.39 to $3.73. During the same period, the earnings estimates per share for 2024 have improved from $4.12 to $4.35. Year to date, shares of ANIP have surged 58.6%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters, witnessing an earnings surprise of 91.56% on average. In the last reported quarter, ANI Pharmaceuticals’ earnings beat estimates by 100.00%.
In the past 30 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of ANVS have lost 6.2%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
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