Moving Target: ONXX after Advisory Committee vote Print E-mail
By Staff and Wire Reports   
Friday, 22 June 2012 02:45
icon_newsnotesWe told our readers on Monday that ONXX would be a great stock to accumulate despite the fact that there were so many shorts were focused on Kyprolis (carfilzomib), which is due for a review by ODAC (the FDA’s Oncologic Drugs Advisory Committee) on June 20th.  Shares of ONXX gapped up from $44.45 to close at $63.78 on Thursday.
As we saw a couple of days after our report, the Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11-0 [with 1 abstention] that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis™ (proposed brand name for carfilzomib). Onyx is committed to bringing Kyprolis to patients as quickly as possible and the FDA will complete its review.

The Kyprolis NDA is based on the 003-A1 study, an open-label, single-arm Phase 2b trial as well as supportive data from additional studies. The 003-A1 trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.

Supporting the company’s prospects is a strong balance sheet, which is nearly debt free and contains $685 million worth of current assets (of $133 million is held as cash or cash equivalents). In the first quarter of 2012, the company reported a net loss of $56,212 after huge increases in the R&D budget. This implies at least two years of smooth operation (without the sale of any non-cash assets),  which is helped significantly by significant and increasing revenue from Nexavar (sorafenib).

Analysts who cover the stock are starting to adjust coverage of the stock. Remember that many of these analysts have direct contact and relationships with members of the management team at ONXX when you do your Due Diligence and try to read their notes carefully. Below are the latest upgrades and target price adjustments, note that today's prices are already past most of the analysts' targets. At this point it appears that the $73 - $75 targets may be in play, but there are no assurances that the stock will ever reach those prices given the current fears in the overall market. In fact, this could turn into a "sell on news" following the pending approval. In short, don't chase this trade if you missed it. If you made money, it may be time to take profits and watch the dust settle.

Onyx Pharma is banking on the approval of Kyprolis as currently it has only one marketed product, Nexavar, in its portfolio. That drug is marketed worldwide by Onyx Pharma's parter, Bayer, as a treatment for unresectable liver cancer and advanced kidney cancer. Bayer is looking to expand Nexavar’s label with the hope that they can boost the sales potential of Nexavar.
  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) was upgraded by analysts at Brean Murray Carret & Co. from a "hold" rating to a "buy" rating. They now have a $60.00 price target on the stock.
  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) was upgraded by analysts at Brean Murray from a "hold" rating to a "buy" rating. They now have a $60.00 price target on the stock.
  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) was upgraded by analysts at Robert W. Baird from a "neutral" rating to an "outperform" rating.
  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) was upgraded by analysts at Cowen from a "neutral" rating to an "outperform" rating.
  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) was upgraded by analysts at Morgan Stanley from an "underweight" rating to an "equal weight" rating. They now have a $39.00 price target on the stock.

"Today's ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review."

The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.

The Kyprolis NDA is based on the 003-A1 study, an open-label, single-arm Phase 2b trial as well as supportive data from additional studies. The 003-A1 trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.

Source: PR Newswire (http://s.tt/1fgHJ)

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11-0 [with 1 abstention] that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis™ (proposed brand name for carfilzomib). Onyx is developing Kyprolis for use in multiple myeloma across a variety of treatment lines.   

"Today's ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review."

The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.

Source: PR Newswire (http://s.tt/1fgHJ)

  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) had its price target raised by analysts at Rodman & Renshaw from $57.00 to $73.00. They now have an "outperform" rating on the stock.
  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) had its price target raised by analysts at Maxim Group to $75.00.
  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) had its price target raised by analysts at JPMorgan Chase to $66.00.
  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) had its price target raised by analysts at Jefferies Group to $55.00.
  • Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) had its price target raised by analysts at Bank of America to $62.00.
The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.





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