On March 8, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the fourth quarter and year ended December 31, 2015 (Filing, Q4/Annual, Dynavax Technologies, 2015, MAR 8, 2016, View Source [SID:1234509418]).

The Company had $196.1 million in cash, cash equivalents and marketable securities as of December 31, 2015.
Total revenues for the year ended December 31, 2015, decreased by $7.0 million or 63 percent compared to the same period in 2014, primarily due to a $5.2 million decrease in collaboration revenue due to winding down of work performed for the AZD1419 program and expiration of our collaboration agreement with GSK in 2014.
Operating expenses increased by $6.8 million or seven percent during 2015 compared to 2014, primarily due to costs related to HBV-23, the Phase 3 clinical study of HEPLISAV-B completed in October 2015, preparation for the commercial launch of HEPLISAV-B in the United States and clinical trial expense for SD-101, Dynavax’s cancer immunotherapeutic product candidate.

The net loss allocable to common stockholders for the year ended December 31, 2015 was $106.8 million, or $3.25 per share, compared to $90.7 million, or $3.45 per share for the year ended December 31, 2014.

"During 2015, we completed HBV-23 and significantly strengthened the Company’s cash position. Earlier this year we reported that this third pivotal study had met both co-primary endpoints. We plan to resubmit the HEPLISAV-B BLA (Biologics License Application) to the FDA by the end of this month. Based on our expectation of a six-month review, if our application is approved we expect to launch this product in the fourth quarter of this year," said Eddie Gray, chief executive officer of Dynavax.

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On March 8, 2016 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported financial results for the fourth quarter and year ended December 31, 2015(Press release, Rigel, MAR 8, 2016, View Source;p=RssLanding&cat=news&id=2146948 [SID:1234509426]).

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"Fostamatinib is our top priority for 2016 with the first results of our Phase 3 studies in immune thrombocytopenic purpura anticipated in the middle of the year," said Raul Rodriguez, president and chief executive officer of Rigel. "Also this year, we expect the readouts of the two other fostamatinib clinical programs, the Phase 2 in IgA nephropathy and the recently announced Phase 2 proof-of-concept study in autoimmune hemolytic anemia," he added.

For the fourth quarter of 2015, Rigel reported a net loss of $12.7 million, or $0.14 per share, compared to a net loss of $22.3 million, or $0.25 per share, in the fourth quarter of 2014. Weighted average shares outstanding for the fourth quarters of 2015 and 2014 were 89.0 million and 87.8 million, respectively.

Contract revenues from collaborations of $8.5 million in the fourth quarter of 2015 were primarily comprised of the amortization of the $30.0 million upfront payment from Bristol-Myers Squibb (BMS), as well as a license fee from a third party pursuant to a license agreement executed in October 2015. Contract revenues from collaborations of $8.3 million in the fourth quarter of 2014 were comprised of non-refundable payments from AstraZeneca AB (AZ) as a result of its continued development of R256 in asthma.

Rigel reported total costs and expenses of $21.3 million in the fourth quarter of 2015, compared to $30.6 million in the fourth quarter of 2014. Costs and expenses in the fourth quarter of 2014 included a loss on executing a sublease, as well as stock-based compensation expense and severance costs related to the retirement of Rigel’s former chief executive officer.

For the year ended December 31, 2015, Rigel reported contract revenues from collaborations of $28.9 million and a net loss of $51.5 million, or $0.58 per basic and diluted share, compared to contract revenues from collaborations of $8.3 million and a net loss of $90.9 million, or $1.04 per basic and diluted share, in 2014. Contract revenues from collaborations in 2015 were mainly comprised of $16.6 million from the amortization of the $30.0 million upfront payment from BMS and upfront payments received from other collaborators. Contract revenues from collaborations in 2014 were comprised of non-refundable payments from AZ as a result of its continued development of R256 in asthma.

As of December 31, 2015, Rigel had cash, cash equivalents and short-term investments of $126.3 million, compared to $143.2 million as of December 31, 2014. Rigel expects this amount to be sufficient to fund operations into the third quarter of 2017.

On March 08, 2016 XBiotech Inc. (NASDAQ:XBIT) reported that the Company has now submitted its Marketing Authorization Application (MAA) for its candidate therapy (Xilonix) for advanced colorectal cancer to the European Medicines Agency (EMA) (Press release, XBiotech, MAR 8, 2016, View Source [SID1234556367]). Submission of the MAA for Xilonix is necessary for the Company to gain approval to sell the drug in European Union member nations. The Company, which only recently was granted eligibility to submit its MAA through the Centralised Procedure, has made a remarkably quick turnaround for delivery of the extensive MAA documentation needed for the EMA review.

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John Simard, CEO of XBiotech, commented, "With submission of the Marketing Authorization Application, we now look forward to the review process."

Few agents are reliably able to mediate durable responses in metastatic disease. And many agents have significant trade-offs in terms of side effects. In patients with advanced disease, often weakened from successive rounds of cytotoxic therapy, the risk-benefit associated with further therapy is often questionable. Based on novel objective response (OR) criteria, developed by XBiotech in conjunction with the EMA’s Scientific Advice Working Group, the candidate therapy subject of the MAA was recently evaluated in a Phase III clinical study for the ability to control disease-related symptoms that inversely correlate with survival. The Company believes using the symptom-based objective response criteria will allow better assessment of overall benefit from therapy in advanced cancer patients.

On March 8, 2016 Genmab A/S (Nasdaq Copenhagen: GEN) reported an update on development plans for ofatumumab in autoimmune indications focusing on relapsing multiple sclerosis following the transfer of the rights to ofatumumab in this disease area from GlaxoSmithKline (GSK) to Novartis at the end of 2015 (Press release, Genmab, MAR 8, 2016, View Source [SID:1234509401]). Phase III studies are expected to be initiated by Novartis with the subcutaneous formulation of ofatumumab as therapy for patients with relapsing multiple sclerosis during the second half of 2016.

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The Phase III study of the subcutaneous formulation of ofatumumab in pemphigus vulgaris, which was started by GSK will be discontinued to focus on relapsing multiple sclerosis. The decision to discontinue the trial was not related to any safety or tolerability concerns. There are no current plans to develop ofatumumab in neuromyelitis optica.

"We are very pleased with Novartis’ commitment to move the development of ofatumumab forward in multiple sclerosis and look forward to the initiation of the Phase III studies in the second half of this year," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. Arzerra is also approved in the U.S. as extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).

The subcutaneous formulation of ofatumumab is also being investigated by Novartis in multiple sclerosis. The use of ofatumumab in multiple sclerosis is investigational and is not currently approved in any market.

Arzerra is marketed under a collaboration agreement between Genmab and Novartis.

On March 8, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the fourth quarter and year ended December 31, 2015 (Press release, Dynavax Technologies, MAR 8, 2016, View Source [SID:1234509405]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Company had $196.1 million in cash, cash equivalents and marketable securities as of December 31, 2015.

Total revenues for the year ended December 31, 2015, decreased by $7.0 million or 63 percent compared to the same period in 2014, primarily due to a $5.2 million decrease in collaboration revenue due to winding down of work performed for the AZD1419 program and expiration of our collaboration agreement with GSK in 2014.

Operating expenses increased by $6.8 million or seven percent during 2015 compared to 2014, primarily due to costs related to HBV-23, the Phase 3 clinical study of HEPLISAV-B completed in October 2015, preparation for the commercial launch of HEPLISAV-B in the United States and clinical trial expense for SD-101, Dynavax’s cancer immunotherapeutic product candidate.

The net loss allocable to common stockholders for the year ended December 31, 2015 was $106.8 million, or $3.25 per share, compared to $90.7 million, or $3.45 per share for the year ended December 31, 2014.

"During 2015, we completed HBV-23 and significantly strengthened the Company’s cash position. Earlier this year we reported that this third pivotal study had met both co-primary endpoints. We plan to resubmit the HEPLISAV-B BLA (Biologics License Application) to the FDA by the end of this month. Based on our expectation of a six-month review, if our application is approved we expect to launch this product in the fourth quarter of this year," said Eddie Gray, chief executive officer of Dynavax.